Republican leaders of the Senate and House Committees overseeing the Centers for Medicare and Medicaid Services (CMS) raised concerns about a recent CMS decision they claim could restrict coverage of a federally approved Alzheimer’s treatment and any similar future treatments.
In a May 2 letter sent to CMS Administrator Chiquita Brooks-LaSure, U.S. House Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA) and U.S. Senate Health, Education, Labor and Pensions Ranking Member Richard Burr (R-NC) and two other GOP lawmakers outlined their issues with a recent CMS coverage decision regarding monoclonal antibodies (mAbs) targeting amyloid for the treatment of Alzheimer’s disease.
“In particular, CMS’s national coverage determination strays from precedent, subordinates the clinical judgment and expertise of the Food and Drug Administration (FDA), and suggests a problematic new standard that risks chilling innovation and jeopardizing access to the cutting-edge treatments of the future,” the lawmakers wrote. “We urge CMS to reconsider this approach and to operate within the bounds of its statutory authorities and directives, which this latest decision oversteps.”
Traditionally, for instance, the lawmakers wrote that CMS has generally provided coverage for FDA-approved indications of drugs and biologics, in addition to credible off-label uses, and that the agency has rarely subjected medications to the national coverage determination process because the FDA has the resources, expertise and experience needed to make key judgments on safety and efficacy.
Restricting Medicare access through the coverage with evidence development (CED) paradigm to an FDA-approved indicated use of a drug or biologic is unprecedented, they wrote.
“The final coverage decision for antiamyloid mAbs, by contrast, will severely restrict access to all drugs and biologics in this emerging class, even for antibodies that demonstrate a direct clinical benefit,” wrote the lawmakers. “On the basis of its interpretation of trial data for a single product, CMS has rendered coverage for a wide range of potential Alzheimer’s treatments untenable.”
The congressional members also noted several other problems with the final CMS decision, including that it inappropriately supplants FDA’s authority and exceeds its own; means many beneficiaries will receive a placebo, and some may even need to pay cost-sharing for it; and risks deterring and eroding the approval pathway, meaning delayed access to treatments, according to their letter.
“Given the lack of clarity in the agency’s final decision,” the lawmakers requested that Administrator Brooks-LaSure provide information by May 19 on several questions, including how the CMS coverage decision will result in some Medicare beneficiaries receiving, and potentially even paying for, a placebo, when they are enrolled in trials for medications deemed safe and effective by the FDA, and if CMS can cite any precedent for applying CED to the FDA-approved indications of any drugs and biologics, among others.