New Alzheimer's drug renews push for Medicare coverage
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The Biden administration's decision last week to continue restricting Medicare coverage for a class of Alzheimer's drugs has angered some Republicans and renewed a thorny debate over when seniors should have access to new treatments — and under what conditions.
Why it matters: The issue raises fundamental questions about government discretion and how much data is needed before making a drug available to the public. But it's an especially fraught debate with Alzheimer's — a degenerative disease with no cure that that slowly destroys memory and thinking skills.
State of play: Medicare administrators set parameters for covering a class of Alzheimer's drugs last year, after Biogen's Aduhelm received accelerated approval under unprecedented circumstances from the Food and Drug Administration.
- Many experts argued there wasn't adequate data to prove the drug worked and a congressional investigation found that the FDA didn't follow its own guidance and collaborated inappropriately with the drugmaker.
- The FDA in January green-lighted another Alzheimer's drug with a similar mechanism, Eisai and Biogen's Leqembi, through accelerated approval. This time, scientists generally agree that the clinical trials were well conducted, even if they question the real-world efficacy of the drug.
- The Alzheimer's Association asked the Centers for Medicare and Medicaid Services to reconsider its decision in light of circumstances. Last week, however, CMS turned down the request and said it would maintain the restrictions and only pay for the class of drugs in specific settings.
- "After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration," CMS wrote in a statement.
What they're saying: "This is an unprecedented overreach by the administration to override its own FDA," House Energy and Commerce Chair Cathy McMorris Rodgers and Ways and Means chair Jason Smith wrote in a joint statement Friday.
- "The Biden Administration's move to restrict coverage for novel Alzheimer's drugs will chill innovation in developing new medicines and treatments for patients facing life-threatening illnesses," they added.
- The Alzheimer's Association echoed the sentiment. "CMS' role is to provide health care coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate," Joanne Pike, Alzheimer's Association CEO, said in a statement after the decision was released.
The big picture: Although the focus is on Medicare coverage given the demographics of most Alzheimer's patients, the agency's decision has also been viewed as a signal to commercial insurers.
- State Medicaid plans and commercial payers' policies for covering the approximately $28,200-a-year drug vary significantly, according to a new report by researchers from Tufts Medical Center that was funded by the Alzheimer's Association.
- Only 41% of Medicaid plans — which are required to cover Aduhelm for qualified beneficiaries — had made their coverage policies available, and those that did had significantly different eligibility requirements.
- Only five of the 35 largest commercial plans studied covered the drug for enrollees. The study notes that all coverage policies were written specifically for Aduhelm, unlike Medicare's, which covers the entire class of anti-amyloid drugs.
What we're watching: It's unclear whether House Republicans will bring up legislation on the subject, which could garner bipartisan support. Members of the House and Senate from both parties had recently urged CMS to reconsider the policy.
- Leqembi is expected to receive traditional FDA approval as soon as this summer, which would make it eligible for broader Medicare coverage under existing CMS rules.
- That could take some of the momentum out of any ongoing Hill conversations. But on the other hand, members and advocacy groups could argue that what really matters here is the precedent being set — and whether the government is denying care for some of the most dire conditions.
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