The VA health system, which provides medical benefits to more than 9 million veterans, rebuked the drug due to lack of demonstrated efficacy and safety concerns.
The Department of Veterans Affairs has announced that it will not include aducanumab (Aduhelm; Biogen) on its national formulary list, citing a lack of evidence of clinical benefit and safety concerns.1
The Alzheimer disease treatment—the first disease-modifying therapy approved for this indication—has come under much scrutiny since the FDA pushed through its controversial approval decision in June of this year.
With an average expected cost of $56,000 per year, coverage of aducanumab is being weighed carefully by payers, with a decision yet to be made by the Centers for Medicare & Medicaid Services.
Although the VA broadly recommends against prescribing aducanumab for patients with Alzheimer dementia or mild cognitive impairment, it does make an exception for "highly selected patients by experts and centers that have the necessary diagnostic and management expertise—and only by those with the needed resources for close monitoring to assure safety."
The VA further defined criteria, noting that the prescriber must be a VA neurologist, psychiatrist, or geriatrician who specializes in the treatment of dementia; the patient has a recent brain MRI and amyloid PET imaging and/or cerebrospinal fluid analysis that demonstrates clinical criteria for MCI or mild AD with Alzheimer disease pathology; the patient has a Clinical Dementia Rating Global score of 0.5 or Functional Assessment Staging Test score of 2 or 3, and a Mini-Mental State Examination score of at least 24; and neuroradiology specialists are available to review serial MRI scans to evaluate evidence of amyloid-related imaging abnormalities (ARIA), among others.
Notably, the VA also added aducanumab to its "non-promotable" list, which bans the therapy from being promoted or detailed by pharmaceutical sales representatives.
A report released by a group VA physicians2 pointed to the significant cost that treatment with aducanumab would incur on the health system, totaling in excess of $4 billion annually, which doesn't account for additional costs associated with screening, consultations, imaging, and monitoring. Noting that this projected, conservative cost estimate accounts for 40% of the total VA pharmacy budget for 2021, the authors concluded that use of aducanumab among VA beneficiaries "would threaten to overwhelm VA resources."
The messaging from the VA echoes similar evaluations from other groups, including the Institute for Clinical and Economic Review, who in July suggested that Biogen must drastically reduce the price of the therapy in order for it to be considered cost-effective, with suggested price estimates ranging from $2,500 to $23,100 per patient per year—a significant drop from Biogen's $56,000 per year list price.
Reports suggest that a decision from CMS may not come until the first quarter of 2022; in the meantime, Biogen and Eisai will answer the call from the FDA to conduct a phase 4, real-world observational study of aducanumab to evaluate the long-term efficacy and safety of the anti-amyloid agent.