GAP President John Dwyer was featured in McKnights Senior Living on the CMS decision to support only traditionally FDA-approved drugs.
A Thursday announcement by the Centers for Medicare & Medicaid Services regarding coverage of Alzheimer’s drugs is being met with skepticism by some industry advocates who say that “the devil is in the details.”
CMS Administrator Chiquita Brooks-LaSure announced Thursday morning that the Medicare program will cover drugs that may slow the progression of Alzheimer’s disease “if the Food and Drug Administration grants traditional approval.”
Under that condition, she said, “CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered.”The approach is consistent with CMS’ national coverage determination, she added.
Groups such as the Alzheimer’s Association, however, said that the coverage is contingent on provider participation in a registry, which the group called an “unnecessary barrier.” The association said that although registries are an important tool to gather necessary real-world evidence to transform and improve patient care, they should not be a requirement for coverage of an FDA-approved treatment.
Similarly, Global Alzheimer’s Platform Foundation President John M. Dwyer said that “it’s too early to celebrate” and the “devil is in the details,” adding that CMS is “still insisting on placing unprecedented data collection efforts on doctors and patients.”
“GAP is concerned about the undue burden this plan imposes on Alzheimer’s patients,” Dwyer said in a statement. “It is not full coverage of an FDA-approved treatment for all beneficiaries, free of any additional bureaucratic hurdles.”
In her announcement, Brooks-LaSure said that Medicare will cover drugs that receive traditional FDA approval when a physician and clinical team participates in a registry that collects evidence about how the drugs work in the real world. Clinicians can submit evidence through a CMS-facilitated portaal once a drug gains traditional approval.
CMS indicated that it is working with multiple organizations that are opening their own registries and will have more information as they come online.
In April 2022, Medicare announced that it would limit its coverage of FDA-approved monoclonal antibody treatments used to treat amyloid plaques in the brains of those living with Alzheimer’s. The federal government only covers drugs approved under the FDA standard review process, not under the accelerated review program. CMS’ decision about Alzheimer’s medications further limits coverage to treatments administered through clinical trials or other studies.
According to Brooks-LaSure’s announcement, coverage criteria includes being enrolled in Medicare Part B and having a diagnosis of mild cognitive impairment or early dementia caused by Alzheimer’s disease in addition to having a qualified physician participate in a registry.
Dwyer said that coverage depending on a “qualifying physician participating in a registry” may limit access for those who don’t live in a major metropolitan medical center or who may not have a local healthcare provider equipped to add electronic data entry to their everyday practice pattern.
“Ever since CMS issued its decision in 2022 denying coverage of Alzheimer’s treatments approved for under the FDA’s accelerated approval pathway, the agency has held up its policies as routine,” Dwyer said, asking for a reversal of the coverage with evidence decision. “Rationing healthcare is not routine, and it’s not within the agency’s legal mandate to do so.”
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss the results of a confirmatory trial of lecanemab (Leqembi) on June 9, with a potential decision on a traditional approval possible within weeks. Broader Medicare coverage would begin on the same day the drug is approved.
Under CMS’ coverage policy, if the FDA grants traditional approval to other drugs in this class of monoclonal antibody treatments, the drugs also would be eligible for broader coverage. Two drugs in this class have received accelerated approval form the FDA, but no drug in this class has received traditional approval.