Category: ACR

ACR Applauds Senate Introduction of Safe Step Act

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The following is a press release from ACR dated last Thursday:

The American College of Rheumatology (ACR) today commended leaders in the United States Senate for introducing the bipartisan Safe Step Act of 2019 (S. 2546), legislation that would place reasonable limits on step therapy, a troubling practice that requires patients to try—and fail—treatments preferred by their insurance company and pharmacy benefits manager before a doctor-prescribed option can be approved.

“With the Senate introduction of the Safe Step Act, we are one step closer to removing a treatment barrier that hurts patients,” said Angus Worthing, MD, FACR, FACP, a practicing rheumatologist and chair of the ACR Government Affairs Committee. “We applaud Congressional leaders for recognizing that forcing patients to ‘fail first’ through harmful step therapy practices puts them at unnecessary risk, prolongs pain and discomfort, worsens patient outcomes, and undermines the clinical judgment of medical professionals across the country. We urge Congress to quickly pass the Safe Step Act so that patients can appropriately seek exceptions to ‘fail first’ policies and quickly start accessing the treatments they need.”

Introduced in the Senate this week by Senators Lisa Murkowski (R-AK), Bill Cassidy (R-LA), Doug Jones (D-AL), and five other bipartisan co-sponsors, the Safe Step Act would implement transparent guidelines to prevent inappropriate use of step therapy in employer-sponsored health plans and create a clear process for patients and doctors to seek reasonable exceptions. The legislation builds on reforms passed in 25 states to address this pervasive practice that delays effective care and puts patients at unnecessary risk. While state efforts to limit insurers’ use of step therapy are an important development, Congressional action is needed to address the use of step therapy in employer-provided plans, which are regulated by federal law.

If enacted, the legislation will go a long way towards removing the treatment barriers created by step therapy.

According to a 2019 national patient survey conducted by the ACR, almost half (46.49%) of respondents who are receiving treatment for a rheumatic disease reported that their insurance company subjected them to step therapy.

A 2016 survey by the Arthritis Foundation found that most respondents experienced negative health effects from treatment delays caused by step therapy. According to the survey:

  • More than 50% of all patients reported having to try two or more different drugs prior to getting the one their doctor had originally ordered;
  • Step therapy was stopped in 39% of cases because the drugs were ineffective;
  • Step therapy was stopped in 20% of cases due to worsening conditions; and
  • Nearly 25% of patients who switched insurance providers were required to repeat step therapy with their new carrier.

A version of the Safe Step Act (H.R. 2279) was introduced in the House of Representatives in April by Representatives Raul Ruiz, MD (D-CA) and Brad Wenstrup, DPM (R-OH), two physicians who have encountered step therapy in their own practices.

ACR Responds to CY2020 Medicare Physician Fee Schedule Proposed Rule

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The following is a press release from the ACR released yesterday:

In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) applauded a provision in the CY2020 Physician Fee Schedule proposed rule that would increase Medicare reimbursement for evaluation and management (E/M) services to more appropriately reflect the time and expertise these face-to-face services require. The ACR also urged CMS to make additional changes that would facilitate the delivery of high-quality rheumatology care.

“We applaud CMS for taking steps to ensure rheumatologists and other cognitive specialists are adequately reimbursed for the time-intensive, high-value services they provide,” said Paula Marchetta, MD, MBA, president of the ACR. “These proposed changes will help ensure Medicare beneficiaries living with rheumatic disease can continue to receive the healthcare services they need and deserve.”

The proposed changes to E/M coding represent a welcome reversal from a previous CMS proposal that would have significantly cut reimbursement for specialists who provide care to patients with complex conditions. According to a 2018 report from the Medicare Payment and Advisory Commission (MedPAC), healthcare services billed under E/M codes – which include examinations, disease diagnosis, risk assessments, and care coordination – are grossly under-compensated by Medicare.

The new changes align with the American Medical Association’s recommendations that were developed in collaboration with the ACR and other organizations representing cognitive specialties.

