Jennifer Lubell

The gluten-free section in the grocery store didn’t exist when Renee Euler, MS, RD, LD, was diagnosed with celiac disease 30 years ago. A physician handed her a fax about the gluten-free diet from a national support group and said: “Here, read this.”

There was no Google to inform decisions. Patients had to rely on fact sheets or a book from the library.

Courtesy Erin Smith

Q: What fears did you have to push past to get to where you are in your career?

Ms. Euler: Leaving a successful career as a landscape architect and going back to school was definitely a huge hurdle. When I started my practice in 2017, in my area there were no outpatient GI dietitians providing specialized care for adults with conditions like celiac disease, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). I was starting out with no real support.

Realizing that I was going to start a private practice of my own to help the people I wanted to help, was another big fear. “Am I going to succeed? Am I going to fail? What’s going to happen?” But over the years, my practice has grown as I learned to bill insurance and started receiving referrals from a large local GI practice, both of which have been the keys to my success. I have also limited my practice to GI clients so that I can focus my attention on this specialized area of nutrition and stay up to date on the latest developments.
 

Q: What interests you about the intersection between diet and GI disorders?

Ms. Euler: It’s not just about diet. We’re learning so much about how the gut microbiome can have a potential impact [on other parts of our health]. It’s interesting in terms of how we respond to certain foods, for instance, could affect our mental health. This especially applies to IBS and how the microbiome might be connected to these conditions.

It’s very challenging. There is so much information out there that is not super accurate, or it’s misleading.
 

Q: You serve as a liaison between the American Gastroenterological Association and the Academy of Nutrition and Dietetics. As a nutritionist with a focus on GI, how do you work with gastroenterologists to manage GI disorders?

Ms. Euler: Some of the dietary therapies that GI doctors recommend don’t provide sufficient guidance. They hand out that two-page fact sheet about diet and send the patient on their way. A lot of these diets have more nuance than what can be expressed in a two-page handout.

Many times, the physician doesn’t know the nuance, or they don’t have time to go over it. That’s where we can really help.

Patients often want diet to be the answer. They want to be told: “You need to eat this and only this, and everything will be fine, and diet’s going to change your world, and you won’t have to take medication.”

What they often don’t realize and understand, is a lot of these dietary therapies are not black and white. Celiac disease means a gluten-free diet for life. But a lot of these dietary therapies that get thrown out to patients as a possibility, like low FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), are not lifetime diets. They’re tools for us to use to find out what the offending foods are for this person, and what can we do to get their symptoms under control.
 

Q: What is the biggest practice-related challenge in getting patients to alter their diet to improve their symptoms?

Ms. Euler: A lot of patients that come to me already have over restricted diets. They’re trying to solve things themselves. Rightfully so, a lot of them have a lot of food fears because they have been living with very uncomfortable symptoms for years, and they’re trying to find answers. Those food fears unfortunately are reinforced by social media and the news.

One of my biggest challenges with those clients is working through that process of building their confidence to broaden their diets and add foods back in, without causing their symptoms to flare up. The goal is to get them back on track to having a nutritious diet while trying to manage symptoms.
 

Q: Can you give me an anecdotal example of a case that wasn’t easy, and you ended up helping that person?

Ms. Euler: I had a patient who had been listening to all the wellness gurus. She was overrestricted to the point of eating just 10 different foods due to allergic and GI symptoms. Patients like this are definitely a challenge because you have to reorient them to the fact that what they’re doing isn’t necessarily working,

My initial assessments are 90 minutes long, so I have a lot of time to sit with a patient and hear their story and understand their background.

I suggested to the patient: “Why don’t we try adding these foods back in, but eliminating these other types of foods and see whether that would help?” 48 hours later, she sent me an email, telling me that she and her husband had talked this through, and they thought I hit the nail on the head: She was focusing on the wrong foods which were causing problems. Those are always great messages to get from patients, when they say: “Oh my gosh, I hadn’t even considered that.”
 

Q: Describe how you would spend a free Saturday afternoon.

Ms. Euler: They’re so rare – those free Saturday afternoons, but it would probably be a good book that would turn into a nap on the couch.

LIGHTNING ROUND

Do you prefer texting or talking?

Talking in person



What’s your favorite breakfast?

Greek yogurt with fiber, flax seeds, and berries



What’s your favorite junk food?

Ice cream



What’s your favorite fruit?

Garden grown strawberries



What’s your favorite holiday?

Thanksgiving



What’s your favorite type of music?

Jazz



If you weren’t a GI nutritionist, what would you be?

Probably a landscape architect.

The gluten-free section in the grocery store didn’t exist when Renee Euler, MS, RD, LD, was diagnosed with celiac disease 30 years ago. A physician handed her a fax about the gluten-free diet from a national support group and said: “Here, read this.”

There was no Google to inform decisions. Patients had to rely on fact sheets or a book from the library.

Courtesy Erin Smith

Q: What fears did you have to push past to get to where you are in your career?

Ms. Euler: Leaving a successful career as a landscape architect and going back to school was definitely a huge hurdle. When I started my practice in 2017, in my area there were no outpatient GI dietitians providing specialized care for adults with conditions like celiac disease, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). I was starting out with no real support.

Realizing that I was going to start a private practice of my own to help the people I wanted to help, was another big fear. “Am I going to succeed? Am I going to fail? What’s going to happen?” But over the years, my practice has grown as I learned to bill insurance and started receiving referrals from a large local GI practice, both of which have been the keys to my success. I have also limited my practice to GI clients so that I can focus my attention on this specialized area of nutrition and stay up to date on the latest developments.
 

Q: What interests you about the intersection between diet and GI disorders?

Ms. Euler: It’s not just about diet. We’re learning so much about how the gut microbiome can have a potential impact [on other parts of our health]. It’s interesting in terms of how we respond to certain foods, for instance, could affect our mental health. This especially applies to IBS and how the microbiome might be connected to these conditions.

It’s very challenging. There is so much information out there that is not super accurate, or it’s misleading.
 

Q: You serve as a liaison between the American Gastroenterological Association and the Academy of Nutrition and Dietetics. As a nutritionist with a focus on GI, how do you work with gastroenterologists to manage GI disorders?

Ms. Euler: Some of the dietary therapies that GI doctors recommend don’t provide sufficient guidance. They hand out that two-page fact sheet about diet and send the patient on their way. A lot of these diets have more nuance than what can be expressed in a two-page handout.

Many times, the physician doesn’t know the nuance, or they don’t have time to go over it. That’s where we can really help.

Patients often want diet to be the answer. They want to be told: “You need to eat this and only this, and everything will be fine, and diet’s going to change your world, and you won’t have to take medication.”

What they often don’t realize and understand, is a lot of these dietary therapies are not black and white. Celiac disease means a gluten-free diet for life. But a lot of these dietary therapies that get thrown out to patients as a possibility, like low FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), are not lifetime diets. They’re tools for us to use to find out what the offending foods are for this person, and what can we do to get their symptoms under control.
 

Q: What is the biggest practice-related challenge in getting patients to alter their diet to improve their symptoms?

Ms. Euler: A lot of patients that come to me already have over restricted diets. They’re trying to solve things themselves. Rightfully so, a lot of them have a lot of food fears because they have been living with very uncomfortable symptoms for years, and they’re trying to find answers. Those food fears unfortunately are reinforced by social media and the news.

One of my biggest challenges with those clients is working through that process of building their confidence to broaden their diets and add foods back in, without causing their symptoms to flare up. The goal is to get them back on track to having a nutritious diet while trying to manage symptoms.
 

Q: Can you give me an anecdotal example of a case that wasn’t easy, and you ended up helping that person?

Ms. Euler: I had a patient who had been listening to all the wellness gurus. She was overrestricted to the point of eating just 10 different foods due to allergic and GI symptoms. Patients like this are definitely a challenge because you have to reorient them to the fact that what they’re doing isn’t necessarily working,

My initial assessments are 90 minutes long, so I have a lot of time to sit with a patient and hear their story and understand their background.

I suggested to the patient: “Why don’t we try adding these foods back in, but eliminating these other types of foods and see whether that would help?” 48 hours later, she sent me an email, telling me that she and her husband had talked this through, and they thought I hit the nail on the head: She was focusing on the wrong foods which were causing problems. Those are always great messages to get from patients, when they say: “Oh my gosh, I hadn’t even considered that.”
 

Q: Describe how you would spend a free Saturday afternoon.

Ms. Euler: They’re so rare – those free Saturday afternoons, but it would probably be a good book that would turn into a nap on the couch.

LIGHTNING ROUND

Do you prefer texting or talking?

Talking in person



What’s your favorite breakfast?

Greek yogurt with fiber, flax seeds, and berries



What’s your favorite junk food?

Ice cream



What’s your favorite fruit?

Garden grown strawberries



What’s your favorite holiday?

Thanksgiving



What’s your favorite type of music?

Jazz



If you weren’t a GI nutritionist, what would you be?

Probably a landscape architect.

The gluten-free section in the grocery store didn’t exist when Renee Euler, MS, RD, LD, was diagnosed with celiac disease 30 years ago. A physician handed her a fax about the gluten-free diet from a national support group and said: “Here, read this.”

There was no Google to inform decisions. Patients had to rely on fact sheets or a book from the library.

Courtesy Erin Smith

Q: What fears did you have to push past to get to where you are in your career?

Ms. Euler: Leaving a successful career as a landscape architect and going back to school was definitely a huge hurdle. When I started my practice in 2017, in my area there were no outpatient GI dietitians providing specialized care for adults with conditions like celiac disease, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). I was starting out with no real support.

Realizing that I was going to start a private practice of my own to help the people I wanted to help, was another big fear. “Am I going to succeed? Am I going to fail? What’s going to happen?” But over the years, my practice has grown as I learned to bill insurance and started receiving referrals from a large local GI practice, both of which have been the keys to my success. I have also limited my practice to GI clients so that I can focus my attention on this specialized area of nutrition and stay up to date on the latest developments.
 

Q: What interests you about the intersection between diet and GI disorders?

Ms. Euler: It’s not just about diet. We’re learning so much about how the gut microbiome can have a potential impact [on other parts of our health]. It’s interesting in terms of how we respond to certain foods, for instance, could affect our mental health. This especially applies to IBS and how the microbiome might be connected to these conditions.

It’s very challenging. There is so much information out there that is not super accurate, or it’s misleading.
 

Q: You serve as a liaison between the American Gastroenterological Association and the Academy of Nutrition and Dietetics. As a nutritionist with a focus on GI, how do you work with gastroenterologists to manage GI disorders?

Ms. Euler: Some of the dietary therapies that GI doctors recommend don’t provide sufficient guidance. They hand out that two-page fact sheet about diet and send the patient on their way. A lot of these diets have more nuance than what can be expressed in a two-page handout.

Many times, the physician doesn’t know the nuance, or they don’t have time to go over it. That’s where we can really help.

Patients often want diet to be the answer. They want to be told: “You need to eat this and only this, and everything will be fine, and diet’s going to change your world, and you won’t have to take medication.”

What they often don’t realize and understand, is a lot of these dietary therapies are not black and white. Celiac disease means a gluten-free diet for life. But a lot of these dietary therapies that get thrown out to patients as a possibility, like low FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), are not lifetime diets. They’re tools for us to use to find out what the offending foods are for this person, and what can we do to get their symptoms under control.
 

Q: What is the biggest practice-related challenge in getting patients to alter their diet to improve their symptoms?

Ms. Euler: A lot of patients that come to me already have over restricted diets. They’re trying to solve things themselves. Rightfully so, a lot of them have a lot of food fears because they have been living with very uncomfortable symptoms for years, and they’re trying to find answers. Those food fears unfortunately are reinforced by social media and the news.

One of my biggest challenges with those clients is working through that process of building their confidence to broaden their diets and add foods back in, without causing their symptoms to flare up. The goal is to get them back on track to having a nutritious diet while trying to manage symptoms.
 

Q: Can you give me an anecdotal example of a case that wasn’t easy, and you ended up helping that person?

Ms. Euler: I had a patient who had been listening to all the wellness gurus. She was overrestricted to the point of eating just 10 different foods due to allergic and GI symptoms. Patients like this are definitely a challenge because you have to reorient them to the fact that what they’re doing isn’t necessarily working,

My initial assessments are 90 minutes long, so I have a lot of time to sit with a patient and hear their story and understand their background.

I suggested to the patient: “Why don’t we try adding these foods back in, but eliminating these other types of foods and see whether that would help?” 48 hours later, she sent me an email, telling me that she and her husband had talked this through, and they thought I hit the nail on the head: She was focusing on the wrong foods which were causing problems. Those are always great messages to get from patients, when they say: “Oh my gosh, I hadn’t even considered that.”
 

Q: Describe how you would spend a free Saturday afternoon.

Ms. Euler: They’re so rare – those free Saturday afternoons, but it would probably be a good book that would turn into a nap on the couch.

LIGHTNING ROUND

Do you prefer texting or talking?

Talking in person



What’s your favorite breakfast?

Greek yogurt with fiber, flax seeds, and berries



What’s your favorite junk food?

Ice cream



What’s your favorite fruit?

Garden grown strawberries



What’s your favorite holiday?

Thanksgiving



What’s your favorite type of music?

Jazz



If you weren’t a GI nutritionist, what would you be?

Probably a landscape architect.

Looking back on her career as a gastroenterologist, Mariam Naveed, MD, sees the gastroenterology fellowship program she created at AdventHealth in Orlando, Fla., as a pinnacle moment.

Her first faculty position as assistant program director for the gastroenterology fellowship program at the University of Iowa offered some inspiration. “I loved teaching and working with trainees and knew I always wanted to remain in this realm,” Dr. Naveed said.

When she moved to Orlando to join AdventHealth, she noticed there was no gastroenterology training program. “I was strictly in private practice. Though I love working with patients, I constantly felt like something was missing. When the opportunity to start a fellowship program came, I was highly motivated to bring it to fruition.”

The AdventHealth fellowship is almost done with its inaugural year.

“Starting a fellowship at a new institution is a very challenging yet incredibly rewarding experience,” she said. In this Q&A, she discusses her strategies for dealing with insurance companies and imposter syndrome, and why she looks to her father as her role model in medicine.
 

Q: Why did you choose GI?

Dr. Naveed: Gastroenterology is a rapidly evolving field which makes it incredibly fascinating. The initial draw was that I was always excited to learn about GI physiology and disease. I also was fortunate to train with amazing gastroenterologists during residency. I had great examples of strong and successful female GIs to look up to. Lastly, for the most part, gastroenterologists are all fairly laid back and have an interesting sense of humor.

Q: What gives you the most joy in your day-to-day practice?

