House Republicans want the Biden administration to pull its proposal for Medicare to cover the controversial Alzheimer’s disease drug Aduhelm for only people in clinical trials. 78 House Republicans wrote to Health and Human Services Secretary Xavier Becerra asking questions over the Centers for Medicare & Medicaid Services (CMS) proposed national coverage determination (NCD) on the drug.
“We urge you to abandon and repurpose the NCD to provide for reasonable access to [Food and Drug Administration]-approved [Alzheimer’s Disease] treatments for a broader population of Medicare beneficiaries,” according to the letter led by Rep. Cathy McMorris Rodgers, R-Washington, ranking member on the House Energy and Commerce Committee.
CMS Decision and House Republican Letter
The CMS proposal to restrict Aduhelm coverage to clinical trials stirred up such strong feelings and the 30-day public comment period following every CMS draft decision drew a record 9,956 submissions posted to date, dwarfing the 132 commenters who had weighed in during the agency’s initial feedback period last July. CMS will issue its final decision in April.
The House Republican’s letter is the latest pushback CMS has faced since its proposal was released last month on antibodies intended to treat mild cognitive impairment caused by Alzheimer’s disease. CMS proposed coverage of the drug but only for patients in a qualifying clinical trial intended to study the product’s safety and efficacy in Medicare’s population. The lawmakers cried foul over the decision, arguing that CMS is proposing to restrict access to a drug that has “already been approved by the FDA as safe and effective,” the letter said. They added CMS appears to be questioning the drug regulator’s “expertise and authority.”
“As the FDA is the agency tasked with evaluating clinical evidence, CMS’ unprecedented [coverage proposal] confuses what clinical evidence must be obtained in order to receive Medicare coverage and undermines FDA’s authority,” the Republican lawmakers wrote.
The lawmakers criticized CMS because the NCD “appears to entirely exclude Americans with Down Syndrome from any form of coverage through these trials for Aduhelm and any future amyloid-related treatments.” They point to a policy in the draft decision that said patients may not have any neurological or other medical condition that could lead to cognitive decline other than Alzheimer’s.
“This effectively excludes patients with intellectual and developmental disabilities like Down Syndrome,” the letter said. “This is a startling exclusion of a significant population that might otherwise benefit from coverage of Aduhelm.” The lawmakers ask for CMS to correct or clarify the issue. They also asked the agency several questions on the proposal, including why it decided to extend the policy to the entire class of drugs targeting amyloids. Republicans want to know if CMS plans to use this approach of requiring clinical trials for FDA-approved medications in the future.
Lawmakers noted that the proposal is “not an isolated instance of CMS restricting access to breakthrough medical innovation.” They point to CMS’ decision in December to scrap a Trump-era regulation that would hasten Medicare coverage of newly approved breakthrough medical devices.