This infographic is available in the PDF above.

This infographic is available in the PDF above.

This infographic is available in the PDF above.

A Washington Post article on depression after miscarriage is a reminder that, although couples can suffer deeply from such a loss, there still are ways to provide them with meaningful support (“After miscarriage, I was rocked by depression. Like many other women, I didn’t get follow-up care for this loss,” by Katie C. Reilly, Nov 30, 2019).

Carlo107/Getty Images

Psychiatrists who focus on reproductive psychiatry and collaborative care are trying to change the current therapeutic landscape and improve practitioner awareness and treatment. Ob.gyns. managing patients who have experienced reproductive loss, especially early-term loss, may not immediately refer couples to a therapist or psychiatrist, but we can change this. Practitioners who focus on reproductive health – both physical and mental – are trying to better understand such couples’ experiences, increase their access to care, develop preventative care strategies, and improve provider education.

At the outset, providers who treat patients who have experienced a perinatal loss must recognize that not all individuals will feel that a loss is tragic. Instead, patient reactions occur along a spectrum, and there is no “correct” way to process a loss. A couple’s reaction may depend on a variety of factors, including how late or early in pregnancy the loss occurs, whether the pregnancy is planned or unplanned, and what other psychosocial stressors, such as unstable housing, limited income, and few social supports, may exist. Not every patient experiencing grief, even profoundly, will shed tears; we need to be open to all potential reactions and be mindful when a person may need additional support.

According to the Washington Post article, even though 50% of miscarriages are due to chromosomal abnormalities, women still feel ultimately responsible for the loss. As a society we are bombarded with “experts” in the media telling us the best way, the right way, the healthiest way to live. This barrage of advice distorts our views of what it really means to be a good parent and subtly conveys the idea that mothers are solely responsible for any bad pregnancy outcomes. I remember being fearful of causing unintentional harm to my unborn baby during my own pregnancy. What if I accidentally ate something that would affect her development? Is exposure to second-hand smoke as I walk down the street harming her? How bad would it be if I just had one cup of coffee? My doubts caused quite a bit of distress for me, which is a mild form of the distress I see when counseling couples after their miscarriages.

The article’s author also expressed concern about the emotional sterility of the environment in which miscarriages usually occur: a hospital ED. EDs are designed to promote a level of detachment and to quell any stress for the clinicians so that they can calmly handle unexpected health crises. EDs are not primarily designed to provide patients with emotional support, nor should they be. However, we still can make some improvements to existing ED design to better address couples’ emotional needs. For example, some EDs have placed mental health clinicians on staff, others call patients post discharge to address concerns, and some EDs even provide patients access to mental health trauma teams. Such services are not found in all EDs, and even those that exist may just scratch the surface of what is needed, but they are a step in the right direction. Providing this level of auxiliary care directly from the ED increases patients’ ability to access mental health support in the place where miscarriages are most likely to be first diagnosed and managed.

The American College of Obstetricians and Gynecologists already is trying to fill in the missing pieces when it comes to identifying mood symptoms following miscarriage. One of the key recommendations from the May 2018 Committee Opinion on Redefining the Postpartum Visit is that every woman who has experienced a miscarriage, stillbirth, or neonatal death should receive follow-up care. Mental health is a suggested component of the postpartum care plan. Some outpatient ob.gyn. practices and inpatient units are using screening tools to identify postpartum depression. For example, the Edinburgh Postnatal Depression Scale can be utilized following a miscarriage to help providers identify symptoms of depression and anxiety.

However, advancements in screening practices are only the tip of the iceberg of helping patients following miscarriage. A major question is how do we provide treatment? The trend in psychiatry over the past decade has been toward collaborative care, models that embed psychiatrists and other mental health clinicians in ob.gyn. practices to help guide the diagnosis and treatment of mental health problems. Some psychiatrists practice a co-located model in which they see patients alongside their ob.gyn. colleagues, whereas other psychiatrists treat a larger number of patients by using chart reviews for medication management while relying on behavioral health care managers for counseling and monitoring. Using this model of mental health care, more patients have access to services that are provided in a location familiar to them.

Another step in the right direction is the October 2019 launch of The National Curriculum in Reproductive Psychiatry (NCRP), which provides free educational material for psychiatry faculty and residents to enhance education on topics related to reproductive psychiatry, including miscarriage, loss, and development of trauma disorders. NCRP aspires to develop educational materials for ob.gyn. residents.

In the past we may have missed the mark in recognizing and treating the trauma that prenatal loss can cause, but we are trying to improve our approaches. More and more couples are sharing their experiences and advocating for themselves and others, often creating change in medical practice, and doctors are starting to listen. As any clinician knows, changes to standards of care can take several years to disseminate into general practice, but this gap between knowledge and treatment is now in the forefront of our minds. I am hopeful that we will continue to make advances and provide better care to our patients who have endured the loss of a pregnancy.
 

Dr. Latorre is an assistant professor in the department of psychiatry at the University of Maryland School of Medicine. She has reported no relevant financial disclosures. Email her at obnews@mdedge.com.

A Washington Post article on depression after miscarriage is a reminder that, although couples can suffer deeply from such a loss, there still are ways to provide them with meaningful support (“After miscarriage, I was rocked by depression. Like many other women, I didn’t get follow-up care for this loss,” by Katie C. Reilly, Nov 30, 2019).

Carlo107/Getty Images

Psychiatrists who focus on reproductive psychiatry and collaborative care are trying to change the current therapeutic landscape and improve practitioner awareness and treatment. Ob.gyns. managing patients who have experienced reproductive loss, especially early-term loss, may not immediately refer couples to a therapist or psychiatrist, but we can change this. Practitioners who focus on reproductive health – both physical and mental – are trying to better understand such couples’ experiences, increase their access to care, develop preventative care strategies, and improve provider education.

At the outset, providers who treat patients who have experienced a perinatal loss must recognize that not all individuals will feel that a loss is tragic. Instead, patient reactions occur along a spectrum, and there is no “correct” way to process a loss. A couple’s reaction may depend on a variety of factors, including how late or early in pregnancy the loss occurs, whether the pregnancy is planned or unplanned, and what other psychosocial stressors, such as unstable housing, limited income, and few social supports, may exist. Not every patient experiencing grief, even profoundly, will shed tears; we need to be open to all potential reactions and be mindful when a person may need additional support.

According to the Washington Post article, even though 50% of miscarriages are due to chromosomal abnormalities, women still feel ultimately responsible for the loss. As a society we are bombarded with “experts” in the media telling us the best way, the right way, the healthiest way to live. This barrage of advice distorts our views of what it really means to be a good parent and subtly conveys the idea that mothers are solely responsible for any bad pregnancy outcomes. I remember being fearful of causing unintentional harm to my unborn baby during my own pregnancy. What if I accidentally ate something that would affect her development? Is exposure to second-hand smoke as I walk down the street harming her? How bad would it be if I just had one cup of coffee? My doubts caused quite a bit of distress for me, which is a mild form of the distress I see when counseling couples after their miscarriages.

The article’s author also expressed concern about the emotional sterility of the environment in which miscarriages usually occur: a hospital ED. EDs are designed to promote a level of detachment and to quell any stress for the clinicians so that they can calmly handle unexpected health crises. EDs are not primarily designed to provide patients with emotional support, nor should they be. However, we still can make some improvements to existing ED design to better address couples’ emotional needs. For example, some EDs have placed mental health clinicians on staff, others call patients post discharge to address concerns, and some EDs even provide patients access to mental health trauma teams. Such services are not found in all EDs, and even those that exist may just scratch the surface of what is needed, but they are a step in the right direction. Providing this level of auxiliary care directly from the ED increases patients’ ability to access mental health support in the place where miscarriages are most likely to be first diagnosed and managed.

The American College of Obstetricians and Gynecologists already is trying to fill in the missing pieces when it comes to identifying mood symptoms following miscarriage. One of the key recommendations from the May 2018 Committee Opinion on Redefining the Postpartum Visit is that every woman who has experienced a miscarriage, stillbirth, or neonatal death should receive follow-up care. Mental health is a suggested component of the postpartum care plan. Some outpatient ob.gyn. practices and inpatient units are using screening tools to identify postpartum depression. For example, the Edinburgh Postnatal Depression Scale can be utilized following a miscarriage to help providers identify symptoms of depression and anxiety.

However, advancements in screening practices are only the tip of the iceberg of helping patients following miscarriage. A major question is how do we provide treatment? The trend in psychiatry over the past decade has been toward collaborative care, models that embed psychiatrists and other mental health clinicians in ob.gyn. practices to help guide the diagnosis and treatment of mental health problems. Some psychiatrists practice a co-located model in which they see patients alongside their ob.gyn. colleagues, whereas other psychiatrists treat a larger number of patients by using chart reviews for medication management while relying on behavioral health care managers for counseling and monitoring. Using this model of mental health care, more patients have access to services that are provided in a location familiar to them.

Another step in the right direction is the October 2019 launch of The National Curriculum in Reproductive Psychiatry (NCRP), which provides free educational material for psychiatry faculty and residents to enhance education on topics related to reproductive psychiatry, including miscarriage, loss, and development of trauma disorders. NCRP aspires to develop educational materials for ob.gyn. residents.

In the past we may have missed the mark in recognizing and treating the trauma that prenatal loss can cause, but we are trying to improve our approaches. More and more couples are sharing their experiences and advocating for themselves and others, often creating change in medical practice, and doctors are starting to listen. As any clinician knows, changes to standards of care can take several years to disseminate into general practice, but this gap between knowledge and treatment is now in the forefront of our minds. I am hopeful that we will continue to make advances and provide better care to our patients who have endured the loss of a pregnancy.
 

Dr. Latorre is an assistant professor in the department of psychiatry at the University of Maryland School of Medicine. She has reported no relevant financial disclosures. Email her at obnews@mdedge.com.

A Washington Post article on depression after miscarriage is a reminder that, although couples can suffer deeply from such a loss, there still are ways to provide them with meaningful support (“After miscarriage, I was rocked by depression. Like many other women, I didn’t get follow-up care for this loss,” by Katie C. Reilly, Nov 30, 2019).

Carlo107/Getty Images

Psychiatrists who focus on reproductive psychiatry and collaborative care are trying to change the current therapeutic landscape and improve practitioner awareness and treatment. Ob.gyns. managing patients who have experienced reproductive loss, especially early-term loss, may not immediately refer couples to a therapist or psychiatrist, but we can change this. Practitioners who focus on reproductive health – both physical and mental – are trying to better understand such couples’ experiences, increase their access to care, develop preventative care strategies, and improve provider education.

At the outset, providers who treat patients who have experienced a perinatal loss must recognize that not all individuals will feel that a loss is tragic. Instead, patient reactions occur along a spectrum, and there is no “correct” way to process a loss. A couple’s reaction may depend on a variety of factors, including how late or early in pregnancy the loss occurs, whether the pregnancy is planned or unplanned, and what other psychosocial stressors, such as unstable housing, limited income, and few social supports, may exist. Not every patient experiencing grief, even profoundly, will shed tears; we need to be open to all potential reactions and be mindful when a person may need additional support.

According to the Washington Post article, even though 50% of miscarriages are due to chromosomal abnormalities, women still feel ultimately responsible for the loss. As a society we are bombarded with “experts” in the media telling us the best way, the right way, the healthiest way to live. This barrage of advice distorts our views of what it really means to be a good parent and subtly conveys the idea that mothers are solely responsible for any bad pregnancy outcomes. I remember being fearful of causing unintentional harm to my unborn baby during my own pregnancy. What if I accidentally ate something that would affect her development? Is exposure to second-hand smoke as I walk down the street harming her? How bad would it be if I just had one cup of coffee? My doubts caused quite a bit of distress for me, which is a mild form of the distress I see when counseling couples after their miscarriages.

The article’s author also expressed concern about the emotional sterility of the environment in which miscarriages usually occur: a hospital ED. EDs are designed to promote a level of detachment and to quell any stress for the clinicians so that they can calmly handle unexpected health crises. EDs are not primarily designed to provide patients with emotional support, nor should they be. However, we still can make some improvements to existing ED design to better address couples’ emotional needs. For example, some EDs have placed mental health clinicians on staff, others call patients post discharge to address concerns, and some EDs even provide patients access to mental health trauma teams. Such services are not found in all EDs, and even those that exist may just scratch the surface of what is needed, but they are a step in the right direction. Providing this level of auxiliary care directly from the ED increases patients’ ability to access mental health support in the place where miscarriages are most likely to be first diagnosed and managed.

The American College of Obstetricians and Gynecologists already is trying to fill in the missing pieces when it comes to identifying mood symptoms following miscarriage. One of the key recommendations from the May 2018 Committee Opinion on Redefining the Postpartum Visit is that every woman who has experienced a miscarriage, stillbirth, or neonatal death should receive follow-up care. Mental health is a suggested component of the postpartum care plan. Some outpatient ob.gyn. practices and inpatient units are using screening tools to identify postpartum depression. For example, the Edinburgh Postnatal Depression Scale can be utilized following a miscarriage to help providers identify symptoms of depression and anxiety.

However, advancements in screening practices are only the tip of the iceberg of helping patients following miscarriage. A major question is how do we provide treatment? The trend in psychiatry over the past decade has been toward collaborative care, models that embed psychiatrists and other mental health clinicians in ob.gyn. practices to help guide the diagnosis and treatment of mental health problems. Some psychiatrists practice a co-located model in which they see patients alongside their ob.gyn. colleagues, whereas other psychiatrists treat a larger number of patients by using chart reviews for medication management while relying on behavioral health care managers for counseling and monitoring. Using this model of mental health care, more patients have access to services that are provided in a location familiar to them.