Dr. Naveed: I love learning and teaching. As a program director, I am directly involved with fellows, residents, and students, but there are always additional enrichment opportunities beyond these interactions. I value teaching clinic medical assistants so they feel more confident and empowered in their work. I also try to educate my nurse practitioners. The best compliment at the end of a long day is that they learned something valuable.

Q: How do you stay current with advances in your field?

Dr. Naveed: Between my role as a physician and as an educator, I owe it to my patients and trainees to stay current with advances in the field. But of course, this is challenging, and at times it feels like there are not enough hours in the day. While reading journal articles and attending conferences are great ways to refresh one’s knowledge, the winner for me has been social media (specifically Twitter). It’s easy to find a “Tweetorial” on almost any topic. There are some excellent initiatives on Twitter such as Monday Night IBD, ACG Evidence-Based GI Doc, Scoping Sundays, and GI Journal Club where important articles, new treatment options, and challenging cases are discussed. Of course, I also learn a lot from my fellows and residents.

Q: What fears did you have to push past to get to where you are in your career?

Dr. Naveed: Pushing past imposter syndrome, which is a feeling of self-doubt despite education, experience, and accomplishments. It is something many of us deal with. I’ve had to retire the notion that I am not experienced enough to achieve a particular career goal.

Q: What habits have you established that have benefited your career most?

Dr. Naveed: It’s a challenge to not immediately say “yes” to every opportunity or project. It’s also difficult to learn to delegate. I am lucky to have a great team, and I have learned that delegating certain tasks or projects helps everyone grow. Also, if I say no to an opportunity, I still try to suggest another colleague or mentee who may be interested and/or a good fit.
 

Q: Describe your biggest practice-related challenge and what you are doing to address it.

Dr. Naveed: Pushback from insurance companies to approve medications or interventions is incredibly frustrating for myself and the patient. It is also incredibly time consuming and requires significant clinical bandwidth that could otherwise be used in other capacities. While not a solution, I at least try to make sure the patient is kept updated and understands causes of delay, and more importantly, what we are doing to address the issue. I have realized that it’s always preferable to empower the patient, rather than leave them uninformed, which can foster frustration and dissatisfaction.

Q: What teacher or mentor had the greatest impact on you?

Dr. Naveed: I have been blessed with many mentors at different points in my medical career that have greatly impacted and shaped my journey. During my fellowship at University of Texas Southwestern (UTSW), Nisa Kubiliun, MD, was not only a mentor, but also an incredible sponsor. She saw potential in me and encouraged involvement in activities critical for career advancement. Arjmand Mufti, MD, the former program director of the UTSW GI fellowship, is still always just a call away when I need advice regarding my GI fellowship program at AdventHealth. I also have mentors and sponsors within my own institution who invest time and energy into my success.

Q: Outside of teachers and mentors, who or what has had the strongest influence in your life?

Dr. Naveed: My father, who is also a physician, has had a profound influence on my personal and professional development. His own medical journey has been incredibly unique. He has practiced medicine internationally, trained and worked in a traditional academic setting, established a very successful private practice, and now has transitioned to running a hospital-based practice. He has seen it all (and he’s also a brilliant physician), and he is always able to talk me through any situation.

Q: What principles guide you?

Dr. Naveed: Treating my patients how I would want a physician to treat my family is central to my practice. Also, I try to approach any successes with gratitude, and likewise, be patient with inevitable failures. It can be challenging, but I try to find the lesson in every failed venture.

Q: What would you do differently if you had a chance?

Dr. Naveed: I have always had an interest in international medical missions but have yet to participate in one. I have previously passed on such opportunities, thinking it was not the right time, but in hindsight I wish I had taken the leap. I still hope to eventually accomplish this goal.

Q: Describe a scene of your vision for the future.

Dr. Naveed: I hope that our GI fellowship continues to flourish and attract exceptional faculty and candidates. I want to remain involved in graduate medical education, but I hope to continue to challenge myself and advance within this domain. Most importantly, I hope I can continue to balance my career aspirations with my personal goals. I want to continue to be present for my family and kids.

Q: Describe how you would spend a free Saturday afternoon.

Dr. Naveed: You can usually find me at the local farmer’s market with my husband and kids. Afterwards, we’re definitely going to get Chick-fil-A followed by ice cream.

Lightning round

If you weren’t a gastroenterologist, what would you be?
International event planner.

How many cups of coffee do you drink per day?
Usually three.

Favorite breakfast?
Eggs, corned beef hash, toast.

Texting or talking?
Texting always unless it’s Mom or Dad. They always get a call.

Place you most want to travel?
Japan.

Follow Dr. Naveed on Twitter at @MN_GIMD

Looking back on her career as a gastroenterologist, Mariam Naveed, MD, sees the gastroenterology fellowship program she created at AdventHealth in Orlando, Fla., as a pinnacle moment.

Her first faculty position as assistant program director for the gastroenterology fellowship program at the University of Iowa offered some inspiration. “I loved teaching and working with trainees and knew I always wanted to remain in this realm,” Dr. Naveed said.

When she moved to Orlando to join AdventHealth, she noticed there was no gastroenterology training program. “I was strictly in private practice. Though I love working with patients, I constantly felt like something was missing. When the opportunity to start a fellowship program came, I was highly motivated to bring it to fruition.”

The AdventHealth fellowship is almost done with its inaugural year.

“Starting a fellowship at a new institution is a very challenging yet incredibly rewarding experience,” she said. In this Q&A, she discusses her strategies for dealing with insurance companies and imposter syndrome, and why she looks to her father as her role model in medicine.
 

Q: Why did you choose GI?

Dr. Naveed: Gastroenterology is a rapidly evolving field which makes it incredibly fascinating. The initial draw was that I was always excited to learn about GI physiology and disease. I also was fortunate to train with amazing gastroenterologists during residency. I had great examples of strong and successful female GIs to look up to. Lastly, for the most part, gastroenterologists are all fairly laid back and have an interesting sense of humor.

Q: What gives you the most joy in your day-to-day practice?

Dr. Naveed: I love learning and teaching. As a program director, I am directly involved with fellows, residents, and students, but there are always additional enrichment opportunities beyond these interactions. I value teaching clinic medical assistants so they feel more confident and empowered in their work. I also try to educate my nurse practitioners. The best compliment at the end of a long day is that they learned something valuable.

Q: How do you stay current with advances in your field?

Dr. Naveed: Between my role as a physician and as an educator, I owe it to my patients and trainees to stay current with advances in the field. But of course, this is challenging, and at times it feels like there are not enough hours in the day. While reading journal articles and attending conferences are great ways to refresh one’s knowledge, the winner for me has been social media (specifically Twitter). It’s easy to find a “Tweetorial” on almost any topic. There are some excellent initiatives on Twitter such as Monday Night IBD, ACG Evidence-Based GI Doc, Scoping Sundays, and GI Journal Club where important articles, new treatment options, and challenging cases are discussed. Of course, I also learn a lot from my fellows and residents.

Q: What fears did you have to push past to get to where you are in your career?

Dr. Naveed: Pushing past imposter syndrome, which is a feeling of self-doubt despite education, experience, and accomplishments. It is something many of us deal with. I’ve had to retire the notion that I am not experienced enough to achieve a particular career goal.

Q: What habits have you established that have benefited your career most?

Dr. Naveed: It’s a challenge to not immediately say “yes” to every opportunity or project. It’s also difficult to learn to delegate. I am lucky to have a great team, and I have learned that delegating certain tasks or projects helps everyone grow. Also, if I say no to an opportunity, I still try to suggest another colleague or mentee who may be interested and/or a good fit.
 

Q: Describe your biggest practice-related challenge and what you are doing to address it.

Dr. Naveed: Pushback from insurance companies to approve medications or interventions is incredibly frustrating for myself and the patient. It is also incredibly time consuming and requires significant clinical bandwidth that could otherwise be used in other capacities. While not a solution, I at least try to make sure the patient is kept updated and understands causes of delay, and more importantly, what we are doing to address the issue. I have realized that it’s always preferable to empower the patient, rather than leave them uninformed, which can foster frustration and dissatisfaction.

Q: What teacher or mentor had the greatest impact on you?

Dr. Naveed: I have been blessed with many mentors at different points in my medical career that have greatly impacted and shaped my journey. During my fellowship at University of Texas Southwestern (UTSW), Nisa Kubiliun, MD, was not only a mentor, but also an incredible sponsor. She saw potential in me and encouraged involvement in activities critical for career advancement. Arjmand Mufti, MD, the former program director of the UTSW GI fellowship, is still always just a call away when I need advice regarding my GI fellowship program at AdventHealth. I also have mentors and sponsors within my own institution who invest time and energy into my success.

Q: Outside of teachers and mentors, who or what has had the strongest influence in your life?

Dr. Naveed: My father, who is also a physician, has had a profound influence on my personal and professional development. His own medical journey has been incredibly unique. He has practiced medicine internationally, trained and worked in a traditional academic setting, established a very successful private practice, and now has transitioned to running a hospital-based practice. He has seen it all (and he’s also a brilliant physician), and he is always able to talk me through any situation.

Q: What principles guide you?

Dr. Naveed: Treating my patients how I would want a physician to treat my family is central to my practice. Also, I try to approach any successes with gratitude, and likewise, be patient with inevitable failures. It can be challenging, but I try to find the lesson in every failed venture.

Q: What would you do differently if you had a chance?

Dr. Naveed: I have always had an interest in international medical missions but have yet to participate in one. I have previously passed on such opportunities, thinking it was not the right time, but in hindsight I wish I had taken the leap. I still hope to eventually accomplish this goal.

Q: Describe a scene of your vision for the future.

Dr. Naveed: I hope that our GI fellowship continues to flourish and attract exceptional faculty and candidates. I want to remain involved in graduate medical education, but I hope to continue to challenge myself and advance within this domain. Most importantly, I hope I can continue to balance my career aspirations with my personal goals. I want to continue to be present for my family and kids.

Q: Describe how you would spend a free Saturday afternoon.

Dr. Naveed: You can usually find me at the local farmer’s market with my husband and kids. Afterwards, we’re definitely going to get Chick-fil-A followed by ice cream.

Lightning round

If you weren’t a gastroenterologist, what would you be?
International event planner.

How many cups of coffee do you drink per day?
Usually three.

Favorite breakfast?
Eggs, corned beef hash, toast.

Texting or talking?
Texting always unless it’s Mom or Dad. They always get a call.

Place you most want to travel?
Japan.

Follow Dr. Naveed on Twitter at @MN_GIMD

Looking back on her career as a gastroenterologist, Mariam Naveed, MD, sees the gastroenterology fellowship program she created at AdventHealth in Orlando, Fla., as a pinnacle moment.

Her first faculty position as assistant program director for the gastroenterology fellowship program at the University of Iowa offered some inspiration. “I loved teaching and working with trainees and knew I always wanted to remain in this realm,” Dr. Naveed said.

When she moved to Orlando to join AdventHealth, she noticed there was no gastroenterology training program. “I was strictly in private practice. Though I love working with patients, I constantly felt like something was missing. When the opportunity to start a fellowship program came, I was highly motivated to bring it to fruition.”

The AdventHealth fellowship is almost done with its inaugural year.

“Starting a fellowship at a new institution is a very challenging yet incredibly rewarding experience,” she said. In this Q&A, she discusses her strategies for dealing with insurance companies and imposter syndrome, and why she looks to her father as her role model in medicine.
 

Q: Why did you choose GI?

Dr. Naveed: Gastroenterology is a rapidly evolving field which makes it incredibly fascinating. The initial draw was that I was always excited to learn about GI physiology and disease. I also was fortunate to train with amazing gastroenterologists during residency. I had great examples of strong and successful female GIs to look up to. Lastly, for the most part, gastroenterologists are all fairly laid back and have an interesting sense of humor.

Q: What gives you the most joy in your day-to-day practice?

Dr. Naveed: I love learning and teaching. As a program director, I am directly involved with fellows, residents, and students, but there are always additional enrichment opportunities beyond these interactions. I value teaching clinic medical assistants so they feel more confident and empowered in their work. I also try to educate my nurse practitioners. The best compliment at the end of a long day is that they learned something valuable.

Q: How do you stay current with advances in your field?

Dr. Naveed: Between my role as a physician and as an educator, I owe it to my patients and trainees to stay current with advances in the field. But of course, this is challenging, and at times it feels like there are not enough hours in the day. While reading journal articles and attending conferences are great ways to refresh one’s knowledge, the winner for me has been social media (specifically Twitter). It’s easy to find a “Tweetorial” on almost any topic. There are some excellent initiatives on Twitter such as Monday Night IBD, ACG Evidence-Based GI Doc, Scoping Sundays, and GI Journal Club where important articles, new treatment options, and challenging cases are discussed. Of course, I also learn a lot from my fellows and residents.

Q: What fears did you have to push past to get to where you are in your career?

Dr. Naveed: Pushing past imposter syndrome, which is a feeling of self-doubt despite education, experience, and accomplishments. It is something many of us deal with. I’ve had to retire the notion that I am not experienced enough to achieve a particular career goal.

Q: What habits have you established that have benefited your career most?

Dr. Naveed: It’s a challenge to not immediately say “yes” to every opportunity or project. It’s also difficult to learn to delegate. I am lucky to have a great team, and I have learned that delegating certain tasks or projects helps everyone grow. Also, if I say no to an opportunity, I still try to suggest another colleague or mentee who may be interested and/or a good fit.
 

Q: Describe your biggest practice-related challenge and what you are doing to address it.

Dr. Naveed: Pushback from insurance companies to approve medications or interventions is incredibly frustrating for myself and the patient. It is also incredibly time consuming and requires significant clinical bandwidth that could otherwise be used in other capacities. While not a solution, I at least try to make sure the patient is kept updated and understands causes of delay, and more importantly, what we are doing to address the issue. I have realized that it’s always preferable to empower the patient, rather than leave them uninformed, which can foster frustration and dissatisfaction.

Q: What teacher or mentor had the greatest impact on you?

Dr. Naveed: I have been blessed with many mentors at different points in my medical career that have greatly impacted and shaped my journey. During my fellowship at University of Texas Southwestern (UTSW), Nisa Kubiliun, MD, was not only a mentor, but also an incredible sponsor. She saw potential in me and encouraged involvement in activities critical for career advancement. Arjmand Mufti, MD, the former program director of the UTSW GI fellowship, is still always just a call away when I need advice regarding my GI fellowship program at AdventHealth. I also have mentors and sponsors within my own institution who invest time and energy into my success.

Q: Outside of teachers and mentors, who or what has had the strongest influence in your life?

Dr. Naveed: My father, who is also a physician, has had a profound influence on my personal and professional development. His own medical journey has been incredibly unique. He has practiced medicine internationally, trained and worked in a traditional academic setting, established a very successful private practice, and now has transitioned to running a hospital-based practice. He has seen it all (and he’s also a brilliant physician), and he is always able to talk me through any situation.

