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Medicare will only cover Biogen's Alzheimer's therapy Aduhelm during clinical trials, the Centers for Medicare and Medicaid Services announced Thursday, finalizing a proposal from January. The announcement paves the way for CMS to reduce Medicare Part B premiums. Health and Human Services Secretary Xavier Becerra said last month that CMS was waiting on a final coverage decision for Aduhelm to fully assess its impact on Part B premiums for 2022, which increased 15% from last year, in part because of projected spending on the drug. (Goldman and Deveraux, 4/7)

The decision reflects a wide spectrum of opinion on whether Aduhelm is effective enough to warrant greater distribution. A monoclonal antibody taken as a monthly infusion, the drug is the first new treatment for Alzheimer’s approved by the FDA since 2003. Its cost — $28,200 per patient, per year — also has raised concerns. (Bernstein and Roubein, 4/7)

Aduhelm received "conditional" approval from the FDA in June with the requirement that further trials show the drug slows cognitive decline and is safe. As the first Alzheimer's drug to win approval in about 20 years, it spurred excitement and an intense advocacy push from Alzheimer's patient groups. But it has been widely panned within the medical community over unproven clinical benefits, serious side effects and $28,000 annual price tag. That put it at the center of an intense lobbying battle in recent months, as well as congressional debates over the FDA's "accelerated approval" process. (Reed, 4/8)

It’s a blow to Biogen, which has been campaigning for the Centers for Medicare and Medicaid Services to reverse its stance since the initial coverage proposal was announced in January. Analysts at RBC Capital Markets said Thursday that the news, while in line with expectations, “likely spells the end for Aduhelm.” At the same time, it “leaves a clear door open” for other drugs in development. That includes potential new medicines from Eli Lilly & Co. and Roche Holding AG. The decision strikes a middle ground, keeping a hard line on Aduhelm while creating a path to payment for newer treatments with solid evidence. (Tozzi and Langreth, 4/7)

CMS rarely restricts coverage of prescription drugs, and its decision to only pay for Aduhelm in the context of additional clinical trials, where its risk-benefit profile can be further studied, drew polarizing reactions from the medical community. Some doctors think the decision is a much needed correction for the FDA’s misplaced exuberance for Aduhelm. “I absolutely agree with the agency’s decision to restrict Aduhelm,” said Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School who resigned from an FDA advisory committee in protest of the agency’s decision to approve the drug. ... But other doctors are disturbed by the CMS decision. They say the agency is overstepping its bounds and discriminating against people with Alzheimer’s disease. (Cross, 4/7)

Ever since Medicare proposed to sharply limit coverage of the controversial Alzheimer’s drug Aduhelm, the agency has been deluged with impassioned pleas. Groups representing patients insisted the federal insurance program pay for the drug. Many Alzheimer’s experts and doctors cautioned against broadly covering a treatment that has uncertain benefit and serious safety risks. (Belluck, 4/7)

The furious debate over Biogen’s Alzheimer’s treatment has now sparked controversy at the Alliance for Aging Research, an advocacy group that has seen half of its scientific advisory board members resign after learning the organization had lobbied against a Medicare proposal to restrict coverage of the medication. The resignations by nine of 17 board members followed a rally the organization held last month in front of the Centers for Medicare & Medicaid Services offices to protest a preliminary decision concerning the Alzheimer’s treatment. (Silverman, 4/7)