The Alzheimer’s Death Panel

 President Biden says he wants to increase access to health care. But that’s hard to square with the unprecedented proposal from the Centers for Medicare and Medicaid Services this month to restrict Medicare payment for a class of new treatments for Alzheimer’s disease.

CMS recommendation follows controversy over Biogen’s Food and Drug Administration approval last summer in its treatment of Alzheimer’s disease Aduhelm. The monoclonal antibody eliminates amyloid plaque in the brain, a hallmark of the disease. It is the first treatment shown in clinical trials to slow the progression of Alzheimer’s disease.

A randomized controlled trial showed that a high dose of the treatment eliminated 71% of plaque buildup after 18 months and significantly slowed disease progression, as assessed by caregivers and doctors. Another trial also showed amyloid clearance but failed to demonstrate a significant impact on disease progression.

Biogen erred in stopping the two trials earlier. But he then worked with the FDA on a post-hoc review to figure out the discordant results. A major discrepancy: the patients of 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 from the public health left, say the successful trial was likely a false positive since other experimental monoclonal antibodies showed no effect on amyloid or progression. of the disease. Some neurologists also believe that removing amyloid is ineffective because Alzheimer’s disease has other causes.

No one disputes that many factors likely contribute to Alzheimer’s disease. But Aduhelm is the first drug to show a significant effect on disease progression in early-stage patients. It has the potential to extend the time patients can live independently and spend with loved ones, while researchers work on other therapies that target different disease pathways.

Critics have urged the FDA to require another large trial before granting approval. It would take several years. The FDA instead granted expedited approval to Aduhelm, which Congress has authorized to give patients faster access to promising drugs that treat serious conditions and address an unmet medical need when there is uncertainty about their advantages.

After losing to 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 FDA-approved monoclonal targeting Alzheimer’s amyloid if patients enroll in a randomized controlled trial. CMS reverses the decision of the FDA and the doctors who want to prescribe the drugs.

Three more amyloid-targeting monoclonals by Eli Lilly, Roche and a Biogen-Eisai partnership showed positive results in early trials, some stronger than Aduhelm. Drugmakers could get fast-track FDA approval within the next two years after they finish compiling clinical trial data. But it doesn’t matter how effective these treatments are in clinical trials.

Under CMS’s proposal, Medicare will only pay them if patients enroll in duplicate trials in which they could be assigned a placebo instead of the drug. Yet patients with Alzheimer’s disease will only be able to enroll in these trials if they live near major health care centers with the resources to conduct them. Bad luck for the seniors of Fargo.

CMS also states that “the diversity of patients included in each trial should be representative of the national population diagnosed with Alzheimer’s disease.” It’s a salute to liberal criticism that Aduhelm’s trials included too few black people, who are twice as likely to develop dementia as white people. Yet restricting CMS coverage will disproportionately harm black patients.

There is vigorous scientific debate about the role of amyloid in Alzheimer’s disease and the causes of the disease. According to CMS, this is irrelevant because it indicates that the biggest contributor to cognitive decline is cerebrovascular disease, including stroke. “The implication is that any treatment specifically targeting amyloid may be less effective the higher the level of mixed disease in a given patient,” says CMS. But CMS could use that same reasoning to restrict any future Alzheimer’s treatments, not just those that target amyloid.

***

CMS, which reports to the secretary of HHS, has yet to make a final payment decision. A better option is for CMS to require healthcare providers to collect real-world efficacy and safety data for Aduhelm. But that wouldn’t achieve the left’s goal of limiting expensive treatment for seniors. Liberals warn Medicare spending will skyrocket if seniors have access to Aduhelm, which costs $28,200 a year.

This is the real reason the Biden administration wants to preemptively restrict Medicare coverage of all amyloid-targeting monoclonals. Progressives want to expand Medicare benefits to win the votes of seniors, then ration treatments to contain government spending. Drugs for Alzheimer’s disease will not be the last target of rationing.

https://newsnetdaily.com/the-alzheimers-death-panel-wsj-top-stories/