More and more lawmakers on both sides of the aisle are pressing the Biden administration to overturn a controversial Medicare coverage proposal for Biogen’s Alzheimer’s disease drug Aduhelm.
Last week, a collection of more than 40 bipartisan lawmakers wrote to Department of Health and Human Services and Centers for Medicare & Medicaid Services (CMS) leadership over the proposal, a final decision on which must be released this month. The lawmakers charge that the proposal will deny access to Aduhelm, which has been dogged by questions over its efficacy and high price tag since being approved by the Food and Drug Administration last year.
The letter follows similar remarks and missives by bipartisan lawmakers over the coverage proposal, which has ignited a fervent opposition campaign from drugmakers and patient advocacy groups.
In January, CMS proposed Medicare only cover the class of drugs that includes Aduhelm—which targets amyloid beta plaques to help treat mild cognitive impairment from Alzheimer’s disease—for beneficiaries who are in qualifying clinical trials. The decision was a nod to the high price of Aduhelm, which manufacturer Biogen halved at the end of last year, and lingering questions over the drug’s efficacy when it was approved last year by the FDA.
CMS said at the time that the proposal is the result of a thorough review that found the risks may outweigh any benefits from the drug.
But the 40 lawmakers wrote in a letter led by Rep. Nanette Diaz Barragan, D-California, that the coverage proposal represents key access issues among beneficiaries.
“A progressive disease such as Alzheimer’s by its nature requires the earliest possible intervention which is the direction science is moving,” the letter said. “By attacking the disease early, though, evidence of direct clinical benefit is very hard to discern.”
However, the coverage proposal could ensure that patients get the drug when it is too late to help the patient, the letter added.
“We believe that as more evidence is gathered, patients and their families should be given the choice as whether, when faced with a disease that is a death sentence, to access approved AD treatments in consultation with their doctors,” lawmakers wrote.
They were also concerned that CMS’ requirement to confirm safety and effectiveness could duplicate similar processes conducted by the FDA.
The letter is similar to other missives from lawmakers concerned about the decision.
A group of four Democratic senators wrote to CMS last month outlining concerns over whether any clinical trial requirement could limit access to treatments for people of color.
More than 70 House Republicans called for CMS to pull back on the proposal back in February.
It remains unclear how the lawmaker pressure could impact CMS, which did not immediately return a request for comment.
CMS must make a final coverage decision on Aduhelm by April 11.