CMS sheds light on its registry plan for Alzheimer’s drugs

The Centers for Medicare and Medicaid Services (CMS) in the US has provided more details about the controversial plan to require participation in a patient registry as a condition for reimbursement of amyloid-targeting Alzheimer’s disease drugs.

CMS has already said Medicare – the US health plan for seniors aged 65 and older – will cover drugs like Eisai and Biogen’s Leqembi (lecanemab) if they get full regulatory approval from the FDA, but critics claim the registry requirement is placing an unnecessary obstacle in front of patient access and is an over-reach of CMS’ powers.

Under the new plan, Medicare would require all prescribing physicians to take part in a real-world data collection effort for any patient who is prescribed amyloid drugs that make it through to full approval. Currently, CMS limits Medicare reimbursement of all drugs in the category to patients enrolled in clinical trials.

Eisai and Biogen already have accelerated approval for Leqembi, and are due to hear from the FDA about a full approval by 6th July. The drug won unanimous support from an FDA advisory committee earlier this month.

In an update on the plan, CMS promised that the registry would be free to use, and have a centralised portal featuring drop-down menus to make data entry as simple as possible, although it has not yet said how long the process will take.

Clinicians will have to provide their National Provider Identifier (NPI) and address, the patient’s demographic and clinical information, including the results of amyloid testing and cognition assessment scores, whether they are taking anticoagulant or antiplatelet drugs, and if they have evidence of brain swelling or haemorrhage.

CMS said it is collecting the data to “evaluate the appropriateness of the treatment for the Medicare population” and gauge whether it can meaningfully improve health outcomes in community practice.

It also wants to investigate how so-called ARIA side effects with amyloid targeting drugs – including brain oedema and haemorrhage – are affected by “the characteristics of patients, treating clinicians, and setting” and gauge how those risks change over time.

While the update provides some new information, it likely isn’t yet detailed enough to assuage the concerns of patient organisations and advocacy groups that have expressed concerns about the impact of registry participation on patient access, particularly among ethnic minorities.

Lobbying group UsAgainstAlzheimer’s, which has been pressuring CMS to allow freer access to new Alzheimer’s drugs, has said it is concerned that the registry commitment means patients in rural communities and areas without large, urban hospital systems may struggle to participate.

CMS also indicated that it is working with organisations that are setting up their own registries and, once more are available, clinicians will be able to choose one in which to participate.