Medicare proposes to cover Aduhelm only for patients in clinical trials

Following Biogen’s price cuts, advocacy groups for Alzheimer’s patients urged CMS to reduce premium increases. On Monday, Secretary of Health and Human Services Xavier Becerra said he was instructing CMS to re-examine the premium increase “given the dramatic change in the price of Alzheimer’s medicine Aduhelm.”

Aduhelm was approved by the Food and Drug Administration in June in a decision that was heavily criticized by many doctors and Alzheimer’s experts because results from clinical studies showed that it had significant safety risks and unclear benefits for patients.

Congress is investigating whether the FDA worked too closely with Biogen and why Aduhelm was approved despite strong objections from some senior FDA officials and the agency’s independent advisory committee.

So far, only a small number of patients – a fraction of the number Biogen and industry analysts had initially expected – have used Aduhelm, a monoclonal antibody administered as a monthly infusion. Many major US health care providers have declined to offer the drug, citing questions about the benefits and risks.

Medicare officials are meant to determine coverage based on whether a drug is an “affordable and necessary” treatment, a phrase that usually “means sufficient evidence of improved health outcomes,” said Dr. Sean Tunis, a former CMS official who is now a senior research fellow at the Center for Evaluation of Value and Risk in Health at Tufts Medical Center.

Medicare’s decision on Aduhelm will also establish standards for the evaluation of several similar Alzheimer’s drugs in the pipeline.

The FDA itself acknowledged in its approval of Aduhelm that there was insufficient evidence that it would help patients. Instead, it gave the green light to the drug – the first new treatment for Alzheimer’s in 18 years – under a program called “accelerated approval”, which allows the authorization of untested drugs for serious diseases with few treatment options if the drug affects a biological mechanism in a way that considered “reasonable likelihood of predicting clinical benefit.”

The FDA said it based accelerated approval on Aduhelm’s reduction of a protein called amyloid, which clumps into plaques in the brains of people with Alzheimer’s. However, many Alzheimer’s specialists say that extensive research has shown little evidence that reducing amyloid slows down cognitive decline. The FDA also required Biogen to conduct another clinical study to determine if the drug provided any evidence of benefit. In the years it will take before that trial is completed, Aduhelm will be available to patients.

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