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At Actify Neurotherapies, a longtime provider of ketamine infusion therapy, Steven P. Levine, MD, and staff are busy making preparations for a new offering: intranasal esketamine.
The nasal spray, called Spravato and developed by Janssen Pharmaceuticals, was approved by the Food and Drug Administration in March 2019 for treatment-resistant depression in adults who have failed at least two oral antidepressants of different classes.
“We’ve been anticipating this for years,” said Dr. Levine, founder and chief medical officer for Actify Neurotherapies, formerly Ketamine Treatment Centers.“Being used to giving IV ketamine every day, this really fits right into our daily practice. For us, [it means] adding a few staff members here and there to make sure we have adequate monitoring, [and] setting up recovery spaces so that patients have a nice place to spend time.”
Dr. Levine is far from alone. After the recent intranasal esketamine approval, many psychiatrists are considering how they might integrate the medication into their practice. The FDA is managing the drug under a Risk Evaluation and Mitigation Strategy (REMS) program, which requires prescriber training on esketamine risks and patient monitoring. Facilities must be licensed to dispense esketamine and are required to monitor patients in person for at least 2 hours after administration.
The rigid requirements are important for safety, but they mean that a limited number of psychiatrists will likely have the capacity to deliver the medication, said Gerard Sanacora, MD, PhD, director of the Yale Depression Research Program in New Haven, Conn., and a principal investigator for several clinical trials associated with the esketamine nasal spray. Psychiatrists interested in providing the medication have much to consider in the way of logistics, structure, and staffing.
“The requirements do [present] hurdles,” Dr. Sanacora said. “This is a medication that requires a fair amount of infrastructure. This is not going to be a treatment that is going to be given by every corner psychiatrist.”
In addition to delivery obstacles, questions remain about the ideal Spravato regimen, particularly the optimal dose frequency during maintenance and the best way to track long-term outcomes. Some have also raised concerns about the potential for esketamine/ketamine abuse following the FDA approval.
Despite the questions, one thing most psychiatrists agree on is the need for intranasal esketamine and its promising impact.
“There’s no secret that at this point: We really haven’t put a dent in the rates of depression and the rates of suicide over the past several decades,” Dr. Levine said. “We’ve needed something that’s truly new, something that’s innovative. It makes the FDA approval of intranasal esketamine a really big deal. It’s a new mechanism, a new approach to depression, and provides hope to patients and the field of psychiatry.”
Addressing delivery challenges
After the FDA approval, Jacqueline Posada, MD, was tasked with helping a small psychiatry practice develop the framework to incorporate intranasal esketamine. Dr. Posada, a consultation-liaison psychiatry fellow at the Inova Fairfax Hospital-George Washington University program in Falls Church, Va., started by creating a comprehensive screening form for esketamine candidates, developing an informed-consent protocol, and researching storage guidelines for an outpatient practice.
Before the practice could move forward, however, Dr. Posada learned that building regulations for the office prohibited “medical procedures” from occurring in the space. While the 10-doctor practice is associated with George Washington University, Washington, it is located several blocks away in an office setting.
“It was pretty disappointing,” Dr. Posada said. “Our organization is looking for another spot that allows psychiatry to administer a medical procedure. There’s a lot of people who are in private practice who are in a type of office building that may restrict medical procedures. Depending on the type of space they are renting, they need to know what is allowed in their office building.”
Patient privacy is also a primary consideration when delivering the medication. Dr. Posada said she and her staff had contemplated conducting the 2-hour patient monitoring in a group setting, but that idea was quickly thwarted.
“Our plan was in 15- to 20-minute appointments, administer the esketamine, and have maybe 5-10 people monitored in a room with barriers between each chair,” she said. “We were advised by our privacy officer that that could hinder patient confidentiality and was not a viable option for administering the medication in our practice.”
Practices should also determine a long-term treatment plan for each patient receiving esketamine, Dr. Sanacora said, particularly in light of data suggesting that a substantial number of patients will relapse if treatment is stopped. A long-term treatment plan should be considered prior to, or at the same time that esketamine treatment is initiated.
Comanagement of patients by clinicians is another essential part of esketamine treatment, Dr. Sanacora added.
“It is going to be important for the community clinicians not directly offering the treatment to develop close and ongoing relationships with the clinicians and sites that are offering this treatment to optimize the care of their patients,” he said. “Conversely, it is going to be imperative that the esketamine providers develop effective and efficient methods of maintaining close communications with the referring clinicians.”
