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Over the last several years, payer policies that dictate and restrict treatments for patients with inflammatory bowel diseases (IBD) have proliferated. The implementation of new coverage restrictions, expansion of services and procedures requiring prior authorization (PA), and dosing and access restriction to covered drugs, and the requirement of repeated treatment reviews including nonmedical switching for stable patients are widespread. The AGA administered a member needs assessment survey in December 2021 to determine the extent to which these policies harm patients and overburden gastroenterologists and their staff.
Survey findings
Most of the 100 surveyed members reported facing administrative burdens that prevented timely access to patient care. Utilization management practices such as PA, step therapy, and nonmedical switching and dosing restrictions create critical barriers to high quality GI care for patients with chronic conditions and jeopardize the physician-patient relationship. At a time when physicians have faced unprecedented challenges because of the public health emergency from the COVID-19 pandemic, these burdens also contribute to increasing physician burnout.
Prior authorization: Among AGA members, 96% of members said that PA is burdensome, with 61% indicating that it is significantly burdensome. Almost 99% of members indicated that PA has a negative impact on patients’ access to clinically appropriate treatments; 89% reported that the burden associated with PA has increased over the last 5 years in their practice.
Step therapy: Among members, 87% described the impact step therapy has on their practice as burdensome. Almost 90% of members said step therapy negatively impacted patients’ access to clinically appropriate treatments. Almost 90% of members felt that there was an overall negative impact on patient clinical outcomes for those patients who were required to follow a step therapy protocol.
Nonmedical switching and dosing restrictions: Out of all members, 86% reported an increase in nonmedical switching and dosing restrictions over the last 5 years; 79% of members noted that these restrictions had a negative impact on patient clinical outcomes.
An increasing number of insurance companies are restricting effective biologic therapy to Food and Drug Administration–labeled doses, in direct conflict with current established best practices. It is most concerning that many patients who had been stable on optimized dosing are suddenly notified that they will no longer be able to receive the dose or treatment frequency prescribed by their physician. The concept of optimizing drug therapy based on disease activity and therapeutic drug monitoring is well established, and artificial restrictions to FDA-labeled doses force unnecessary drug deescalation. This transparent effort to reduce costs lacks evidence for safety. Our sickest patients often require higher doses for induction in order to respond, given drug losses, yet some payers refuse to cover the doses these patients require. This new payer-centered effort prioritizes cost containment over the judgment of the treating physician. It causes direct patient harm risking efficacy or loss of response, and subsequent irreversible disease-related complications.
Medicare drug costs
Medicare patients receiving self-injectable or oral medications are not eligible for co-pay assistance programs through pharmaceutical companies because of federal rules. For non-Medicare patients, these programs reduce the co-pay costs to as low as $5 per month. Medicare patients are able to receive infusions like infliximab and vedolizumab at no cost. However, any self-injectable or oral agent can carry a co-pay of over $1,000. Other than for patients meeting income-based eligibility requirements (e.g., below the poverty line), these treatments become prohibitively expensive. Thousands of patients have had to discontinue their self-injectable and/or oral medications because of this cost or have been denied access to the therapy altogether because of cost.
Need for change
These recent changes in insurance policies have resulted in increased harm to our patients with IBD rather than improving the safety or quality of their care. These changes create barriers to disease treatment and have not improved quality of care, patient outcomes, or quality of life. The AGA and other societies have published multiple guidelines and literature on the management of patients with IBD that should serve as the foundation for insurers’ medication coverage policies. Additionally, insurance companies should seek input from panels of IBD experts when developing their medication coverage policies to ensure they are patient oriented and facilitate high-quality IBD care.
The following are opportunities for insurers to improve the IBD drug approval process:
- Simplify the appeal process.
- Guarantee rapid response/turnaround to appeal processes to avoid additional delays in care.
- Incorporate experienced expert review by a gastroenterologist.
- Ensure coverage of drug and disease monitoring.
- Integrate expert input in policy development.