The ACR also urged CMS to adopt a number of other changes in the final rule, including:

  • Clarify that proposed documentation reduction requirements take place in calendar year 2020. The proposed rule includes modifications to CMS’ documentation policy so that, for established patients, physicians and healthcare professionals are not required to document information in the provider’s note that is already present in a patient’s medical record. This change would greatly alleviate the paperwork burden on physicians and will enable them to focus more of their attention towards patients. The ACR is asking that CMS clarify that these changes take effect at the beginning of 2020 so that physicians can benefit from immediate relief.
  • Implement the Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) program in a manner that is voluntary and based on measures that are meaningful to clinical care. The ACR expressed concerns about CMS’ intent to move forward with the new program without more robust vetting and stakeholder input. In particular, the ACR urged CMS to include, at a minimum, an opt-in policy for the potential MVP pilot program and reiterated its opposition to the agency’s proposal to layer population health of administrative claims-based measures into the MVP since they do not provide a granular enough level of information for physicians to make improvements in practice.
  • Reverse the removal of specific Qualified Clinical Data Registry Measures. The ACR believes that CMS’ plan to remove measures 178: Rheumatoid Arthritis: Function Status Assessment and 182: Functional Outcome Assessment would significantly undermine efforts to lay the necessary groundwork to establish additional rheumatology outcome measures. The ACR hopes to work with CMS on this issue before the rule is finalized.
  • Work with the Center for Medicare and Medicaid Innovation (CMMI) to adopt Alternative Payment Model (APM) options that would encourage more providers to participate in disease-specific Physician Focused APMs. The ACR notes that there are few APMs that are feasible for rheumatologists and that the current nominal risk criteria make it difficult for smaller practices to attempt the APM track.  The ACR is submitting its rheumatoid arthritis APM in the coming weeks and hopes that CMS and CMMI will consider expanding APM options for rheumatology professionals.

“The ACR remains dedicated to ensuring that rheumatologists and rheumatology interprofessional team members have the resources they need to work with CMS and provide patients with high-quality care,” Dr. Marchetta concluded. “In order to achieve those objectives, payment programs must be designed to reflect the way clinicians treat patients. We hope to continue serving as a resource to the agency as it moves forward with the rulemaking process.”

National Patient Survey Highlights Healthcare Challenges for the 1 in 4 Americans Living with Rheumatic Disease

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The following is a press release from the ACR dated yesterday:

Americans living with rheumatic disease face significant healthcare challenges, according to a national patient survey released this week by the American College of Rheumatology and its Simple Tasks™ public awareness campaign.

More than 1,500 U.S. adults living with rheumatic disease responded to the survey, which asked a range of questions related to healthcare access, affordability and lifestyle. The results come as patients, providers and policymakers throughout the U.S. recognize Rheumatic Disease Awareness Month (RDAM).

Key survey findings include:

  • Even though 90 percent of respondents reported having health insurance coverage, nearly 60 percent said they had difficulty affording their medications or treatments in the past year.
  • Almost half of patients receiving treatment for a rheumatic disease reported that their insurance company subjected them to step therapy, a process that requires them to try – and fail – treatments preferred by the insurance company before a doctor-prescribed option can be approved, even when a patient’s doctor is uncertain the insurer-preferred option will be effective.
  • One-quarter of respondents reported out-of-pocket costs greater than $1,000 per year for treatment, while six percent of patients reported out-of-pockets costs greater than $5,000 per year.
  • Close to 60 percent of respondents are currently being treated by a rheumatologist or have been referred to seek treatment by a rheumatologist. However, two-thirds had to wait more than 30 days after referral before getting an initial appointment with a rheumatologist.
  • Almost two-thirds of patients reported that their rheumatic disease limited their ability to perform simple tasks such as eating, getting dressed, cooking, or running errands.

“These findings make clear that Americans living with rheumatic disease – regardless of age, gender, or income level – struggle to find affordable care,” said Paula Marchetta, MD, MBA, president of the ACR. “To address these challenges, it is crucial for patients, clinicians, and policymakers to work together to improve access to rheumatology care so that patients can live longer, healthier, and more fulfilling lives.”

Rheumatology patients recently joined the ACR on Capitol Hill to urge lawmakers to support legislation that would improve patient access by expanding the rheumatology workforce and placing reasonable limits on the use of step therapy.

Last year, the ACR examined access, affordability, and lifestyle challenges in the 2018 Rheumatic Disease Report Card, which graded each of the 50 states and the District of Columbia on the factors associated with an individual’s ability to live well with a rheumatic disease. The 2019 survey provides additional context to these challenges by asking patients directly how their disease impacts daily life.

