The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).
Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval. About a week later, nonprofit watchdog group Public Citizen called for high-profile resignations of FDA officials due to the approval.
In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.
Yesterday’s CMS policy stated that Aduhelm and any future monoclonal antibodies directed against amyloid approved by the FDA will be covered by Medicare under coverage with evidence development (CED). As part of the decision, CMS will provide enhanced access and coverage for those with Medicare who are participating in CMS-approved studies, according to a news release.
Any new drugs in the class that receive traditional FDA approval may be available in additional care settings that people with Medicare can use, such as an outpatient department or an infusion center.
CMS also ruled that, for drugs that the FDA has not determined to show a clinical benefit, Medicare will cover them in the case of FDA- or NIH-approved trials, with the center set to support the FDA by covering the drug and any related services for people with Medicare who are participating in these trials.
“Alzheimer’s disease is a highly destructive illness that affects millions of Americans and their families. CMS has a responsibility to ensure that people with Medicare have equitable and appropriate access to therapies that are reasonable and necessary for use in the Medicare population,” CMS Administrator Chiquita Brooks-LaSure said in the release. “This final National Coverage Determination reflects CMS’ commitment to provide the American public with a transparent, trusted, evidence-based decision – without regard to cost – that is made only after a thorough analysis of public feedback. Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants.”
Aduhelm is currently the only monoclonal antibody directed against amyloid that has been granted FDA approval through its accelerated program for the treatment of Alzheimer’s disease, with both FDA and NIH approving clinical trials that are ongoing to continue to study the drug and ensure there is a “reasonable assurance of a clinical benefit.”
Eisai issued a statement following the CMS policy ruling saying that it respects that the CMS has committed to “quickly reconsider the National Coverage Determination (NCD) once an anti-amyloid drug for the treatment of [Alzheimer’s] has met the [CED] requirements with quality evidence.”
“Eisai anticipates completing our anti-amyloid-beta (Aβ) protofibril antibody lecanemab’s rolling submission of a Biologics License Application to the FDA under the accelerated approval pathway in the first quarter of our fiscal year 2022, which began April 1, 2022,” the statement said. “Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai believes Clarity AD has a robust design, which could meet the “high level of evidence” criteria set forth by CMS in the NCD decision memo if the result is positive; therefore, creating the potential for CMS to reconsider full coverage of lecanemab should it be approved by the Food and Drug Administration. We look forward to engaging constructively with CMS to ensure appropriate Medicare beneficiaries have access to this potential new therapy.”