Another step in the right direction is the October 2019 launch of The National Curriculum in Reproductive Psychiatry (NCRP), which provides free educational material for psychiatry faculty and residents to enhance education on topics related to reproductive psychiatry, including miscarriage, loss, and development of trauma disorders. NCRP aspires to develop educational materials for ob.gyn. residents.

In the past we may have missed the mark in recognizing and treating the trauma that prenatal loss can cause, but we are trying to improve our approaches. More and more couples are sharing their experiences and advocating for themselves and others, often creating change in medical practice, and doctors are starting to listen. As any clinician knows, changes to standards of care can take several years to disseminate into general practice, but this gap between knowledge and treatment is now in the forefront of our minds. I am hopeful that we will continue to make advances and provide better care to our patients who have endured the loss of a pregnancy.
 

Dr. Latorre is an assistant professor in the department of psychiatry at the University of Maryland School of Medicine. She has reported no relevant financial disclosures. Email her at obnews@mdedge.com.

ORLANDO – There is a deficit in scientific research for sexual- and gender-minority (SGM) patients in dermatology, despite dermatologists being uniquely suited to help these patients, Angelo Landriscina, MD, said at the ODAC Dermatology, Aesthetic, & Clinical Conference.

Updating understanding of SGM patients

Much of the medical community’s understanding of SGM patients hasn’t been updated in decades, Dr. Landriscina said. For example, medical school students typically learn about SGM risk factors that only apply to men who have sex with men (MSM), but there is new interest in caring for transgender patients within dermatology. The focus on classical notions for treating MSM can be reductive, Dr. Landriscina explained. “It boils a whole community of people down to one disease process. I think that we need to expand the thought that there are other associations here. There are other risks these patients face.”

In contrast, dermatologists who strive to understand their patients can better see them as a whole person, can engage in a better differential diagnosis, are aware of the current comorbidities SGM patients face that affect dermatologic disease, and can even work with the patient toward preventative care.

“It’s been decades since we’ve had a paradigm shift about this, and I think it’s time,” he said.

Overall, SGM patients have a higher likelihood of suffering from mental illness and suicidal ideation, with 10%-20% of lesbian, gay, and bisexual patients attempting suicide. Gender-minority patients have a significantly higher rate of attempting suicide at 40%. SGM patients are also more likely to be homeless and uninsured, and have the highest rates of tobacco, alcohol, and illicit drug use. In the SGM population, there is a higher likelihood of being victimized, and discriminated against, with this risk being much higher in transgender patients.

For MSM, there is a high risk of HIV and other STIs such as herpes simplex virus type 2 (HSV2), human papillomavirus (HPV), gonorrhea, and chlamydia, Dr. Landriscina said. They are also at risk for hepatitis A, B, and C; clusters of meningococcal meningitis; and human herpes virus 8. While MSM are more likely to use sunscreen, they also are more likely to use tanning beds and not wear protective clothing outdoors, and are at a greater risk of skin cancer. The risks of body dysmorphia and eating disorders are also increased for MSM.

While there is not as much research on risk factors for women who have sex with women (WSW), they are still at risk for HIV, HSV, and HPV and are less likely to engage in safe sex practices. For women who have sex with both men and other women, there is an even greater risk of STIs. While WSW are more likely to perceive less need for screening, they should be given the same screening as all other women, and dermatologists can help by ensuring these patients are connected with primary care providers, he said.
 

Dermatologic sequelae for transgender patients

For patients who transition from male to female, there is little information on their sexual risk from studies, but their care should be managed similarly to MSM, Dr. Landriscina said. When seeing transgender patients, dermatologists should be aware of issues of gender dysphoria, but not offer any intervention without first having a conversation about the patient’s hopes and goals. “Not every patient will have the means or desire to have everything that you can offer,” he said.

For patients who choose to undergo a female-to-male transition, dermatological sequelae may include classical manifestations of androgen excess from hormone therapy such as acne and androgenic alopecia; acne, miliaria, tinea corporis, contact dermatitis from chest binding; and surgical scars and keloids. For acne, isotretinoin is an option if a case is severe, but dermatologists should be aware these patients may still be able to become pregnant. There is no consensus on treatment for androgenic alopecia, but use of finasteride might block wanted secondary sex characteristics, Dr. Landriscina noted.

Patients who undergo a male-to-female transition may develop melasma or asteatotic eczema while receiving estrogen therapy; unwanted facial or body hair; and complications from illicit “filler” injections that may cause foreign-body granulomas, bacterial or atypical mycobacterial infection, lymphedema, and scarring.

Transgender patients may choose to undergo aesthetic treatments that can affirm their gender and decrease their gender dysphoria, augment the effects of hormone therapy and gender-confirmation surgery, and improve their quality of life. “While this has classically fallen under the purview of plastic surgery, I feel like we’re uniquely positioned to provide really life-changing aesthetic services to these patients,” Dr. Landriscina said.

Creating an inclusive environment is key to successfully caring for SGM patients. Any practice policies should have SGM-inclusive language, employees should receive mandatory LGBTQ+ focused training, and a point person should oversee LGBTQ+ matters, according to the Joint Commission’s LGBT Guide. Practices should also begin collecting data on sexual orientation and gender identity, which may help patients who are reluctant to vocally disclose their sexual orientation and gender identity and expand understanding of SGM patients. “Before you even walk into that visit, you know what the patient’s identity is, how they want to be addressed,” said Dr. Landriscina. “It also shows patients that you value what their identities are and that you’re competent in taking care of them.”

Dr. Landriscina encouraged attendees to take the information they learned in the session and “run with it.”

“Go for it. Keep learning,” he said. “There’s more about this topic than I even had the chance to include. Your patients are going to appreciate your dedication to them.”

ORLANDO – There is a deficit in scientific research for sexual- and gender-minority (SGM) patients in dermatology, despite dermatologists being uniquely suited to help these patients, Angelo Landriscina, MD, said at the ODAC Dermatology, Aesthetic, & Clinical Conference.

Updating understanding of SGM patients

Much of the medical community’s understanding of SGM patients hasn’t been updated in decades, Dr. Landriscina said. For example, medical school students typically learn about SGM risk factors that only apply to men who have sex with men (MSM), but there is new interest in caring for transgender patients within dermatology. The focus on classical notions for treating MSM can be reductive, Dr. Landriscina explained. “It boils a whole community of people down to one disease process. I think that we need to expand the thought that there are other associations here. There are other risks these patients face.”

In contrast, dermatologists who strive to understand their patients can better see them as a whole person, can engage in a better differential diagnosis, are aware of the current comorbidities SGM patients face that affect dermatologic disease, and can even work with the patient toward preventative care.

“It’s been decades since we’ve had a paradigm shift about this, and I think it’s time,” he said.

Overall, SGM patients have a higher likelihood of suffering from mental illness and suicidal ideation, with 10%-20% of lesbian, gay, and bisexual patients attempting suicide. Gender-minority patients have a significantly higher rate of attempting suicide at 40%. SGM patients are also more likely to be homeless and uninsured, and have the highest rates of tobacco, alcohol, and illicit drug use. In the SGM population, there is a higher likelihood of being victimized, and discriminated against, with this risk being much higher in transgender patients.

For MSM, there is a high risk of HIV and other STIs such as herpes simplex virus type 2 (HSV2), human papillomavirus (HPV), gonorrhea, and chlamydia, Dr. Landriscina said. They are also at risk for hepatitis A, B, and C; clusters of meningococcal meningitis; and human herpes virus 8. While MSM are more likely to use sunscreen, they also are more likely to use tanning beds and not wear protective clothing outdoors, and are at a greater risk of skin cancer. The risks of body dysmorphia and eating disorders are also increased for MSM.

While there is not as much research on risk factors for women who have sex with women (WSW), they are still at risk for HIV, HSV, and HPV and are less likely to engage in safe sex practices. For women who have sex with both men and other women, there is an even greater risk of STIs. While WSW are more likely to perceive less need for screening, they should be given the same screening as all other women, and dermatologists can help by ensuring these patients are connected with primary care providers, he said.
 

Dermatologic sequelae for transgender patients

For patients who transition from male to female, there is little information on their sexual risk from studies, but their care should be managed similarly to MSM, Dr. Landriscina said. When seeing transgender patients, dermatologists should be aware of issues of gender dysphoria, but not offer any intervention without first having a conversation about the patient’s hopes and goals. “Not every patient will have the means or desire to have everything that you can offer,” he said.

For patients who choose to undergo a female-to-male transition, dermatological sequelae may include classical manifestations of androgen excess from hormone therapy such as acne and androgenic alopecia; acne, miliaria, tinea corporis, contact dermatitis from chest binding; and surgical scars and keloids. For acne, isotretinoin is an option if a case is severe, but dermatologists should be aware these patients may still be able to become pregnant. There is no consensus on treatment for androgenic alopecia, but use of finasteride might block wanted secondary sex characteristics, Dr. Landriscina noted.

Patients who undergo a male-to-female transition may develop melasma or asteatotic eczema while receiving estrogen therapy; unwanted facial or body hair; and complications from illicit “filler” injections that may cause foreign-body granulomas, bacterial or atypical mycobacterial infection, lymphedema, and scarring.

Transgender patients may choose to undergo aesthetic treatments that can affirm their gender and decrease their gender dysphoria, augment the effects of hormone therapy and gender-confirmation surgery, and improve their quality of life. “While this has classically fallen under the purview of plastic surgery, I feel like we’re uniquely positioned to provide really life-changing aesthetic services to these patients,” Dr. Landriscina said.

Creating an inclusive environment is key to successfully caring for SGM patients. Any practice policies should have SGM-inclusive language, employees should receive mandatory LGBTQ+ focused training, and a point person should oversee LGBTQ+ matters, according to the Joint Commission’s LGBT Guide. Practices should also begin collecting data on sexual orientation and gender identity, which may help patients who are reluctant to vocally disclose their sexual orientation and gender identity and expand understanding of SGM patients. “Before you even walk into that visit, you know what the patient’s identity is, how they want to be addressed,” said Dr. Landriscina. “It also shows patients that you value what their identities are and that you’re competent in taking care of them.”

Dr. Landriscina encouraged attendees to take the information they learned in the session and “run with it.”

“Go for it. Keep learning,” he said. “There’s more about this topic than I even had the chance to include. Your patients are going to appreciate your dedication to them.”

ORLANDO – There is a deficit in scientific research for sexual- and gender-minority (SGM) patients in dermatology, despite dermatologists being uniquely suited to help these patients, Angelo Landriscina, MD, said at the ODAC Dermatology, Aesthetic, & Clinical Conference.

Updating understanding of SGM patients

Much of the medical community’s understanding of SGM patients hasn’t been updated in decades, Dr. Landriscina said. For example, medical school students typically learn about SGM risk factors that only apply to men who have sex with men (MSM), but there is new interest in caring for transgender patients within dermatology. The focus on classical notions for treating MSM can be reductive, Dr. Landriscina explained. “It boils a whole community of people down to one disease process. I think that we need to expand the thought that there are other associations here. There are other risks these patients face.”

In contrast, dermatologists who strive to understand their patients can better see them as a whole person, can engage in a better differential diagnosis, are aware of the current comorbidities SGM patients face that affect dermatologic disease, and can even work with the patient toward preventative care.

“It’s been decades since we’ve had a paradigm shift about this, and I think it’s time,” he said.

Overall, SGM patients have a higher likelihood of suffering from mental illness and suicidal ideation, with 10%-20% of lesbian, gay, and bisexual patients attempting suicide. Gender-minority patients have a significantly higher rate of attempting suicide at 40%. SGM patients are also more likely to be homeless and uninsured, and have the highest rates of tobacco, alcohol, and illicit drug use. In the SGM population, there is a higher likelihood of being victimized, and discriminated against, with this risk being much higher in transgender patients.

For MSM, there is a high risk of HIV and other STIs such as herpes simplex virus type 2 (HSV2), human papillomavirus (HPV), gonorrhea, and chlamydia, Dr. Landriscina said. They are also at risk for hepatitis A, B, and C; clusters of meningococcal meningitis; and human herpes virus 8. While MSM are more likely to use sunscreen, they also are more likely to use tanning beds and not wear protective clothing outdoors, and are at a greater risk of skin cancer. The risks of body dysmorphia and eating disorders are also increased for MSM.

While there is not as much research on risk factors for women who have sex with women (WSW), they are still at risk for HIV, HSV, and HPV and are less likely to engage in safe sex practices. For women who have sex with both men and other women, there is an even greater risk of STIs. While WSW are more likely to perceive less need for screening, they should be given the same screening as all other women, and dermatologists can help by ensuring these patients are connected with primary care providers, he said.
 

Dermatologic sequelae for transgender patients

For patients who transition from male to female, there is little information on their sexual risk from studies, but their care should be managed similarly to MSM, Dr. Landriscina said. When seeing transgender patients, dermatologists should be aware of issues of gender dysphoria, but not offer any intervention without first having a conversation about the patient’s hopes and goals. “Not every patient will have the means or desire to have everything that you can offer,” he said.

