NEW YORK – The US Centers for Medicare & Medicaid Services on Thursday provided further details on its plan to cover the emerging class of anti-amyloid monoclonal antibody treatments for Alzheimer's disease.
CMS had previously indicated it would cover such treatments for Medicare patients once they are granted traditional approval from the US Food and Drug Administration, as long as they are administered in settings where doctors are collecting real-world data on how the drugs are impacting patients' long-term outcomes and on their usefulness within a registry.
The government payor's coverage plan comes as the FDA is expected to decide by July 6 whether to convert the accelerated approval granted to Eisai and Biogen's Leqembi (lecanemab), a drug in this class, to a full traditional approval.
In its latest announcement, CMS said it will facilitate a nationwide portal through which clinicians can submit outcomes and other information, or they can use registries hosted by other organizations that meet CMS's privacy and data collection requirements. CMS will list these other registries on its website.
CMS plans to use the collected data to study the appropriateness of these new anti-amyloid Alzheimer's drugs for the Medicare population. For example, it plans to assess whether the drugs meaningfully improve health outcomes and whether the treatments' benefits and harms change over time or vary by patients' characteristics, prescribing clinicians, or setting.
Clinicians will have to submit information on patient demographics, clinical diagnosis, and adverse events, whether the patient is taking anticoagulation or antiplatelet drugs, and results of an amyloid PET scan, cerebrospinal fluid analysis, or other testing done to determine the presence of amyloid, according to CMS.
Although providers will be asked to submit data on amyloid test results, CMS has not detailed plans to cover such testing, which industry observers have said could hinder adoption of anti-amyloid treatments.
Amyloid tests are not typically reimbursed by Medicare; however, a CMS spokesperson in an emailed statement said the agency is reconsidering its policy for amyloid PET scans and expects to issue a proposed national coverage determination on the issue soon. Currently, amyloid PET imaging is covered only when performed within certain studies and limited to only one scan per Medicare patient across their lifetime. CMS does not have a national coverage policy for CSF or other amyloid tests, leaving decisions to local Medicare Administrative Contractors.