According to the Centers for Disease Control and Prevention (CDC), an estimated one in four Americans – 54 million U.S. adults –  have been diagnosed with a rheumatic disease, an umbrella term that includes conditions such as rheumatoid arthritis, lupus, gout, osteoarthritis, Sjögren’s syndrome, juvenile idiopathic arthritis, and hundreds of lesser known diseases.

Hundreds of thousands of children also live with arthritis and other rheumatic diseases. The CDC estimates that as many as 300,000 children in the U.S. have some type of juvenile arthritis. Rheumatic diseases are the nation’s leading cause of disability and generate $140 billion in annual health costs. Although there is no cure for rheumatic disease, early intervention and diagnosis by a rheumatologist can help patients manage symptoms and lifestyle limitations to live healthier and more active lives.

The Rheumatic Disease Patient Survey was conducted by the American College of Rheumatology using the online polling tool SurveyMonkey Audience. The survey was conducted June 28-29, 2019, among a nationally representative sample of 1,517 adults ages 18 and older living in the United States.

To learn more about the survey and view an executive summary of the results, visit http://simpletasks.org/Survey.

370 Healthcare Groups Send Letter to Congress Urging Prior Authorization Reform in Medicare Advantage

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The following is a press release from the ACR:

The American College of Rheumatology (ACR), along with 369 other leading patient, physician, and healthcare professional organizations, sent a letter to Congress urging passage of the Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107), a bipartisan bill to protect Medicare Advantage beneficiaries from prior authorization requirements that needlessly delay or deny access to medically necessary care.

Introduced by Representatives Suzan DelBene (D-WA), Mike Kelly (R-PA), Roger Marshall, MD (R-KS), and Ami Bera, MD (D-CA), the Improving Seniors’ Timely Access to Care Act would make it easier for patients to access medically necessary treatments by requiring the Centers for Medicare & Medicaid Services (CMS) to regulate the use of prior authorization by Medicare Advantage plans. The bill would also increase transparency by mandating that health insurance plans report to CMS their prior authorization usage rate and the frequency with which they approve or deny coverage.

“While intended to control costs, the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies,” said Paula Marchetta, MD, MBA, president of the ACR. “Many healthcare plans now use prior authorization indiscriminately, ensnaring the treatment delivery process in webs of red tape and creating gratuitous hurdles for patients and providers. Patients, physician groups, hospital associations and other key stakeholders all agree that reform is needed.”

According to a study conducted by the American Medical Association, over a quarter of doctors surveyed said prior authorization has led to a “serious adverse event” for patients, such as hospitalization and permanent bodily damage. The same study found that 91 percent of doctors say that prior authorization is associated with treatment delays.

As part of the Regulatory Relief Coalition – a group of national physician specialty organizations – the ACR has been a staunch advocate for reducing regulatory burdens in the Medicare program to assure patients have access to timely and medically necessary treatment.

The full letter is available here.

Rheumatology Leaders Concerned CVS/Aetna Merger Will Hinder Efforts to Lower Drug Costs

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The following is a statement from Angus Worthing, MD, ACR Government Affairs Committee Chair:

“As policy makers and healthcare professionals continue to work together on ways to lower drug costs for patients, the ACR has worked to educate leaders in Congress about the lack of transparency from pharmacy benefits managers (PBMs) on the savings they are negotiating and whether those are being passed to patients. Though PBMs claim to use their position to negotiate lower drug prices, there has been no proof that rebates have been used to reduce the burden on patients and the healthcare system at large.

In recent years, several states have enacted legislation to hold PBMs accountable and crack down on secretive practices that drive up costs for consumers. State legislation has included gag clause bans, restrictions on claw-back provisions in PBM-insurer contracts, licensure of PBMs in states where they operate, and provisions that protect community pharmacies from unfair PBM auditing practices. These are positive developments, but without the full disclosure of rebates and discounts it is not possible to determine how the rebate system impacts drug prices and patient costs.

The ACR is concerned that the federal district court’s recent decision to approve the merger of CVS Health Corporation and Aetna hinders progress that has been made towards creating transparency and will make it easier for costs savings to remain secret. We hope that regulators will now actively watch the conduct of the merged company to ensure patients are protected.”