Q: What principles guide you?

Dr. Naveed: Treating my patients how I would want a physician to treat my family is central to my practice. Also, I try to approach any successes with gratitude, and likewise, be patient with inevitable failures. It can be challenging, but I try to find the lesson in every failed venture.

Q: What would you do differently if you had a chance?

Dr. Naveed: I have always had an interest in international medical missions but have yet to participate in one. I have previously passed on such opportunities, thinking it was not the right time, but in hindsight I wish I had taken the leap. I still hope to eventually accomplish this goal.

Q: Describe a scene of your vision for the future.

Dr. Naveed: I hope that our GI fellowship continues to flourish and attract exceptional faculty and candidates. I want to remain involved in graduate medical education, but I hope to continue to challenge myself and advance within this domain. Most importantly, I hope I can continue to balance my career aspirations with my personal goals. I want to continue to be present for my family and kids.

Q: Describe how you would spend a free Saturday afternoon.

Dr. Naveed: You can usually find me at the local farmer’s market with my husband and kids. Afterwards, we’re definitely going to get Chick-fil-A followed by ice cream.

Lightning round

If you weren’t a gastroenterologist, what would you be?
International event planner.

How many cups of coffee do you drink per day?
Usually three.

Favorite breakfast?
Eggs, corned beef hash, toast.

Texting or talking?
Texting always unless it’s Mom or Dad. They always get a call.

Place you most want to travel?
Japan.

Follow Dr. Naveed on Twitter at @MN_GIMD

At first, the prospect of starting a new novel practice was daunting, said Russ Arjal, MD, AGAF, a gastroenterologist in San Luis Obispo, Calif., who in 2021 launched Telebelly Health, a virtual care gastroenterology clinic that partners with health systems to offer GI care services throughout the country.

Dr. Arjal, who as a cofounder of Telebelly Health also serves as chief medical officer and president of the practice, previously served as vice president of Puget Sound Gastroenterology and practiced in the Seattle area for 13 years. He served as vice president of clinical affairs for Gastro Health, the nation’s second-largest gastroenterology group, which acquired the Puget Sound practice in 2019. But then in 2021, he founded Telebelly with Sheri Rudberg, MBA, JD, who serves as CEO of the business; Alex Brown, who leads product development; and Nakort Valles, who serves as the company’s chief technology officer.

Building a new business whose goal is to transform GI health care delivery has been his biggest challenge to date. “I am proud of Telebelly because its goals are goals we all share, which is to try to get people in the door and take good care of them,” Dr. Arjal said.

Through virtual care clinics like Telebelly Health, patients can see a provider who is affiliated with a practice, even if the provider is in another state provided he or she is licensed in the patient’s home state. Some states have passed legislation to permanently allow out-of-state physicians to practice telehealth in their state if they follow the state’s requirements. In some states, that may amount to accepting an out-of-state medical license or requiring out-of-state clinicians to pass an exam.

Telebelly Health has served thousands of patients since September when the practice was launched. “We are scaling pretty quickly and will be doubling the number of providers in the next couple of months,” Dr. Arjal said.

In this Q&A, he talks more about his new business venture and his vision for the future of medicine.

Question: Why did you choose GI?

Answer: I wanted to do something that was cognitive where I interacted with and really got to know patients. I also wanted to be a proceduralist. I never wanted to be a surgeon – I knew that wasn’t for me. I fell in love with GI the first year in med school. I thought the pathology was interesting, and what GIs did in the acute setting as well as the outpatient setting was compelling.



Q. What achievement are you most proud of?

A. Prior to Telebelly, I led a large regional GI group in a competitive marketplace. Now, with Telebelly, building a team with a vision to transform the space has been the biggest challenge I have taken on. It’s still a work in progress, but we’ve had a great start. Starting a company wasn’t easy. It was something that I didn’t know a lot about, so I had to take a fair bit of risk. I wasn’t sure if I had it in me at the beginning. It’s not something I’d ever done before, so I was testing myself. I am proud that we were able to launch the company and have successfully scaled it. It’s been more successful than I expected.



Q. Describe your biggest practice-related challenge and what you are doing to address it.

A. Access to care. I think it’s very hard to see somebody with GI expertise and it certainly got worse during the pandemic. In my previous role, we used advanced practice providers. We tried to implement technology, sometimes effectively, sometimes not. But in general, we wanted to try to increase the supply of providers and compress these patient journeys to get people in the door. But that’s still a very difficult challenge we’re all trying to solve.



Q. What teacher or mentor had the greatest impact on you?

A. I would say two: James Trotter, MD, a hepatologist at the University of Colorado where I trained. He had a terrific impact in the sense that he was 100% focused on patients and got to know them as people. This taught me what it meant to be a clinician that was sort of a humanist. He cared so much for his patients that I still think about what Jim would do in a room today, 15 years after I finished my fellowship.

When I started my first job at Puget Sound Gastroenterology in the Seattle area, Robin Sloane, MD, was one of the senior partners of the group. I had a lot to learn after finishing fellowship. He was wonderful and gracious and really taught me a ton about the practical aspects of medicine. I felt this was an extension of my training in that he was a real clinician who really cared deeply for his patients. If I hadn’t met those two, my career and maybe my view of just what I did day-to-day would be different. They were both very, very impactful for me.



Q. Outside of teachers and mentors, who has had the strongest influence on your life?

A. Two people: my mother and my wife. My mother was a single parent and we were immigrants to the country. She was an ambitious woman who didn’t let anything stop her. I certainly learned a ton about resilience, work ethic. She’s somebody who always treated people well. My wife also supported and believed in me, and without her, I would not have had the courage to start a company.



Q. Describe a scene of your vision for the future.

A. I think we need to change our mindset in terms of how we interact with patients. I think there’s going to be a lot of clinical testing that is performed away from the physician’s office. It’s going to become more democratized and more decentralized. And I think in the future, patients will have more agency in how they interact with the system. I think artificial intelligence will potentially augment all of this as well. We’ll have patients who are more engaged, have more choice and easier access to expert care. They’ll come in with more information on their hands and they won’t have to wait as long. I think the wait times to get to a GI clinic now are way too long.

What I’d also like to see are providers spending more time doing things that they’re trained to do rather than documentation, summarizing data, and dealing with administrative headaches. I think almost everybody has that goal, but I think that’s achievable.

I want providers to have an iron man or iron woman suit when they see a patient, to have more data at their fingertips, to spend more time with the patients and have smarter visits.



Q. What did you fear most early in your career?

A. Failure for the most part, and comfort. For a long time, I wanted to start a company and change the space. Fear of failure has been ingrained in me and I think that’s true for a lot of physicians. I had always been a perfectionist.



Q. What gives you the most joy in your day-to-day practice?

A. Seeing patients is by far the thing I enjoy most. I don’t love documenting or digging up information, but I like getting to know folks. In general, I’m a social person and my outpatient clinic gives me the most joy, probably more than anything else.

Q. How do you stay current with advances in your field?

A. I’m curious about all new things, so I stay current through traditional means: I go to conferences regularly, I take postgraduate courses, I listen to podcasts, talk to colleagues, and read journals on a regular basis. But there are a lot of adjacent sources I pay attention to as well, such as nonmedical journals and nonmedical podcasts. I talk to folks outside the space and try to learn from them as well.



Q. What habits have you established that have benefited your career?

A. I do the same thing every day before my clinic days or my endoscopy days. I make reading a part of each day so I can slow down and be more present. Every day I try not to perform just what I do workwise, but I try to find some balance either with my family, or through exercise. I think I’ve been pretty good at separating work life from personal life.
 

Lightning round questions

Texting or talking? Talking.

Favorite junk food? Peanut butter M&Ms.

How many cups of coffee do you drink per day? Three.

If you weren’t a gastroenterologist, what would you be? Venture capitalist.

Introvert or extrovert? Both.

At first, the prospect of starting a new novel practice was daunting, said Russ Arjal, MD, AGAF, a gastroenterologist in San Luis Obispo, Calif., who in 2021 launched Telebelly Health, a virtual care gastroenterology clinic that partners with health systems to offer GI care services throughout the country.

Dr. Arjal, who as a cofounder of Telebelly Health also serves as chief medical officer and president of the practice, previously served as vice president of Puget Sound Gastroenterology and practiced in the Seattle area for 13 years. He served as vice president of clinical affairs for Gastro Health, the nation’s second-largest gastroenterology group, which acquired the Puget Sound practice in 2019. But then in 2021, he founded Telebelly with Sheri Rudberg, MBA, JD, who serves as CEO of the business; Alex Brown, who leads product development; and Nakort Valles, who serves as the company’s chief technology officer.

Building a new business whose goal is to transform GI health care delivery has been his biggest challenge to date. “I am proud of Telebelly because its goals are goals we all share, which is to try to get people in the door and take good care of them,” Dr. Arjal said.

Through virtual care clinics like Telebelly Health, patients can see a provider who is affiliated with a practice, even if the provider is in another state provided he or she is licensed in the patient’s home state. Some states have passed legislation to permanently allow out-of-state physicians to practice telehealth in their state if they follow the state’s requirements. In some states, that may amount to accepting an out-of-state medical license or requiring out-of-state clinicians to pass an exam.

Telebelly Health has served thousands of patients since September when the practice was launched. “We are scaling pretty quickly and will be doubling the number of providers in the next couple of months,” Dr. Arjal said.

In this Q&A, he talks more about his new business venture and his vision for the future of medicine.

Question: Why did you choose GI?

Answer: I wanted to do something that was cognitive where I interacted with and really got to know patients. I also wanted to be a proceduralist. I never wanted to be a surgeon – I knew that wasn’t for me. I fell in love with GI the first year in med school. I thought the pathology was interesting, and what GIs did in the acute setting as well as the outpatient setting was compelling.



Q. What achievement are you most proud of?

A. Prior to Telebelly, I led a large regional GI group in a competitive marketplace. Now, with Telebelly, building a team with a vision to transform the space has been the biggest challenge I have taken on. It’s still a work in progress, but we’ve had a great start. Starting a company wasn’t easy. It was something that I didn’t know a lot about, so I had to take a fair bit of risk. I wasn’t sure if I had it in me at the beginning. It’s not something I’d ever done before, so I was testing myself. I am proud that we were able to launch the company and have successfully scaled it. It’s been more successful than I expected.



Q. Describe your biggest practice-related challenge and what you are doing to address it.

A. Access to care. I think it’s very hard to see somebody with GI expertise and it certainly got worse during the pandemic. In my previous role, we used advanced practice providers. We tried to implement technology, sometimes effectively, sometimes not. But in general, we wanted to try to increase the supply of providers and compress these patient journeys to get people in the door. But that’s still a very difficult challenge we’re all trying to solve.



Q. What teacher or mentor had the greatest impact on you?

A. I would say two: James Trotter, MD, a hepatologist at the University of Colorado where I trained. He had a terrific impact in the sense that he was 100% focused on patients and got to know them as people. This taught me what it meant to be a clinician that was sort of a humanist. He cared so much for his patients that I still think about what Jim would do in a room today, 15 years after I finished my fellowship.

When I started my first job at Puget Sound Gastroenterology in the Seattle area, Robin Sloane, MD, was one of the senior partners of the group. I had a lot to learn after finishing fellowship. He was wonderful and gracious and really taught me a ton about the practical aspects of medicine. I felt this was an extension of my training in that he was a real clinician who really cared deeply for his patients. If I hadn’t met those two, my career and maybe my view of just what I did day-to-day would be different. They were both very, very impactful for me.



Q. Outside of teachers and mentors, who has had the strongest influence on your life?

A. Two people: my mother and my wife. My mother was a single parent and we were immigrants to the country. She was an ambitious woman who didn’t let anything stop her. I certainly learned a ton about resilience, work ethic. She’s somebody who always treated people well. My wife also supported and believed in me, and without her, I would not have had the courage to start a company.



Q. Describe a scene of your vision for the future.

A. I think we need to change our mindset in terms of how we interact with patients. I think there’s going to be a lot of clinical testing that is performed away from the physician’s office. It’s going to become more democratized and more decentralized. And I think in the future, patients will have more agency in how they interact with the system. I think artificial intelligence will potentially augment all of this as well. We’ll have patients who are more engaged, have more choice and easier access to expert care. They’ll come in with more information on their hands and they won’t have to wait as long. I think the wait times to get to a GI clinic now are way too long.

What I’d also like to see are providers spending more time doing things that they’re trained to do rather than documentation, summarizing data, and dealing with administrative headaches. I think almost everybody has that goal, but I think that’s achievable.

I want providers to have an iron man or iron woman suit when they see a patient, to have more data at their fingertips, to spend more time with the patients and have smarter visits.



Q. What did you fear most early in your career?

A. Failure for the most part, and comfort. For a long time, I wanted to start a company and change the space. Fear of failure has been ingrained in me and I think that’s true for a lot of physicians. I had always been a perfectionist.



Q. What gives you the most joy in your day-to-day practice?

A. Seeing patients is by far the thing I enjoy most. I don’t love documenting or digging up information, but I like getting to know folks. In general, I’m a social person and my outpatient clinic gives me the most joy, probably more than anything else.

Q. How do you stay current with advances in your field?

A. I’m curious about all new things, so I stay current through traditional means: I go to conferences regularly, I take postgraduate courses, I listen to podcasts, talk to colleagues, and read journals on a regular basis. But there are a lot of adjacent sources I pay attention to as well, such as nonmedical journals and nonmedical podcasts. I talk to folks outside the space and try to learn from them as well.



Q. What habits have you established that have benefited your career?

A. I do the same thing every day before my clinic days or my endoscopy days. I make reading a part of each day so I can slow down and be more present. Every day I try not to perform just what I do workwise, but I try to find some balance either with my family, or through exercise. I think I’ve been pretty good at separating work life from personal life.
 

Lightning round questions

Texting or talking? Talking.

Favorite junk food? Peanut butter M&Ms.

How many cups of coffee do you drink per day? Three.

If you weren’t a gastroenterologist, what would you be? Venture capitalist.

Introvert or extrovert? Both.

At first, the prospect of starting a new novel practice was daunting, said Russ Arjal, MD, AGAF, a gastroenterologist in San Luis Obispo, Calif., who in 2021 launched Telebelly Health, a virtual care gastroenterology clinic that partners with health systems to offer GI care services throughout the country.

Dr. Arjal, who as a cofounder of Telebelly Health also serves as chief medical officer and president of the practice, previously served as vice president of Puget Sound Gastroenterology and practiced in the Seattle area for 13 years. He served as vice president of clinical affairs for Gastro Health, the nation’s second-largest gastroenterology group, which acquired the Puget Sound practice in 2019. But then in 2021, he founded Telebelly with Sheri Rudberg, MBA, JD, who serves as CEO of the business; Alex Brown, who leads product development; and Nakort Valles, who serves as the company’s chief technology officer.

