Advocates on both sides of a debate over dramatically restricting Medicare’s coverage of an expensive and controversial Alzheimer’s treatment are waging competing campaigns to influence a final decision in April.
The dispute also raises larger questions about whether lawmakers and regulators will revisit the fast-track pathway under which the drug was approved, with the issue even entangling Robert Califf’s embattled nomination to lead the Food and Drug Administration.
In January, the Centers for Medicare & Medicaid Services proposed restricting coverage of Aduhelm, a new monoclonal antibody treatment from Biogen and Eisai that targets brain plaques, to patients participating in approved clinical trials only. If finalized, the decision would also extend to future amyloid products for Alzheimer’s disease.
