Medicare finalizes its restrictions on new Alzheimer’s drug

 Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.

The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug.

The decision has implications beyond Aduhelm’s manufacturer, Biogen, as well. The coverage decision is not specific to Aduhelm, and could apply to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval.

In a major win for Lilly, however, Medicare said it will not require the exact same restrictions for drugs that aren’t approved based on surrogate endpoints. That could give other drug makers an opening to sidestep the same restrictions even if they’re making a similar medication for Alzheimer’s disease.

Since the Food and Drug Administration approved the drug last summer, doctors and scientists have raised questions about whether it actually works, government watchdogs have begun investigating whether the FDA followed proper procedure to approve it, and policy experts have questioned whether it is effective enough to justify its hefty price tag.

Medicare officials even hiked the entire program’s premiums to anticipate a potential flood of patients taking the pricey medication. But the new restrictions mean the drug will put less of a financial burden on the Medicare program. Health secretary Xavier Becerra said he soon plans to make a decision on whether to lower Medicare premiums for older adults after Medicare’s coverage decision for Aduhelm.

Aduhelm’s limited coverage policy is unprecedented, as Medicare almost always covers drugs if the FDA approves them. Aduhelm has been different because the agency approved the treatment without a guarantee that patients actually will see slower cognitive decline. The process that led to the drug’s approval is the subject of multiple investigations, following STAT’s reporting that Biogen had an extensive back-channel relationship with the FDA.

Medicare will also limit those who can get the drug to people who have mild forms of cognitive impairment or mild dementia, and who have amyloid plaques, the proteins Aduhelm is designed to target, in their brain. The patient population is narrower than the one the FDA approved the drug to treat, as the FDA did not require proof of amyloid plaques.

The narrow coverage policy is a major blow to Biogen, which had hoped that access to the Medicare patient market could invigorate the drug’s meager sales.

https://www.statnews.com/2022/04/07/medicare-final-decision-alzheimers-coverage-biogen-aduhelm/