Building a new business whose goal is to transform GI health care delivery has been his biggest challenge to date. “I am proud of Telebelly because its goals are goals we all share, which is to try to get people in the door and take good care of them,” Dr. Arjal said.

Through virtual care clinics like Telebelly Health, patients can see a provider who is affiliated with a practice, even if the provider is in another state provided he or she is licensed in the patient’s home state. Some states have passed legislation to permanently allow out-of-state physicians to practice telehealth in their state if they follow the state’s requirements. In some states, that may amount to accepting an out-of-state medical license or requiring out-of-state clinicians to pass an exam.

Telebelly Health has served thousands of patients since September when the practice was launched. “We are scaling pretty quickly and will be doubling the number of providers in the next couple of months,” Dr. Arjal said.

In this Q&A, he talks more about his new business venture and his vision for the future of medicine.

Question: Why did you choose GI?

Answer: I wanted to do something that was cognitive where I interacted with and really got to know patients. I also wanted to be a proceduralist. I never wanted to be a surgeon – I knew that wasn’t for me. I fell in love with GI the first year in med school. I thought the pathology was interesting, and what GIs did in the acute setting as well as the outpatient setting was compelling.



Q. What achievement are you most proud of?

A. Prior to Telebelly, I led a large regional GI group in a competitive marketplace. Now, with Telebelly, building a team with a vision to transform the space has been the biggest challenge I have taken on. It’s still a work in progress, but we’ve had a great start. Starting a company wasn’t easy. It was something that I didn’t know a lot about, so I had to take a fair bit of risk. I wasn’t sure if I had it in me at the beginning. It’s not something I’d ever done before, so I was testing myself. I am proud that we were able to launch the company and have successfully scaled it. It’s been more successful than I expected.



Q. Describe your biggest practice-related challenge and what you are doing to address it.

A. Access to care. I think it’s very hard to see somebody with GI expertise and it certainly got worse during the pandemic. In my previous role, we used advanced practice providers. We tried to implement technology, sometimes effectively, sometimes not. But in general, we wanted to try to increase the supply of providers and compress these patient journeys to get people in the door. But that’s still a very difficult challenge we’re all trying to solve.



Q. What teacher or mentor had the greatest impact on you?

A. I would say two: James Trotter, MD, a hepatologist at the University of Colorado where I trained. He had a terrific impact in the sense that he was 100% focused on patients and got to know them as people. This taught me what it meant to be a clinician that was sort of a humanist. He cared so much for his patients that I still think about what Jim would do in a room today, 15 years after I finished my fellowship.

When I started my first job at Puget Sound Gastroenterology in the Seattle area, Robin Sloane, MD, was one of the senior partners of the group. I had a lot to learn after finishing fellowship. He was wonderful and gracious and really taught me a ton about the practical aspects of medicine. I felt this was an extension of my training in that he was a real clinician who really cared deeply for his patients. If I hadn’t met those two, my career and maybe my view of just what I did day-to-day would be different. They were both very, very impactful for me.



Q. Outside of teachers and mentors, who has had the strongest influence on your life?

A. Two people: my mother and my wife. My mother was a single parent and we were immigrants to the country. She was an ambitious woman who didn’t let anything stop her. I certainly learned a ton about resilience, work ethic. She’s somebody who always treated people well. My wife also supported and believed in me, and without her, I would not have had the courage to start a company.



Q. Describe a scene of your vision for the future.

A. I think we need to change our mindset in terms of how we interact with patients. I think there’s going to be a lot of clinical testing that is performed away from the physician’s office. It’s going to become more democratized and more decentralized. And I think in the future, patients will have more agency in how they interact with the system. I think artificial intelligence will potentially augment all of this as well. We’ll have patients who are more engaged, have more choice and easier access to expert care. They’ll come in with more information on their hands and they won’t have to wait as long. I think the wait times to get to a GI clinic now are way too long.

What I’d also like to see are providers spending more time doing things that they’re trained to do rather than documentation, summarizing data, and dealing with administrative headaches. I think almost everybody has that goal, but I think that’s achievable.

I want providers to have an iron man or iron woman suit when they see a patient, to have more data at their fingertips, to spend more time with the patients and have smarter visits.



Q. What did you fear most early in your career?

A. Failure for the most part, and comfort. For a long time, I wanted to start a company and change the space. Fear of failure has been ingrained in me and I think that’s true for a lot of physicians. I had always been a perfectionist.



Q. What gives you the most joy in your day-to-day practice?

A. Seeing patients is by far the thing I enjoy most. I don’t love documenting or digging up information, but I like getting to know folks. In general, I’m a social person and my outpatient clinic gives me the most joy, probably more than anything else.

Q. How do you stay current with advances in your field?

A. I’m curious about all new things, so I stay current through traditional means: I go to conferences regularly, I take postgraduate courses, I listen to podcasts, talk to colleagues, and read journals on a regular basis. But there are a lot of adjacent sources I pay attention to as well, such as nonmedical journals and nonmedical podcasts. I talk to folks outside the space and try to learn from them as well.



Q. What habits have you established that have benefited your career?

A. I do the same thing every day before my clinic days or my endoscopy days. I make reading a part of each day so I can slow down and be more present. Every day I try not to perform just what I do workwise, but I try to find some balance either with my family, or through exercise. I think I’ve been pretty good at separating work life from personal life.
 

Lightning round questions

Texting or talking? Talking.

Favorite junk food? Peanut butter M&Ms.

How many cups of coffee do you drink per day? Three.

If you weren’t a gastroenterologist, what would you be? Venture capitalist.

Introvert or extrovert? Both.

A deeper understanding of the mechanisms underlying the success of fecal microbiota transplantation (FMT) is needed to further improve its effectiveness, according to two recent reviews published in Cell Host and Microbe.

Both research teams agree that more needs to be known about how various underexplored factors – such as the patient’s diet and genetic background, how closely the donor’s microbial composition matches the patient’s existing microbiome, and the presence of nonbacterial gut inhabitants like viruses and fungi – affect FMT success, according to a press release.

FMT is most often used to treat recurrent Clostridioides difficile infections, which don’t always respond to antibiotics. Success rates range from 60% to 90%, depending on the administration route and study design, notes an international research team led by Abbas Yadegar, PhD, a medical bacteriologist at the Shahid Beheshti University of Medical Sciences in Tehran, Iran.

The understanding of how FMT works is incomplete, however, and the reasons some patients fail to benefit is unclear, note Dr. Yadegar and colleagues. Little attention has been paid to the role that other components of the patient’s microbiome, along with outside factors, play in the treatment’s success, they add.

“We wanted other researchers to look beyond changes in stool microbial composition and function, which have been the focus of research in the past few years,” Dr. Yadegar’s team said in a statement provided to this news organization.

Dr. Yadegar and colleagues’ review of more than 130 studies summarizes recent evidence on the mechanisms contributing to FMT success against recurrent C. difficile infection, highlights knowledge gaps, and proposes future research directions in the field.

Factors that influence FMT’s effectiveness and the potential the procedure holds for treatment of other diseases associated with gut dysbiosis are the subject of a review of 149 studies by a team of researchers led by Serena Porcari, MD, a gastroenterologist at the Fondazione Policlinico Universitario Gemelli and Università Cattolica del Sacro Cuore, in Rome.

“Our main goal was not only to unravel the different mechanisms of FMT efficacy but also to introduce some mindset shifts that are needed to bring FMT forward, mainly covering the gap that exists between basic scientists and clinicians,” Gianluca Ianiro, MD, PhD, a senior researcher in digestive diseases who works with Dr. Porcari and is the review’s lead author, told this news organization.
 

Engraftment may influence success

Engraftment of donor microbial strains in recipients appears to be key to the therapeutic success of FMT, both reviews note.

Three factors influence engraftment: the donor’s bacteria fitness relative to the recipient, the bacteria already present in the recipient, and whether antibiotics are used prior to FMT to open a niche for the incoming donor microbes, according to Dr. Yadegar and colleagues.

How to calculate strain engraftment has not yet been standardized in the field, and the number of strains detected in the recipient’s fecal sample is dependent on the depth of sequencing techniques, Dr. Porcari and colleagues note.

The use of whole-genome sequencing has enabled more precise evaluation of engraftment, they add.

“With this approach, microbial engraftment has been associated with clinical success, regardless of the disease, in a large metagenomic metanalysis of 24 FMT trials and almost 1,400 fecal samples,” Dr. Porcari and colleagues write. However, these results have not been replicated, likely because of differences between the studies.

More study on the topic is needed, both articles note.

“Because the recent metagenomics studies compared pre- and post-FMT only in cases with successful treatment outcomes, it is not possible to link engraftment to clinical outcomes,” Dr. Yadegar and colleagues write in their statement to this news organization.
 

A closer look at donor-recipient pairings

Clinicians usually enlist healthy, carefully screened individuals as FMT donors.

However, both research groups conclude that fine-scale taxonomic and metabolic analyses of donor and recipient microbiomes would better inform clinical decisions, especially when treating diseases other than C. difficile.

This may call for a more personalized approach to choosing donor-recipient pairings. Investigators should assess the patient’s diet and genetic background and how closely the donor’s microbiome matches that of the patient.

“Most studies focused on profiling stool samples before and after FMT without also including functional analyses; therefore, there are still a lot of aspects of host microbial interactions that remain unknown,” write Dr. Yadegar and colleagues in their statement.

Ecologic factors, including diet and host genetics, are often not included in clinical studies of C. difficile, but they “may potentially be the missing links” to treatment failure in the small portion of patients whose condition doesn’t respond to FMT, they write.

Pairing donor-recipient combinations on the basis of dietary patterns and preferences could improve FMT efficacy because the donor microbiota would be preadapted to the recipient’s diet, Dr. Yadegar and colleagues write. The team is examining how donor and recipient diet may affect outcomes.

Dr. Porcari and colleagues add that while some studies support the existence of shared characteristics that make up super-donors, others found that the optimal donor is more patient specific. They call for personalized selection strategies that employ microbiome sequencing tools rather than a “one stool fits all” approach.

Currently, many clinicians aren’t familiar with microbiome sequencing and analysis, but they’ll need to be in the near future, note Dr. Porcari and colleagues.

“Identifying microbiome characteristics that maximize strain engraftment in the FMT will allow clinicians to select the best donor for each single patient,” they write.
 

The possible role of viruses and fungi

In FMT research, investigators tend to focus on the bacteria in the human microbiome. However, viruses and fungi also appear to play a role, both articles note.

“Other microbial kingdoms that inhabit the intestine should be taken into account when considering predictors of post-FMT microbial transfer,” write Dr. Porcari and colleagues.

Although few studies have examined the gut virome’s impact on FMT effectiveness against C. difficile, the existing research, although limited, indicates that bacteriophage viruses could play a role, Dr. Yadegar and colleagues note. For example, high levels of donor-derived Caudoviralesbacteriophages in recipients were associated with FMT efficacy in one preliminary study, they write.

In a small human study, fecal filtrate from healthy donors who had bacteriophages but no live bacteria successfully treated five patients with recurrent C. difficile infection, Dr. Yadegar and colleagues write.

“Therefore, the idea that viruses may play a role is very provocative,” write Dr. Yadegar’s team in their statement.

It’s important to note that these studies are associative, which means they can’t definitively answer the question of how or whether viruses play a role, Dr. Yadegar’s team added.

Researchers “know even less about how fungi may or may not play a role,” write Dr. Yadegar and colleagues. However, in early research that involved patients who had successfully undergone FMT for C. difficile, there was higher relative abundance of Saccharomyces and Aspergillus, whereas Candida, if prominent, may impede response, they write in their article.

Additionally, to explore whether live bacteria are necessary for FMT to work, Dr. Yadegar and colleagues informed this news organization that they are conducting a study “comparing traditional FMT to a fecal filtrate that contains no live bacteria, but has all other components, to see if we can achieve similar success rates in recurrent C. difficile infection.”
 

Repeat treatment for sustained response

Dr. Yadegar’s team offered another important takeaway: A single FMT treatment will not sustain a positive response, especially when treating chronic noncommunicable conditions in which intestinal dysbiosis may play a role. Repeat treatment will be needed, as with other chronic conditions. This has been shown even in C. difficile infection.

“Recent studies have documented a significant advantage of repeated FMT over single FMT on the cure rates of recurrent C. difficile,” especially for patients with inflammatory bowel disorder, Dr. Yadegar’s team told this news organization.

“What we don’t know is which patient is likely to respond to microbial-based therapy, or what the dose or frequency should be, or which bacteria are responsible for the effects,” Dr. Yadegar and team said.

Dr. Porcari and colleagues are examining whether FMT could be refined to improve its success against other diseases. This may involve selecting specific donors, monitoring the gut microbiome of both donors and recipients, or using a specific means of delivery, such as lyophilized capsules, Dr. Ianiro said.

A response to FMT for chronic, noncommunicable disorders typically is not sustained long term, note Dr. Porcari and colleagues. However, they add that “sequential transplants have been applied in this setting with promising results, suggesting that chronic modulation of the patient microbiome may be beneficial in noncommunicable chronic disorders.” Dr. Porcari and colleagues point to the success of repeated, long-term FMT in studies of patients with ulcerative colitis and irritable bowel syndrome.

The use of cutting-edge technologies for microbiome assessment and a change in the view of FMT as only an acute, single-use therapy could improve FMT protocols and outcomes for noncommunicable conditions, they write.
 

Expanding FMT beyond C. difficile

Dr. Yadegar and colleagues’ article “really breaks down what is known about the mechanisms of FMT in C. difficile infection, which is important as other live biotherapeutic products are developed,” Colleen Kelly, MD, an associate professor of medicine at Brown University in Providence, R.I., who was not involved with the reviews, said in an interview.

Dr. Yadegar and colleagues concur. They note in a press release that as the mechanisms behind FMT success are understood, that information should be used to design new standardized therapies.

“Although highly effective, there are substantial drawbacks with [FMT], including infectious risks and sparse long-term safety data,” they write. “Better treatment options for recurrent C. difficile infections that are targeted, safe, and donor-independent are thus desired.”

In December 2022, the U.S. Food and Drug Administration approved the first fecal microbiota product, Rebyota, to prevent recurrence of C. difficile. More recently, in April 2023, the FDA approved Vowst, a pill for treating recurrent C. difficile infections.

Dr. Kelly also noted that the article by Dr. Yadegar and colleagues “may help us understand why a small percentage of patients fail to achieve cure after FMT.”