Tennis Champion Venus Williams Encourages Patients to get “Back on Top” in New PSA about Rheumatic Disease

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The following is a press release from ACR from earlier this week:

World champion tennis player, Venus Williams, is teaming up with the American College of Rheumatology (ACR) to share important information about rheumatic diseases in a new public service announcement (PSA) set to air nationwide this fall.

Williams is the official spokesperson for September’s Rheumatic Disease Awareness Month (RDAM), an annual event sponsored by the ACR and its public awareness campaign, Simple Tasks™. In the PSA, Williams discusses her experience living with a rheumatic disease and journey to diagnosis. After six years of swollen joints, fatigue, and eye and mouth dryness, Williams was finally diagnosed with Sjögren’s syndrome in 2011. After working with a rheumatologist and making some lifestyle changes, she was able to manage her disease and continue playing professional tennis.

“As a professional athlete, I know what it feels like to want your body to perform at its best, but I also know what it’s like to be one of the 54 million Americans battling a rheumatic disease,” says Williams. “Today, I follow my rheumatologist’s treatment plan and am feeling healthy and energized.”

Throughout the month of September, Americans living with rheumatic disease are encouraged to visit www.RDAM.org  to learn more about how to better manage their disease and sign up to join the Simple Tasks community. Individuals who sign up during the month will be entered into a drawing to receive an item signed by Venus. Community members will receive bi-monthly updates from the ACR’s Simple Tasks team with health and wellness articles, policy updates, and special events/opportunities for patients from Simple Tasks’ Rheum4You blog. Interested individuals can sign up at http://simpletasks.org/join/.

RDAM was created by the ACR in 2016 to increase public understanding and awareness of the symptoms, risk factors, treatment options, economic impact, and lifestyle or healthcare challenges associated with rheumatic diseases. An estimated 54 million U.S. adults––or one in four Americans over the age of 18––have been diagnosed with a rheumatic disease, an umbrella term that includes diseases like rheumatoid arthritis, lupus, gout, osteoarthritis, Sjögren’s syndrome, juvenile idiopathic arthritis, and hundreds of lesser-known conditions.

Rheumatic diseases do not just affect the elderly.  Hundreds of thousands of children live with arthritis and other rheumatic diseases. The CDC estimates that as many as 300,000 children have some type of juvenile arthritis. Rheumatic diseases are the nation’s leading cause of disability and generate $140 billion in annual health costs. Although there is no cure for rheumatic disease, early intervention and diagnosis by a rheumatologist can help patients manage symptoms and lifestyle limitations to live more healthy and normal lives.

“The sooner a person is diagnosed and referred to the correct specialist to receive proper treatment for rheumatic disease, the better a patient’s chances are of managing their disease and enjoying a fuller, healthier life,” said Paula Marchetta, MD, MBA, president of the ACR. “During this September’s awareness month and beyond, I encourage all Americans living with rheumatic disease to join our community, learn about how to manage their disease, and participate in the ACR’s ongoing efforts to enact policies that promote safe, effective, affordable and accessible care and treatments. Everyone’s voice matters.”

Rheumatic Disease Awareness Month and the Rheum4You Newsletter are sponsored by Simple Tasks, a public awareness campaign from the American College of Rheumatology. To learn more about rheumatic diseases and Rheumatic Disease Awareness Month, visitRDAM.org.

ACR Applauds Bipartisan Legislation to Improve Oversight and Transparency of Prior Authorization Use

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The following is a press release issued by ACR as of last week Friday:

WASHINGTON, D.C. – The American College of Rheumatology (ACR) today applauded the introduction of the Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107), a bipartisan bill to protect patients enrolled in Medicare Advantage plans from prior authorization requirements that needlessly delay or deny access to medically necessary care.

The bipartisan legislation, which is sponsored by Representatives Suzan DelBene (D-WA), Mike Kelly (R-PA), Roger Marshall (R-KS), and Ami Bera (D-CA) would require the Centers for Medicare and Medicaid Services (CMS) to regulate the use of prior authorization by Medicare Advantage plans, including establishing a process to make ‘real-time decisions’ for services that are routinely approved. These plans would also be required to offer an electronic prior authorization process and report to CMS on how extensively they use prior authorization, as well as how often they approve or deny medications and services.

“For far too long, patients have faced unnecessary and unreasonable care delays due to insurers’ overzealous use of prior authorization,” said Paula Marchetta, MD, MBA, president of the ACR. “This practice creates significant burdens for physicians and can put patient’s health in jeopardy. We applaud Congressional leaders for standing up to ensure America’s Medicare beneficiaries are able to get the care they need and deserve.”

