The Biden administration has started to investigate whether Medicare should cover the extremely pricey Alzheimer’s drug aducanumab.
The Centers for Medicare & Medicaid Services announced Monday it is opening a National Coverage Determination (NCD) analysis on the drug that will cost patients $56,000 a year. Advocates and experts have called for the agency to move quickly to decide whether to cover the drug.
“We want to consider Medicare coverage of new treatments very carefully in light of the evidence available,” said CMS Administrator Chiquita Brooks-LaSure, in a statement Monday. “That’s why our process will include opportunities to hear from many stakeholders.”
The FDA granted accelerated approval to the drug last month despite warnings from its own advisors about the effectiveness. The drug was approved to break down amyloid plaques thought to worsen the disease.
Currently, local Medicare Administrator Contractors are deciding whether to clear reimbursement of the product, which manufacturer Biogen has priced at $56,000 a year.
CMS will evaluate national reimbursement based on several factors including an assessment of any clinical evidence, public comments and professional society guidelines.
Experts have urged the agency to act quickly on a national decision to cut down on any variation among local prices.
CMS can go several routes with the coverage process, including limiting reimbursement to only certain groups or choosing not cover it at all. Any decision though will have a major impact on spending, as 80% of Medicare beneficiaries will be eligible for the drug, according to a report in Health Affairs.
An estimate from the Kaiser Family Foundation projected that full approval of the drug at $56,000 a year could increase total spending on drugs by $29 billion.
CMS' decision comes a few days after the FDA launched an investigation into interactions between Biogen and agency drug reviewers before the approval decision.