Patient advocates are strongly criticizing a decision by the Centers for Medicare & Medicaid Services to stand by its highly restrictive coverage for new dementia drugs. They argue it will unreasonably deny the possibility of treatment to those diagnosed with Alzheimer’s disease.
The Alzheimer’s Association in December asked CMS to reconsider its standing national coverage determination for monoclonal antibody drugs that target amyloid brain plaques with the goal of slowing disease progression. The federal agency last year confined coverage of Biogen’s new drug aducanumab (Aduhelm) and any future drugs in the class to clinical trial participants only.
On Wednesday, CMS said it will not revisit that original determination, a disappointment to those waiting for potential access to Eisai’s and Biogen’s monoclonal antibody drug lecanemab (Leqembi), approved in January.
The Alzheimer’s Association shot back. CMS covers all other FDA-approved drugs but those in this new drug class, it argued in a statement released Thursday.
“CMS’s role is to provide healthcare coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate,” Joanne Pike, DrPH, Alzheimer’s Association president and CEO, said.
“The Alzheimer’s Association is appalled that the Biden Administration is extending its unjust decision to deny access to FDA-approved treatments for people living with Alzheimer’s — a fatal disease,” the organization said.
It pointed to a bipartisan letter signed by 72 congressional leaders and sent to the Department of Health and Human Services on Feb. 6, emphasizing the importance of access.
Patient advocate UsAgainstAlzheimer’s also weighed in, stating that “the CMS refusal to reconsider its decision not to cover Alzheimer’s drugs – which it made without seeing any data on the new drug – will have very dire consequences for people living with Alzheimer’s.”
Recent approval
Leqembi was approved in early January. Like aducanumab, it was granted a fast-tracked approval process on the basis of being “reasonably likely to predict a clinical benefit to patients.”
On Wednesday, CMS said that while it regretted the decision, the drug does not meet its criteria for allowing broader coverage.
“As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary. This standard differs from the criteria used by the FDA to assess whether medications are safe and effective,” the agency said.
CMS added that it may reconsider its decision when new evidence of clinical benefit becomes available, or when a drug in the class receives traditional FDA approval based on clinical benefit.
Cost-control argument
Some detractors said CMS’s decision reflected an effort to control costs related to the new drug class, a problem that reared its head when Aduhelm was approved and Medicare premiums rose in response. An unusually large, recommended premium increase for 2022 was designed to create reserves to cover Aduhelm’s potential use, CMS reported at the time. But Aduhelm, approved under a cloud of controversy, was not widely embraced by neurologists and has been little used.
The potential effectiveness of Leqembi, meanwhile, has been demonstrated in clinical trials minus the uncertainty associated with Aduhelm, whose trial data was widely questioned.
“We believe that CMS is standing by the decision to deny medically necessary care because they want to control costs,” said Jim Taylor, president and CEO of Voices of Alzheimer’s, an advocate for Alzheimer’s treatment access. “CMS is denying access in a way that particularly affects people who are already facing other systemic disadvantages,” he added in a Thursday statement.
Physicians who treat people living with Alzheimer’s anticipated these arguments. The American Academy of Neurology in February 2022 expressed concern that CMS’s original decision on Aduhelm coverage would block future access to new Alzheimer’s drugs. It has advocated for an “off-ramp” that would allow the agency to quickly change the national coverage determination when appropriate treatment candidates are approved.
“Should each new amyloid therapy start from a position of extremely limited coverage, regardless of demonstrated benefit, patients without the means to access care under the [national coverage determination] will effectively be barred from accessing treatment,” it said in a letter to CMS at the time.
“Each day matters to someone living with early stage Alzheimer’s disease when it comes to slowing the progression of this disease,” Pike of the Alzheimer’s Association said about the agency’s decision to stay the course. “CMS’s policy to block access to these treatments eliminates people’s options, resulting in continued irreversible disease progression and contributing to greater health inequities.”