Regarding Dr. Porcari and colleagues’ article, Dr. Kelly said, “There is a lot of hope that FMT or other gut microbiome therapies will be beneficial for conditions outside of C. difficile.

“They do a good job reviewing the state of the science of FMT and highlight the many unknowns around the use of FMT in conditions outside of C. difficile,” added Dr. Kelly, who has been using FMT to treat C. difficile for more than 15 years.

Data supporting FMT for conditions such as ulcerative colitis and autism are compelling, Dr. Kelly acknowledged. But in her view, FMT isn’t ready for “prime time” outside of C. difficile – at least not yet.

“Academic investigators and those in industry are actively conducting research in many non–C. difficile indications, and I predict we will see the emergence of gut microbiome–based therapies for other indications within the next 5-10 years,” Dr. Kelly said.

Dr. Yadegar reports no relevant financial relationships. One coauthor of the Yadegar study has served on the adjudication board for Finch Therapeutics and has received consulting fees and a speaking honorarium from Rebiotix/Ferring Pharmaceuticals. Dr. Ianiro reports no relevant financial relationships. Dr. Kelly has consulted for Sebela Pharmaceuticals and is one of the principal investigators for the FMT National Patient Registry funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

A version of this article originally appeared on Medscape.com.

A deeper understanding of the mechanisms underlying the success of fecal microbiota transplantation (FMT) is needed to further improve its effectiveness, according to two recent reviews published in Cell Host and Microbe.

Both research teams agree that more needs to be known about how various underexplored factors – such as the patient’s diet and genetic background, how closely the donor’s microbial composition matches the patient’s existing microbiome, and the presence of nonbacterial gut inhabitants like viruses and fungi – affect FMT success, according to a press release.

FMT is most often used to treat recurrent Clostridioides difficile infections, which don’t always respond to antibiotics. Success rates range from 60% to 90%, depending on the administration route and study design, notes an international research team led by Abbas Yadegar, PhD, a medical bacteriologist at the Shahid Beheshti University of Medical Sciences in Tehran, Iran.

The understanding of how FMT works is incomplete, however, and the reasons some patients fail to benefit is unclear, note Dr. Yadegar and colleagues. Little attention has been paid to the role that other components of the patient’s microbiome, along with outside factors, play in the treatment’s success, they add.

“We wanted other researchers to look beyond changes in stool microbial composition and function, which have been the focus of research in the past few years,” Dr. Yadegar’s team said in a statement provided to this news organization.

Dr. Yadegar and colleagues’ review of more than 130 studies summarizes recent evidence on the mechanisms contributing to FMT success against recurrent C. difficile infection, highlights knowledge gaps, and proposes future research directions in the field.

Factors that influence FMT’s effectiveness and the potential the procedure holds for treatment of other diseases associated with gut dysbiosis are the subject of a review of 149 studies by a team of researchers led by Serena Porcari, MD, a gastroenterologist at the Fondazione Policlinico Universitario Gemelli and Università Cattolica del Sacro Cuore, in Rome.

“Our main goal was not only to unravel the different mechanisms of FMT efficacy but also to introduce some mindset shifts that are needed to bring FMT forward, mainly covering the gap that exists between basic scientists and clinicians,” Gianluca Ianiro, MD, PhD, a senior researcher in digestive diseases who works with Dr. Porcari and is the review’s lead author, told this news organization.
 

Engraftment may influence success

Engraftment of donor microbial strains in recipients appears to be key to the therapeutic success of FMT, both reviews note.

Three factors influence engraftment: the donor’s bacteria fitness relative to the recipient, the bacteria already present in the recipient, and whether antibiotics are used prior to FMT to open a niche for the incoming donor microbes, according to Dr. Yadegar and colleagues.

How to calculate strain engraftment has not yet been standardized in the field, and the number of strains detected in the recipient’s fecal sample is dependent on the depth of sequencing techniques, Dr. Porcari and colleagues note.

The use of whole-genome sequencing has enabled more precise evaluation of engraftment, they add.

“With this approach, microbial engraftment has been associated with clinical success, regardless of the disease, in a large metagenomic metanalysis of 24 FMT trials and almost 1,400 fecal samples,” Dr. Porcari and colleagues write. However, these results have not been replicated, likely because of differences between the studies.

More study on the topic is needed, both articles note.

“Because the recent metagenomics studies compared pre- and post-FMT only in cases with successful treatment outcomes, it is not possible to link engraftment to clinical outcomes,” Dr. Yadegar and colleagues write in their statement to this news organization.
 

A closer look at donor-recipient pairings

Clinicians usually enlist healthy, carefully screened individuals as FMT donors.

However, both research groups conclude that fine-scale taxonomic and metabolic analyses of donor and recipient microbiomes would better inform clinical decisions, especially when treating diseases other than C. difficile.

This may call for a more personalized approach to choosing donor-recipient pairings. Investigators should assess the patient’s diet and genetic background and how closely the donor’s microbiome matches that of the patient.

“Most studies focused on profiling stool samples before and after FMT without also including functional analyses; therefore, there are still a lot of aspects of host microbial interactions that remain unknown,” write Dr. Yadegar and colleagues in their statement.

Ecologic factors, including diet and host genetics, are often not included in clinical studies of C. difficile, but they “may potentially be the missing links” to treatment failure in the small portion of patients whose condition doesn’t respond to FMT, they write.

Pairing donor-recipient combinations on the basis of dietary patterns and preferences could improve FMT efficacy because the donor microbiota would be preadapted to the recipient’s diet, Dr. Yadegar and colleagues write. The team is examining how donor and recipient diet may affect outcomes.

Dr. Porcari and colleagues add that while some studies support the existence of shared characteristics that make up super-donors, others found that the optimal donor is more patient specific. They call for personalized selection strategies that employ microbiome sequencing tools rather than a “one stool fits all” approach.

Currently, many clinicians aren’t familiar with microbiome sequencing and analysis, but they’ll need to be in the near future, note Dr. Porcari and colleagues.

“Identifying microbiome characteristics that maximize strain engraftment in the FMT will allow clinicians to select the best donor for each single patient,” they write.
 

The possible role of viruses and fungi

In FMT research, investigators tend to focus on the bacteria in the human microbiome. However, viruses and fungi also appear to play a role, both articles note.

“Other microbial kingdoms that inhabit the intestine should be taken into account when considering predictors of post-FMT microbial transfer,” write Dr. Porcari and colleagues.

Although few studies have examined the gut virome’s impact on FMT effectiveness against C. difficile, the existing research, although limited, indicates that bacteriophage viruses could play a role, Dr. Yadegar and colleagues note. For example, high levels of donor-derived Caudoviralesbacteriophages in recipients were associated with FMT efficacy in one preliminary study, they write.

In a small human study, fecal filtrate from healthy donors who had bacteriophages but no live bacteria successfully treated five patients with recurrent C. difficile infection, Dr. Yadegar and colleagues write.

“Therefore, the idea that viruses may play a role is very provocative,” write Dr. Yadegar’s team in their statement.

It’s important to note that these studies are associative, which means they can’t definitively answer the question of how or whether viruses play a role, Dr. Yadegar’s team added.

Researchers “know even less about how fungi may or may not play a role,” write Dr. Yadegar and colleagues. However, in early research that involved patients who had successfully undergone FMT for C. difficile, there was higher relative abundance of Saccharomyces and Aspergillus, whereas Candida, if prominent, may impede response, they write in their article.

Additionally, to explore whether live bacteria are necessary for FMT to work, Dr. Yadegar and colleagues informed this news organization that they are conducting a study “comparing traditional FMT to a fecal filtrate that contains no live bacteria, but has all other components, to see if we can achieve similar success rates in recurrent C. difficile infection.”
 

Repeat treatment for sustained response

Dr. Yadegar’s team offered another important takeaway: A single FMT treatment will not sustain a positive response, especially when treating chronic noncommunicable conditions in which intestinal dysbiosis may play a role. Repeat treatment will be needed, as with other chronic conditions. This has been shown even in C. difficile infection.

“Recent studies have documented a significant advantage of repeated FMT over single FMT on the cure rates of recurrent C. difficile,” especially for patients with inflammatory bowel disorder, Dr. Yadegar’s team told this news organization.

“What we don’t know is which patient is likely to respond to microbial-based therapy, or what the dose or frequency should be, or which bacteria are responsible for the effects,” Dr. Yadegar and team said.

Dr. Porcari and colleagues are examining whether FMT could be refined to improve its success against other diseases. This may involve selecting specific donors, monitoring the gut microbiome of both donors and recipients, or using a specific means of delivery, such as lyophilized capsules, Dr. Ianiro said.

A response to FMT for chronic, noncommunicable disorders typically is not sustained long term, note Dr. Porcari and colleagues. However, they add that “sequential transplants have been applied in this setting with promising results, suggesting that chronic modulation of the patient microbiome may be beneficial in noncommunicable chronic disorders.” Dr. Porcari and colleagues point to the success of repeated, long-term FMT in studies of patients with ulcerative colitis and irritable bowel syndrome.

The use of cutting-edge technologies for microbiome assessment and a change in the view of FMT as only an acute, single-use therapy could improve FMT protocols and outcomes for noncommunicable conditions, they write.
 

Expanding FMT beyond C. difficile

Dr. Yadegar and colleagues’ article “really breaks down what is known about the mechanisms of FMT in C. difficile infection, which is important as other live biotherapeutic products are developed,” Colleen Kelly, MD, an associate professor of medicine at Brown University in Providence, R.I., who was not involved with the reviews, said in an interview.

Dr. Yadegar and colleagues concur. They note in a press release that as the mechanisms behind FMT success are understood, that information should be used to design new standardized therapies.

“Although highly effective, there are substantial drawbacks with [FMT], including infectious risks and sparse long-term safety data,” they write. “Better treatment options for recurrent C. difficile infections that are targeted, safe, and donor-independent are thus desired.”

In December 2022, the U.S. Food and Drug Administration approved the first fecal microbiota product, Rebyota, to prevent recurrence of C. difficile. More recently, in April 2023, the FDA approved Vowst, a pill for treating recurrent C. difficile infections.

Dr. Kelly also noted that the article by Dr. Yadegar and colleagues “may help us understand why a small percentage of patients fail to achieve cure after FMT.”

Regarding Dr. Porcari and colleagues’ article, Dr. Kelly said, “There is a lot of hope that FMT or other gut microbiome therapies will be beneficial for conditions outside of C. difficile.

“They do a good job reviewing the state of the science of FMT and highlight the many unknowns around the use of FMT in conditions outside of C. difficile,” added Dr. Kelly, who has been using FMT to treat C. difficile for more than 15 years.

Data supporting FMT for conditions such as ulcerative colitis and autism are compelling, Dr. Kelly acknowledged. But in her view, FMT isn’t ready for “prime time” outside of C. difficile – at least not yet.

“Academic investigators and those in industry are actively conducting research in many non–C. difficile indications, and I predict we will see the emergence of gut microbiome–based therapies for other indications within the next 5-10 years,” Dr. Kelly said.

Dr. Yadegar reports no relevant financial relationships. One coauthor of the Yadegar study has served on the adjudication board for Finch Therapeutics and has received consulting fees and a speaking honorarium from Rebiotix/Ferring Pharmaceuticals. Dr. Ianiro reports no relevant financial relationships. Dr. Kelly has consulted for Sebela Pharmaceuticals and is one of the principal investigators for the FMT National Patient Registry funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

A version of this article originally appeared on Medscape.com.

A deeper understanding of the mechanisms underlying the success of fecal microbiota transplantation (FMT) is needed to further improve its effectiveness, according to two recent reviews published in Cell Host and Microbe.

Both research teams agree that more needs to be known about how various underexplored factors – such as the patient’s diet and genetic background, how closely the donor’s microbial composition matches the patient’s existing microbiome, and the presence of nonbacterial gut inhabitants like viruses and fungi – affect FMT success, according to a press release.

FMT is most often used to treat recurrent Clostridioides difficile infections, which don’t always respond to antibiotics. Success rates range from 60% to 90%, depending on the administration route and study design, notes an international research team led by Abbas Yadegar, PhD, a medical bacteriologist at the Shahid Beheshti University of Medical Sciences in Tehran, Iran.

The understanding of how FMT works is incomplete, however, and the reasons some patients fail to benefit is unclear, note Dr. Yadegar and colleagues. Little attention has been paid to the role that other components of the patient’s microbiome, along with outside factors, play in the treatment’s success, they add.

“We wanted other researchers to look beyond changes in stool microbial composition and function, which have been the focus of research in the past few years,” Dr. Yadegar’s team said in a statement provided to this news organization.

Dr. Yadegar and colleagues’ review of more than 130 studies summarizes recent evidence on the mechanisms contributing to FMT success against recurrent C. difficile infection, highlights knowledge gaps, and proposes future research directions in the field.

Factors that influence FMT’s effectiveness and the potential the procedure holds for treatment of other diseases associated with gut dysbiosis are the subject of a review of 149 studies by a team of researchers led by Serena Porcari, MD, a gastroenterologist at the Fondazione Policlinico Universitario Gemelli and Università Cattolica del Sacro Cuore, in Rome.

“Our main goal was not only to unravel the different mechanisms of FMT efficacy but also to introduce some mindset shifts that are needed to bring FMT forward, mainly covering the gap that exists between basic scientists and clinicians,” Gianluca Ianiro, MD, PhD, a senior researcher in digestive diseases who works with Dr. Porcari and is the review’s lead author, told this news organization.
 

Engraftment may influence success

Engraftment of donor microbial strains in recipients appears to be key to the therapeutic success of FMT, both reviews note.

Three factors influence engraftment: the donor’s bacteria fitness relative to the recipient, the bacteria already present in the recipient, and whether antibiotics are used prior to FMT to open a niche for the incoming donor microbes, according to Dr. Yadegar and colleagues.

How to calculate strain engraftment has not yet been standardized in the field, and the number of strains detected in the recipient’s fecal sample is dependent on the depth of sequencing techniques, Dr. Porcari and colleagues note.

The use of whole-genome sequencing has enabled more precise evaluation of engraftment, they add.

“With this approach, microbial engraftment has been associated with clinical success, regardless of the disease, in a large metagenomic metanalysis of 24 FMT trials and almost 1,400 fecal samples,” Dr. Porcari and colleagues write. However, these results have not been replicated, likely because of differences between the studies.

More study on the topic is needed, both articles note.

“Because the recent metagenomics studies compared pre- and post-FMT only in cases with successful treatment outcomes, it is not possible to link engraftment to clinical outcomes,” Dr. Yadegar and colleagues write in their statement to this news organization.
 

A closer look at donor-recipient pairings

Clinicians usually enlist healthy, carefully screened individuals as FMT donors.

However, both research groups conclude that fine-scale taxonomic and metabolic analyses of donor and recipient microbiomes would better inform clinical decisions, especially when treating diseases other than C. difficile.

