CMS update on Alzheimer's coverage raises questions

Sabine van Erp

The Centres for Medicare and Medicaid Services (CMS) has formally announced its intention to allow coverage of new amyloid-targeting drugs for Alzheimer’s disease if they get full FDA approval – with one caveat that is raising concerns among patient groups.

The wrinkle in CMS' announcement is that it will require physicians prescribing the new drugs to participate in registry studies – managed through a single, nationwide portal – which will collect data on how the drugs work in a real-world setting.

At the moment, two amyloid drugs have been given accelerated approval by the FDA – Eisai and Biogen’s Leqembi (lecanemab) and Aduhelm (aducanumab) – with reimbursed use restricted to patients enrolled in clinical trials under a coverage with evidence development (CED) stipulation.

A decision on full approval of Leqembi could be the first to arrive, shortly after an FDA advisory committee meeting due to take place next week. Meanwhile, another amyloid drug, Eli Lilly’s donanemab, is also being prepared for regulatory submission after a positive phase 3 readout.

In a statement, the CMS said that if the FDA grants traditional approval, “then Medicare will cover it in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs.” Broader Medicare coverage would begin on the same day the FDA grants traditional approval, it added.

The registry requirement has raised a red flag for the lobbying group UsAgainstAlzheimer’s, which has been pressuring CMS to allow freer access to the new drugs.

Chair and co-founder George Vradenburg said that the organisation was “encouraged” by the CMS announcement, but is concerned that the registry commitment means rural communities and areas without large, urban hospital systems may struggle to participate.

He is also asking whether minority populations and those without financial means will have equitable access and what burden participating in registries will impose on doctors and patients.

“All Medicare patients should receive coverage to label without restricting access based on where you live or who your doctor is,” commented Vradenburg.

“In the end, CMS is still imposing a requirement on Alzheimer’s patients that hasn’t been required for anyone else who wants an FDA-approved drug.”

CMS insists that there is a strong precedent for using registries to gather data on new therapies, adding that the portal will be easy to use and will provide researchers with important information to carry out studies that will “build knowledge of how these drugs can potentially help people.”

The Alzheimer’s Association disagrees, saying that while registries are important tools they “should not be a requirement for coverage of an FDA-approved treatment.”

Image by Sabine van Erp from Pixabay