Prior authorization is a process used by many insurers, including Medicare Advantage plans, whereby a prescribing physician must obtain approval from the insurer before the patient can begin treatment. This is a time-consuming process that often involves a patient facing weeks-long delays before being able to start life-altering therapies.

While originally intended to control costs by reducing unnecessary tests and procedures, many health plans are now indiscriminately using prior authorization, creating additional hurdles for patients and physicians that can lead to delays in treatment that may endanger patients’ health. The process for obtaining this approval can be lengthy and typically requires a physician or their staff to spend many hours each week negotiating with insurance companies – time that could be better spent taking care of patients.

The ACR has been working to advance this legislation as part of the Regulatory Relief Coalition, a group of national physician specialty organizations advocating for a reduction in Medicare program regulatory burdens to protect patients’ timely access to care.

This week, the Coalition released a national survey of 1602 physicians detailing the extent to which prior authorization places burdens on physicians and puts patients at risk. The survey found that 87 percent of physicians report that prior authorization has a significant (40 percent) or somewhat (47 percent) negative impact on patients’ clinical outcomes. Nearly a third of physicians surveyed said their patients often abandon treatment due to prior authorization. Furthermore, 84 percent of survey respondents said that the regulatory burdens associated with prior authorization has significantly increased over the past five years with half of all practices reporting 11 or more requests per week.

ACR Statement on CMS Medicare Advantage Final Rule

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The following is a press release from the ACR dated Friday, May 17:

In August 2018, the CMS announced that Medicare Advantage (MA) plans would be allowed to utilize step therapy for Part B drugs. The American College of Rheumatology (ACR) expressed strong concerns about this proposal. The rheumatology community received some good news in this week’s final rule from CMS, which makes changes to the original proposal and addresses several of the community’s recommendations.

“We were pleased to see that CMS included the ACR’s suggestion to implement a 365-day ‘lookback’ period for Part B therapies, to determine if the enrollee has been actively taking a Part B medication,” said Angus Worthing, MD, chair of the ACR’s Government Affairs Committee. “The originally proposed 108-day lookback period would have put many of our patients at risk for having to go through step therapy all over again. Extending this period to 365 days will help to protect these patients, and we appreciate CMS listening to our feedback.”

In this way, patients who are stable on their current medication will be able to remain on their prescribed therapy under the final rule. The ACR is also encouraged by CMS’ decision to require plans to respond to appeals within 24-72 hours.

While these are positive changes to the original proposal, additional clarity and transparency is needed to put patients in the driver’s seat. The ACR asks that CMS require MA plans to make the step therapy exception process readily available and understandable on its website for providers, patients, and caregivers. The College would also appreciate more detail on how CMS will ensure MA plans follow this direction and encourages CMS to increase monitoring of MA plans’ implementation of utilization management practices. Utilization review entities should provide detailed explanations for denials of requests for prior authorization or step therapy override, including whether there was any missing information which resulted in the denial.

CMS also finalized regulations related to the Part D Explanation of Benefits to require the inclusion of drug pricing information and lower-cost therapeutic alternatives in the Explanation of Benefits that Part D plans send members.

“The ACR agrees that this information is helpful and beneficiaries should have access to any possible ways to lower their out-of-pocket costs,” said Worthing. “However, we would not support this information being used to force a stable patient to switch to another biologic medication for the sake of cost control. This switch would needlessly disrupt continuity of care and put patients at significant risk for loss of disease control and potentially life-threatening complications.”

Ideally, the ACR hopes that CMS will monitor plans closely for non-medical switching and will require plans to ensure transparency about any utilization management requirements.

The ACR is dedicated to ensuring that rheumatology patients have access to safe, effective and affordable therapies under the Medicare Part B program and will continue to serve as a resource to the agency on this topic.

Rheumatology Leaders Urge Federal Lawmakers to Improve Patient Access to Care

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The following is a press release from the ACR dated yesterday:

Physician and health professional leaders with the American College of Rheumatology (ACR) convened on Capitol Hill this week to urge lawmakers to act on a range of policy issues affecting patient access to care.

