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.
A collection of 78 House Republicans wrote to Health and Human Services Secretary Xavier Becerra Tuesday asking a litany of 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.
The missive 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. So far, the FDA has approved only one version of this drug: Biogen’s Aduhelm.
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. Kaiser Family Foundation has estimated that 6 million people have Alzheimer’s.
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.”
But the FDA’s decision to grant accelerated approval late last year to Aduhelm has been met with skepticism among some critics. The agency gave accelerated approval despite objections from its own advisory panel.
Some large hospital systems such as the Cleveland Clinic have announced they will not prescribe the drug due to concerns over its effectiveness. Major insurers are also wary about whether the drug works.
But FDA said in its approval decision last year that the drug can reduce amyloid beta plaques that are reasonably likely to help improve cognition among Alzheimer’s patients.
“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 also bashed 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.
The Biden administration pulled the rule over concerns that the clinical data necessary to get FDA approval may not apply to Medicare beneficiaries’ complex care needs.
CMS told Fierce Healthcare that it has received the letter but did not comment further. The lawmakers want answers to the questions by Feb. 18.
The letter is the latest pushback CMS has received based on the decision. The pharmaceutical industry and Alzheimer’s advocacy groups have said CMS is restricting access to an FDA-approved treatment.
Biogen halved the price of Aduhelm last year after the initial launch price of $56,000 generated a major backlash.
CMS must issue a final coverage decision by April 11 and is holding a comment period to get feedback on the proposal.