Reimbursement comes with upfront cost
As far as payment, Dr. Levine expects that the nasal spray will be widely reimbursed. Clinics must first purchase the medication and insurers will reimburse them later for the drug, a method commonly referred to as “buy and bill.” The upfront cost could be too expensive for some physicians.
“That’s not something psychiatrists are used to, storing a controlled substance on site, having the financial outlay of keeping inventory of an expensive drug, and waiting for reimbursement,” Dr. Levine said.
Practices can also bill an evaluation and management code for the treatment as well as for observation time. At this point, it appears insurers will not cover psychotherapy delivered at the same time, which is disappointing, he said.
Sanjay J. Mathew, MD, a psychiatry professor and vice chair for research at Baylor College of Medicine, Houston, said because many psychiatrists who specialize in psychopharmacology and who see treatment-resistant depression patients do not accept private insurance or Medicare/Medicaid, patient access to the drug may be limited.
“Given the REMS and the need for 2-hour monitoring following the treatment, I believe that primarily, specialized clinics and centers for ‘interventional psychiatry’ will be the early adopters,” he said. “The typical office-based psychiatrist who does not accept insurance, and does not have means to store and dispense a controlled substance or monitor patients, may not readily adopt this new approach.”
Experts say abuse potential low
Meanwhile, the potential for abuse with intranasal esketamine is low, considering the REMS requirements, said Mark S. Gold, MD, an addiction medicine specialist. If practices follow the guidelines, which restrict patients from taking the medication home, misuse is not likely.
However, the drug’s counterpart, ketamine, which has been abused globally for decades, may see an uptick in illicit use after the recent FDA approval of esketamine, Dr. Gold said. Ketamine is currently produced in clandestine labs for use on the club scene and for date rape purposes, Dr. Gold said. Most recently, ketamine has been mixed with cocaine and referred to as “Calvin Klein” for street use.
“You do have the unintended consequence when a medication is approved, [that] the general public may not be sophisticated enough to understand dose, duration, and supervised administration, and think that street ketamine is equally a medication,” Dr. Gold said. “You have the capacity for black market ketamine to undercut the price and be distributed in a form that can be extremely dangerous and life threatening. Just calling it ketamine provides confusion and the opportunity for black market sales distribution and increases in use.”
Dr. Mathew hopes the REMS designation will not only aid in risk mitigation for esketamine, but also result in valuable postapproval information with respect to longer term safety and efficacy. Questions that still need to be addressed include the best antidepressant regimens in conjunction with intranasal esketamine, the ideal long-term monitoring method, and the potential impact of benzodiazepines on response to Spravato.
“These answers will come with more research – phase 4 postmarketing studies – and also clinical experience in the community, as clinicians begin to prescribe esketamine,” Dr. Mathew said. “Input from organizations, such as the American Society of Ketamine Physicians, will be important as well.”
Dr. Levine, Dr. Posada, and Dr. Gold reported no disclosures. Dr. Sanacora served as principal investigator for several clinical trials associated with intranasal esketamine. Dr. Mathew served as a consultant to several pharmaceutical companies, including Janssen.
At Actify Neurotherapies, a longtime provider of ketamine infusion therapy, Steven P. Levine, MD, and staff are busy making preparations for a new offering: intranasal esketamine.
The nasal spray, called Spravato and developed by Janssen Pharmaceuticals, was approved by the Food and Drug Administration in March 2019 for treatment-resistant depression in adults who have failed at least two oral antidepressants of different classes.
“We’ve been anticipating this for years,” said Dr. Levine, founder and chief medical officer for Actify Neurotherapies, formerly Ketamine Treatment Centers.“Being used to giving IV ketamine every day, this really fits right into our daily practice. For us, [it means] adding a few staff members here and there to make sure we have adequate monitoring, [and] setting up recovery spaces so that patients have a nice place to spend time.”
Dr. Levine is far from alone. After the recent intranasal esketamine approval, many psychiatrists are considering how they might integrate the medication into their practice. The FDA is managing the drug under a Risk Evaluation and Mitigation Strategy (REMS) program, which requires prescriber training on esketamine risks and patient monitoring. Facilities must be licensed to dispense esketamine and are required to monitor patients in person for at least 2 hours after administration.
The rigid requirements are important for safety, but they mean that a limited number of psychiatrists will likely have the capacity to deliver the medication, said Gerard Sanacora, MD, PhD, director of the Yale Depression Research Program in New Haven, Conn., and a principal investigator for several clinical trials associated with the esketamine nasal spray. Psychiatrists interested in providing the medication have much to consider in the way of logistics, structure, and staffing.
