With Food and Drug Administration approval decisions for the amyloid antibodies lecanemab and donanemab expected this year, the Centers for Medicare and Medicaid Services have clarified how they plan to cover these drugs. In a June 1 statement, the agency confirmed its earlier decision that coverage for traditionally approved anti-amyloid antibodies will be contingent on physicians entering treatment and outcome data into a patient registry (Apr 2022 news). “Clinicians will be able to submit this evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval, and will collect information via an easy-to-use format,” the agency said.
One such patient registry in development is ALZ-NET, by the Alzheimer’s Association (Aug 2022 conference news). At AD/PD 2023 in Gothenburg, Sweden, the association’s Maria Carrillo said that more than 100 U.S. sites are enrolled, and the first 18 patients have been registered. Other countries, including Japan, Australia, and the U.K., are interested in starting similar programs, she added. For its part, CMS did not name specific registries, but noted that it is working with several organizations that are developing such programs. Qualifying registries will eventually be listed on the CMS website. Researchers will have access to de-identified data from these registries, the agency added.
Advocacy groups criticized the decision.“[It] may limit access to those who are not located in a major metropolitan center, or who may or may not have a trusted local healthcare provider equipped to add electronic data entry to their everyday practice pattern,” the Global Alzheimer’s Platform Foundation said in a statement.
Industry seemed less concerned, with one analyst noting that AD patients on amyloid immunotherapy need high levels of monitoring in any case, due to the risk of ARIA, aka amyloid-related imaging abnormalities. Thus, the therapy will already be restricted in practice to people who can make frequent visits to well-equipped medical centers. Real-world data collection is a growing practice for new medication types.
The FDA’s Advisory Committee meets June 9 to make recommendations on traditional approval of lecanemab (Mar 2023 news). The antibody is already available under the accelerated approval pathway, but this use is not covered by CMS (Jan 2023 news). The FDA is expected to consider an application for donanemab full approval, based on its positive Phase 3 results, later this year (May 2023 news).—Madolyn Bowman Rogers
- Drilling Down into the CMS Aduhelm Decision—A Primer
- Bringing Aduhelm—and Antibodies to Come—Into Practice
- Decision Date on Leqembi Traditional Approval Set for July
- U.S. FDA Gives Green Light to Leqembi, aka Lecanemab
- And Then There Were Three: Donanemab Phase 3 Trial Positive