- The Department of Veteran Affairs will not broadly cover Biogen's new Alzheimer's drug Aduhelm, recommending against use of the controversial and costly therapy in an update to its national formulary for prescription medicines.
- The policy, which was first reported by Endpoints News, provides for exceptions for the treatment of "highly selected patients" at medical centers with the experience and tools to appropriately diagnose an eligible individual and monitor for possible side effects.
- The VA's decision is another sign of pushback to Aduhelm, which is backed by conflicting clinical trial evidence that's left many doctors uncertain of whether the drug actually improves Alzheimer's patients' cognition and function.
Since Aduhelm's June 7 approval by the Food and Drug Administration, several influential health centers, as well as a handful of regional private insurers, have decided against offering or covering Biogen's drug. And in the two months since the FDA's clearance, relatively few patients have received treatment as many of the roughly 900 sites Biogen is targeting for Aduhelm's launch in the U.S. have not yet decided on a policy for use.
The drugmaker is optimistic those policies will begin to fall into place, but the controversy over the FDA's approval has intensified as reports from STAT and The New York Times have raised questions about the agency's decisionmaking process. Earlier this month, the federal health department's inspector general opened a review of how the FDA grants accelerated drug clearances, citing the unusual aspects of the Aduhelm OK.
The watchdog estimates its investigation won't be complete until fiscal year 2023, however.
In the meantime, pressure will fall to insurers to decide on appropriate use of Aduhelm. Most of the 6 million Americans with Alzheimer's are covered by Medicare, which recently began formal consideration of a single national coverage policy for the drug. That process will take nine months, leaving coverage decisions to the regional contractors who help run the federal program.
The VA's decision, which is the first nationwide policy on Aduhelm, is a blow to Biogen, even if veterans covered by the program are still able to access the drug under certain criteria. The drugmaker said in June it was working with the agency to "finalize a multi-year agreement" to support veterans' access to Aduhelm.
"While VA PBM acknowledges the recent FDA decision on [Aduhelm], given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal, we recommend against offering this agent to patients with Alzheimer's dementia (mild or otherwise) or mild cognitive impairment," states the VA notice, which was prepared last month.
VA providers can request coverage of medicines not listed on the national formulary, but the agency's policy lays out stricter standards for recommended use than what's described on Aduhelm's label granted by the FDA. Notably, providers are asked to conduct or obtain brain imaging scans that confirm the presence of the toxic protein Aduhelm targets.
The policy also recommends testing for a gene that was associated with higher risk of brain swelling in clinical testing, and advises against giving Aduhelm to patients who have a history of bleeding disorders, or who are on blood thinning medication.
In an emailed statement, Biogen said veterans in the VA system would still have "a pathway to access Aduhelm" under the criteria spelled out by the agency.
"Biogen remains committed to ensuring veterans have access to the latest therapies for Alzheimer’s and we will continue to engage closely with the VA as they evaluate potential updates to their guidance," the company said.
Biogen says Aduhelm will cost an average of $56,000 per patient per year, although since that estimate is based on weight the cost for some could be several thousand dollars more. The price tag is higher than even some Wall Street analysts had expected, and far exceeds what the Institute for Clinical and Economic Review, an independent drug pricing group, has said would be cost effective.
In addition to the drug itself, the required brain MRIs and other related scans could mean the total cost of treatment approaches $100,000, an executive at the consulting firm IPD analytics told ICER in a meeting last month.
The VA covers a number of other older Alzheimer's drugs such as donepezil and memantine, which are only able to modestly alleviate disease symptoms.
Note: This story has been updated to include comment from Biogen.