The Centers for Medicare and Medicaid Services proposed Tuesday to let Medicare cover monoclonal antibodies as an Alzheimer's treatment Aduhelm in the context of clinical studies.
The coverage designation allows Medicare to cover the controversial Alzheimer's drug Aduhelm when used in clinical trials. The trials must seek to answer research questions about whether the use of monoclonal antibodies used for Alzheimer's treatment make a meaningful different in disease progression and what adverse events are associated with its use.
"This is unusual... but we believe it is appropriate for the Medicare population to issue this proposed decision," Tamara Syrek Jensen, director of the coverage and analysis group at the CMS Center for Clinical Standards and Quality, said in response to a reporter question on a Tuesday press call.
Medicare beneficiaries participating in trials must have a clinical diagnosis of mild cognitive impairment due to Alzheimer's and evidence of amyloid pathology consistent with Alzheimer's. Beneficiaries can't have other conditions that would contribute significantly to cognitive decline, medical conditions likely to increase significant adverse side effects or be expected to die during the study.
Medicare will cover one beta amyloid positron emission tomography (PET) scan per patient for approved trials that require the scan as part of their protocol. CMS also covers PET scans for Alzheimer's only in the context of clinical trials.
Jensen said CMS does not yet know how many patients will be enrolled in these trials, but said the agency expects to start accepting trial applications as soon as a final coverage determination is made. Payment and coding instructions will also come out after the final decision on coverage.
That determination is expected in April. An additional 30-day comment period on the decision will open before the final ruling.
Global Alzheimer's Platform Foundation, a not-for-profit devoted to reducing time and cost of Alzheimer's clinical trials, admonished the preliminary decision and urged CMS to issue a full coverage determination instead. Underserved Alzheimer's patients may have less access to the drug as a result of CMS' decision, GAP Foundation President John Dwyer said. Black and Hispanic individuals are more likely to develop Alzheimer's, according to the Alzheimer's Association.
"This preliminary ruling throws patient access out the window for most Americans," Dwyer said in a statement.
Jensen emphasized on the press call that clinical trials must be representative of the national population of Alzheimer's patients.
Dually eligible beneficiaries will be able to receive Aduhelm through a clinical trial, and CMS plans to provide additional direction to states on covering the drug and others in its class once the final coverage determination comes out, a CMS spokesperson said. The National Association of Medicaid Directors previously expressed concern about the impact of Aduhelm on state budgets if Medicaid has to bear the costs of Aduhelm for dually-eligible beneficiaries.
The Food and Drug Administration approved Aduhelm, the first monoclonal antibody targeting amyloid for the treatment of Alzheimer's, in June. The approval was granted despite questions over whether the drug is actually effective at treating Alzheimer's and some concerns over its safety.
Biogen, which manufactures Aduhelm, slashed the price of the drug by nearly 50% in December in an effort to get more patients prescribed. But some experts say the medication is still overvalued, and some health systems have said they won't prescribe the medication at all due to doubts over its effectiveness. At its original price, experts predicted Aduhelm would cost Medicare $29 billion annually. CMS does not factor drug price into its national coverage determinations.
CMS in November announced a 15% increase in beneficiaries' Medicare Part B premiums for 2022, citing Aduhelm's potential cost to the program as a reason for the increase. But Health and Human Services Department Secretary Xavier Becerra directed CMS to reevaluate Medicare Part B premiums Monday. A CMS spokesperson said Tuesday that the agency is still evaluating the premiums.