“The requirements do [present] hurdles,” Dr. Sanacora said. “This is a medication that requires a fair amount of infrastructure. This is not going to be a treatment that is going to be given by every corner psychiatrist.”
In addition to delivery obstacles, questions remain about the ideal Spravato regimen, particularly the optimal dose frequency during maintenance and the best way to track long-term outcomes. Some have also raised concerns about the potential for esketamine/ketamine abuse following the FDA approval.
Despite the questions, one thing most psychiatrists agree on is the need for intranasal esketamine and its promising impact.
“There’s no secret that at this point: We really haven’t put a dent in the rates of depression and the rates of suicide over the past several decades,” Dr. Levine said. “We’ve needed something that’s truly new, something that’s innovative. It makes the FDA approval of intranasal esketamine a really big deal. It’s a new mechanism, a new approach to depression, and provides hope to patients and the field of psychiatry.”
Addressing delivery challenges
After the FDA approval, Jacqueline Posada, MD, was tasked with helping a small psychiatry practice develop the framework to incorporate intranasal esketamine. Dr. Posada, a consultation-liaison psychiatry fellow at the Inova Fairfax Hospital-George Washington University program in Falls Church, Va., started by creating a comprehensive screening form for esketamine candidates, developing an informed-consent protocol, and researching storage guidelines for an outpatient practice.
Before the practice could move forward, however, Dr. Posada learned that building regulations for the office prohibited “medical procedures” from occurring in the space. While the 10-doctor practice is associated with George Washington University, Washington, it is located several blocks away in an office setting.
“It was pretty disappointing,” Dr. Posada said. “Our organization is looking for another spot that allows psychiatry to administer a medical procedure. There’s a lot of people who are in private practice who are in a type of office building that may restrict medical procedures. Depending on the type of space they are renting, they need to know what is allowed in their office building.”
Patient privacy is also a primary consideration when delivering the medication. Dr. Posada said she and her staff had contemplated conducting the 2-hour patient monitoring in a group setting, but that idea was quickly thwarted.
“Our plan was in 15- to 20-minute appointments, administer the esketamine, and have maybe 5-10 people monitored in a room with barriers between each chair,” she said. “We were advised by our privacy officer that that could hinder patient confidentiality and was not a viable option for administering the medication in our practice.”
Practices should also determine a long-term treatment plan for each patient receiving esketamine, Dr. Sanacora said, particularly in light of data suggesting that a substantial number of patients will relapse if treatment is stopped. A long-term treatment plan should be considered prior to, or at the same time that esketamine treatment is initiated.
Comanagement of patients by clinicians is another essential part of esketamine treatment, Dr. Sanacora added.
“It is going to be important for the community clinicians not directly offering the treatment to develop close and ongoing relationships with the clinicians and sites that are offering this treatment to optimize the care of their patients,” he said. “Conversely, it is going to be imperative that the esketamine providers develop effective and efficient methods of maintaining close communications with the referring clinicians.”
Reimbursement comes with upfront cost
As far as payment, Dr. Levine expects that the nasal spray will be widely reimbursed. Clinics must first purchase the medication and insurers will reimburse them later for the drug, a method commonly referred to as “buy and bill.” The upfront cost could be too expensive for some physicians.
“That’s not something psychiatrists are used to, storing a controlled substance on site, having the financial outlay of keeping inventory of an expensive drug, and waiting for reimbursement,” Dr. Levine said.
Practices can also bill an evaluation and management code for the treatment as well as for observation time. At this point, it appears insurers will not cover psychotherapy delivered at the same time, which is disappointing, he said.
Sanjay J. Mathew, MD, a psychiatry professor and vice chair for research at Baylor College of Medicine, Houston, said because many psychiatrists who specialize in psychopharmacology and who see treatment-resistant depression patients do not accept private insurance or Medicare/Medicaid, patient access to the drug may be limited.
“Given the REMS and the need for 2-hour monitoring following the treatment, I believe that primarily, specialized clinics and centers for ‘interventional psychiatry’ will be the early adopters,” he said. “The typical office-based psychiatrist who does not accept insurance, and does not have means to store and dispense a controlled substance or monitor patients, may not readily adopt this new approach.”
Experts say abuse potential low
Meanwhile, the potential for abuse with intranasal esketamine is low, considering the REMS requirements, said Mark S. Gold, MD, an addiction medicine specialist. If practices follow the guidelines, which restrict patients from taking the medication home, misuse is not likely.