This may call for a more personalized approach to choosing donor-recipient pairings. Investigators should assess the patient’s diet and genetic background and how closely the donor’s microbiome matches that of the patient.

“Most studies focused on profiling stool samples before and after FMT without also including functional analyses; therefore, there are still a lot of aspects of host microbial interactions that remain unknown,” write Dr. Yadegar and colleagues in their statement.

Ecologic factors, including diet and host genetics, are often not included in clinical studies of C. difficile, but they “may potentially be the missing links” to treatment failure in the small portion of patients whose condition doesn’t respond to FMT, they write.

Pairing donor-recipient combinations on the basis of dietary patterns and preferences could improve FMT efficacy because the donor microbiota would be preadapted to the recipient’s diet, Dr. Yadegar and colleagues write. The team is examining how donor and recipient diet may affect outcomes.

Dr. Porcari and colleagues add that while some studies support the existence of shared characteristics that make up super-donors, others found that the optimal donor is more patient specific. They call for personalized selection strategies that employ microbiome sequencing tools rather than a “one stool fits all” approach.

Currently, many clinicians aren’t familiar with microbiome sequencing and analysis, but they’ll need to be in the near future, note Dr. Porcari and colleagues.

“Identifying microbiome characteristics that maximize strain engraftment in the FMT will allow clinicians to select the best donor for each single patient,” they write.
 

The possible role of viruses and fungi

In FMT research, investigators tend to focus on the bacteria in the human microbiome. However, viruses and fungi also appear to play a role, both articles note.

“Other microbial kingdoms that inhabit the intestine should be taken into account when considering predictors of post-FMT microbial transfer,” write Dr. Porcari and colleagues.

Although few studies have examined the gut virome’s impact on FMT effectiveness against C. difficile, the existing research, although limited, indicates that bacteriophage viruses could play a role, Dr. Yadegar and colleagues note. For example, high levels of donor-derived Caudoviralesbacteriophages in recipients were associated with FMT efficacy in one preliminary study, they write.

In a small human study, fecal filtrate from healthy donors who had bacteriophages but no live bacteria successfully treated five patients with recurrent C. difficile infection, Dr. Yadegar and colleagues write.

“Therefore, the idea that viruses may play a role is very provocative,” write Dr. Yadegar’s team in their statement.

It’s important to note that these studies are associative, which means they can’t definitively answer the question of how or whether viruses play a role, Dr. Yadegar’s team added.

Researchers “know even less about how fungi may or may not play a role,” write Dr. Yadegar and colleagues. However, in early research that involved patients who had successfully undergone FMT for C. difficile, there was higher relative abundance of Saccharomyces and Aspergillus, whereas Candida, if prominent, may impede response, they write in their article.

Additionally, to explore whether live bacteria are necessary for FMT to work, Dr. Yadegar and colleagues informed this news organization that they are conducting a study “comparing traditional FMT to a fecal filtrate that contains no live bacteria, but has all other components, to see if we can achieve similar success rates in recurrent C. difficile infection.”
 

Repeat treatment for sustained response

Dr. Yadegar’s team offered another important takeaway: A single FMT treatment will not sustain a positive response, especially when treating chronic noncommunicable conditions in which intestinal dysbiosis may play a role. Repeat treatment will be needed, as with other chronic conditions. This has been shown even in C. difficile infection.

“Recent studies have documented a significant advantage of repeated FMT over single FMT on the cure rates of recurrent C. difficile,” especially for patients with inflammatory bowel disorder, Dr. Yadegar’s team told this news organization.

“What we don’t know is which patient is likely to respond to microbial-based therapy, or what the dose or frequency should be, or which bacteria are responsible for the effects,” Dr. Yadegar and team said.

Dr. Porcari and colleagues are examining whether FMT could be refined to improve its success against other diseases. This may involve selecting specific donors, monitoring the gut microbiome of both donors and recipients, or using a specific means of delivery, such as lyophilized capsules, Dr. Ianiro said.

A response to FMT for chronic, noncommunicable disorders typically is not sustained long term, note Dr. Porcari and colleagues. However, they add that “sequential transplants have been applied in this setting with promising results, suggesting that chronic modulation of the patient microbiome may be beneficial in noncommunicable chronic disorders.” Dr. Porcari and colleagues point to the success of repeated, long-term FMT in studies of patients with ulcerative colitis and irritable bowel syndrome.

The use of cutting-edge technologies for microbiome assessment and a change in the view of FMT as only an acute, single-use therapy could improve FMT protocols and outcomes for noncommunicable conditions, they write.
 

Expanding FMT beyond C. difficile

Dr. Yadegar and colleagues’ article “really breaks down what is known about the mechanisms of FMT in C. difficile infection, which is important as other live biotherapeutic products are developed,” Colleen Kelly, MD, an associate professor of medicine at Brown University in Providence, R.I., who was not involved with the reviews, said in an interview.

Dr. Yadegar and colleagues concur. They note in a press release that as the mechanisms behind FMT success are understood, that information should be used to design new standardized therapies.

“Although highly effective, there are substantial drawbacks with [FMT], including infectious risks and sparse long-term safety data,” they write. “Better treatment options for recurrent C. difficile infections that are targeted, safe, and donor-independent are thus desired.”

In December 2022, the U.S. Food and Drug Administration approved the first fecal microbiota product, Rebyota, to prevent recurrence of C. difficile. More recently, in April 2023, the FDA approved Vowst, a pill for treating recurrent C. difficile infections.

Dr. Kelly also noted that the article by Dr. Yadegar and colleagues “may help us understand why a small percentage of patients fail to achieve cure after FMT.”

Regarding Dr. Porcari and colleagues’ article, Dr. Kelly said, “There is a lot of hope that FMT or other gut microbiome therapies will be beneficial for conditions outside of C. difficile.

“They do a good job reviewing the state of the science of FMT and highlight the many unknowns around the use of FMT in conditions outside of C. difficile,” added Dr. Kelly, who has been using FMT to treat C. difficile for more than 15 years.

Data supporting FMT for conditions such as ulcerative colitis and autism are compelling, Dr. Kelly acknowledged. But in her view, FMT isn’t ready for “prime time” outside of C. difficile – at least not yet.

“Academic investigators and those in industry are actively conducting research in many non–C. difficile indications, and I predict we will see the emergence of gut microbiome–based therapies for other indications within the next 5-10 years,” Dr. Kelly said.

Dr. Yadegar reports no relevant financial relationships. One coauthor of the Yadegar study has served on the adjudication board for Finch Therapeutics and has received consulting fees and a speaking honorarium from Rebiotix/Ferring Pharmaceuticals. Dr. Ianiro reports no relevant financial relationships. Dr. Kelly has consulted for Sebela Pharmaceuticals and is one of the principal investigators for the FMT National Patient Registry funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

A version of this article originally appeared on Medscape.com.

Kadirawel Iswara, MD’s accomplishments go far beyond gastroenterology into humanitarian pursuits.

After the 2004 Indian Ocean earthquake and tsunami, he traveled to his home country of Sri Lanka to help people who were in need and establish an orphanage. He has applied his skills as a gastroenterologist in the U.S. military and the New York City Police Department.

Question: What gives you joy in day-to-day practice?

Dr. Iswara: One of the main joys is my colleagues, coworkers, fellows, and my patients. The patients come No. 1. As I walk into my practice area or in the hospital, there is a sense of inner happiness in my mind to see the smiles of the patients and the greetings I get from the patients and all the coworkers. I also see smiling patients with anxiety in their face, trying to get my attention to take care of them.

After I see the patient, I change to a different mode, a kind of a professional mode to give the best to the people whom I’m caring for, who are trusting me with their lives.

One thing I do in my mind before I even start the day, I do a silent prayer to guide me, to give compassionate care and safe care. I will not harm anyone who is depending on my care.
 

Q: Who was your mentor?

Dr. Iswara: I was lucky enough to have been trained by Baroukh El Kodsi, MD, at Maimonides Medical Center. He recently passed away and was a legend in Brooklyn. I was his first-generation trainee, and I was able to pass on my skills to my trainees. Now so many people who are in Brooklyn; they were trained by me, so it’s kind of growth by generations.

When I finished the training with Dr. Kodsi, he hired me as an associate director of the GI department at Maimonides. I became the program director, then division chief, then I became a director of advanced endoscopy. All these gastroenterology procedures started after 1975 while I was doing the training, so I was one of the pioneers to bring all this new technology to our hospital. I’m still involved in fellowship education.
 

Q: Can we talk more about your accomplishments? Perhaps you can discuss your AGA award and what you received it for.

Dr. Iswara: I’m humbled and honored by this role, and I’ll be forever grateful to AGA for this prestigious honor at the late stage of my career.

I have been a continuous AGA member for the last 45 years. I probably have one of the longest durations of being an actively practicing gastroenterologist in Brooklyn. I’ve also done academic work, teaching so many young gastroenterologists, motivating several of them to become leading gastroenterologists.
 

Q: If you could describe a scene of your vision for the future, what it would it be in terms of how gastroenterology is practiced?

Dr. Iswara: I’d like to see the newer generation practice more of a clinical medicine than technical medicine. Sometimes when I see the young people, they sit in front of the computer more than talking and touching the patient. There has to be some sort of a balance where the newer people should be taught more bedside personal care, touching the patient, looking at the patient’s face. They are kind of under pressure to write longer notes than to examine the patient, so I think this has to change.

Q: Describe how you would spend a free Saturday afternoon.

Dr. Iswara: When I was in the military, I was told that to prevent battle fatigue you had to take a rest. I really try to take a rest almost 2 hours every day in the daytime. This rejuvenates me.

We live in New York, and I love to go to shows, especially magic shows. I love magic and illusion. 

On free Saturday evenings, I also spend time with my grandchildren in the city, watching them in their baseball, soccer, swimming, and other activities. I love to spend time with them.
 

Lightning round

Texting or talking?
Texting

Favorite city in the U.S. besides the one you live?
Naples, Fla.

Favorite breakfast?
Pancakes

Dark Chocolate or milk chocolate?
Cadbury from England

Last movie you watched?
“To Sir, With Love”

Kadirawel Iswara, MD’s accomplishments go far beyond gastroenterology into humanitarian pursuits.

After the 2004 Indian Ocean earthquake and tsunami, he traveled to his home country of Sri Lanka to help people who were in need and establish an orphanage. He has applied his skills as a gastroenterologist in the U.S. military and the New York City Police Department.

Question: What gives you joy in day-to-day practice?

Dr. Iswara: One of the main joys is my colleagues, coworkers, fellows, and my patients. The patients come No. 1. As I walk into my practice area or in the hospital, there is a sense of inner happiness in my mind to see the smiles of the patients and the greetings I get from the patients and all the coworkers. I also see smiling patients with anxiety in their face, trying to get my attention to take care of them.

After I see the patient, I change to a different mode, a kind of a professional mode to give the best to the people whom I’m caring for, who are trusting me with their lives.

One thing I do in my mind before I even start the day, I do a silent prayer to guide me, to give compassionate care and safe care. I will not harm anyone who is depending on my care.
 

Q: Who was your mentor?

Dr. Iswara: I was lucky enough to have been trained by Baroukh El Kodsi, MD, at Maimonides Medical Center. He recently passed away and was a legend in Brooklyn. I was his first-generation trainee, and I was able to pass on my skills to my trainees. Now so many people who are in Brooklyn; they were trained by me, so it’s kind of growth by generations.

When I finished the training with Dr. Kodsi, he hired me as an associate director of the GI department at Maimonides. I became the program director, then division chief, then I became a director of advanced endoscopy. All these gastroenterology procedures started after 1975 while I was doing the training, so I was one of the pioneers to bring all this new technology to our hospital. I’m still involved in fellowship education.
 

Q: Can we talk more about your accomplishments? Perhaps you can discuss your AGA award and what you received it for.

Dr. Iswara: I’m humbled and honored by this role, and I’ll be forever grateful to AGA for this prestigious honor at the late stage of my career.

I have been a continuous AGA member for the last 45 years. I probably have one of the longest durations of being an actively practicing gastroenterologist in Brooklyn. I’ve also done academic work, teaching so many young gastroenterologists, motivating several of them to become leading gastroenterologists.
 

Q: If you could describe a scene of your vision for the future, what it would it be in terms of how gastroenterology is practiced?

Dr. Iswara: I’d like to see the newer generation practice more of a clinical medicine than technical medicine. Sometimes when I see the young people, they sit in front of the computer more than talking and touching the patient. There has to be some sort of a balance where the newer people should be taught more bedside personal care, touching the patient, looking at the patient’s face. They are kind of under pressure to write longer notes than to examine the patient, so I think this has to change.

Q: Describe how you would spend a free Saturday afternoon.

Dr. Iswara: When I was in the military, I was told that to prevent battle fatigue you had to take a rest. I really try to take a rest almost 2 hours every day in the daytime. This rejuvenates me.

We live in New York, and I love to go to shows, especially magic shows. I love magic and illusion. 

On free Saturday evenings, I also spend time with my grandchildren in the city, watching them in their baseball, soccer, swimming, and other activities. I love to spend time with them.
 

Lightning round

Texting or talking?
Texting

Favorite city in the U.S. besides the one you live?
Naples, Fla.

Favorite breakfast?
Pancakes

Dark Chocolate or milk chocolate?
Cadbury from England

Last movie you watched?
“To Sir, With Love”

Kadirawel Iswara, MD’s accomplishments go far beyond gastroenterology into humanitarian pursuits.

After the 2004 Indian Ocean earthquake and tsunami, he traveled to his home country of Sri Lanka to help people who were in need and establish an orphanage. He has applied his skills as a gastroenterologist in the U.S. military and the New York City Police Department.

Question: What gives you joy in day-to-day practice?

Dr. Iswara: One of the main joys is my colleagues, coworkers, fellows, and my patients. The patients come No. 1. As I walk into my practice area or in the hospital, there is a sense of inner happiness in my mind to see the smiles of the patients and the greetings I get from the patients and all the coworkers. I also see smiling patients with anxiety in their face, trying to get my attention to take care of them.

After I see the patient, I change to a different mode, a kind of a professional mode to give the best to the people whom I’m caring for, who are trusting me with their lives.

One thing I do in my mind before I even start the day, I do a silent prayer to guide me, to give compassionate care and safe care. I will not harm anyone who is depending on my care.
 

Q: Who was your mentor?

Dr. Iswara: I was lucky enough to have been trained by Baroukh El Kodsi, MD, at Maimonides Medical Center. He recently passed away and was a legend in Brooklyn. I was his first-generation trainee, and I was able to pass on my skills to my trainees. Now so many people who are in Brooklyn; they were trained by me, so it’s kind of growth by generations.

