Medicare coverage of Alzheimer's drug Aduhelm may soon be dramatically limited. The CMS is asking for public comments before finalizing the decision.
Last week, the Centers for Medicare and Medicaid Services (CMS) released a proposal limiting Medicare coverage of the anti-amyloid drug Aduhelm to only participants who participate in clinical trials. The plan stipulates that Aduhelm and any anti-amyloid treatments approved in the future may need to undergo another clinical trial that meets CMS’s standards for efficacy and diversity before coverage is widely available.
Now, the CMS wants to hear from the public before making its final decision in April 2022. The proposal, which can be read in full at this link, is open to public comment through February 10, 2022. Feedback from the patients and families this decision affects is more important than ever, so find instructions and the link where you can share your comment below.
How we got here
But first, as you may already know, the controversy around Aduhelm is plentiful — and complicated: The drug aducanumab, which hit the market under the brand name Aduhhelm in 2021 at a sky-high $56,000 per year per patient and was subsequently reduced by half, has been blamed, at least in part, for 2022’s spike in Medicare costs. It is the only potentially disease-modifying treatment approved for this devastating disease, designed to alter the pathology of Alzheimer’s in the brain, as opposed to just treating the disease’s symptoms once they appear.
Some say the Food and Drug Administration (FDA) was hasty in its approval of the drug, as the data doesn’t clearly indicate the drug is effective. Further, it wasn’t tested in a racially diverse population. All this debate has led to corporate turmoil, resignations at the FDA, even a Congressional investigation into the drug’s approval. And outside of the “bureaucratic gobbledygook” — as Being Patient reporter and Voices of Alzheimer’s founder Phil Gutis recently put it — some patients say the drug helped them during clinical trials, and they, along with patient advocate groups, are calling for easier access.
Medicare currently supports some 44 million beneficiaries — about 15 percent of the U.S. population. (One in 10 of those beneficiaries relies solely on Medicare for their healthcare coverage.) As the U.S. general population ages, the total number enrolled is expected to rise to 79 million by 2030. Meanwhile, with this aging population, the burden of Alzheimer’s will grow too, by an estimate of more than 50 percent.
There are other disease-modifying drugs in the pipeline which might help address this rising demand for better treatments, but again, those drugs will be subject to the CMS decision on Aduhelm, too.
Make your voice heard
The CMS’s proposal for Aduhelm is more or less unprecedented, and the language in the decision, and its longterm repercussions, are still being deciphered by the many parties — from patients to drugmakers — who would be affected if it is indeed finalized following the comment period and review. According to James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, it is “the first time that C.M.S. limited Medicare beneficiaries’ access to an FDA-approved drug in this way.” The federal insurance program generally does cover any drug approved by the FDA for the purpose for which it was approved, Chambers recently told the New York Times. The date set for the final determination is April 11, 2022.
CMS Administrator Chiquita Brooks-LaSure said in a statement released January 11, 2022 that the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”