However, the drug’s counterpart, ketamine, which has been abused globally for decades, may see an uptick in illicit use after the recent FDA approval of esketamine, Dr. Gold said. Ketamine is currently produced in clandestine labs for use on the club scene and for date rape purposes, Dr. Gold said. Most recently, ketamine has been mixed with cocaine and referred to as “Calvin Klein” for street use.
“You do have the unintended consequence when a medication is approved, [that] the general public may not be sophisticated enough to understand dose, duration, and supervised administration, and think that street ketamine is equally a medication,” Dr. Gold said. “You have the capacity for black market ketamine to undercut the price and be distributed in a form that can be extremely dangerous and life threatening. Just calling it ketamine provides confusion and the opportunity for black market sales distribution and increases in use.”
Dr. Mathew hopes the REMS designation will not only aid in risk mitigation for esketamine, but also result in valuable postapproval information with respect to longer term safety and efficacy. Questions that still need to be addressed include the best antidepressant regimens in conjunction with intranasal esketamine, the ideal long-term monitoring method, and the potential impact of benzodiazepines on response to Spravato.
“These answers will come with more research – phase 4 postmarketing studies – and also clinical experience in the community, as clinicians begin to prescribe esketamine,” Dr. Mathew said. “Input from organizations, such as the American Society of Ketamine Physicians, will be important as well.”
Dr. Levine, Dr. Posada, and Dr. Gold reported no disclosures. Dr. Sanacora served as principal investigator for several clinical trials associated with intranasal esketamine. Dr. Mathew served as a consultant to several pharmaceutical companies, including Janssen.
At Actify Neurotherapies, a longtime provider of ketamine infusion therapy, Steven P. Levine, MD, and staff are busy making preparations for a new offering: intranasal esketamine.
The nasal spray, called Spravato and developed by Janssen Pharmaceuticals, was approved by the Food and Drug Administration in March 2019 for treatment-resistant depression in adults who have failed at least two oral antidepressants of different classes.
“We’ve been anticipating this for years,” said Dr. Levine, founder and chief medical officer for Actify Neurotherapies, formerly Ketamine Treatment Centers.“Being used to giving IV ketamine every day, this really fits right into our daily practice. For us, [it means] adding a few staff members here and there to make sure we have adequate monitoring, [and] setting up recovery spaces so that patients have a nice place to spend time.”
Dr. Levine is far from alone. After the recent intranasal esketamine approval, many psychiatrists are considering how they might integrate the medication into their practice. The FDA is managing the drug under a Risk Evaluation and Mitigation Strategy (REMS) program, which requires prescriber training on esketamine risks and patient monitoring. Facilities must be licensed to dispense esketamine and are required to monitor patients in person for at least 2 hours after administration.
The rigid requirements are important for safety, but they mean that a limited number of psychiatrists will likely have the capacity to deliver the medication, said Gerard Sanacora, MD, PhD, director of the Yale Depression Research Program in New Haven, Conn., and a principal investigator for several clinical trials associated with the esketamine nasal spray. Psychiatrists interested in providing the medication have much to consider in the way of logistics, structure, and staffing.
“The requirements do [present] hurdles,” Dr. Sanacora said. “This is a medication that requires a fair amount of infrastructure. This is not going to be a treatment that is going to be given by every corner psychiatrist.”
In addition to delivery obstacles, questions remain about the ideal Spravato regimen, particularly the optimal dose frequency during maintenance and the best way to track long-term outcomes. Some have also raised concerns about the potential for esketamine/ketamine abuse following the FDA approval.
Despite the questions, one thing most psychiatrists agree on is the need for intranasal esketamine and its promising impact.
“There’s no secret that at this point: We really haven’t put a dent in the rates of depression and the rates of suicide over the past several decades,” Dr. Levine said. “We’ve needed something that’s truly new, something that’s innovative. It makes the FDA approval of intranasal esketamine a really big deal. It’s a new mechanism, a new approach to depression, and provides hope to patients and the field of psychiatry.”
Addressing delivery challenges
After the FDA approval, Jacqueline Posada, MD, was tasked with helping a small psychiatry practice develop the framework to incorporate intranasal esketamine. Dr. Posada, a consultation-liaison psychiatry fellow at the Inova Fairfax Hospital-George Washington University program in Falls Church, Va., started by creating a comprehensive screening form for esketamine candidates, developing an informed-consent protocol, and researching storage guidelines for an outpatient practice.
Before the practice could move forward, however, Dr. Posada learned that building regulations for the office prohibited “medical procedures” from occurring in the space. While the 10-doctor practice is associated with George Washington University, Washington, it is located several blocks away in an office setting.
