The Alzheimer's Death Panel

"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 Eli Lilly, 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 how effective these treatments prove to be in clinical trials.

Under CMS's proposal, Medicare will only pay for them if patients enroll in duplicative trials in which they could get assigned a placebo instead of the drug. Yet Alzheimer's patients won't be able to enroll in these trials unless they live near large health-care centers that have the resources to conduct them. Tough luck for seniors in Fargo.

CMS also says "the diversity of patients included in each trial must be representative of the national population diagnosed with AD." This is a bow to liberal criticism that the Aduhelm trials included too few blacks, who are twice as likely to develop dementia than whites. Yet the CMS coverage restriction will disproportionately harm black patients.

There is vigorous scientific debate about amyloid's role in Alzheimer's and what causes the disease. According to CMS, this is irrelevant since it says the biggest contributor to cognitive decline is cerebrovascular disease, including strokes. "The implication is that any treatment targeting amyloid specifically may be less effective the greater the level of mixed disease in a given patient," CMS says. But CMS could use this same rationale to restrict any future Alzheimer's treatment, not merely those that target amyloid.

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CMS, which reports to the HHS secretary, still must make a final payment decision. A better option is for CMS to require health-care providers to collect data about Aduhelm's real-world effectiveness and safety. But this wouldn't achieve the left's goal, which is to limit costly treatments for seniors. Liberals warn Medicare spending will explode if seniors get access to Aduhelm, which costs $28,200 annually.

This is the real reason the Biden Administration wants to pre-emptively restrict Medicare coverage of all amyloid-targeting monoclonals. Progressives want to expand Medicare benefits to win senior votes, then ration treatments to contain government spending. Alzheimer's drugs won't be the last rationing target." [1]

1. The Alzheimer's Death Panel
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 24 Jan 2022: A.18.