The US Centers for Medicare & Medicaid Services (CMS) said Monday that it is launching a review process to determine whether Medicare will establish a national coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer's disease. The national coverage determination (NCD) analysis will apply to Biogen and Eisai's Aduhelm (aducanumab), which was granted accelerated approval by the FDA last month, as well as any future monoclonal antibodies that target amyloid as a way of treating Alzheimer's patients.
"We want to consider Medicare coverage of new treatments very carefully in light of the evidence available," stated CMS Administrator Chiquita Brooks-LaSure, adding "that's why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease."
Aduhelm was awarded accelerated approval on June 7 based on the surrogate endpoint of reduction of beta-amyloid plaques in the brain, which the FDA said was "reasonably likely to result in clinical benefit." However, the decision sparked an intense backlash amid doubts about its clinical efficacy. There has also been concern about how its annual $56,000 cost could impact Medicare, with one analysis estimating that if 1 million Medicare beneficiaries were to receive Aduhelm, the cost to CMS would exceed $57 billion in a single year.
According to CMS, coverage for Aduhelm is currently determined at the local level by Medicare administrative contractors, who represent 12 jurisdictions across the country. CMS said the analysis will look at whether the evidence meets the Medicare law's requirements that items or services be "reasonable and necessary for the diagnosis or treatment of illness or injury," adding that it uses a process that includes "an assessment of the clinical evidence such as published clinical studies, professional society guidelines and public comments to determine coverage." The federal agency said it expects to give a proposed decision within six months and a final decision within nine months.
Late last week, the FDA narrowed the prescribing label for Aduhelm, recommending the therapy be initiated in those with mild cognitive impairment or mild dementia stage of disease, which was the patient population studied in clinical trials of the drug. That news was followed shortly afterward by FDA Commissioner Janet Woodcock asking the Office of Inspector General to open an independent investigation into interactions that took place between representatives of Biogen and FDA staff in the period that led up to the contentious approval.
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