When I finished the training with Dr. Kodsi, he hired me as an associate director of the GI department at Maimonides. I became the program director, then division chief, then I became a director of advanced endoscopy. All these gastroenterology procedures started after 1975 while I was doing the training, so I was one of the pioneers to bring all this new technology to our hospital. I’m still involved in fellowship education.
 

Q: Can we talk more about your accomplishments? Perhaps you can discuss your AGA award and what you received it for.

Dr. Iswara: I’m humbled and honored by this role, and I’ll be forever grateful to AGA for this prestigious honor at the late stage of my career.

I have been a continuous AGA member for the last 45 years. I probably have one of the longest durations of being an actively practicing gastroenterologist in Brooklyn. I’ve also done academic work, teaching so many young gastroenterologists, motivating several of them to become leading gastroenterologists.
 

Q: If you could describe a scene of your vision for the future, what it would it be in terms of how gastroenterology is practiced?

Dr. Iswara: I’d like to see the newer generation practice more of a clinical medicine than technical medicine. Sometimes when I see the young people, they sit in front of the computer more than talking and touching the patient. There has to be some sort of a balance where the newer people should be taught more bedside personal care, touching the patient, looking at the patient’s face. They are kind of under pressure to write longer notes than to examine the patient, so I think this has to change.

Q: Describe how you would spend a free Saturday afternoon.

Dr. Iswara: When I was in the military, I was told that to prevent battle fatigue you had to take a rest. I really try to take a rest almost 2 hours every day in the daytime. This rejuvenates me.

We live in New York, and I love to go to shows, especially magic shows. I love magic and illusion. 

On free Saturday evenings, I also spend time with my grandchildren in the city, watching them in their baseball, soccer, swimming, and other activities. I love to spend time with them.
 

Lightning round

Texting or talking?
Texting

Favorite city in the U.S. besides the one you live?
Naples, Fla.

Favorite breakfast?
Pancakes

Dark Chocolate or milk chocolate?
Cadbury from England

Last movie you watched?
“To Sir, With Love”

Sharmila Anandasabapathy, MD, knew she wanted to focus on endoscopy when she first started her career. Her passion would someday translate into a worldwide effort to expand and test this technology.

While leading an endoscopy unit in New York City, Dr. Anandasabapathy began developing endoscopic and imaging technologies for underresourced and underserved areas. These technologies eventually made their way into global clinical trials.

“We’ve gone to clinical trial in over 2,000 patients worldwide. When I made that jump into global GI, I was able to make that jump into global health in general,” said Dr. Anandasabapathy.

Baylor College of Medicine

As vice president for global programs at Baylor College of Medicine in Houston, Dr. Anandasabapathy currently focuses on clinical and translational research.

“We’re looking at the development of new, low-cost devices for early cancer detection in GI globally. I oversee our global programs across the whole college, so it’s GI, it’s surgery, it’s anesthesia, it’s obstetrics, it’s everything.”

In an interview, Dr. Anandasabapathy discussed what attracted her to gastroenterology and why she always takes the time to smile at her patients.
 

Q: Why did you choose GI? 

A: There’s two questions in there: Why I chose GI and why I chose endoscopy.

I chose GI because when I was in my internal medicine training, they seemed like the happiest people in the hospital. They liked what they did. You could make a meaningful impact even at 3 a.m. if you were coming in for a variceal bleed. Everybody seemed happy with their choice of specialty. I was ready to be an oncologist, and I ended up becoming a gastroenterologist.

I chose endoscopy because it was where I wanted to be when I woke up in the morning. I was happy there. I love the procedures; I love the hand-eye coordination. I liked the fact that these were relatively shorter procedures, that it was technology based, and there was infinite growth.
 

Q: Was there a time when you really helped a patient by doing that endoscopy, preventing Barrett’s esophagus or even cancer?

A: I can think of several times where we had early cancers and it was a question between endoscopic treatment or surgery. It was always discussed with the surgeons. We made the decision within a multidisciplinary group and with the patient, but we usually went with the endoscopic options and the patients have done great. We’ve given them a greater quality of life, and I think that’s really rewarding.

Q: What gives you the most joy in your day-to-day practice?

A: My patients. I work with Barrett’s esophagus patients, and they tend to be well informed about the research and the science. I’m lucky to have a patient population that is really interested and willing to participate in that. I also like my students, my junior faculty. I like teaching and the global application of teaching.

Q: What fears did you have to push past to get to where you are in your career?

A: That I would never become an independent researcher and do it alone. I was able to, over time. The ability to transition from being independent to teaching others and making them independent is a wonderful one.

Early on when I was doing GI, I remember looking at my division, and there were about 58 gastroenterologists and only 2 women. I thought at the time, “Well, can I do it? Is this a field that is conducive with being a woman and having a family?” It turned out that it is. Today, I’m really gratified to see that there are more women in GI than there ever were before.
 

Q: Have you ever received advice that you’ve ignored?A: Yes. Early in my training in internal medicine, I was told that I smiled too much and that my personality was such that patients and others would think I was too glib. Medicine was a serious business, and you shouldn’t be smiling. That’s not my personality – I’m not Eeyore. I think it’s served me well to be positive, and it’s served me well with patients to be smiling. Especially when you’re dealing with patients who have precancer or dysplasia and are scared – they want reassurance and they want a level of confidence. I’m glad I ignored that advice.

Q: What would be your advice to medical students?

A: Think about where you want to be when you wake up in the morning. If it’s either in a GI practice or doing GI research or doing endoscopy, then you should absolutely do it.

Lightning round

Cat person or dog person

Dog



Favorite sport

Tennis



What song do you have to sing along with when you hear it?

Dancing Queen



Favorite music genre

1980s pop



Favorite movie, show, or book

Wuthering Heights
 

Dr. Anandasabapathy is on LinkedIn and on Twitter at @anandasabapathy , @bcmglobalhealth , and @bcm_gihep .

Sharmila Anandasabapathy, MD, knew she wanted to focus on endoscopy when she first started her career. Her passion would someday translate into a worldwide effort to expand and test this technology.

While leading an endoscopy unit in New York City, Dr. Anandasabapathy began developing endoscopic and imaging technologies for underresourced and underserved areas. These technologies eventually made their way into global clinical trials.

“We’ve gone to clinical trial in over 2,000 patients worldwide. When I made that jump into global GI, I was able to make that jump into global health in general,” said Dr. Anandasabapathy.

Baylor College of Medicine

As vice president for global programs at Baylor College of Medicine in Houston, Dr. Anandasabapathy currently focuses on clinical and translational research.

“We’re looking at the development of new, low-cost devices for early cancer detection in GI globally. I oversee our global programs across the whole college, so it’s GI, it’s surgery, it’s anesthesia, it’s obstetrics, it’s everything.”

In an interview, Dr. Anandasabapathy discussed what attracted her to gastroenterology and why she always takes the time to smile at her patients.
 

Q: Why did you choose GI? 

A: There’s two questions in there: Why I chose GI and why I chose endoscopy.

I chose GI because when I was in my internal medicine training, they seemed like the happiest people in the hospital. They liked what they did. You could make a meaningful impact even at 3 a.m. if you were coming in for a variceal bleed. Everybody seemed happy with their choice of specialty. I was ready to be an oncologist, and I ended up becoming a gastroenterologist.

I chose endoscopy because it was where I wanted to be when I woke up in the morning. I was happy there. I love the procedures; I love the hand-eye coordination. I liked the fact that these were relatively shorter procedures, that it was technology based, and there was infinite growth.
 

Q: Was there a time when you really helped a patient by doing that endoscopy, preventing Barrett’s esophagus or even cancer?

A: I can think of several times where we had early cancers and it was a question between endoscopic treatment or surgery. It was always discussed with the surgeons. We made the decision within a multidisciplinary group and with the patient, but we usually went with the endoscopic options and the patients have done great. We’ve given them a greater quality of life, and I think that’s really rewarding.

Q: What gives you the most joy in your day-to-day practice?

A: My patients. I work with Barrett’s esophagus patients, and they tend to be well informed about the research and the science. I’m lucky to have a patient population that is really interested and willing to participate in that. I also like my students, my junior faculty. I like teaching and the global application of teaching.

Q: What fears did you have to push past to get to where you are in your career?

A: That I would never become an independent researcher and do it alone. I was able to, over time. The ability to transition from being independent to teaching others and making them independent is a wonderful one.

Early on when I was doing GI, I remember looking at my division, and there were about 58 gastroenterologists and only 2 women. I thought at the time, “Well, can I do it? Is this a field that is conducive with being a woman and having a family?” It turned out that it is. Today, I’m really gratified to see that there are more women in GI than there ever were before.
 

Q: Have you ever received advice that you’ve ignored?A: Yes. Early in my training in internal medicine, I was told that I smiled too much and that my personality was such that patients and others would think I was too glib. Medicine was a serious business, and you shouldn’t be smiling. That’s not my personality – I’m not Eeyore. I think it’s served me well to be positive, and it’s served me well with patients to be smiling. Especially when you’re dealing with patients who have precancer or dysplasia and are scared – they want reassurance and they want a level of confidence. I’m glad I ignored that advice.

Q: What would be your advice to medical students?

A: Think about where you want to be when you wake up in the morning. If it’s either in a GI practice or doing GI research or doing endoscopy, then you should absolutely do it.

Lightning round

Cat person or dog person

Dog



Favorite sport

Tennis



What song do you have to sing along with when you hear it?

Dancing Queen



Favorite music genre

1980s pop



Favorite movie, show, or book

Wuthering Heights
 

Dr. Anandasabapathy is on LinkedIn and on Twitter at @anandasabapathy , @bcmglobalhealth , and @bcm_gihep .

Sharmila Anandasabapathy, MD, knew she wanted to focus on endoscopy when she first started her career. Her passion would someday translate into a worldwide effort to expand and test this technology.

While leading an endoscopy unit in New York City, Dr. Anandasabapathy began developing endoscopic and imaging technologies for underresourced and underserved areas. These technologies eventually made their way into global clinical trials.

“We’ve gone to clinical trial in over 2,000 patients worldwide. When I made that jump into global GI, I was able to make that jump into global health in general,” said Dr. Anandasabapathy.

Baylor College of Medicine

As vice president for global programs at Baylor College of Medicine in Houston, Dr. Anandasabapathy currently focuses on clinical and translational research.

“We’re looking at the development of new, low-cost devices for early cancer detection in GI globally. I oversee our global programs across the whole college, so it’s GI, it’s surgery, it’s anesthesia, it’s obstetrics, it’s everything.”

In an interview, Dr. Anandasabapathy discussed what attracted her to gastroenterology and why she always takes the time to smile at her patients.
 

Q: Why did you choose GI? 

A: There’s two questions in there: Why I chose GI and why I chose endoscopy.

I chose GI because when I was in my internal medicine training, they seemed like the happiest people in the hospital. They liked what they did. You could make a meaningful impact even at 3 a.m. if you were coming in for a variceal bleed. Everybody seemed happy with their choice of specialty. I was ready to be an oncologist, and I ended up becoming a gastroenterologist.

I chose endoscopy because it was where I wanted to be when I woke up in the morning. I was happy there. I love the procedures; I love the hand-eye coordination. I liked the fact that these were relatively shorter procedures, that it was technology based, and there was infinite growth.
 

Q: Was there a time when you really helped a patient by doing that endoscopy, preventing Barrett’s esophagus or even cancer?

A: I can think of several times where we had early cancers and it was a question between endoscopic treatment or surgery. It was always discussed with the surgeons. We made the decision within a multidisciplinary group and with the patient, but we usually went with the endoscopic options and the patients have done great. We’ve given them a greater quality of life, and I think that’s really rewarding.

Q: What gives you the most joy in your day-to-day practice?

A: My patients. I work with Barrett’s esophagus patients, and they tend to be well informed about the research and the science. I’m lucky to have a patient population that is really interested and willing to participate in that. I also like my students, my junior faculty. I like teaching and the global application of teaching.

Q: What fears did you have to push past to get to where you are in your career?

A: That I would never become an independent researcher and do it alone. I was able to, over time. The ability to transition from being independent to teaching others and making them independent is a wonderful one.

Early on when I was doing GI, I remember looking at my division, and there were about 58 gastroenterologists and only 2 women. I thought at the time, “Well, can I do it? Is this a field that is conducive with being a woman and having a family?” It turned out that it is. Today, I’m really gratified to see that there are more women in GI than there ever were before.
 

Q: Have you ever received advice that you’ve ignored?A: Yes. Early in my training in internal medicine, I was told that I smiled too much and that my personality was such that patients and others would think I was too glib. Medicine was a serious business, and you shouldn’t be smiling. That’s not my personality – I’m not Eeyore. I think it’s served me well to be positive, and it’s served me well with patients to be smiling. Especially when you’re dealing with patients who have precancer or dysplasia and are scared – they want reassurance and they want a level of confidence. I’m glad I ignored that advice.

Q: What would be your advice to medical students?

A: Think about where you want to be when you wake up in the morning. If it’s either in a GI practice or doing GI research or doing endoscopy, then you should absolutely do it.

Lightning round

Cat person or dog person

Dog



Favorite sport

Tennis



What song do you have to sing along with when you hear it?

Dancing Queen



Favorite music genre

1980s pop



Favorite movie, show, or book

Wuthering Heights
 

Dr. Anandasabapathy is on LinkedIn and on Twitter at @anandasabapathy , @bcmglobalhealth , and @bcm_gihep .

Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.

“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”

Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.

“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”

He discussed the events that led to this career change in an interview with GI & Hepatology News.
 

Q: Why did you choose GI?

Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.

Q: What gives you the most joy in your day-to-day practice?

Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.

Q: Describe your biggest practice-related challenge and what you are doing to address it.

Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.

Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
 

Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.

Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.

I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
 

Q: What teacher or mentor had the greatest impact on you?

Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.

Q: What habits have you established that have benefited your career most?

Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.

Lightening round

Superpower?

Optimism

Favorite movie to quote?

The Big Lebowski

What is your favorite form of exercise? 

Elliptical

Name one thing on your bucket list.

Ethiopia travel

How many cups of coffee do you drink per day?

Two-ish

Dr. Leffler is on LinkedIn.

Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.

“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”

Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.

“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”

He discussed the events that led to this career change in an interview with GI & Hepatology News.
 

Q: Why did you choose GI?

Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.

Q: What gives you the most joy in your day-to-day practice?

Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.

Q: Describe your biggest practice-related challenge and what you are doing to address it.

Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.

Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
 

Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.

Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.

I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
 

Q: What teacher or mentor had the greatest impact on you?

Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.

Q: What habits have you established that have benefited your career most?

Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.

Lightening round

Superpower?

Optimism

Favorite movie to quote?

The Big Lebowski

What is your favorite form of exercise? 