Conclusion
Effective patient care in IBD, as well as in other chronic gastrointestinal diseases, requires a collaborative approach to maximize clinical outcomes. It is an exciting time in our field, with rapidly expanding therapeutic options to treat IBD that have the potential to modify the disease course and prevent long-term complications for patients. However, optimizing the use of these treatments to achieve disease remission is challenging and requires the ability to individualize the timely choice of medications at the right dose for each patient to capture and monitor response. The ability to provide individualized, data driven care is essential to improving the quality of life of our patients, as well as to reducing health care spending over time.
Achieving high-value care is a goal that benefits everyone involved in the health care system. Policies that interfere with the timely treatment of sick patients with the right therapies, optimized to achieve disease remission, hurt the very patients that our health care system exists to serve. We cannot stand by while impediments to treatment result in harm to our patients and worsen clinical outcomes. Collaboratively developing aligned incentives can lead us to patient-centered policies that fulfill a shared purpose to optimize the health of people with chronic digestive diseases.
The authors reported having no relevant conflicts of interest.
Dr. Feuerstein is with the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center and is an associate professor of medicine Harvard Medical School, both in Boston. Dr. Sofia is an assistant professor of medicine with the division of gastroenterology and hepatology at Oregon Health and Science University, Portland. Dr. Guha is a professor of medicine at the division of gastroenterology, hepatology and nutrition and is codirector of the Center for Interventional Gastroenterology at UTHealth (iGUT) at UT Health Science Center, Houston. Dr. Streett is a clinical professor of medicine, gastroenterology, and hepatology and director of the IBD Education and Advanced IBD Fellowship at Stanford (Calif.) Medicine.
Over the last several years, payer policies that dictate and restrict treatments for patients with inflammatory bowel diseases (IBD) have proliferated. The implementation of new coverage restrictions, expansion of services and procedures requiring prior authorization (PA), and dosing and access restriction to covered drugs, and the requirement of repeated treatment reviews including nonmedical switching for stable patients are widespread. The AGA administered a member needs assessment survey in December 2021 to determine the extent to which these policies harm patients and overburden gastroenterologists and their staff.
Survey findings
Most of the 100 surveyed members reported facing administrative burdens that prevented timely access to patient care. Utilization management practices such as PA, step therapy, and nonmedical switching and dosing restrictions create critical barriers to high quality GI care for patients with chronic conditions and jeopardize the physician-patient relationship. At a time when physicians have faced unprecedented challenges because of the public health emergency from the COVID-19 pandemic, these burdens also contribute to increasing physician burnout.
Prior authorization: Among AGA members, 96% of members said that PA is burdensome, with 61% indicating that it is significantly burdensome. Almost 99% of members indicated that PA has a negative impact on patients’ access to clinically appropriate treatments; 89% reported that the burden associated with PA has increased over the last 5 years in their practice.
Step therapy: Among members, 87% described the impact step therapy has on their practice as burdensome. Almost 90% of members said step therapy negatively impacted patients’ access to clinically appropriate treatments. Almost 90% of members felt that there was an overall negative impact on patient clinical outcomes for those patients who were required to follow a step therapy protocol.
Nonmedical switching and dosing restrictions: Out of all members, 86% reported an increase in nonmedical switching and dosing restrictions over the last 5 years; 79% of members noted that these restrictions had a negative impact on patient clinical outcomes.
An increasing number of insurance companies are restricting effective biologic therapy to Food and Drug Administration–labeled doses, in direct conflict with current established best practices. It is most concerning that many patients who had been stable on optimized dosing are suddenly notified that they will no longer be able to receive the dose or treatment frequency prescribed by their physician. The concept of optimizing drug therapy based on disease activity and therapeutic drug monitoring is well established, and artificial restrictions to FDA-labeled doses force unnecessary drug deescalation. This transparent effort to reduce costs lacks evidence for safety. Our sickest patients often require higher doses for induction in order to respond, given drug losses, yet some payers refuse to cover the doses these patients require. This new payer-centered effort prioritizes cost containment over the judgment of the treating physician. It causes direct patient harm risking efficacy or loss of response, and subsequent irreversible disease-related complications.