Rheumatology advocates asked lawmakers to support legislation that would reform step therapy and prior authorization practices, strengthen the rheumatology workforce, and preserve patient access to osteoporosis testing. They also educated offices on the need for arthritis research funding through the Department of Defense and the importance of addressing the physician workforce shortage.

“As the demand for rheumatology care continues to grow, rheumatology leaders are committed to advancing policies that will improve care access and quality for the one in four Americans living with a rheumatic disease,” said Paula Marchetta, MD, MBA, president of the ACR. “We had productive conversations with lawmakers about bipartisan, common-sense policy solutions that will ensure patients continue to receive timely and appropriate care for their disease.”

The American College of Rheumatology asked legislators to support the following legislation to improve patient access to care:

  • Safe Step Act of 2019 (H.R. 2279) – Introduced by Representatives Raul Ruiz, MD (D-CA) and Brad Wenstrup, DPM (R-OH), two physicians who have encountered step therapy in their own practices, this bipartisan legislation would place reasonable limits on the use of step therapy in employer-sponsored health plans and create a clear process for patients and doctors to seek exceptions. The legislation builds on reforms passed in 22 states to address this pervasive practice that delays effective care and puts patients at unnecessary risk. While state efforts to limit insurer use of step therapy are an important step forward, Congressional action is needed to address the use of step therapy in employer-provided plans which are regulated by federal law.
  • Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act (S. 283) – Introduced by Senator Susan Collins (R-ME), this legislation would restore a sustainable Medicare payment for DXA bone density scans performed in a physician’s office, which are essential to diagnose osteoporosis and prevent fractures in the Medicare patient population.
  • Prior Authorization reform legislation – Bipartisan legislation is expected to be introduced by Representatives Mike Kelly (R-PA), Suzan DelBene (D-WA), Roger Marshall (R-KS) and Ami Bera (D-CA) that would improve the transparency and efficiency of prior authorization processes, ensuring patients can access care without health-jeopardizing delays.

The American College of Rheumatology also looks forward to working with legislators on the following issues and related policies:

  • Dedicated arthritis research funds through the Department of Defense’s Congressionally Directed Medical Research Program – Using the existing budget at the Department of Defense to establish dedicated funding for arthritis research would better serve the needs of current and former service members living with arthritis and other rheumatic diseases during and after service. Arthritis is the leading cause of disability and a leading cause of medical discharge among service members.
  • Addressing the pediatric medical workforce shortage through the Strengthening our Pediatric Workforce Act (H.R. 1656) and the Reauthorization of the Pediatric Specialty Loan Repayment Program. Introduced by Representative Lloyd Smucker (R-PA), H.R. 1656 would amend the Public Health Service Act to provide support for initiatives that address pediatric public health disparities in children’s hospitals’ graduate medical education programs. Legislation is needed to reauthorize the now expired Pediatric Specialty Loan Repayment Program, which provided loan repayment for pediatric subspecialists.

For additional information about the ACR’s legislative priorities, please visit: https://www.rheumatology.org/Advocacy/Federal-Advocacy/Key-Issues

ACR Statement on New FDA Biosimilar Interchangeability Guidance

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The following is from Dr. Angus Worthing, Chair of the American College of Rheumatology’s Government Affairs Committee:

“The American College of Rheumatology (ACR) applauds the FDA final guidance, “Considerations in Demonstrating Interchangeability with a Reference Product,” which establishes an approval pathway for interchangeable biosimilars and balances biosimilar uptake and provider confidence concerns while prioritizing the safety of our patients.

Specifically, we are pleased to see that the final guidance expects manufacturers to use robust switching studies. At least three switches with each switch crossing over to the alternate product will be needed to determine whether alternating between a biosimilar and its reference product impacts the safety or efficacy of the drug. The ACR believes these studies will provide an understanding of what patients are likely to experience when changing formularies in a multi-payer, multi-state market.

We are also pleased to see the FDA finalize its approach to safety, immunogenicity, and efficacy for the demonstration of interchangeability. And we agree with the FDA that post-marketing safety monitoring for an interchangeable product should also have robust pharmacovigilance mechanisms in place. In order to improve clarity, the ACR suggests that FDA prescribing information for all biosimilars include statements about whether each agent is or is not interchangeable to the reference product.

The ACR shares the FDA’s goal of ensuring that more affordable treatments reach patients as quickly as possible and appreciates the agency’s measured and thoughtful approach throughout this process.”