Elliptical

Name one thing on your bucket list.

Ethiopia travel

How many cups of coffee do you drink per day?

Two-ish

Dr. Leffler is on LinkedIn.

Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.

“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”

Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.

“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”

He discussed the events that led to this career change in an interview with GI & Hepatology News.
 

Q: Why did you choose GI?

Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.

Q: What gives you the most joy in your day-to-day practice?

Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.

Q: Describe your biggest practice-related challenge and what you are doing to address it.

Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.

Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
 

Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.

Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.

I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
 

Q: What teacher or mentor had the greatest impact on you?

Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.

Q: What habits have you established that have benefited your career most?

Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.

Lightening round

Superpower?

Optimism

Favorite movie to quote?

The Big Lebowski

What is your favorite form of exercise? 

Elliptical

Name one thing on your bucket list.

Ethiopia travel

How many cups of coffee do you drink per day?

Two-ish

Dr. Leffler is on LinkedIn.

Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.

“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.

The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”

He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”

The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.

It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.

Kaiser Permanente

Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
 

Insurance often drives the conversation

The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.

Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.

Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.

Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”

However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.

This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.

But not all physicians are quick to prescribe biosimilars.

Julie Miller Photography

Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”

Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
 

Conversations about cost

Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.

If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.

Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.

Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”

Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.

“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.

Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”

For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.

Biosimilars 101: Familiarizing patients

Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.

Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.

Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar. 

rubberball/Getty Images

As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.

When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.

Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.

In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
 

A village approach to education

When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.

The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar. 

This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”

Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”

Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.

No consensus on interchangeability

Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.

If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.

The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.

In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).

“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.

Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”

Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.

“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
 

Resources for physicians, patients

The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.

The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.

Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.

“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.

Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.

Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.

A version of this article originally appeared on Medscape.com.

Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.

“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.

The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”

He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”

The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.

It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.

Kaiser Permanente

Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
 

Insurance often drives the conversation

The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.

Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.

Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.

Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”

However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.

This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.

But not all physicians are quick to prescribe biosimilars.

Julie Miller Photography

Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”

Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
 

Conversations about cost

Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.

If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.

Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.

Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”

Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.

“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.

Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”

For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.

Biosimilars 101: Familiarizing patients

Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.

Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.

Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar. 

rubberball/Getty Images

As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.

When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.

Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.

In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
 

A village approach to education

When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.

The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar. 

This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”

Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”

Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.

No consensus on interchangeability

Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.

If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.

The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.

In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).

“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.

Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”

Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.

“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
 

Resources for physicians, patients

The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.

The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.

Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.

“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.

Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.

Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.

A version of this article originally appeared on Medscape.com.

Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.

“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.

The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”

He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”

The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.

It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.

Kaiser Permanente

Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
 

Insurance often drives the conversation

The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.

Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.

Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.

Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”

However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.

This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.

But not all physicians are quick to prescribe biosimilars.

Julie Miller Photography

Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”

Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
 

Conversations about cost

Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.

If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.

Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.

Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”

Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.

“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.

Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”

For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.

Biosimilars 101: Familiarizing patients

Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.

Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.

Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar. 

rubberball/Getty Images

As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.

When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.

Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.

In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
 

A village approach to education

When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.

The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar. 

This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”

Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”

Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.

No consensus on interchangeability

Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.

If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.

The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.

In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).

“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.

Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”

Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.

“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
 

Resources for physicians, patients

The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.

The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.

Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.

“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.

Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.

Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.

A version of this article originally appeared on Medscape.com.

Someone once told Christina Tennyson, MD, that clinical medicine was a grind. Instead of veering away from the profession, she dove in. Medicine will always have its frustrations, she acknowledged.

However, “finding areas that interest me and incorporating those into clinical practice has really helped me enjoy the practice of medicine,” said Dr. Tennyson, who works at Augusta Health in Fishersville, Va.

Firefly Photography

It has also inspired her to think outside the box in her gastroenterology practice. What her patients eat and the lifestyle choices they make is a central focus of her work. In an interview, she talked about the rewards and challenges of practicing medicine in a rural area and embracing lifestyle medicine to improve the health of patients with digestive diseases.

Q: Why did you choose GI?
Dr. Tennyson: I always had an interest in nutrition. During training at medical school at NYU [New York University], I also really loved learning all I could about internal medicine. I worked with a great surgical team as a student and enjoyed being in the operating room. Although I knew I didn’t want to enter surgery, the experience encouraged me to pursue gastroenterology as it involved nutrition, internal medicine, and procedures as well as my favorite organ, the small bowel. I worked with some great mentors in gastroenterology, such as Dr. David Metz and Dr. Dave Katzka, at the University of Pennsylvania as a resident. I enjoyed taking care of patients with both acute and chronic conditions as well as the mix of doing procedures and seeing patients in the office. It also provided me the opportunity to incorporate nutrition into my clinical practice.

Q: What gives you the most joy in your day-to-day practice?
Dr. Tennyson: I enjoy helping my patients make meaningful lifestyle changes that can positively impact digestive health and well-being. I try to address topics related to lifestyle medicine in most of my clinical visits including eating more fiber/plants, exercise, positive relationships, and stress management. Many of the conditions we treat as gastroenterologists can benefit from addressing aspects of lifestyle along with our conventional medical therapies. I reinforce that attention to these areas can make a difference. I enjoy sharing recipes, books, and websites that I have found helpful.

Q: How has your job changed since you first began your career?
Dr. Tennyson: After fellowship, I joined the faculty at Columbia University and worked at the Celiac Disease Center seeing patients, teaching, and performing clinical research under the mentorship of Peter Green, MD, and Suzanne Lewis, MD. It was a great opportunity to learn and practice in a tertiary center. I later switched roles and joined a general multispecialty community practice in Brooklyn [N.Y.] affiliated with an academic medical center. After practicing in New York for 10 years, I left my clinical practice and performed locums work for several years in underserved rural areas. I enjoyed working in rural areas and took a permanent position at a community hospital in Virginia’s Shenandoah Valley.

Lightning round

What's your superpower? 
Finding fun in mundane things

Favorite movie to quote? 
The Princess Bride

What is your favorite form of exercise? 
A hike in the woods 

Name one thing on your bucket list. 
Galapagos Islands trip before my kids grow up 

Cats or dogs? 
Dogs

Summer or winter? 
Summer

Someone once told Christina Tennyson, MD, that clinical medicine was a grind. Instead of veering away from the profession, she dove in. Medicine will always have its frustrations, she acknowledged.

However, “finding areas that interest me and incorporating those into clinical practice has really helped me enjoy the practice of medicine,” said Dr. Tennyson, who works at Augusta Health in Fishersville, Va.

Firefly Photography

It has also inspired her to think outside the box in her gastroenterology practice. What her patients eat and the lifestyle choices they make is a central focus of her work. In an interview, she talked about the rewards and challenges of practicing medicine in a rural area and embracing lifestyle medicine to improve the health of patients with digestive diseases.

Q: Why did you choose GI?
Dr. Tennyson: I always had an interest in nutrition. During training at medical school at NYU [New York University], I also really loved learning all I could about internal medicine. I worked with a great surgical team as a student and enjoyed being in the operating room. Although I knew I didn’t want to enter surgery, the experience encouraged me to pursue gastroenterology as it involved nutrition, internal medicine, and procedures as well as my favorite organ, the small bowel. I worked with some great mentors in gastroenterology, such as Dr. David Metz and Dr. Dave Katzka, at the University of Pennsylvania as a resident. I enjoyed taking care of patients with both acute and chronic conditions as well as the mix of doing procedures and seeing patients in the office. It also provided me the opportunity to incorporate nutrition into my clinical practice.

Q: What gives you the most joy in your day-to-day practice?
Dr. Tennyson: I enjoy helping my patients make meaningful lifestyle changes that can positively impact digestive health and well-being. I try to address topics related to lifestyle medicine in most of my clinical visits including eating more fiber/plants, exercise, positive relationships, and stress management. Many of the conditions we treat as gastroenterologists can benefit from addressing aspects of lifestyle along with our conventional medical therapies. I reinforce that attention to these areas can make a difference. I enjoy sharing recipes, books, and websites that I have found helpful.

Q: How has your job changed since you first began your career?
Dr. Tennyson: After fellowship, I joined the faculty at Columbia University and worked at the Celiac Disease Center seeing patients, teaching, and performing clinical research under the mentorship of Peter Green, MD, and Suzanne Lewis, MD. It was a great opportunity to learn and practice in a tertiary center. I later switched roles and joined a general multispecialty community practice in Brooklyn [N.Y.] affiliated with an academic medical center. After practicing in New York for 10 years, I left my clinical practice and performed locums work for several years in underserved rural areas. I enjoyed working in rural areas and took a permanent position at a community hospital in Virginia’s Shenandoah Valley.

Lightning round

What's your superpower? 
Finding fun in mundane things

Favorite movie to quote? 
The Princess Bride

What is your favorite form of exercise? 
A hike in the woods 

Name one thing on your bucket list. 
Galapagos Islands trip before my kids grow up 

Cats or dogs? 
Dogs

Summer or winter? 
Summer

Someone once told Christina Tennyson, MD, that clinical medicine was a grind. Instead of veering away from the profession, she dove in. Medicine will always have its frustrations, she acknowledged.

However, “finding areas that interest me and incorporating those into clinical practice has really helped me enjoy the practice of medicine,” said Dr. Tennyson, who works at Augusta Health in Fishersville, Va.

Firefly Photography

It has also inspired her to think outside the box in her gastroenterology practice. What her patients eat and the lifestyle choices they make is a central focus of her work. In an interview, she talked about the rewards and challenges of practicing medicine in a rural area and embracing lifestyle medicine to improve the health of patients with digestive diseases.

Q: Why did you choose GI?
Dr. Tennyson: I always had an interest in nutrition. During training at medical school at NYU [New York University], I also really loved learning all I could about internal medicine. I worked with a great surgical team as a student and enjoyed being in the operating room. Although I knew I didn’t want to enter surgery, the experience encouraged me to pursue gastroenterology as it involved nutrition, internal medicine, and procedures as well as my favorite organ, the small bowel. I worked with some great mentors in gastroenterology, such as Dr. David Metz and Dr. Dave Katzka, at the University of Pennsylvania as a resident. I enjoyed taking care of patients with both acute and chronic conditions as well as the mix of doing procedures and seeing patients in the office. It also provided me the opportunity to incorporate nutrition into my clinical practice.

Q: What gives you the most joy in your day-to-day practice?
Dr. Tennyson: I enjoy helping my patients make meaningful lifestyle changes that can positively impact digestive health and well-being. I try to address topics related to lifestyle medicine in most of my clinical visits including eating more fiber/plants, exercise, positive relationships, and stress management. Many of the conditions we treat as gastroenterologists can benefit from addressing aspects of lifestyle along with our conventional medical therapies. I reinforce that attention to these areas can make a difference. I enjoy sharing recipes, books, and websites that I have found helpful.

Q: How has your job changed since you first began your career?
Dr. Tennyson: After fellowship, I joined the faculty at Columbia University and worked at the Celiac Disease Center seeing patients, teaching, and performing clinical research under the mentorship of Peter Green, MD, and Suzanne Lewis, MD. It was a great opportunity to learn and practice in a tertiary center. I later switched roles and joined a general multispecialty community practice in Brooklyn [N.Y.] affiliated with an academic medical center. After practicing in New York for 10 years, I left my clinical practice and performed locums work for several years in underserved rural areas. I enjoyed working in rural areas and took a permanent position at a community hospital in Virginia’s Shenandoah Valley.

Lightning round

What's your superpower? 
Finding fun in mundane things

Favorite movie to quote? 
The Princess Bride

What is your favorite form of exercise? 
A hike in the woods 

Name one thing on your bucket list. 
Galapagos Islands trip before my kids grow up 

Cats or dogs? 
Dogs

Summer or winter? 
Summer

Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.

Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.

Even with more drugs to choose from, some gastroenterologists may be hesitant to make a switch. “Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.

Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status?  How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.

Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.

Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”

Others are skeptical that the adalimumab biosimilars will save patients much money.

Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.

Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
 

2023 broadens scope of adalimumab treatments

The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.

AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.

“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.

The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product. 

The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).

“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.

At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.

Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.

An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”

FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
 

Remicade as a yardstick

Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.

Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.

Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.

Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.

For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.

However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.

“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.

Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.

A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.

If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.

Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.

“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.

Insurance will guide treatment

Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.

Patients should consult with their providers and insurance companies to see what therapies are available, he advised.

Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.

Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.

In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.

A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.

Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.

Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.

As a community physician, Dr. Oldfield has specific concerns about accessibility.

The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.

When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.

“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.

Landscape on cost is uncertain

At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.

At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.

Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.

Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.

The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.

AbbVie did not respond to several requests for comment.

Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.

Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.

Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.

“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”

Educating, advising patients

Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.

Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.

Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”

The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.

It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.

Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.

Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at  gastro.org/biosimilars .

Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.

Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.

Even with more drugs to choose from, some gastroenterologists may be hesitant to make a switch. “Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.

Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status?  How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.

Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.

Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”

Others are skeptical that the adalimumab biosimilars will save patients much money.

Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.

Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
 

2023 broadens scope of adalimumab treatments

The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.

AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.

“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.

The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product. 

The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).

“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.

At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.

Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.

An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”

FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
 

Remicade as a yardstick

Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.

Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.

Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.

Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.

For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.

However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.

“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.

Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.

A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.

If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.

Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.

“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.

Insurance will guide treatment

Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.

Patients should consult with their providers and insurance companies to see what therapies are available, he advised.

Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.

Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.

In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.

A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.

Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.

Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.

As a community physician, Dr. Oldfield has specific concerns about accessibility.

The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.

When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.

“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.

Landscape on cost is uncertain

At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.

At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.

Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.

Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.

The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.

AbbVie did not respond to several requests for comment.

Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.

Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.

Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.

“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”

Educating, advising patients

Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.

Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.

Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”

The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.

It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.

Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.

Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at  gastro.org/biosimilars .

Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.

Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.

Even with more drugs to choose from, some gastroenterologists may be hesitant to make a switch. “Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.

Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status?  How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.

Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.

Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”

Others are skeptical that the adalimumab biosimilars will save patients much money.

Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.

Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
 

2023 broadens scope of adalimumab treatments

The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.

AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.

“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.

The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product. 

The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).

“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.

At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.

Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.

An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”

FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
 

Remicade as a yardstick

Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.

Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.

Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.

Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.

For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.

However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.

“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.

Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.

A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.

If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.

Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.

“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.

Insurance will guide treatment

Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.

Patients should consult with their providers and insurance companies to see what therapies are available, he advised.

Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.

Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.

In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.

A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.

Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.

Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.

As a community physician, Dr. Oldfield has specific concerns about accessibility.

The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.

When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.

“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.

Landscape on cost is uncertain

At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.

At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.

Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.

Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.

The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.

AbbVie did not respond to several requests for comment.

Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.

Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.

Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.

“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”

Educating, advising patients

Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.

Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.

Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”

The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.

It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.

Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.

Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at  gastro.org/biosimilars .