For patients who choose to undergo a female-to-male transition, dermatological sequelae may include classical manifestations of androgen excess from hormone therapy such as acne and androgenic alopecia; acne, miliaria, tinea corporis, contact dermatitis from chest binding; and surgical scars and keloids. For acne, isotretinoin is an option if a case is severe, but dermatologists should be aware these patients may still be able to become pregnant. There is no consensus on treatment for androgenic alopecia, but use of finasteride might block wanted secondary sex characteristics, Dr. Landriscina noted.

Patients who undergo a male-to-female transition may develop melasma or asteatotic eczema while receiving estrogen therapy; unwanted facial or body hair; and complications from illicit “filler” injections that may cause foreign-body granulomas, bacterial or atypical mycobacterial infection, lymphedema, and scarring.

Transgender patients may choose to undergo aesthetic treatments that can affirm their gender and decrease their gender dysphoria, augment the effects of hormone therapy and gender-confirmation surgery, and improve their quality of life. “While this has classically fallen under the purview of plastic surgery, I feel like we’re uniquely positioned to provide really life-changing aesthetic services to these patients,” Dr. Landriscina said.

Creating an inclusive environment is key to successfully caring for SGM patients. Any practice policies should have SGM-inclusive language, employees should receive mandatory LGBTQ+ focused training, and a point person should oversee LGBTQ+ matters, according to the Joint Commission’s LGBT Guide. Practices should also begin collecting data on sexual orientation and gender identity, which may help patients who are reluctant to vocally disclose their sexual orientation and gender identity and expand understanding of SGM patients. “Before you even walk into that visit, you know what the patient’s identity is, how they want to be addressed,” said Dr. Landriscina. “It also shows patients that you value what their identities are and that you’re competent in taking care of them.”

Dr. Landriscina encouraged attendees to take the information they learned in the session and “run with it.”

“Go for it. Keep learning,” he said. “There’s more about this topic than I even had the chance to include. Your patients are going to appreciate your dedication to them.”

Numerous articles, books, and newspaper editorials have been written about the “crisis” in mental health care in our country from various perspectives, and the phrase is often used that the mental health system is “broken.” It seems that lately, this topic is often brought up after the most recent mass shooting.¹

Philip T. Yanos, PhD, correctly asked recently whether we should be talking about a “broken” system, because implicit in the phrase is the assumption that the mental health system was once “whole,” and he has pointed out² chronic deficiencies, such as the absence of affordable housing, and the availability of services to those with chronic mental illness.

In addition, many authors have asserted that, with deinstitutionalization – which occurred starting with the Community Mental Health Act of 1963 – homelessness also became a big problem for people in our prisons and jails, which became the default treatment providers for many of those with serious mental illness.Once authors make this point, they often offer up ways to start addressing various parts of the system, and it usually comes down to asking for more funding for more outpatient treatment and services as well as more inpatient beds. Some authors make the point³ that people with mental illness often lack insight into their illness and the need for treatment. Thus, we have the quandary of people with severe mental illness not believing that they need help, and thus not even trying to access services, which can lead to homelessness and jail time.

But what of those individuals with serious mental health problems who aren’t facing those obstacles and complications? What about individuals who aren’t facing homelessness, who haven’t gotten embroiled in the legal system, who do have insurance coverage, who live in areas with sufficient numbers of outpatient mental health centers to choose from, and who have no problems finding an inpatient bed when needed? Let’s suppose that we have an individual who does have insight into his mental illness and need for treatment, and is motivated to seek treatment. How responsive is the system to such individuals? That will be the focus on my article.

In a recent report,⁴ the author quotes American Psychiatric Association President Bruce J. Schwartz, MD, appealing to members of the U.S. Congress to step in. According to the author, Dr. Schwartz’s position is that the crisis in American mental health begins specifically with a drastic, and growing, shortage of psychiatric beds, especially in publicly funded state and county hospital beds. From there, the crisis spreads to the nation’s city streets, and its jails and prisons, where the largest number of people with serious mental illness now reside. He also talks about a shortage of psychiatrists and child psychiatrists, and says the shortage is likely to worsen. The proposed solution to this problem, of course, is more funding from Congress to open more psychiatric beds, as well as providing more funding for mental health in general and funding to residency programs to increase the numbers of psychiatrists.

I respect the opinions of Dr. Schwartz and that of the other authors who want to talk about lack of adequate beds, outpatient clinics and services, insufficient numbers of psychiatrists, and a lack of funding by Congress. However, I would like to provide further information, from a personal perspective, which causes me to believe that the problem is even more complex than that, and that the failures of the system are compounded by a dysfunctional culture within the ranks of professional caregivers. In other words, once the pieces are in place and assembled, the mental health system still seems to be “broken” but from within. I worry about apathy and an absence of motivation to provide good or even adequate services by the very people who are or should be aware of the problems and what it takes to help our vulnerable patients lead better lives.

I have practiced psychiatry for many years in various settings. I have spent many years working as an inpatient psychiatrist in a large state hospital. I have worked in community mental health outpatient settings. I have also worked in a private practice doing both inpatient and outpatient patient care as well as significant forensic work. At the hospitals, I have witnessed and prepared internal reports about patients who are “revolving doors.” Such patients often had more than 50 psychiatric hospitalizations and no apparent solution to keep them stable enough in the community.

But mental illness is not just a career for me. In addition to being psychiatrist, I am the father of a son with severe and persistent mental illness. I have watched him struggle to find stability. He, too, has been in and out of hospitals. My wife is also in the mental health field. She and I have endlessly tried to work with our son’s local community mental health center to provide them with feedback and to get them to respond to his needs – often with great frustration. It has been our impression that clinicians have difficulty listening to us and understanding the difficulties our son is having, from my son’s case manager to the treating psychiatrist, to the director of the agency. We have tried shifting him to other programs in a neighboring county, including one known to be a “model” program, but had the same issues.

Psychiatry is more of an art than science. Our other medical colleagues can try to resolve a clinical problem, no matter their rank, by ordering the right blood test or getting certain imaging. Psychiatry has no such biomarkers, or validated tests, to rely on to resolve disputes. We have only our training and experience and, unfortunately, our biases. If we don’t agree with a colleague, we often resort to rank and argument.

It is hard to hear, but psychiatrists sometimes resort to name-calling, often behind their colleagues’ backs, and to acting superior. There seems to be a certain attitude. Psychiatrists (just as can colleagues in other specialties) can be insufferably arrogant.

My personal experience has been that the hospital and the community often don’t communicate well. This seems to be a systems problem, as is the case for many complex unsolvable problems. I have been to discharge meetings involving hospital staff and the receiving community system. The attitude of the inpatient psychiatrist is often: “If you guys only did your job better, this patient wouldn’t keep having to be admitted. It’s your job to keep him out of the hospital.”

Alternatively, the community rejects this attitude and points to the absence of resources that prevents them from seeing patients in a timely manner and from adequately monitoring them. They say they are shackled by their resource constraints and that the endless admissions are inevitable. Further, the outpatient psychiatrists complain bitterly that all the inpatient doctors do is make a bunch of useless medication changes and then don’t keep patients in long enough to make sure the patient stays well. And on and on the arguments go with no resolution.

Sadly, and confirmed by my personal experience, when well-meaning and knowledgeable family members try to communicate with the community mental health system about their son’s mental disintegration, the community agency often doesn’t welcome the feedback. They resort to “confidentiality” concerns, often ill advised. Their opinion seems to be that the patient, (i.e. the patient who is falling apart and is becoming psychotic), should be the one calling the agency, waiting on hold forever, and not getting a call back. When my son has been in this situation, he has hung up his telephone out of frustration, then headed off to the emergency room, where he knew he would be seen.

The other area of frustration is that of the ideal of recovery. Mental health programs love to tout that their mission is “recovery,” and they list it as one of their primary areas of vision and goals. Yet, when we tried to communicate with community clinicians, they usually ignored our request to assist our son with supported employment and to help him achieve independence and a social life. When we tried to convey our recovery concerns to the psychiatrist, the usual response was also to ignore it and focus on “meds, meds, meds,” which most psychiatrists seem to view as their mission and area of expertise. Many psychiatrists have embraced the “bio-bio-bio” model of evaluation and treatment⁵ with only lip service paid to the “biopsychosocial” theory they like to say they advocate. When we reached out to our son’s psychiatrists and could get through, we found that they mostly failed to display much interest in paying attention to broader areas of functioning, instead focusing on symptoms, which they could observe in person.

So, I add to the chorus complaining that our mental health system is broken. Broken not only in terms of adequate funding, but also broken from within. It would require much wisdom and self-examination to even begin to address the problem. Without a better plan, throwing money at this broken system won’t improve the lives of our seriously ill and vulnerable psychiatric patients.
 

Dr. Kausch is a clinical and forensic psychiatrist who is on the faculty at Case Western Reserve University in Cleveland as an assistant clinical professor. He spends most of his time seeing patients through the Akron General/Cleveland Clinic health system. He has published in the area of forensic psychiatry, addictions, pathological gambling, and suicide. He has recently taken an interest in conducting marital therapy and is now publishing in that area as well.

References

1. Doroshow D. “We need to stop focusing on the mental health of mass shooters.” Washington Post. 2019 May 20.

2. Yanos P. “Is the mental health system ‘broken’?” Psychology Today. 2018 Oct 11.

3. Orenstein N. “How to fix a broken mental health system.” The Atlantic. 2016 Jun 8.

4. Moran M. APA rings alarm in nation’s capitol about crisis in mental health care. Psychiatr News. 2020 Jan 1.

5. Paris J. “Psychotherapy in an Age of Neuroscience.” New York: Oxford University Press, 2017.

Numerous articles, books, and newspaper editorials have been written about the “crisis” in mental health care in our country from various perspectives, and the phrase is often used that the mental health system is “broken.” It seems that lately, this topic is often brought up after the most recent mass shooting.¹

Philip T. Yanos, PhD, correctly asked recently whether we should be talking about a “broken” system, because implicit in the phrase is the assumption that the mental health system was once “whole,” and he has pointed out² chronic deficiencies, such as the absence of affordable housing, and the availability of services to those with chronic mental illness.

In addition, many authors have asserted that, with deinstitutionalization – which occurred starting with the Community Mental Health Act of 1963 – homelessness also became a big problem for people in our prisons and jails, which became the default treatment providers for many of those with serious mental illness.Once authors make this point, they often offer up ways to start addressing various parts of the system, and it usually comes down to asking for more funding for more outpatient treatment and services as well as more inpatient beds. Some authors make the point³ that people with mental illness often lack insight into their illness and the need for treatment. Thus, we have the quandary of people with severe mental illness not believing that they need help, and thus not even trying to access services, which can lead to homelessness and jail time.

But what of those individuals with serious mental health problems who aren’t facing those obstacles and complications? What about individuals who aren’t facing homelessness, who haven’t gotten embroiled in the legal system, who do have insurance coverage, who live in areas with sufficient numbers of outpatient mental health centers to choose from, and who have no problems finding an inpatient bed when needed? Let’s suppose that we have an individual who does have insight into his mental illness and need for treatment, and is motivated to seek treatment. How responsive is the system to such individuals? That will be the focus on my article.

In a recent report,⁴ the author quotes American Psychiatric Association President Bruce J. Schwartz, MD, appealing to members of the U.S. Congress to step in. According to the author, Dr. Schwartz’s position is that the crisis in American mental health begins specifically with a drastic, and growing, shortage of psychiatric beds, especially in publicly funded state and county hospital beds. From there, the crisis spreads to the nation’s city streets, and its jails and prisons, where the largest number of people with serious mental illness now reside. He also talks about a shortage of psychiatrists and child psychiatrists, and says the shortage is likely to worsen. The proposed solution to this problem, of course, is more funding from Congress to open more psychiatric beds, as well as providing more funding for mental health in general and funding to residency programs to increase the numbers of psychiatrists.

I respect the opinions of Dr. Schwartz and that of the other authors who want to talk about lack of adequate beds, outpatient clinics and services, insufficient numbers of psychiatrists, and a lack of funding by Congress. However, I would like to provide further information, from a personal perspective, which causes me to believe that the problem is even more complex than that, and that the failures of the system are compounded by a dysfunctional culture within the ranks of professional caregivers. In other words, once the pieces are in place and assembled, the mental health system still seems to be “broken” but from within. I worry about apathy and an absence of motivation to provide good or even adequate services by the very people who are or should be aware of the problems and what it takes to help our vulnerable patients lead better lives.

I have practiced psychiatry for many years in various settings. I have spent many years working as an inpatient psychiatrist in a large state hospital. I have worked in community mental health outpatient settings. I have also worked in a private practice doing both inpatient and outpatient patient care as well as significant forensic work. At the hospitals, I have witnessed and prepared internal reports about patients who are “revolving doors.” Such patients often had more than 50 psychiatric hospitalizations and no apparent solution to keep them stable enough in the community.

But mental illness is not just a career for me. In addition to being psychiatrist, I am the father of a son with severe and persistent mental illness. I have watched him struggle to find stability. He, too, has been in and out of hospitals. My wife is also in the mental health field. She and I have endlessly tried to work with our son’s local community mental health center to provide them with feedback and to get them to respond to his needs – often with great frustration. It has been our impression that clinicians have difficulty listening to us and understanding the difficulties our son is having, from my son’s case manager to the treating psychiatrist, to the director of the agency. We have tried shifting him to other programs in a neighboring county, including one known to be a “model” program, but had the same issues.

Psychiatry is more of an art than science. Our other medical colleagues can try to resolve a clinical problem, no matter their rank, by ordering the right blood test or getting certain imaging. Psychiatry has no such biomarkers, or validated tests, to rely on to resolve disputes. We have only our training and experience and, unfortunately, our biases. If we don’t agree with a colleague, we often resort to rank and argument.