“It was pretty disappointing,” Dr. Posada said. “Our organization is looking for another spot that allows psychiatry to administer a medical procedure. There’s a lot of people who are in private practice who are in a type of office building that may restrict medical procedures. Depending on the type of space they are renting, they need to know what is allowed in their office building.”
Patient privacy is also a primary consideration when delivering the medication. Dr. Posada said she and her staff had contemplated conducting the 2-hour patient monitoring in a group setting, but that idea was quickly thwarted.
“Our plan was in 15- to 20-minute appointments, administer the esketamine, and have maybe 5-10 people monitored in a room with barriers between each chair,” she said. “We were advised by our privacy officer that that could hinder patient confidentiality and was not a viable option for administering the medication in our practice.”
Practices should also determine a long-term treatment plan for each patient receiving esketamine, Dr. Sanacora said, particularly in light of data suggesting that a substantial number of patients will relapse if treatment is stopped. A long-term treatment plan should be considered prior to, or at the same time that esketamine treatment is initiated.
Comanagement of patients by clinicians is another essential part of esketamine treatment, Dr. Sanacora added.
“It is going to be important for the community clinicians not directly offering the treatment to develop close and ongoing relationships with the clinicians and sites that are offering this treatment to optimize the care of their patients,” he said. “Conversely, it is going to be imperative that the esketamine providers develop effective and efficient methods of maintaining close communications with the referring clinicians.”
Reimbursement comes with upfront cost
As far as payment, Dr. Levine expects that the nasal spray will be widely reimbursed. Clinics must first purchase the medication and insurers will reimburse them later for the drug, a method commonly referred to as “buy and bill.” The upfront cost could be too expensive for some physicians.
“That’s not something psychiatrists are used to, storing a controlled substance on site, having the financial outlay of keeping inventory of an expensive drug, and waiting for reimbursement,” Dr. Levine said.
Practices can also bill an evaluation and management code for the treatment as well as for observation time. At this point, it appears insurers will not cover psychotherapy delivered at the same time, which is disappointing, he said.
Sanjay J. Mathew, MD, a psychiatry professor and vice chair for research at Baylor College of Medicine, Houston, said because many psychiatrists who specialize in psychopharmacology and who see treatment-resistant depression patients do not accept private insurance or Medicare/Medicaid, patient access to the drug may be limited.
“Given the REMS and the need for 2-hour monitoring following the treatment, I believe that primarily, specialized clinics and centers for ‘interventional psychiatry’ will be the early adopters,” he said. “The typical office-based psychiatrist who does not accept insurance, and does not have means to store and dispense a controlled substance or monitor patients, may not readily adopt this new approach.”
Experts say abuse potential low
Meanwhile, the potential for abuse with intranasal esketamine is low, considering the REMS requirements, said Mark S. Gold, MD, an addiction medicine specialist. If practices follow the guidelines, which restrict patients from taking the medication home, misuse is not likely.
However, the drug’s counterpart, ketamine, which has been abused globally for decades, may see an uptick in illicit use after the recent FDA approval of esketamine, Dr. Gold said. Ketamine is currently produced in clandestine labs for use on the club scene and for date rape purposes, Dr. Gold said. Most recently, ketamine has been mixed with cocaine and referred to as “Calvin Klein” for street use.
“You do have the unintended consequence when a medication is approved, [that] the general public may not be sophisticated enough to understand dose, duration, and supervised administration, and think that street ketamine is equally a medication,” Dr. Gold said. “You have the capacity for black market ketamine to undercut the price and be distributed in a form that can be extremely dangerous and life threatening. Just calling it ketamine provides confusion and the opportunity for black market sales distribution and increases in use.”
Dr. Mathew hopes the REMS designation will not only aid in risk mitigation for esketamine, but also result in valuable postapproval information with respect to longer term safety and efficacy. Questions that still need to be addressed include the best antidepressant regimens in conjunction with intranasal esketamine, the ideal long-term monitoring method, and the potential impact of benzodiazepines on response to Spravato.
“These answers will come with more research – phase 4 postmarketing studies – and also clinical experience in the community, as clinicians begin to prescribe esketamine,” Dr. Mathew said. “Input from organizations, such as the American Society of Ketamine Physicians, will be important as well.”
Dr. Levine, Dr. Posada, and Dr. Gold reported no disclosures. Dr. Sanacora served as principal investigator for several clinical trials associated with intranasal esketamine. Dr. Mathew served as a consultant to several pharmaceutical companies, including Janssen.