The Alzheimer’s Death Panel – WSJ
President
Biden
says he wants to increase healthcare access. But this is hard to square with the Centers for Medicare and Medicaid Services’ unprecedented proposal this month to restrict Medicare payment for a class of novel Alzheimer’s treatments.
The CMS recommendation follows the controversy over Food and Drug Administration approval last summer of
Biogen’s
Alzheimer’s treatment Aduhelm. The monoclonal antibody clears amyloid plaque in the brain, a hallmark of the disease. It is the first treatment shown in clinical trials to slow Alzheimer’s progression.
A randomized controlled trial showed a high-dose of the treatment removed 71% of the plaque buildup after 18 months and significantly slowed disease progression, as rated by patient care-givers and doctors. Another trial also showed amyloid clearance but failed to demonstrate a significant impact on disease progression.
Biogen made a mistake by halting both trials early. But it later worked with the FDA on a post-hoc review to understand the discordant results. One major discrepancy: Patients in the second received less treatment. The longer patients in both trials received a high-dose of the drug, the less they deteriorated.
Aduhelm’s critics, largely on the public-health left, claim that the successful trial was likely a false positive since other experimental monoclonal antibodies have failed to show an effect on amyloid or disease progression. Some neurologists also believe clearing amyloid is ineffective because Alzheimer’s has other causes.
Nobody disputes that many factors probably contribute to Alzheimer’s. But Aduhelm is the first drug to show a meaningful effect on disease progression in early-stage patients. It has the potential to extend the time that patients can live independently and spend with their loved ones, while researchers work on other therapies that target different disease pathways.
Critics urged the FDA to require another large trial before granting approval. That would take several years. The FDA instead granted Aduhelm accelerated approval, which Congress authorized to give patients earlier access to promising drugs that treat serious conditions and fill an unmet medical need when there is some uncertainty about their benefits.
After losing at the FDA, Aduhelm’s critics lobbied CMS to restrict Medicare coverage. CMS has almost always covered FDA-approved drugs. But now it says Medicare will only pay for Aduhelm and any future Alzheimer’s amyloid-targeting monoclonals approved by the FDA if patients enroll in a randomized controlled trial. CMS is overruling the FDA and doctors who may wish to prescribe the drugs.
Three other amyloid-targeting monoclonals by
Roche and a Biogen-Eisai partnership have shown positive results in early trials, some stronger than Aduhelm. The drug makers may obtain FDA accelerated approval in the next two years after they finish compiling data from clinical trials. But it won’t matter…
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