It is hard to hear, but psychiatrists sometimes resort to name-calling, often behind their colleagues’ backs, and to acting superior. There seems to be a certain attitude. Psychiatrists (just as can colleagues in other specialties) can be insufferably arrogant.

My personal experience has been that the hospital and the community often don’t communicate well. This seems to be a systems problem, as is the case for many complex unsolvable problems. I have been to discharge meetings involving hospital staff and the receiving community system. The attitude of the inpatient psychiatrist is often: “If you guys only did your job better, this patient wouldn’t keep having to be admitted. It’s your job to keep him out of the hospital.”

Alternatively, the community rejects this attitude and points to the absence of resources that prevents them from seeing patients in a timely manner and from adequately monitoring them. They say they are shackled by their resource constraints and that the endless admissions are inevitable. Further, the outpatient psychiatrists complain bitterly that all the inpatient doctors do is make a bunch of useless medication changes and then don’t keep patients in long enough to make sure the patient stays well. And on and on the arguments go with no resolution.

Sadly, and confirmed by my personal experience, when well-meaning and knowledgeable family members try to communicate with the community mental health system about their son’s mental disintegration, the community agency often doesn’t welcome the feedback. They resort to “confidentiality” concerns, often ill advised. Their opinion seems to be that the patient, (i.e. the patient who is falling apart and is becoming psychotic), should be the one calling the agency, waiting on hold forever, and not getting a call back. When my son has been in this situation, he has hung up his telephone out of frustration, then headed off to the emergency room, where he knew he would be seen.

The other area of frustration is that of the ideal of recovery. Mental health programs love to tout that their mission is “recovery,” and they list it as one of their primary areas of vision and goals. Yet, when we tried to communicate with community clinicians, they usually ignored our request to assist our son with supported employment and to help him achieve independence and a social life. When we tried to convey our recovery concerns to the psychiatrist, the usual response was also to ignore it and focus on “meds, meds, meds,” which most psychiatrists seem to view as their mission and area of expertise. Many psychiatrists have embraced the “bio-bio-bio” model of evaluation and treatment⁵ with only lip service paid to the “biopsychosocial” theory they like to say they advocate. When we reached out to our son’s psychiatrists and could get through, we found that they mostly failed to display much interest in paying attention to broader areas of functioning, instead focusing on symptoms, which they could observe in person.

So, I add to the chorus complaining that our mental health system is broken. Broken not only in terms of adequate funding, but also broken from within. It would require much wisdom and self-examination to even begin to address the problem. Without a better plan, throwing money at this broken system won’t improve the lives of our seriously ill and vulnerable psychiatric patients.
 

Dr. Kausch is a clinical and forensic psychiatrist who is on the faculty at Case Western Reserve University in Cleveland as an assistant clinical professor. He spends most of his time seeing patients through the Akron General/Cleveland Clinic health system. He has published in the area of forensic psychiatry, addictions, pathological gambling, and suicide. He has recently taken an interest in conducting marital therapy and is now publishing in that area as well.

References

1. Doroshow D. “We need to stop focusing on the mental health of mass shooters.” Washington Post. 2019 May 20.

2. Yanos P. “Is the mental health system ‘broken’?” Psychology Today. 2018 Oct 11.

3. Orenstein N. “How to fix a broken mental health system.” The Atlantic. 2016 Jun 8.

4. Moran M. APA rings alarm in nation’s capitol about crisis in mental health care. Psychiatr News. 2020 Jan 1.

5. Paris J. “Psychotherapy in an Age of Neuroscience.” New York: Oxford University Press, 2017.

Numerous articles, books, and newspaper editorials have been written about the “crisis” in mental health care in our country from various perspectives, and the phrase is often used that the mental health system is “broken.” It seems that lately, this topic is often brought up after the most recent mass shooting.¹

Philip T. Yanos, PhD, correctly asked recently whether we should be talking about a “broken” system, because implicit in the phrase is the assumption that the mental health system was once “whole,” and he has pointed out² chronic deficiencies, such as the absence of affordable housing, and the availability of services to those with chronic mental illness.

In addition, many authors have asserted that, with deinstitutionalization – which occurred starting with the Community Mental Health Act of 1963 – homelessness also became a big problem for people in our prisons and jails, which became the default treatment providers for many of those with serious mental illness.Once authors make this point, they often offer up ways to start addressing various parts of the system, and it usually comes down to asking for more funding for more outpatient treatment and services as well as more inpatient beds. Some authors make the point³ that people with mental illness often lack insight into their illness and the need for treatment. Thus, we have the quandary of people with severe mental illness not believing that they need help, and thus not even trying to access services, which can lead to homelessness and jail time.

But what of those individuals with serious mental health problems who aren’t facing those obstacles and complications? What about individuals who aren’t facing homelessness, who haven’t gotten embroiled in the legal system, who do have insurance coverage, who live in areas with sufficient numbers of outpatient mental health centers to choose from, and who have no problems finding an inpatient bed when needed? Let’s suppose that we have an individual who does have insight into his mental illness and need for treatment, and is motivated to seek treatment. How responsive is the system to such individuals? That will be the focus on my article.

In a recent report,⁴ the author quotes American Psychiatric Association President Bruce J. Schwartz, MD, appealing to members of the U.S. Congress to step in. According to the author, Dr. Schwartz’s position is that the crisis in American mental health begins specifically with a drastic, and growing, shortage of psychiatric beds, especially in publicly funded state and county hospital beds. From there, the crisis spreads to the nation’s city streets, and its jails and prisons, where the largest number of people with serious mental illness now reside. He also talks about a shortage of psychiatrists and child psychiatrists, and says the shortage is likely to worsen. The proposed solution to this problem, of course, is more funding from Congress to open more psychiatric beds, as well as providing more funding for mental health in general and funding to residency programs to increase the numbers of psychiatrists.

I respect the opinions of Dr. Schwartz and that of the other authors who want to talk about lack of adequate beds, outpatient clinics and services, insufficient numbers of psychiatrists, and a lack of funding by Congress. However, I would like to provide further information, from a personal perspective, which causes me to believe that the problem is even more complex than that, and that the failures of the system are compounded by a dysfunctional culture within the ranks of professional caregivers. In other words, once the pieces are in place and assembled, the mental health system still seems to be “broken” but from within. I worry about apathy and an absence of motivation to provide good or even adequate services by the very people who are or should be aware of the problems and what it takes to help our vulnerable patients lead better lives.

I have practiced psychiatry for many years in various settings. I have spent many years working as an inpatient psychiatrist in a large state hospital. I have worked in community mental health outpatient settings. I have also worked in a private practice doing both inpatient and outpatient patient care as well as significant forensic work. At the hospitals, I have witnessed and prepared internal reports about patients who are “revolving doors.” Such patients often had more than 50 psychiatric hospitalizations and no apparent solution to keep them stable enough in the community.

But mental illness is not just a career for me. In addition to being psychiatrist, I am the father of a son with severe and persistent mental illness. I have watched him struggle to find stability. He, too, has been in and out of hospitals. My wife is also in the mental health field. She and I have endlessly tried to work with our son’s local community mental health center to provide them with feedback and to get them to respond to his needs – often with great frustration. It has been our impression that clinicians have difficulty listening to us and understanding the difficulties our son is having, from my son’s case manager to the treating psychiatrist, to the director of the agency. We have tried shifting him to other programs in a neighboring county, including one known to be a “model” program, but had the same issues.

Psychiatry is more of an art than science. Our other medical colleagues can try to resolve a clinical problem, no matter their rank, by ordering the right blood test or getting certain imaging. Psychiatry has no such biomarkers, or validated tests, to rely on to resolve disputes. We have only our training and experience and, unfortunately, our biases. If we don’t agree with a colleague, we often resort to rank and argument.

It is hard to hear, but psychiatrists sometimes resort to name-calling, often behind their colleagues’ backs, and to acting superior. There seems to be a certain attitude. Psychiatrists (just as can colleagues in other specialties) can be insufferably arrogant.

My personal experience has been that the hospital and the community often don’t communicate well. This seems to be a systems problem, as is the case for many complex unsolvable problems. I have been to discharge meetings involving hospital staff and the receiving community system. The attitude of the inpatient psychiatrist is often: “If you guys only did your job better, this patient wouldn’t keep having to be admitted. It’s your job to keep him out of the hospital.”

Alternatively, the community rejects this attitude and points to the absence of resources that prevents them from seeing patients in a timely manner and from adequately monitoring them. They say they are shackled by their resource constraints and that the endless admissions are inevitable. Further, the outpatient psychiatrists complain bitterly that all the inpatient doctors do is make a bunch of useless medication changes and then don’t keep patients in long enough to make sure the patient stays well. And on and on the arguments go with no resolution.

Sadly, and confirmed by my personal experience, when well-meaning and knowledgeable family members try to communicate with the community mental health system about their son’s mental disintegration, the community agency often doesn’t welcome the feedback. They resort to “confidentiality” concerns, often ill advised. Their opinion seems to be that the patient, (i.e. the patient who is falling apart and is becoming psychotic), should be the one calling the agency, waiting on hold forever, and not getting a call back. When my son has been in this situation, he has hung up his telephone out of frustration, then headed off to the emergency room, where he knew he would be seen.

The other area of frustration is that of the ideal of recovery. Mental health programs love to tout that their mission is “recovery,” and they list it as one of their primary areas of vision and goals. Yet, when we tried to communicate with community clinicians, they usually ignored our request to assist our son with supported employment and to help him achieve independence and a social life. When we tried to convey our recovery concerns to the psychiatrist, the usual response was also to ignore it and focus on “meds, meds, meds,” which most psychiatrists seem to view as their mission and area of expertise. Many psychiatrists have embraced the “bio-bio-bio” model of evaluation and treatment⁵ with only lip service paid to the “biopsychosocial” theory they like to say they advocate. When we reached out to our son’s psychiatrists and could get through, we found that they mostly failed to display much interest in paying attention to broader areas of functioning, instead focusing on symptoms, which they could observe in person.

So, I add to the chorus complaining that our mental health system is broken. Broken not only in terms of adequate funding, but also broken from within. It would require much wisdom and self-examination to even begin to address the problem. Without a better plan, throwing money at this broken system won’t improve the lives of our seriously ill and vulnerable psychiatric patients.
 

Dr. Kausch is a clinical and forensic psychiatrist who is on the faculty at Case Western Reserve University in Cleveland as an assistant clinical professor. He spends most of his time seeing patients through the Akron General/Cleveland Clinic health system. He has published in the area of forensic psychiatry, addictions, pathological gambling, and suicide. He has recently taken an interest in conducting marital therapy and is now publishing in that area as well.

References

1. Doroshow D. “We need to stop focusing on the mental health of mass shooters.” Washington Post. 2019 May 20.

2. Yanos P. “Is the mental health system ‘broken’?” Psychology Today. 2018 Oct 11.

3. Orenstein N. “How to fix a broken mental health system.” The Atlantic. 2016 Jun 8.

4. Moran M. APA rings alarm in nation’s capitol about crisis in mental health care. Psychiatr News. 2020 Jan 1.

5. Paris J. “Psychotherapy in an Age of Neuroscience.” New York: Oxford University Press, 2017.

The Food and Drug Administration has approved a triple-combination tablet (Trijardy XR), comprising empagliflozin (Jardiance), linagliptin (Tradjenta), and extended-release metformin hydrochloride, for the treatment of adults with type 2 diabetes.

Trijardy XR will be available in four different dosages and is indicated as a once-daily treatment, together with diet and exercise, for adults who are already on treatment for type 2 disease but require additional agents to attain healthy hemoglobin A_1c targets, according to a statement released by Eli Lilly, which will market the newly approved treatment together with Boehringer Ingelheim.

“Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment,” Ralph DeFronzo, MD, professor and diabetes division chief at the University of Texas Health San Antonio, said in the release.

All three drugs are separately well-established therapies for type 2 diabetes. Metformin is the most commonly prescribed treatment for type 2. Empagliflozin, a sodium-glucose transporter 2 inhibitor, and linagliptin, a single-dose dipeptidyl peptidase–4 inhibitor, are approved for the reduction of blood sugar in patients with type 2 disease, and empagliflozin is also approved for lowering the risk of cardiovascular death in adults with type 2 and established cardiovascular disease, according to the statement. (In 2015, the FDA approved a combination of empagliflozin and linagliptin, Glyxambi, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.)

The approval of the triple-combination treatment was based on findings from two randomized, open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and extended-release metformin hydrochloride fixed-dose combination tablets, as well as their individual components. In addition, the trials established that the safety profile of the combination therapy was similar to the safety profiles of the components, the statement said.

Lactic acidosis, pancreatitis, and heart failure are among the side effects associated with the combination therapy, with upper respiratory tract infection and gastroenteritis among the most common. Serious side effects include dehydration, ketoacidosis, kidney problems, urinary tract and vaginal yeast infections, and hypoglycemia.

As with empagliflozin and linagliptin alone, the combination therapy is not recommended for individuals with type 1 diabetes or diabetic ketoacidosis, and it has not been tested in patients with a history of pancreatitis. The combination also has a warning for lactic acidosis, a rare, but serious, condition that can arise with metformin accumulation.

The combination product is contraindicated for people with kidney problems and end-stage renal disease or who are on dialysis; have metabolic acidosis or diabetic ketoacidosis; or are allergic to empagliflozin, linagliptin, or metformin.

