The Centers for Medicare and Medicaid Services will limit Aduhelm coverage to only participants in approved clinical trials.
UPDATE: 3 March 2024, 8:24 P.M. ET. In February 2024, Biogen took Aduhelm off the market, citing financial concerns. Although the drug did receive accelerated, conditional FDA approval for the treatment of early Alzheimer’s disease in 2021, it is no longer available to new patients. The company announced it would sunset trials in May 2024 and cease supplying the drug to current patients in November 2024.
Major U.S. healthcare providers have refused to offer Biogen’s controversial anti-amyloid Alzheimer’s drug, Aduhelm. Now, the drug will face further limitations on accessibility in the form of insurance coverage. After a deliberation process, the Centers for Medicare and Medicaid Services (CMS) has announced they plan to limit coverage of the drug to Aduhelm clinical trial participants only.
The proposal — which is open for public comment until February 11, 2022, with a final decision expected April 11, 2022 — would affect patients who have a diagnosis of mild cognitive impairment (MCI) or early stage Alzheimer’s disease and who are participating in CMS approved trials or those supported by the National Institutes of Health.
Medicare currently supports some 44 million beneficiaries — about 15 percent of the U.S. population. (One in 10 of those beneficiaries relies solely on Medicare for their healthcare coverage.) As the U.S. general population ages, the total number enrolled is expected to rise to 79 million by 2030. Meanwhile, with this aging population, the burden of Alzheimer’s will grow too, by an estimate of more than 50 percent.
CMS Administrator Chiquita Brooks-LaSure said in a statement released that the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
After its 2021 Food and Drug Administration (FDA) approval, Aduhelm has been riddled with controversy, despite concerns from some medical experts about its benefit to patients.
The drug came onto the market with a hefty price tag of $56,000, only to be cut in half after lackluster sales and many hospitals continue to opt-out of providing the drug to its patients. After losing a bid for approval in Europe and Japan at the end of last year, Biogen slashed the price to $28,200 — still significantly higher than the cost-effective price estimated by the Institute for Clinical and Economic Review.
Congress is also investigating off-the-record meetings between Biogen and the FDA prior to its approval and why Aduhelm was given the go ahead despite strong objection from an independent advisory committee.
“There is now a fair amount of pressure on CMS to reassess the premium, including the recent announcement by [Department of Health and Human Services] Secretary Becerra,” Tricia Neuman, senior vice president of the Henry J. Kaiser Family Foundation and executive director of its program on Medicare policy, told Being Patient over email.
Susan Peschin, president and CEO of the Alliance for Aging Research, told Being Patient: “According to CMS’s national coverage analysis that they put out last summer, [CMS] intended to apply to the entire class of monoclonal antibody therapies directed in amyloid for the treatment of Alzheimer’s disease.”
It remains unclear just how this decision may go on to impact other anti-amyloid drugs in the pipeline, including Biogen and Esai’s lecanemab, Eli Lilly’s donanemab, and Roche and Genentech’s gantenerumab. According to the memo, the same strict standards for efficacy data, along with CMS-approved trials, will be necessary in order future anti-amyloids to receive coverage.
CMS opted for the route of coverage with evidence development (CED), which is usually reserved for medical devices and procedures. Peschin said this route could make it harder for people to sign up for medical trials.
While the scientific community continues to be question the drug’s efficacy, patient advocacy groups are concerned about increasingly limited access to the only approved anti-amyloid on the market.
“Today’s announcement from CMS is shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics,” Alzheimer’s Association CEO Harry Johns said in a statement. “With the approach proposed by CMS, access to treatment would now only be available to a privileged few — those with access to research institutions — exacerbating and creating further health inequities.”
Medicare is still deciding whether it will develop a national policy for coverage of monoclonal antibody drugs aimed against amyloid for the treatment of Alzheimer’s disease. That decision is expected in April 2022.
In the meantime, other anti-amyloid drugs in the drug development pipeline must show a meaningful benefit to cognition and function in order to receive CMS coverage.
Updated 11:33 A.M. ET 12 January 2022 to include a quote from the Alzheimer’s Association. Updated 12:01 A.M. ET 19 January 2022 to include details about the CMS decision’s public comment period.
