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CMS Will Cover Alzheimer’s Drugs Leqembi, Donanemab — With Strings Attached

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The drugs must have full “traditional” FDA approval and patients need to be enrolled in a registry that collects post-approval data efficacy and safety when the drugs are used in clinical practice.

The Centers for Medicare and Medicaid Services cleared the way for coverage of Leqembi (lecanemab) and other Alzheimer’s disease drugs today, although coverage will be contingent on patients being enrolled in registries that are designed to yield evidence of their safety and efficacy as they are used in clinical practice.

The coverage will also be contingent upon the drug receiving full “traditional” approval by the FDA. The FDA approved Leqembi on an accelerated approval basis in January , which isn’t as stringent as the traditional approval.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to discuss the results of a confirmatory trial, called Clarity AD, for Leqembi at a meeting on June 9, and the FDA is provisionally scheduled to make a decision on whether to grant full approval on July 6.

Today’s CMS coverage decision is also likely to affect the future of Eli Lilly’s investigational Alzheimer’s drug, donanemab. The FDA rejected the company’s application for accelerated approval for donanemab in January, but Lilly said then it plans on applying for full approval later the year. Lilly issued a press release on May 3 trumpeting positive clinical trials results for donanemab and said in that release that it will present full results at the Alzheimer’s Association International Conference in Amsterdam in July.

Today’s announcement was criticized by drug companies and a large Alzheimer’s advocacy organization. Reuters reported that an Lilly spokesman said the registry requirement will create “unnecessary barriers and contradicts CMS' promise of broad coverage to all Medicare beneficiaries.” According to Reuters, Eisai, the Japanese company that developed Leqembi, issued a milder statement that said without knowing the details, it was difficult to say the registry requirement will affect patient access.

A news release from Alzheimer’s Association’s today lauded registries but said they should not be made a requirement for coverage of an FDA-approved treatment.

Backdrop for today’s announcement was CMS’ April 2022 coverage decision for Aduhelm (aducanumab) that limited coverage to patients enrolled in clinical trials. Aduhelm, like Leqembi and donanemab, attacks the beta amyloid plaques in the brain that many researchers believe are instrumental in causing Alzheimer’s. But Aduhelm only received accelerated approval from the FDA, not full traditional approval, and even accelerated approval was highly controversial because of doubts about the strength of the evidence for the drug. The restriction to coverage to people in clinical trials marginalized Aduhelm. Congressional investigations into the approval concluded the FDA’s process was “rife with irregularities.”

In contrast, there has been little if any criticism of the FDA’s approval of Leqembi, even though Biogen, which developed and marketed Aduhelm, is collaborating with Eisai on the drug.

Eisai has priced Leqembi so the cost of a year’s treatment, at the list price, is $26,500.

Today’s CMS announcement says that clinicians will be able to submit evidence about an FDA-approved Alzheimer’s drug through an CMS-facilitated portal that will be available when a drug gets full approval and that the format will be easy to use.

The announcement said there is precedent for the registry requirement, pointing to the requirement that clinicians and hospitals track outcomes of transcatheter aortic valve replacement after it received FDA approval.

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