The Food and Drug Administration has approved a triple-combination tablet (Trijardy XR), comprising empagliflozin (Jardiance), linagliptin (Tradjenta), and extended-release metformin hydrochloride, for the treatment of adults with type 2 diabetes.

Trijardy XR will be available in four different dosages and is indicated as a once-daily treatment, together with diet and exercise, for adults who are already on treatment for type 2 disease but require additional agents to attain healthy hemoglobin A_1c targets, according to a statement released by Eli Lilly, which will market the newly approved treatment together with Boehringer Ingelheim.

“Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment,” Ralph DeFronzo, MD, professor and diabetes division chief at the University of Texas Health San Antonio, said in the release.

All three drugs are separately well-established therapies for type 2 diabetes. Metformin is the most commonly prescribed treatment for type 2. Empagliflozin, a sodium-glucose transporter 2 inhibitor, and linagliptin, a single-dose dipeptidyl peptidase–4 inhibitor, are approved for the reduction of blood sugar in patients with type 2 disease, and empagliflozin is also approved for lowering the risk of cardiovascular death in adults with type 2 and established cardiovascular disease, according to the statement. (In 2015, the FDA approved a combination of empagliflozin and linagliptin, Glyxambi, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.)

The approval of the triple-combination treatment was based on findings from two randomized, open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and extended-release metformin hydrochloride fixed-dose combination tablets, as well as their individual components. In addition, the trials established that the safety profile of the combination therapy was similar to the safety profiles of the components, the statement said.

Lactic acidosis, pancreatitis, and heart failure are among the side effects associated with the combination therapy, with upper respiratory tract infection and gastroenteritis among the most common. Serious side effects include dehydration, ketoacidosis, kidney problems, urinary tract and vaginal yeast infections, and hypoglycemia.

As with empagliflozin and linagliptin alone, the combination therapy is not recommended for individuals with type 1 diabetes or diabetic ketoacidosis, and it has not been tested in patients with a history of pancreatitis. The combination also has a warning for lactic acidosis, a rare, but serious, condition that can arise with metformin accumulation.

The combination product is contraindicated for people with kidney problems and end-stage renal disease or who are on dialysis; have metabolic acidosis or diabetic ketoacidosis; or are allergic to empagliflozin, linagliptin, or metformin.

The Food and Drug Administration has approved a triple-combination tablet (Trijardy XR), comprising empagliflozin (Jardiance), linagliptin (Tradjenta), and extended-release metformin hydrochloride, for the treatment of adults with type 2 diabetes.

Trijardy XR will be available in four different dosages and is indicated as a once-daily treatment, together with diet and exercise, for adults who are already on treatment for type 2 disease but require additional agents to attain healthy hemoglobin A_1c targets, according to a statement released by Eli Lilly, which will market the newly approved treatment together with Boehringer Ingelheim.

“Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment,” Ralph DeFronzo, MD, professor and diabetes division chief at the University of Texas Health San Antonio, said in the release.

All three drugs are separately well-established therapies for type 2 diabetes. Metformin is the most commonly prescribed treatment for type 2. Empagliflozin, a sodium-glucose transporter 2 inhibitor, and linagliptin, a single-dose dipeptidyl peptidase–4 inhibitor, are approved for the reduction of blood sugar in patients with type 2 disease, and empagliflozin is also approved for lowering the risk of cardiovascular death in adults with type 2 and established cardiovascular disease, according to the statement. (In 2015, the FDA approved a combination of empagliflozin and linagliptin, Glyxambi, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.)

The approval of the triple-combination treatment was based on findings from two randomized, open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and extended-release metformin hydrochloride fixed-dose combination tablets, as well as their individual components. In addition, the trials established that the safety profile of the combination therapy was similar to the safety profiles of the components, the statement said.

Lactic acidosis, pancreatitis, and heart failure are among the side effects associated with the combination therapy, with upper respiratory tract infection and gastroenteritis among the most common. Serious side effects include dehydration, ketoacidosis, kidney problems, urinary tract and vaginal yeast infections, and hypoglycemia.

As with empagliflozin and linagliptin alone, the combination therapy is not recommended for individuals with type 1 diabetes or diabetic ketoacidosis, and it has not been tested in patients with a history of pancreatitis. The combination also has a warning for lactic acidosis, a rare, but serious, condition that can arise with metformin accumulation.

The combination product is contraindicated for people with kidney problems and end-stage renal disease or who are on dialysis; have metabolic acidosis or diabetic ketoacidosis; or are allergic to empagliflozin, linagliptin, or metformin.

Although biosimilar versions of tumor necrosis factor inhibitors (TNFis) have been available to U.S. rheumatologists and their patients for over 3 years, uptake has thus far been slow.

monkeybusinessimages/thinkstockphotos.com

In an analysis of data from a large commercial payer, the two available biosimilars for infliximab (Remicade) accounted for less than 1% of TNFi prescribing since the first biosimilar to infliximab was approved in 2016.

The study, published in Arthritis & Rheumatology, involved a total of 1.1 million TNFi prescriptions or infusions received by 95,906 patients from 2016 to 2019. Investigators found that uptake of biosimilar infliximab was essentially flat, standing at 0.1% of prescribing in the second quarter of 2017, and topping out at 0.9% in the first quarter of 2019. For branded infliximab, prescribing was also stable, but accounted for about 20% of overall biologic dispensing in each quarter of the period studied.

There are currently two biosimilar medications to the originator infliximab, which is one of five originator biologics available to treat rheumatic diseases in the United States: infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). The former was approved in 2016 and the latter in 2017, said study author Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her coauthors.

“Our paper reports a disappointingly low uptake of biosimilar infliximab since the first quarter of 2017 using claims data from a large private health plan. The main and maybe the only reason to consider using a biosimilar is cost saving,” said Dr. Kim in an interview. “Our results suggest that current modest cost savings from infliximab biosimilars in the U.S. are not sufficient to promote their widespread use.”

In the payer database study conducted by Dr. Kim and colleagues, the insurer paid similar mean amounts per patient per quarter for originator and biosimilar infliximab in mid-2017 ($8,322 versus $8,656). By the end of 2018, a gap appeared, with the insurer paying a mean quarterly per-patient sum of $8,111 for biosimilar infliximab compared with $9,535 for the branded biologic.

“The lack of market penetration and very modest price reductions for biosimilars have left policymakers, payers, physicians, and the public frustrated, particularly because sales in Europe continue to rapidly expand and robust cost-savings have materialized,” wrote Jinoos Yazdany, MD, MPH, in an editorial accompanying the study.

Dr. Yazdany, professor and chief of the division of rheumatology at the University of California, San Francisco, noted that increased spending on biologics in the United States – which increased by 50% from 2014 to 2018 – has been driven by rising prices as well as increased uptake of biologic therapies.

At least in part, Europe has been able to reap cost savings where the United States hasn’t because fundamental differences in health care reimbursement can ease sweeping biosimilar adoption, Dr. Yazdany noted. “Countries like Denmark and Sweden, using the negotiating and purchasing power of their single-payer systems have instituted a winner-takes-all bidding system,” with Denmark seeing cost savings of up to two-thirds when bidding was combined with mandatory switching, she said.

The continued market dominance of originator infliximab means that savings from biosimilars have thus far amounted to about $91 million, far short of the $1 billion that the Congressional Budget Office had projected for this date, Dr. Yazdany said.

One problem in the adoption of biosimilars by U.S. rheumatologists may have been uneven marketing and pricing across different types of practice, Colin C. Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the American College of Rheumatology’s Committee on Rheumatologic Care, said in an interview.

“Rheumatologists have generally developed comfort with biosimilars, although this is not universal. The core message, that all biologics vary and that this is OK, is getting out. In general, rheumatologists also understand the problem with high drug prices and the threat to patient access,” Dr. Edgerton said. But “the early marketing and pricing focus for biosimilars seemed to be on hospitals and facilities, and this did not work effectively for community rheumatologists, where the majority of care is delivered. We have been pleased to see a manufacturer pivot toward community rheumatology where additional efforts need to be made to bend the curve on biosimilar adoption. It is critical for practices with experience using biosimilars to educate peers, and this is where networks of practicing rheumatologists are important.”

In Dr. Yazdany’s editorial, she cited four structural factors impeding biosimilar uptake and downstream savings.

First, she cites ongoing actions by pharmaceutical companies, which create a “patent thicket” that has the effect of fencing off originator biologics from biosimilars long beyond the original 12-year exclusivity period. Supporting the notion that “patent thickets” are a common strategy, Dr. Yazdany noted that almost half of the patent applications that AbbVie has filed for adalimumab (Humira) have come in after the original exclusivity period expired in 2014. Humira’s price has risen 18% yearly during this period.

The complicated role played by pharmacy benefit managers (PBMs) is another factor in slow adoption, said Dr. Yazdany: When manufacturers offer rebates to PBMs, the price of the originator biologic may be less than its biosimilar. Further, manufacturers may sign multiyear rebate agreements just before a biosimilar launch; PBMs are also sometimes threatened with the withdrawal of rebates if they offer biosimilars, she noted.

Third, prescriber inertia may also be at play, Dr. Yazdany noted, not least because patients often see little difference in out-of-pocket costs when they make the switch to a biosimilar – PBM rebates are not necessarily passed on to patients. Payers may not reimburse a biosimilar, or formularies can be built without them, influencing prescribing, and there’s usually no reimbursement incentive for biosimilar prescribing in the nonpublic sector, she said. To the contrary, infusing a drug with a higher price often means higher reimbursement for the administering clinician, since commercial insurance reimbursement is often calculated as a percent of the charge for the drug.

Further contributing to inertia is the extra time required for patient education and writing a new set of orders – all work that can’t be captured for extra reimbursement. Dr. Edgerton said that rheumatologists can talk with patients about the “nocebo effect” relating to biosimilars. “This is a phenomenon in which patients are thought to experience worsening symptoms associated with negative beliefs about biosimilars. There has been a study in Arthritis Care & Research addressing this concern. The authors found that positive framing of biosimilars led to more participants being willing to switch than negative framing. This suggests that clinicians have an important role in informing patients about biosimilars, and addressing hesitancy.”

Finally, Dr. Yazdany pointed out that for a pharmaceutical company pursuing biosimilar approval, the regulatory pathway itself can provide its own set of complications and confusion. Biosimilars are not exact molecular replicas of the originator biologic, and these differences can change efficacy and immunogenicity, and also affect stability. Hence, a company wishing to market a biosimilar has to show the Food and Drug Administration that safety and efficacy aren’t affected by a switch to biosimilar from an originator biologic. Extrapolation from one indication to another can be made – with scientific justification.

Rheumatologists are mindful of the potential differences between biosimilars and the originator biologic, as evinced in a recent position statement from the American College of Rheumatology. The position statement advises that “extrapolation should be pursued with caution,” and asks for clear labeling when biosimilars have been designated “interchangeable” with their biosimilar. Interchangeability can clear the way for pharmacy substitution of a prescribed biologic, though Dr. Yazdany noted that 40 states have passed legislation requiring prescriber notification.

The FDA is currently using postmarketing pharmacovigilance to monitor biosimilar performance in the real world, and a recent systematic review “should provide some reassurance,” wrote Dr. Yazdany, citing the study, which looked at 14,000 patients who had a total of 14 disease indications for biosimilar use. The 90-article review largely found no differences in safety, efficacy, or immunogenicity between originators and their biosimilars. Dr. Yazdany recommended greater openness to incorporating the European experience in the FDA’s ongoing reassessment.

A further way forward can come through tackling the patent thicket with the proposed bipartisan Biologic Patent Transparency Act, which would require publication of biologic patents in a one-stop publicly searchable database. Going further with legislation to address anticompetitive activity by pharmaceutical companies could shorten the runway to biosimilar launching considerably, she noted.

The complicated landscape of PBMs and rebates affects many sectors of health care, and new policy efforts are needed here as well, she said. Reimbursement strategies – and much-needed continuing medical education – can both ease prescriber unfamiliarity with biosimilars and provide incentives for their use, she concluded.

Dr. Kim concurred that change is needed before the United States is likely to reap significant economic benefit from biosimilars. “The uptake of biosimilars and their impact on overall health care cost needs to be reevaluated when we have more biosimilars available in the next 3-4 years. However, for now, it appears that substantial savings achieved in some European countries – for example, Denmark – may not be possible without systemic reform of the U.S. pharmaceutical market,” she said.

Dr. Yazdany is supported by the Alice Betts Endowed Chair in Arthritis Research, the Russel/Engleman Research Center at the University of California, San Francisco, and the National Institutes of Health. She has received independent research grants from Pfizer and Genentech and research consulting fees from Eli Lilly and AstraZeneca.

Dr. Kim’s study was supported by the division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women’s Hospital, and Arnold Ventures. Dr. Kim has received research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche.

koakes@mdedge.com

SOURCES: Kim SC et al. Arthritis Rheumatol. 2020 Jan 13. doi: 10.1002/art.41201; Yazdany J. Arthritis Rheumatol. 2020 Jan 10. doi: 10.1002/art.41203.

Although biosimilar versions of tumor necrosis factor inhibitors (TNFis) have been available to U.S. rheumatologists and their patients for over 3 years, uptake has thus far been slow.

monkeybusinessimages/thinkstockphotos.com

In an analysis of data from a large commercial payer, the two available biosimilars for infliximab (Remicade) accounted for less than 1% of TNFi prescribing since the first biosimilar to infliximab was approved in 2016.

