CMS said it will cover monoclonal antibodies to treat Alzheimer’s disease if they are approved through the standard review process and not through an accelerated approval.
The Centers for Medicare & Medicaid Services (CMS) has indicated it won’t change its coverage policies regarding FDA-approved monoclonal antibodies directed against amyloid to treat patients with Alzheimer’s disease. In a final national coverage determination, CMS said there still isn’t enough evidence to consider changing its coverage.
Last year, CMS issued a national coverage determination (NCD) that indicated FDA-approved monoclonal antibodies to treat Alzheimer’s disease would be covered if they are approved through the standard review process and not through an accelerated approval. This decision was made to address coverage questions related to Eisai/Biogen’s Aduhelm (aducanumab). The FDA had approved the therapy in June 2021, even though an advisory committee in November 2020 recommended against approval. Controversy immediately surrounded Aduhelm because of mixed results from clinical trials and Biogen's pricing of the therapy, which the company eventually reduced by half.
After the coverage determination, the Alzheimer’s Association took issue with the decision, saying it restricted access and historically, CMS had not previously limited accessed to an FDA-approved drug. The association also objected to the decision because they said it also applied to future therapies.
In December 2022, the Alzheimer’s Association requested that CMS review its coverage after data showed that Eisai/Biogen’s second monoclonal antibody, Leqembi (lecanemab), improved cognitive decline in patients with Alzheimer’s disease. Lecanemab resulted in statistically significant results, reducing clinical decline on the global cognitive and functional scale by 27%.
The Alzheimer’s Association said in its recent statement that CMS continues to block people from accessing FDA-approved medications. “CMS’ role is to provide health care coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate. Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary,” Joanne Pike, Dr.PH., Alzheimer’s Association president and CEO, said in a statement.
CMS, in its final determination, said its role is to examine whether a medication is reasonable and necessary. “If a monoclonal antibody directed against amyloid for the treatment of Alzheimer’s disease subsequently receives traditional FDA approval, CMS will provide broader coverage using the framework we announced last year,” CMS said. CMS also said that they would review any new evidence that becomes available that could lead to a reconsideration of its policy.
Just after receiving accelerated approval for Leqembi in January 2023, Eisai/Biogen submitted a supplemental biologics license application (sBLA) for full approval. The application is based on data from the phase 3 confirmatory Clarity AD clinical trial. In this study, lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and also published in the Jan. 5, 2023, issue of The New England Journal of Medicine.
Eisai anticipated that CMS would wait for the traditional FDA approval of Leqembi to make a public statement about any coverage change, a spokesperson told Formulary Watch. "Eisai has actively and transparently been sharing our Leqembi trial data with CMS, including publications and pending publications. To date, Eisai has not received any details of deficits in the data set at this time."
Eisai indicated that it is engaging with CMS about Leqembi and its Clarity AD trial, not the overall class. "Eisai is proud to bring forward high-quality and well-designed trial results, and is actively working with CMS to determine the most efficient path to appropriate access for Medicare beneficiaries while also being mindful of the urgency we feel from the Alzheimer’s patient, caregiver, and provider community," the spokeperson said.