Earlier this year, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure and Food and Drug Administration (FDA) Commissioner Robert M. Califf, MD, released a joint statement following the narrow Medicare coverage of Aduhelm, a drug for patients with Alzheimer’s disease.
In June 2021, Aduhelm was approved by the FDA via accelerated approval to treat amyloid plaques that can contribute to cognitive impairment, caused by Alzheimer’s disease.
CMS proposed to offer Medicare coverage for the class of drugs that treats amyloid plaques – of which Aduhelm is currently the only member – but only to beneficiaries in a qualifying clinical trial. After some public pushback, CMS finalized the coverage proposal, but broadened which trials are eligible for reimbursement, to include FDA application trials and studies conducted by the National Institutes of Health. CMS also created another pathway for more broad coverage, if it receives traditional FDA approval in the future.
In the joint statement, Brooks-LaSure and Califf note that “the work of both of our agencies is critical to ensure that medical products are available to people across the country.” The statement also noted that “[u]nderpinning both of our agencies’ work is the unwavering commitment to use reliable data to ensure that effective treatments are made available to patients.”
The FDA bases its decisions on whether to approve new medical products on “careful evaluation of the available data and a determination that the medical product is safe and effective for its intended use.” FDA also has the authority after approval to require additional studies “regarding the anticipated clinical benefit for the medical product.”
For its role, CMS can “conduct its own independent review to determine whether an item or service should be covered nationally by Medicare, including examining whether it is reasonable and necessary for use in the Medicare population.”
The joint statement concludes by noting that Brooks-LaSure and Califf “recognize the impact these decisions have on people with serious and life-threatening conditions and their loved ones” and cemented the agencies’ “common goal of wanting to advance the development and availability of innovative medical products.”
PhRMA Statement
Nicole Longo, spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA) vocalized the Association’s frustration with the CMS decision, saying “CMS largely ignored concerns raised by patients, providers, manufacturers, policymakers and numerous other stakeholders and chose to finalize a policy that may effectively prevent doctors and patients from deciding whether a particular FDA-approved medicine is the right option for them. This decision sets the dangerous precedent of restricting Medicare Part B coverage and patient access for new and future FDA-approved medicines for patients with Alzheimer’s disease. CMS has further complicated matters by taking the unprecedented step of applying different standards for coverage of medicines depending on the FDA approval pathway taken, undermining the scientific assessment by experts at FDA. We hope the Administration reconsiders this policy immediately.”