The study, published in Arthritis & Rheumatology, involved a total of 1.1 million TNFi prescriptions or infusions received by 95,906 patients from 2016 to 2019. Investigators found that uptake of biosimilar infliximab was essentially flat, standing at 0.1% of prescribing in the second quarter of 2017, and topping out at 0.9% in the first quarter of 2019. For branded infliximab, prescribing was also stable, but accounted for about 20% of overall biologic dispensing in each quarter of the period studied.

There are currently two biosimilar medications to the originator infliximab, which is one of five originator biologics available to treat rheumatic diseases in the United States: infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). The former was approved in 2016 and the latter in 2017, said study author Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her coauthors.

“Our paper reports a disappointingly low uptake of biosimilar infliximab since the first quarter of 2017 using claims data from a large private health plan. The main and maybe the only reason to consider using a biosimilar is cost saving,” said Dr. Kim in an interview. “Our results suggest that current modest cost savings from infliximab biosimilars in the U.S. are not sufficient to promote their widespread use.”

In the payer database study conducted by Dr. Kim and colleagues, the insurer paid similar mean amounts per patient per quarter for originator and biosimilar infliximab in mid-2017 ($8,322 versus $8,656). By the end of 2018, a gap appeared, with the insurer paying a mean quarterly per-patient sum of $8,111 for biosimilar infliximab compared with $9,535 for the branded biologic.

“The lack of market penetration and very modest price reductions for biosimilars have left policymakers, payers, physicians, and the public frustrated, particularly because sales in Europe continue to rapidly expand and robust cost-savings have materialized,” wrote Jinoos Yazdany, MD, MPH, in an editorial accompanying the study.

Dr. Yazdany, professor and chief of the division of rheumatology at the University of California, San Francisco, noted that increased spending on biologics in the United States – which increased by 50% from 2014 to 2018 – has been driven by rising prices as well as increased uptake of biologic therapies.

At least in part, Europe has been able to reap cost savings where the United States hasn’t because fundamental differences in health care reimbursement can ease sweeping biosimilar adoption, Dr. Yazdany noted. “Countries like Denmark and Sweden, using the negotiating and purchasing power of their single-payer systems have instituted a winner-takes-all bidding system,” with Denmark seeing cost savings of up to two-thirds when bidding was combined with mandatory switching, she said.

The continued market dominance of originator infliximab means that savings from biosimilars have thus far amounted to about $91 million, far short of the $1 billion that the Congressional Budget Office had projected for this date, Dr. Yazdany said.

One problem in the adoption of biosimilars by U.S. rheumatologists may have been uneven marketing and pricing across different types of practice, Colin C. Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the American College of Rheumatology’s Committee on Rheumatologic Care, said in an interview.

“Rheumatologists have generally developed comfort with biosimilars, although this is not universal. The core message, that all biologics vary and that this is OK, is getting out. In general, rheumatologists also understand the problem with high drug prices and the threat to patient access,” Dr. Edgerton said. But “the early marketing and pricing focus for biosimilars seemed to be on hospitals and facilities, and this did not work effectively for community rheumatologists, where the majority of care is delivered. We have been pleased to see a manufacturer pivot toward community rheumatology where additional efforts need to be made to bend the curve on biosimilar adoption. It is critical for practices with experience using biosimilars to educate peers, and this is where networks of practicing rheumatologists are important.”

In Dr. Yazdany’s editorial, she cited four structural factors impeding biosimilar uptake and downstream savings.

First, she cites ongoing actions by pharmaceutical companies, which create a “patent thicket” that has the effect of fencing off originator biologics from biosimilars long beyond the original 12-year exclusivity period. Supporting the notion that “patent thickets” are a common strategy, Dr. Yazdany noted that almost half of the patent applications that AbbVie has filed for adalimumab (Humira) have come in after the original exclusivity period expired in 2014. Humira’s price has risen 18% yearly during this period.

The complicated role played by pharmacy benefit managers (PBMs) is another factor in slow adoption, said Dr. Yazdany: When manufacturers offer rebates to PBMs, the price of the originator biologic may be less than its biosimilar. Further, manufacturers may sign multiyear rebate agreements just before a biosimilar launch; PBMs are also sometimes threatened with the withdrawal of rebates if they offer biosimilars, she noted.

Third, prescriber inertia may also be at play, Dr. Yazdany noted, not least because patients often see little difference in out-of-pocket costs when they make the switch to a biosimilar – PBM rebates are not necessarily passed on to patients. Payers may not reimburse a biosimilar, or formularies can be built without them, influencing prescribing, and there’s usually no reimbursement incentive for biosimilar prescribing in the nonpublic sector, she said. To the contrary, infusing a drug with a higher price often means higher reimbursement for the administering clinician, since commercial insurance reimbursement is often calculated as a percent of the charge for the drug.

Further contributing to inertia is the extra time required for patient education and writing a new set of orders – all work that can’t be captured for extra reimbursement. Dr. Edgerton said that rheumatologists can talk with patients about the “nocebo effect” relating to biosimilars. “This is a phenomenon in which patients are thought to experience worsening symptoms associated with negative beliefs about biosimilars. There has been a study in Arthritis Care & Research addressing this concern. The authors found that positive framing of biosimilars led to more participants being willing to switch than negative framing. This suggests that clinicians have an important role in informing patients about biosimilars, and addressing hesitancy.”

Finally, Dr. Yazdany pointed out that for a pharmaceutical company pursuing biosimilar approval, the regulatory pathway itself can provide its own set of complications and confusion. Biosimilars are not exact molecular replicas of the originator biologic, and these differences can change efficacy and immunogenicity, and also affect stability. Hence, a company wishing to market a biosimilar has to show the Food and Drug Administration that safety and efficacy aren’t affected by a switch to biosimilar from an originator biologic. Extrapolation from one indication to another can be made – with scientific justification.

Rheumatologists are mindful of the potential differences between biosimilars and the originator biologic, as evinced in a recent position statement from the American College of Rheumatology. The position statement advises that “extrapolation should be pursued with caution,” and asks for clear labeling when biosimilars have been designated “interchangeable” with their biosimilar. Interchangeability can clear the way for pharmacy substitution of a prescribed biologic, though Dr. Yazdany noted that 40 states have passed legislation requiring prescriber notification.

The FDA is currently using postmarketing pharmacovigilance to monitor biosimilar performance in the real world, and a recent systematic review “should provide some reassurance,” wrote Dr. Yazdany, citing the study, which looked at 14,000 patients who had a total of 14 disease indications for biosimilar use. The 90-article review largely found no differences in safety, efficacy, or immunogenicity between originators and their biosimilars. Dr. Yazdany recommended greater openness to incorporating the European experience in the FDA’s ongoing reassessment.

A further way forward can come through tackling the patent thicket with the proposed bipartisan Biologic Patent Transparency Act, which would require publication of biologic patents in a one-stop publicly searchable database. Going further with legislation to address anticompetitive activity by pharmaceutical companies could shorten the runway to biosimilar launching considerably, she noted.

The complicated landscape of PBMs and rebates affects many sectors of health care, and new policy efforts are needed here as well, she said. Reimbursement strategies – and much-needed continuing medical education – can both ease prescriber unfamiliarity with biosimilars and provide incentives for their use, she concluded.

Dr. Kim concurred that change is needed before the United States is likely to reap significant economic benefit from biosimilars. “The uptake of biosimilars and their impact on overall health care cost needs to be reevaluated when we have more biosimilars available in the next 3-4 years. However, for now, it appears that substantial savings achieved in some European countries – for example, Denmark – may not be possible without systemic reform of the U.S. pharmaceutical market,” she said.

Dr. Yazdany is supported by the Alice Betts Endowed Chair in Arthritis Research, the Russel/Engleman Research Center at the University of California, San Francisco, and the National Institutes of Health. She has received independent research grants from Pfizer and Genentech and research consulting fees from Eli Lilly and AstraZeneca.

Dr. Kim’s study was supported by the division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women’s Hospital, and Arnold Ventures. Dr. Kim has received research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche.

koakes@mdedge.com

SOURCES: Kim SC et al. Arthritis Rheumatol. 2020 Jan 13. doi: 10.1002/art.41201; Yazdany J. Arthritis Rheumatol. 2020 Jan 10. doi: 10.1002/art.41203.

Although biosimilar versions of tumor necrosis factor inhibitors (TNFis) have been available to U.S. rheumatologists and their patients for over 3 years, uptake has thus far been slow.

monkeybusinessimages/thinkstockphotos.com

In an analysis of data from a large commercial payer, the two available biosimilars for infliximab (Remicade) accounted for less than 1% of TNFi prescribing since the first biosimilar to infliximab was approved in 2016.

The study, published in Arthritis & Rheumatology, involved a total of 1.1 million TNFi prescriptions or infusions received by 95,906 patients from 2016 to 2019. Investigators found that uptake of biosimilar infliximab was essentially flat, standing at 0.1% of prescribing in the second quarter of 2017, and topping out at 0.9% in the first quarter of 2019. For branded infliximab, prescribing was also stable, but accounted for about 20% of overall biologic dispensing in each quarter of the period studied.

There are currently two biosimilar medications to the originator infliximab, which is one of five originator biologics available to treat rheumatic diseases in the United States: infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). The former was approved in 2016 and the latter in 2017, said study author Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her coauthors.

“Our paper reports a disappointingly low uptake of biosimilar infliximab since the first quarter of 2017 using claims data from a large private health plan. The main and maybe the only reason to consider using a biosimilar is cost saving,” said Dr. Kim in an interview. “Our results suggest that current modest cost savings from infliximab biosimilars in the U.S. are not sufficient to promote their widespread use.”

In the payer database study conducted by Dr. Kim and colleagues, the insurer paid similar mean amounts per patient per quarter for originator and biosimilar infliximab in mid-2017 ($8,322 versus $8,656). By the end of 2018, a gap appeared, with the insurer paying a mean quarterly per-patient sum of $8,111 for biosimilar infliximab compared with $9,535 for the branded biologic.

“The lack of market penetration and very modest price reductions for biosimilars have left policymakers, payers, physicians, and the public frustrated, particularly because sales in Europe continue to rapidly expand and robust cost-savings have materialized,” wrote Jinoos Yazdany, MD, MPH, in an editorial accompanying the study.

Dr. Yazdany, professor and chief of the division of rheumatology at the University of California, San Francisco, noted that increased spending on biologics in the United States – which increased by 50% from 2014 to 2018 – has been driven by rising prices as well as increased uptake of biologic therapies.

At least in part, Europe has been able to reap cost savings where the United States hasn’t because fundamental differences in health care reimbursement can ease sweeping biosimilar adoption, Dr. Yazdany noted. “Countries like Denmark and Sweden, using the negotiating and purchasing power of their single-payer systems have instituted a winner-takes-all bidding system,” with Denmark seeing cost savings of up to two-thirds when bidding was combined with mandatory switching, she said.

The continued market dominance of originator infliximab means that savings from biosimilars have thus far amounted to about $91 million, far short of the $1 billion that the Congressional Budget Office had projected for this date, Dr. Yazdany said.

One problem in the adoption of biosimilars by U.S. rheumatologists may have been uneven marketing and pricing across different types of practice, Colin C. Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the American College of Rheumatology’s Committee on Rheumatologic Care, said in an interview.

“Rheumatologists have generally developed comfort with biosimilars, although this is not universal. The core message, that all biologics vary and that this is OK, is getting out. In general, rheumatologists also understand the problem with high drug prices and the threat to patient access,” Dr. Edgerton said. But “the early marketing and pricing focus for biosimilars seemed to be on hospitals and facilities, and this did not work effectively for community rheumatologists, where the majority of care is delivered. We have been pleased to see a manufacturer pivot toward community rheumatology where additional efforts need to be made to bend the curve on biosimilar adoption. It is critical for practices with experience using biosimilars to educate peers, and this is where networks of practicing rheumatologists are important.”

In Dr. Yazdany’s editorial, she cited four structural factors impeding biosimilar uptake and downstream savings.

First, she cites ongoing actions by pharmaceutical companies, which create a “patent thicket” that has the effect of fencing off originator biologics from biosimilars long beyond the original 12-year exclusivity period. Supporting the notion that “patent thickets” are a common strategy, Dr. Yazdany noted that almost half of the patent applications that AbbVie has filed for adalimumab (Humira) have come in after the original exclusivity period expired in 2014. Humira’s price has risen 18% yearly during this period.

The complicated role played by pharmacy benefit managers (PBMs) is another factor in slow adoption, said Dr. Yazdany: When manufacturers offer rebates to PBMs, the price of the originator biologic may be less than its biosimilar. Further, manufacturers may sign multiyear rebate agreements just before a biosimilar launch; PBMs are also sometimes threatened with the withdrawal of rebates if they offer biosimilars, she noted.

Third, prescriber inertia may also be at play, Dr. Yazdany noted, not least because patients often see little difference in out-of-pocket costs when they make the switch to a biosimilar – PBM rebates are not necessarily passed on to patients. Payers may not reimburse a biosimilar, or formularies can be built without them, influencing prescribing, and there’s usually no reimbursement incentive for biosimilar prescribing in the nonpublic sector, she said. To the contrary, infusing a drug with a higher price often means higher reimbursement for the administering clinician, since commercial insurance reimbursement is often calculated as a percent of the charge for the drug.