Medicare drug costs
Medicare patients receiving self-injectable or oral medications are not eligible for co-pay assistance programs through pharmaceutical companies because of federal rules. For non-Medicare patients, these programs reduce the co-pay costs to as low as $5 per month. Medicare patients are able to receive infusions like infliximab and vedolizumab at no cost. However, any self-injectable or oral agent can carry a co-pay of over $1,000. Other than for patients meeting income-based eligibility requirements (e.g., below the poverty line), these treatments become prohibitively expensive. Thousands of patients have had to discontinue their self-injectable and/or oral medications because of this cost or have been denied access to the therapy altogether because of cost.
Need for change
These recent changes in insurance policies have resulted in increased harm to our patients with IBD rather than improving the safety or quality of their care. These changes create barriers to disease treatment and have not improved quality of care, patient outcomes, or quality of life. The AGA and other societies have published multiple guidelines and literature on the management of patients with IBD that should serve as the foundation for insurers’ medication coverage policies. Additionally, insurance companies should seek input from panels of IBD experts when developing their medication coverage policies to ensure they are patient oriented and facilitate high-quality IBD care.
The following are opportunities for insurers to improve the IBD drug approval process:
- Simplify the appeal process.
- Guarantee rapid response/turnaround to appeal processes to avoid additional delays in care.
- Incorporate experienced expert review by a gastroenterologist.
- Ensure coverage of drug and disease monitoring.
- Integrate expert input in policy development.
Conclusion
Effective patient care in IBD, as well as in other chronic gastrointestinal diseases, requires a collaborative approach to maximize clinical outcomes. It is an exciting time in our field, with rapidly expanding therapeutic options to treat IBD that have the potential to modify the disease course and prevent long-term complications for patients. However, optimizing the use of these treatments to achieve disease remission is challenging and requires the ability to individualize the timely choice of medications at the right dose for each patient to capture and monitor response. The ability to provide individualized, data driven care is essential to improving the quality of life of our patients, as well as to reducing health care spending over time.
Achieving high-value care is a goal that benefits everyone involved in the health care system. Policies that interfere with the timely treatment of sick patients with the right therapies, optimized to achieve disease remission, hurt the very patients that our health care system exists to serve. We cannot stand by while impediments to treatment result in harm to our patients and worsen clinical outcomes. Collaboratively developing aligned incentives can lead us to patient-centered policies that fulfill a shared purpose to optimize the health of people with chronic digestive diseases.
The authors reported having no relevant conflicts of interest.
Dr. Feuerstein is with the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center and is an associate professor of medicine Harvard Medical School, both in Boston. Dr. Sofia is an assistant professor of medicine with the division of gastroenterology and hepatology at Oregon Health and Science University, Portland. Dr. Guha is a professor of medicine at the division of gastroenterology, hepatology and nutrition and is codirector of the Center for Interventional Gastroenterology at UTHealth (iGUT) at UT Health Science Center, Houston. Dr. Streett is a clinical professor of medicine, gastroenterology, and hepatology and director of the IBD Education and Advanced IBD Fellowship at Stanford (Calif.) Medicine.
Over the last several years, payer policies that dictate and restrict treatments for patients with inflammatory bowel diseases (IBD) have proliferated. The implementation of new coverage restrictions, expansion of services and procedures requiring prior authorization (PA), and dosing and access restriction to covered drugs, and the requirement of repeated treatment reviews including nonmedical switching for stable patients are widespread. The AGA administered a member needs assessment survey in December 2021 to determine the extent to which these policies harm patients and overburden gastroenterologists and their staff.
Survey findings
Most of the 100 surveyed members reported facing administrative burdens that prevented timely access to patient care. Utilization management practices such as PA, step therapy, and nonmedical switching and dosing restrictions create critical barriers to high quality GI care for patients with chronic conditions and jeopardize the physician-patient relationship. At a time when physicians have faced unprecedented challenges because of the public health emergency from the COVID-19 pandemic, these burdens also contribute to increasing physician burnout.
Prior authorization: Among AGA members, 96% of members said that PA is burdensome, with 61% indicating that it is significantly burdensome. Almost 99% of members indicated that PA has a negative impact on patients’ access to clinically appropriate treatments; 89% reported that the burden associated with PA has increased over the last 5 years in their practice.
Step therapy: Among members, 87% described the impact step therapy has on their practice as burdensome. Almost 90% of members said step therapy negatively impacted patients’ access to clinically appropriate treatments. Almost 90% of members felt that there was an overall negative impact on patient clinical outcomes for those patients who were required to follow a step therapy protocol.
