CMS will formally consider whether to adopt nationwide rules for coverage of Biogen's new Alzheimer's drug Aduhelm, announcing Monday the opening of a determination process that could shape how millions of Americans are able to access the controversial treatment.
Patient advocacy groups and insurers have urged CMS to set a single Medicare policy on coverage of Aduhelm, which Biogen priced at an average cost of $56,000 per year. Experts fear the drug — the first new Alzheimer's treatment approved in nearly two decades and the first ever meant to treat the disease's underlying cause — could add tens of billions of dollars to Medicare spending without clear evidence it actually improves patients' lives.
CMS hasn't yet decided whether it will set a universal policy, known as a national coverage determination. The agency will convene two meetings this month to solicit input, as well as collect comments from the public over the next 30 days.
After gathering information, CMS will post a proposed policy, on which it will ask for further comment over another month-long period. Sometime thereafter, a final determination would be made, a process that CMS estimates will complete within nine months.
"We want to consider Medicare coverage of new treatments very carefully in light of the evidence available," CMS Administrator Chiquita Brooks-LaSure said in a Monday statement. "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."
Many of the estimated millions of Americans living with Alzheimer's are over 65 and would therefore likely be covered through Medicare for treatment with Aduhelm. Currently, coverage is set regionally by 12 insurers that contract with CMS.
The Alzheimer's Association, which advocated for Aduhelm's approval, has pushed for a national coverage determination, arguing that leaving policy for a drug like Aduhelm fragmented could limit patient access. Insurers, through their lobby America's Health Insurance Plans, have also indicated their support for a single policy, though their concerns center on Aduhelm's uncertain clinical benefit and potential broad use.
CMS said its consideration of a national policy for Aduhelm would also apply to drugs like it that target a type of brain plaque associated with Alzheimer's. Eli Lilly recently indicated it would ask the Food and Drug Administration for an accelerated approval of its experimental drug donanemab, and Roche is reportedly considering a similar course with another drug.
In a document posted Monday, the agency said it's seeking comment on the degree of benefit patients would find meaningful. Two identical studies of Aduhelm run by Biogen showed contradictory results, with one finding treatment modestly slowed cognitive and functional decline while the other did not.
CMS is also asking for comment on what patient characteristics are likely to correlate with positive health outcomes from treatment, and the preferred setting for treatment and care. In testing, Biogen enrolled patients with mild dementia who were positive for the type of brain plaque Aduhelm targets. The FDA's original approval, granted June 7, did not limit use of the drug to only those patients, and did not recommend obtaining proof of the plaque's presence as a requirement of treatment.
The FDA, after heavy criticism, last week revised the drug's prescribing information, instructing doctors to initiate treatment only for patients with mild dementia.