Further contributing to inertia is the extra time required for patient education and writing a new set of orders – all work that can’t be captured for extra reimbursement. Dr. Edgerton said that rheumatologists can talk with patients about the “nocebo effect” relating to biosimilars. “This is a phenomenon in which patients are thought to experience worsening symptoms associated with negative beliefs about biosimilars. There has been a study in Arthritis Care & Research addressing this concern. The authors found that positive framing of biosimilars led to more participants being willing to switch than negative framing. This suggests that clinicians have an important role in informing patients about biosimilars, and addressing hesitancy.”

Finally, Dr. Yazdany pointed out that for a pharmaceutical company pursuing biosimilar approval, the regulatory pathway itself can provide its own set of complications and confusion. Biosimilars are not exact molecular replicas of the originator biologic, and these differences can change efficacy and immunogenicity, and also affect stability. Hence, a company wishing to market a biosimilar has to show the Food and Drug Administration that safety and efficacy aren’t affected by a switch to biosimilar from an originator biologic. Extrapolation from one indication to another can be made – with scientific justification.

Rheumatologists are mindful of the potential differences between biosimilars and the originator biologic, as evinced in a recent position statement from the American College of Rheumatology. The position statement advises that “extrapolation should be pursued with caution,” and asks for clear labeling when biosimilars have been designated “interchangeable” with their biosimilar. Interchangeability can clear the way for pharmacy substitution of a prescribed biologic, though Dr. Yazdany noted that 40 states have passed legislation requiring prescriber notification.

The FDA is currently using postmarketing pharmacovigilance to monitor biosimilar performance in the real world, and a recent systematic review “should provide some reassurance,” wrote Dr. Yazdany, citing the study, which looked at 14,000 patients who had a total of 14 disease indications for biosimilar use. The 90-article review largely found no differences in safety, efficacy, or immunogenicity between originators and their biosimilars. Dr. Yazdany recommended greater openness to incorporating the European experience in the FDA’s ongoing reassessment.

A further way forward can come through tackling the patent thicket with the proposed bipartisan Biologic Patent Transparency Act, which would require publication of biologic patents in a one-stop publicly searchable database. Going further with legislation to address anticompetitive activity by pharmaceutical companies could shorten the runway to biosimilar launching considerably, she noted.

The complicated landscape of PBMs and rebates affects many sectors of health care, and new policy efforts are needed here as well, she said. Reimbursement strategies – and much-needed continuing medical education – can both ease prescriber unfamiliarity with biosimilars and provide incentives for their use, she concluded.

Dr. Kim concurred that change is needed before the United States is likely to reap significant economic benefit from biosimilars. “The uptake of biosimilars and their impact on overall health care cost needs to be reevaluated when we have more biosimilars available in the next 3-4 years. However, for now, it appears that substantial savings achieved in some European countries – for example, Denmark – may not be possible without systemic reform of the U.S. pharmaceutical market,” she said.

Dr. Yazdany is supported by the Alice Betts Endowed Chair in Arthritis Research, the Russel/Engleman Research Center at the University of California, San Francisco, and the National Institutes of Health. She has received independent research grants from Pfizer and Genentech and research consulting fees from Eli Lilly and AstraZeneca.

Dr. Kim’s study was supported by the division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women’s Hospital, and Arnold Ventures. Dr. Kim has received research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche.

koakes@mdedge.com

SOURCES: Kim SC et al. Arthritis Rheumatol. 2020 Jan 13. doi: 10.1002/art.41201; Yazdany J. Arthritis Rheumatol. 2020 Jan 10. doi: 10.1002/art.41203.

SNOWMASS, COLO. – The tragic opioid epidemic has “one small bright spot”: an expanding pool of eligible donor hearts for transplantation, Akshay S. Desai, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

For decades, the annual volume of heart transplantations performed in the U.S. was static because of the huge mismatch between donor organ supply and demand. But heart transplant volume has increased steadily in the last few years – a result of the opioid epidemic.

Data from the U.S. Organ Procurement and Transplantation Network show that the proportion of donor hearts obtained from individuals who died from drug intoxication climbed from a mere 1.5% in 1999 to 17.6% in 2017, the most recent year for which data are available. Meanwhile, the size of the heart transplant waiting list, which rose year after year in 2009-2015, has since declined (N Engl J Med. 2019 Feb 7;380[6]:597-9).

“What’s amazing is that, even though these patients might have historically been considered high risk in general, the organs recovered from these patients – and particularly the hearts – don’t seem to be any worse in terms of allograft survival than the organs recovered from patients who died from other causes, which are the traditional sources, like blunt head trauma, gunshot wounds, or stroke, that lead to brain death. In general, these organs are useful and do quite well,” according to Dr. Desai, medical director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital, Boston.

He highlighted several other recent developments in the field of cardiac transplantation that promise to further expand the donor heart pool, including acceptance of hepatitis C–infected donors and organ donation after circulatory rather than brain death. Dr. Desai also drew attention to the unintended perverse consequences of a recent redesign of the U.S. donor heart allocation system and discussed the impressive improvement in clinical outcomes with mechanical circulatory support. He noted that, while relatively few cardiologists practice in the highly specialized centers where heart transplants take place, virtually all cardiologists are affected by advances in heart transplantation since hundreds of thousands of the estimated 7 million Americans with heart failure have advanced disease.

Heart transplantation, he emphasized, is becoming increasingly complex. Recipients are on average older, sicker, and have more comorbidities than in times past. As a result, there is greater need for dual organ transplants: heart/lung, heart/liver, or heart/kidney. Plus, more patients come to transplantation after prior cardiac surgery for implantation of a ventricular assist device, so sensitization to blood products is a growing issue. And, of course, the pool of transplant candidates has expanded.

“We’re now forced to take patients previously considered to have contraindications to transplant; for example, diabetes was a contraindication to transplant in the early years, but now it’s the rule in 35%-40% of our patients who present with advanced heart failure,” the cardiologist noted.
 

Transplants from HCV-infected donors to uninfected recipients

Hearts and lungs from donors with hepatitis C viremia were traditionally deemed unsuitable for transplant. That’s all changed in the current era of highly effective direct-acting antiviral agents for the treatment of HCV infection.

In the DONATE HCV trial, Dr. Desai’s colleagues at Brigham and Women’s Hospital showed that giving HCV-uninfected recipients of hearts or lungs from HCV-viremic donors a shortened 4-week course of treatment with sofosbuvir-velpatasvir (Epclusa) beginning within a few hours after transplantation uniformly blocked viral replication. Six months after transplantation, none of the study participants had a detectable HCV viral load, and all had excellent graft function (N Engl J Med. 2019 Apr 25;380[17]:1606-17).

“This is effective prevention of HCV infection by aggressive upfront therapy,” Dr. Desai explained. “We can now take organs from HCV-viremic patients and use them in solid organ transplantation. This has led to a skyrocketing increase in donors with HCV infection, and those donations have helped us clear the waiting list.”
 

Donation after circulatory death

Australian transplant physicians have pioneered the use of donor hearts obtained after circulatory death in individuals with devastating neurologic injury who didn’t quite meet the criteria for brain death, which is the traditional prerequisite. In the new scenario, withdrawal of life-supporting therapy is followed by circulatory death, then the donor heart is procured and preserved via extracorporeal perfusion until transplantation.

The Australians report excellent outcomes, with rates of overall survival and rejection episodes similar to outcomes from brain-dead donors (J Am Coll Cardiol. 2019 Apr 2;73[12]:1447-59). The first U.S. heart transplant involving donation after circulatory death took place at Duke University in Durham, North Carolina. A multicenter U.S. clinical trial of this practice is underway.

If the results are positive and the practice of donation after circulatory death becomes widely implemented, the U.S. heart donor pool could increase by 30%.
 

Recent overhaul of donor heart allocation system may have backfired

The U.S. donor heart allocation system was redesigned in the fall of 2018 in an effort to reduce waiting times. One of the biggest changes involved breaking down the category with the highest urgency status into three new subcategories based upon sickness. Now, the highest-urgency category is for patients in cardiogenic shock who are supported by extracorporeal membrane oxygenation (ECMO) or other temporary mechanical circulatory support devices.

But an analysis of United Network for Organ Sharing (UNOS) data suggests this change has unintended adverse consequences for clinical outcomes.

Indeed, the investigators reported that the use of ECMO support is fourfold greater in the new system, the use of durable left ventricular assist devices (LVADs) as a bridge to transplant is down, and outcomes are worse. The 180-day rate of freedom from death or retransplantation was 77.9%, down significantly from 93.4% in the former system. In a multivariate analysis, patients transplanted in the new system had an adjusted 2.1-fold increased risk of death or retransplantation (J Heart Lung Transplant. 2020 Jan;39[1]:1-4).

“When you create a new listing system, you create new incentives, and people start to manage patients differently,” Dr. Desai observed. “Increasingly now, the path direct to transplant is through temporary mechanical circulatory support rather than durable mechanical circulatory support. Is that a good idea? We don’t know, but if you look at the best data, those on ECMO or percutaneous VADs have the worst outcomes. So the question of whether we should take the sickest of sick patients directly to transplant as a standard strategy has come under scrutiny.”
 

Improved durable LVAD technology brings impressive clinical outcomes

Results of the landmark MOMENTUM 3 randomized trial showed that 2-year clinical outcomes with the magnetically levitated centrifugal-flow HeartMate 3 LVAD now rival those of percutaneous mitral valve repair using the MitraClip device. Two-year all-cause mortality in the LVAD recipients was 22% versus 29.1% with the MitraClip in the COAPT trial and 34.9% in the MITRA-FR trial. The HeartMate 3 reduces the hemocompatibility issues that plagued earlier-generation durable LVADs, with resultant lower rates of pump thrombosis, stroke, and GI bleeding. Indeed, the outcomes in MOMENTUM 3 were so good – and so similar – with the HeartMate 3, regardless of whether the intended treatment goal was as a bridge to transplant or as lifelong destination therapy, that the investigators have recently proposed doing away with those distinctions.

“It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure,” according to the investigators (JAMA Cardiol. 2020 Jan 15. doi: 10.1001/jamacardio.2019.5323).

The next step forward in LVAD technology is already on the horizon: a fully implantable device that eliminates the transcutaneous drive-line for the power supply, which is prone to infection and diminishes overall quality of life. This investigational device utilizes wireless coplanar energy transfer, with a coil ring placed around the lung and fixed to the chest wall. The implanted battery provides more than 6 hours of power without a recharge (J Heart Lung Transplant. 2019 Apr;38[4]:339-43).

“The first LVAD patient has gone swimming in Kazakhstan,” according to Dr. Desai.

Myocardial recovery in LVAD recipients remains elusive

The initial hope for LVADs was that they would not only be able to serve as a bridge to transplantation or as lifetime therapy, but that the prolonged unloading of the ventricle would enable potent medical therapy to rescue myocardial function so that the device could eventually be explanted. That does happen, but only rarely. In a large registry study, myocardial recovery occurred in only about 1% of patients on mechanical circulatory support. Attempts to enhance the process by add-on stem cell therapy have thus far been ineffective.

“For the moment, recovery is still a hope, not a reality,” the cardiologist said.

He reported serving as a consultant to more than a dozen pharmaceutical or medical device companies and receiving research grants from Alnylam, AstraZeneca, Bayer Healthcare, MyoKardia, and Novartis.

bjancin@mdedge.com
 

SNOWMASS, COLO. – The tragic opioid epidemic has “one small bright spot”: an expanding pool of eligible donor hearts for transplantation, Akshay S. Desai, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

For decades, the annual volume of heart transplantations performed in the U.S. was static because of the huge mismatch between donor organ supply and demand. But heart transplant volume has increased steadily in the last few years – a result of the opioid epidemic.

Data from the U.S. Organ Procurement and Transplantation Network show that the proportion of donor hearts obtained from individuals who died from drug intoxication climbed from a mere 1.5% in 1999 to 17.6% in 2017, the most recent year for which data are available. Meanwhile, the size of the heart transplant waiting list, which rose year after year in 2009-2015, has since declined (N Engl J Med. 2019 Feb 7;380[6]:597-9).

“What’s amazing is that, even though these patients might have historically been considered high risk in general, the organs recovered from these patients – and particularly the hearts – don’t seem to be any worse in terms of allograft survival than the organs recovered from patients who died from other causes, which are the traditional sources, like blunt head trauma, gunshot wounds, or stroke, that lead to brain death. In general, these organs are useful and do quite well,” according to Dr. Desai, medical director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital, Boston.

He highlighted several other recent developments in the field of cardiac transplantation that promise to further expand the donor heart pool, including acceptance of hepatitis C–infected donors and organ donation after circulatory rather than brain death. Dr. Desai also drew attention to the unintended perverse consequences of a recent redesign of the U.S. donor heart allocation system and discussed the impressive improvement in clinical outcomes with mechanical circulatory support. He noted that, while relatively few cardiologists practice in the highly specialized centers where heart transplants take place, virtually all cardiologists are affected by advances in heart transplantation since hundreds of thousands of the estimated 7 million Americans with heart failure have advanced disease.

Heart transplantation, he emphasized, is becoming increasingly complex. Recipients are on average older, sicker, and have more comorbidities than in times past. As a result, there is greater need for dual organ transplants: heart/lung, heart/liver, or heart/kidney. Plus, more patients come to transplantation after prior cardiac surgery for implantation of a ventricular assist device, so sensitization to blood products is a growing issue. And, of course, the pool of transplant candidates has expanded.

“We’re now forced to take patients previously considered to have contraindications to transplant; for example, diabetes was a contraindication to transplant in the early years, but now it’s the rule in 35%-40% of our patients who present with advanced heart failure,” the cardiologist noted.
 

