Medicare on Thursday finalized a decision to severely limit coverage of a costly and controversial new Alzheimer’s drug, announcing that it would only cover the new treatment for patients who receive it as part of a clinical trial.
The drug, Biogen’s Aduhelm, has been the subject of tremendous debate since before the Food and Drug Administration approved it last year as the first new Alzheimer’s treatment in nearly two decades. Once it was approved, patient advocacy groups pressed officials to pay for it despite serious questions about its efficacy and safety risks.
Other analysts warned that broad coverage of the drug’s costs could have dire implications for Medicare’s finances. Biogen initially priced the drug at $56,000 a year before dropping the price to $28,800 a year in the face of weak sales and resistance to using it from many hospitals and doctors. Medicare had enacted a large premium increase for 2022 in part because of the potential costs of Aduhelm. Health and Human Services Secretary Xavier Becerra has said that he would look at lowering premiums once a final coverage decision for Aduhelm was made.
Thursday’s decision by the Centers for Medicare and Medicaid Services (CMS) will likely limit coverage to a small fraction of the estimated 1.5 million Americans who have mild Alzheimer’s-related cognitive decline, delivering a blow to those desperate for new treatment options in the fight against the disease. The decision — highly unusual because Medicare typically covers drugs once they are approved by the FDA — also means that the drug will have less of a financial impact on the health insurance program for seniors.
“It’s our obligation at C.M.S. to really make sure it’s reasonable and necessary,” Chiquita Brooks-LaSure, the administrator of the Centers for Medicare and Medicaid Services, told The New York Times Thursday.
Medicare also said Thursday that it would not automatically limit coverage of similar drugs in the pipeline. “If, unlike with Aduhelm, the F.D.A. finds that there is clear evidence that a drug can help patients, Medicare would cover it for all eligible patients and would only impose a requirement that the patients’ experience be tracked,” Pam Belluck of the Times reports.