Nonmedical switching and dosing restrictions: Out of all members, 86% reported an increase in nonmedical switching and dosing restrictions over the last 5 years; 79% of members noted that these restrictions had a negative impact on patient clinical outcomes.
An increasing number of insurance companies are restricting effective biologic therapy to Food and Drug Administration–labeled doses, in direct conflict with current established best practices. It is most concerning that many patients who had been stable on optimized dosing are suddenly notified that they will no longer be able to receive the dose or treatment frequency prescribed by their physician. The concept of optimizing drug therapy based on disease activity and therapeutic drug monitoring is well established, and artificial restrictions to FDA-labeled doses force unnecessary drug deescalation. This transparent effort to reduce costs lacks evidence for safety. Our sickest patients often require higher doses for induction in order to respond, given drug losses, yet some payers refuse to cover the doses these patients require. This new payer-centered effort prioritizes cost containment over the judgment of the treating physician. It causes direct patient harm risking efficacy or loss of response, and subsequent irreversible disease-related complications.
Medicare drug costs
Medicare patients receiving self-injectable or oral medications are not eligible for co-pay assistance programs through pharmaceutical companies because of federal rules. For non-Medicare patients, these programs reduce the co-pay costs to as low as $5 per month. Medicare patients are able to receive infusions like infliximab and vedolizumab at no cost. However, any self-injectable or oral agent can carry a co-pay of over $1,000. Other than for patients meeting income-based eligibility requirements (e.g., below the poverty line), these treatments become prohibitively expensive. Thousands of patients have had to discontinue their self-injectable and/or oral medications because of this cost or have been denied access to the therapy altogether because of cost.
Need for change
These recent changes in insurance policies have resulted in increased harm to our patients with IBD rather than improving the safety or quality of their care. These changes create barriers to disease treatment and have not improved quality of care, patient outcomes, or quality of life. The AGA and other societies have published multiple guidelines and literature on the management of patients with IBD that should serve as the foundation for insurers’ medication coverage policies. Additionally, insurance companies should seek input from panels of IBD experts when developing their medication coverage policies to ensure they are patient oriented and facilitate high-quality IBD care.
The following are opportunities for insurers to improve the IBD drug approval process:
- Simplify the appeal process.
- Guarantee rapid response/turnaround to appeal processes to avoid additional delays in care.
- Incorporate experienced expert review by a gastroenterologist.
- Ensure coverage of drug and disease monitoring.
- Integrate expert input in policy development.
Conclusion
Effective patient care in IBD, as well as in other chronic gastrointestinal diseases, requires a collaborative approach to maximize clinical outcomes. It is an exciting time in our field, with rapidly expanding therapeutic options to treat IBD that have the potential to modify the disease course and prevent long-term complications for patients. However, optimizing the use of these treatments to achieve disease remission is challenging and requires the ability to individualize the timely choice of medications at the right dose for each patient to capture and monitor response. The ability to provide individualized, data driven care is essential to improving the quality of life of our patients, as well as to reducing health care spending over time.
Achieving high-value care is a goal that benefits everyone involved in the health care system. Policies that interfere with the timely treatment of sick patients with the right therapies, optimized to achieve disease remission, hurt the very patients that our health care system exists to serve. We cannot stand by while impediments to treatment result in harm to our patients and worsen clinical outcomes. Collaboratively developing aligned incentives can lead us to patient-centered policies that fulfill a shared purpose to optimize the health of people with chronic digestive diseases.
The authors reported having no relevant conflicts of interest.
Dr. Feuerstein is with the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center and is an associate professor of medicine Harvard Medical School, both in Boston. Dr. Sofia is an assistant professor of medicine with the division of gastroenterology and hepatology at Oregon Health and Science University, Portland. Dr. Guha is a professor of medicine at the division of gastroenterology, hepatology and nutrition and is codirector of the Center for Interventional Gastroenterology at UTHealth (iGUT) at UT Health Science Center, Houston. Dr. Streett is a clinical professor of medicine, gastroenterology, and hepatology and director of the IBD Education and Advanced IBD Fellowship at Stanford (Calif.) Medicine.