Transplants from HCV-infected donors to uninfected recipients

Hearts and lungs from donors with hepatitis C viremia were traditionally deemed unsuitable for transplant. That’s all changed in the current era of highly effective direct-acting antiviral agents for the treatment of HCV infection.

In the DONATE HCV trial, Dr. Desai’s colleagues at Brigham and Women’s Hospital showed that giving HCV-uninfected recipients of hearts or lungs from HCV-viremic donors a shortened 4-week course of treatment with sofosbuvir-velpatasvir (Epclusa) beginning within a few hours after transplantation uniformly blocked viral replication. Six months after transplantation, none of the study participants had a detectable HCV viral load, and all had excellent graft function (N Engl J Med. 2019 Apr 25;380[17]:1606-17).

“This is effective prevention of HCV infection by aggressive upfront therapy,” Dr. Desai explained. “We can now take organs from HCV-viremic patients and use them in solid organ transplantation. This has led to a skyrocketing increase in donors with HCV infection, and those donations have helped us clear the waiting list.”
 

Donation after circulatory death

Australian transplant physicians have pioneered the use of donor hearts obtained after circulatory death in individuals with devastating neurologic injury who didn’t quite meet the criteria for brain death, which is the traditional prerequisite. In the new scenario, withdrawal of life-supporting therapy is followed by circulatory death, then the donor heart is procured and preserved via extracorporeal perfusion until transplantation.

The Australians report excellent outcomes, with rates of overall survival and rejection episodes similar to outcomes from brain-dead donors (J Am Coll Cardiol. 2019 Apr 2;73[12]:1447-59). The first U.S. heart transplant involving donation after circulatory death took place at Duke University in Durham, North Carolina. A multicenter U.S. clinical trial of this practice is underway.

If the results are positive and the practice of donation after circulatory death becomes widely implemented, the U.S. heart donor pool could increase by 30%.
 

Recent overhaul of donor heart allocation system may have backfired

The U.S. donor heart allocation system was redesigned in the fall of 2018 in an effort to reduce waiting times. One of the biggest changes involved breaking down the category with the highest urgency status into three new subcategories based upon sickness. Now, the highest-urgency category is for patients in cardiogenic shock who are supported by extracorporeal membrane oxygenation (ECMO) or other temporary mechanical circulatory support devices.

But an analysis of United Network for Organ Sharing (UNOS) data suggests this change has unintended adverse consequences for clinical outcomes.

Indeed, the investigators reported that the use of ECMO support is fourfold greater in the new system, the use of durable left ventricular assist devices (LVADs) as a bridge to transplant is down, and outcomes are worse. The 180-day rate of freedom from death or retransplantation was 77.9%, down significantly from 93.4% in the former system. In a multivariate analysis, patients transplanted in the new system had an adjusted 2.1-fold increased risk of death or retransplantation (J Heart Lung Transplant. 2020 Jan;39[1]:1-4).

“When you create a new listing system, you create new incentives, and people start to manage patients differently,” Dr. Desai observed. “Increasingly now, the path direct to transplant is through temporary mechanical circulatory support rather than durable mechanical circulatory support. Is that a good idea? We don’t know, but if you look at the best data, those on ECMO or percutaneous VADs have the worst outcomes. So the question of whether we should take the sickest of sick patients directly to transplant as a standard strategy has come under scrutiny.”
 

Improved durable LVAD technology brings impressive clinical outcomes

Results of the landmark MOMENTUM 3 randomized trial showed that 2-year clinical outcomes with the magnetically levitated centrifugal-flow HeartMate 3 LVAD now rival those of percutaneous mitral valve repair using the MitraClip device. Two-year all-cause mortality in the LVAD recipients was 22% versus 29.1% with the MitraClip in the COAPT trial and 34.9% in the MITRA-FR trial. The HeartMate 3 reduces the hemocompatibility issues that plagued earlier-generation durable LVADs, with resultant lower rates of pump thrombosis, stroke, and GI bleeding. Indeed, the outcomes in MOMENTUM 3 were so good – and so similar – with the HeartMate 3, regardless of whether the intended treatment goal was as a bridge to transplant or as lifelong destination therapy, that the investigators have recently proposed doing away with those distinctions.

“It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure,” according to the investigators (JAMA Cardiol. 2020 Jan 15. doi: 10.1001/jamacardio.2019.5323).

The next step forward in LVAD technology is already on the horizon: a fully implantable device that eliminates the transcutaneous drive-line for the power supply, which is prone to infection and diminishes overall quality of life. This investigational device utilizes wireless coplanar energy transfer, with a coil ring placed around the lung and fixed to the chest wall. The implanted battery provides more than 6 hours of power without a recharge (J Heart Lung Transplant. 2019 Apr;38[4]:339-43).

“The first LVAD patient has gone swimming in Kazakhstan,” according to Dr. Desai.

Myocardial recovery in LVAD recipients remains elusive

The initial hope for LVADs was that they would not only be able to serve as a bridge to transplantation or as lifetime therapy, but that the prolonged unloading of the ventricle would enable potent medical therapy to rescue myocardial function so that the device could eventually be explanted. That does happen, but only rarely. In a large registry study, myocardial recovery occurred in only about 1% of patients on mechanical circulatory support. Attempts to enhance the process by add-on stem cell therapy have thus far been ineffective.

“For the moment, recovery is still a hope, not a reality,” the cardiologist said.

He reported serving as a consultant to more than a dozen pharmaceutical or medical device companies and receiving research grants from Alnylam, AstraZeneca, Bayer Healthcare, MyoKardia, and Novartis.

bjancin@mdedge.com
 

SNOWMASS, COLO. – The tragic opioid epidemic has “one small bright spot”: an expanding pool of eligible donor hearts for transplantation, Akshay S. Desai, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

For decades, the annual volume of heart transplantations performed in the U.S. was static because of the huge mismatch between donor organ supply and demand. But heart transplant volume has increased steadily in the last few years – a result of the opioid epidemic.

Data from the U.S. Organ Procurement and Transplantation Network show that the proportion of donor hearts obtained from individuals who died from drug intoxication climbed from a mere 1.5% in 1999 to 17.6% in 2017, the most recent year for which data are available. Meanwhile, the size of the heart transplant waiting list, which rose year after year in 2009-2015, has since declined (N Engl J Med. 2019 Feb 7;380[6]:597-9).

“What’s amazing is that, even though these patients might have historically been considered high risk in general, the organs recovered from these patients – and particularly the hearts – don’t seem to be any worse in terms of allograft survival than the organs recovered from patients who died from other causes, which are the traditional sources, like blunt head trauma, gunshot wounds, or stroke, that lead to brain death. In general, these organs are useful and do quite well,” according to Dr. Desai, medical director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital, Boston.

He highlighted several other recent developments in the field of cardiac transplantation that promise to further expand the donor heart pool, including acceptance of hepatitis C–infected donors and organ donation after circulatory rather than brain death. Dr. Desai also drew attention to the unintended perverse consequences of a recent redesign of the U.S. donor heart allocation system and discussed the impressive improvement in clinical outcomes with mechanical circulatory support. He noted that, while relatively few cardiologists practice in the highly specialized centers where heart transplants take place, virtually all cardiologists are affected by advances in heart transplantation since hundreds of thousands of the estimated 7 million Americans with heart failure have advanced disease.

Heart transplantation, he emphasized, is becoming increasingly complex. Recipients are on average older, sicker, and have more comorbidities than in times past. As a result, there is greater need for dual organ transplants: heart/lung, heart/liver, or heart/kidney. Plus, more patients come to transplantation after prior cardiac surgery for implantation of a ventricular assist device, so sensitization to blood products is a growing issue. And, of course, the pool of transplant candidates has expanded.

“We’re now forced to take patients previously considered to have contraindications to transplant; for example, diabetes was a contraindication to transplant in the early years, but now it’s the rule in 35%-40% of our patients who present with advanced heart failure,” the cardiologist noted.
 

Transplants from HCV-infected donors to uninfected recipients

Hearts and lungs from donors with hepatitis C viremia were traditionally deemed unsuitable for transplant. That’s all changed in the current era of highly effective direct-acting antiviral agents for the treatment of HCV infection.

In the DONATE HCV trial, Dr. Desai’s colleagues at Brigham and Women’s Hospital showed that giving HCV-uninfected recipients of hearts or lungs from HCV-viremic donors a shortened 4-week course of treatment with sofosbuvir-velpatasvir (Epclusa) beginning within a few hours after transplantation uniformly blocked viral replication. Six months after transplantation, none of the study participants had a detectable HCV viral load, and all had excellent graft function (N Engl J Med. 2019 Apr 25;380[17]:1606-17).

“This is effective prevention of HCV infection by aggressive upfront therapy,” Dr. Desai explained. “We can now take organs from HCV-viremic patients and use them in solid organ transplantation. This has led to a skyrocketing increase in donors with HCV infection, and those donations have helped us clear the waiting list.”
 

Donation after circulatory death

Australian transplant physicians have pioneered the use of donor hearts obtained after circulatory death in individuals with devastating neurologic injury who didn’t quite meet the criteria for brain death, which is the traditional prerequisite. In the new scenario, withdrawal of life-supporting therapy is followed by circulatory death, then the donor heart is procured and preserved via extracorporeal perfusion until transplantation.

The Australians report excellent outcomes, with rates of overall survival and rejection episodes similar to outcomes from brain-dead donors (J Am Coll Cardiol. 2019 Apr 2;73[12]:1447-59). The first U.S. heart transplant involving donation after circulatory death took place at Duke University in Durham, North Carolina. A multicenter U.S. clinical trial of this practice is underway.

If the results are positive and the practice of donation after circulatory death becomes widely implemented, the U.S. heart donor pool could increase by 30%.
 

Recent overhaul of donor heart allocation system may have backfired

The U.S. donor heart allocation system was redesigned in the fall of 2018 in an effort to reduce waiting times. One of the biggest changes involved breaking down the category with the highest urgency status into three new subcategories based upon sickness. Now, the highest-urgency category is for patients in cardiogenic shock who are supported by extracorporeal membrane oxygenation (ECMO) or other temporary mechanical circulatory support devices.

But an analysis of United Network for Organ Sharing (UNOS) data suggests this change has unintended adverse consequences for clinical outcomes.

Indeed, the investigators reported that the use of ECMO support is fourfold greater in the new system, the use of durable left ventricular assist devices (LVADs) as a bridge to transplant is down, and outcomes are worse. The 180-day rate of freedom from death or retransplantation was 77.9%, down significantly from 93.4% in the former system. In a multivariate analysis, patients transplanted in the new system had an adjusted 2.1-fold increased risk of death or retransplantation (J Heart Lung Transplant. 2020 Jan;39[1]:1-4).

“When you create a new listing system, you create new incentives, and people start to manage patients differently,” Dr. Desai observed. “Increasingly now, the path direct to transplant is through temporary mechanical circulatory support rather than durable mechanical circulatory support. Is that a good idea? We don’t know, but if you look at the best data, those on ECMO or percutaneous VADs have the worst outcomes. So the question of whether we should take the sickest of sick patients directly to transplant as a standard strategy has come under scrutiny.”
 

Improved durable LVAD technology brings impressive clinical outcomes

Results of the landmark MOMENTUM 3 randomized trial showed that 2-year clinical outcomes with the magnetically levitated centrifugal-flow HeartMate 3 LVAD now rival those of percutaneous mitral valve repair using the MitraClip device. Two-year all-cause mortality in the LVAD recipients was 22% versus 29.1% with the MitraClip in the COAPT trial and 34.9% in the MITRA-FR trial. The HeartMate 3 reduces the hemocompatibility issues that plagued earlier-generation durable LVADs, with resultant lower rates of pump thrombosis, stroke, and GI bleeding. Indeed, the outcomes in MOMENTUM 3 were so good – and so similar – with the HeartMate 3, regardless of whether the intended treatment goal was as a bridge to transplant or as lifelong destination therapy, that the investigators have recently proposed doing away with those distinctions.

“It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure,” according to the investigators (JAMA Cardiol. 2020 Jan 15. doi: 10.1001/jamacardio.2019.5323).

The next step forward in LVAD technology is already on the horizon: a fully implantable device that eliminates the transcutaneous drive-line for the power supply, which is prone to infection and diminishes overall quality of life. This investigational device utilizes wireless coplanar energy transfer, with a coil ring placed around the lung and fixed to the chest wall. The implanted battery provides more than 6 hours of power without a recharge (J Heart Lung Transplant. 2019 Apr;38[4]:339-43).

“The first LVAD patient has gone swimming in Kazakhstan,” according to Dr. Desai.

Myocardial recovery in LVAD recipients remains elusive

The initial hope for LVADs was that they would not only be able to serve as a bridge to transplantation or as lifetime therapy, but that the prolonged unloading of the ventricle would enable potent medical therapy to rescue myocardial function so that the device could eventually be explanted. That does happen, but only rarely. In a large registry study, myocardial recovery occurred in only about 1% of patients on mechanical circulatory support. Attempts to enhance the process by add-on stem cell therapy have thus far been ineffective.

“For the moment, recovery is still a hope, not a reality,” the cardiologist said.

He reported serving as a consultant to more than a dozen pharmaceutical or medical device companies and receiving research grants from Alnylam, AstraZeneca, Bayer Healthcare, MyoKardia, and Novartis.

bjancin@mdedge.com