House Republicans, advocacy groups urge HHS to abandon measure that would restrict coverage of Biogen's Aduhelm

A group of House Republicans, led by Cathy McMorris Rodgers (R-Wash.), are urging Health and Human Services secretary Xavier Becerra to “abandon and re-propose” a measure that would restrict Medicare coverage of Biogen’s controversial Alzheimer’s disease drug Aduhelm.

Last month, the Centers for Medicare and Medicaid Services’ National Coverage Determination (NCD) proposed that anti-beta-amyloid drugs such as Aduhelm only be covered for patients enrolled in approved clinical studies. The proposal would severely limit the drug's uptake at a perilous time for Biogen, and so the company itself is advocating for broader coverage ahead of a final CMS decision expected in April.

Also Wednesday, Becerra heard from more than 50 patient advocacy groups who oppose the NCD. In their letter to the secretary, the organizations warned that the proposal would have implications beyond Alzheimer’s disease.

"This proposed CMS coverage plan raises concerns because it sets a precedent that could have far-ranging and damaging impacts on approval and access to new therapeutics across all disease areas,” the letter read.

Groups signing off on the letter went beyond those representing Alzheimer's disease patients. They include cancer, HIV/AIDS and muscular dystrophy advocacy organizations.    

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Meanwhile, in the Republicans' letter to Becerra, Rodgers wrote that she was “shocked” to discover that the NDC “severely restricts coverage for a whole class of Alzheimer’s treatments,” including Aduhelm. 

“It also includes those with Down Syndrome from participating in covered trials, even though Alzheimer’s may affect greater than 90% of those with Down Syndrome over the age of 60. This is wrong,” wrote Rodgers, who is the Energy and Commerce Committee’s Republican leader.

By restricting Medicare coverage to those in clinical trials, the Republicans wrote, the government could “unnecessarily deny to patients and their families the hope of breakthrough AD treatments and further eroding Americans’ trust in their public health institutions.”

For its part, CMS contends that existing data on the drug is "insufficient to establish that the treatment is reasonable and necessary" under federal law. The agency is calling for limited coverage through clinical trials in a bid to learn more about its risks and benefits.

RELATED: Aduhelm price drop prompts Becerra to rethink hike to Part B 2022 premiums

The CMS is hearing feedback on its initiative through Thursday. A final decision on coverage is expected in April.