In a surprise move, Eisai announced Monday afternoon that the Veterans Health Administration (VA) has decided to cover Leqembi, an Alzheimer’s treatment developed by the Japanese pharma company in partnership with Biogen.
Leqembi was approved through the Food and Drug Administration’s accelerated approval pathway in January. It will need to show more efficacy and safety data to the agency in order to receive a full approval.
The VA’s decision to cover the drug for certain eligible veterans is a big step for the drug, which showed efficacy in moderately slowing cognitive decline in people with mild cognitive impairment or early-stage Alzheimer’s. Some safety risks, however, remain — making some contenders wary of providing full coverage of the drug.
The move followed a similar approval via the accelerated pathway for Biogen and Eisai’s initial Alzheimer’s drug, Aduhelm. Controversy over Aduhelm’s supposed clinical benefit led to a much lower uptake of the drug than expected, exacerbated further by Medicare’s strict coverage limits on the drug.
Until the VA’s decision, it appeared Leqembi would suffer similar hurdles.
Just last month, the Centers for Medicare and Medicaid Services (CMS) said it would stand firm on its decision to do the same for Leqembi as it did Aduhelm, significantly limiting its coverage to just patients who are enrolled in clinical trials.
“We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable,” CMS said at the time. “After careful review of the request and supporting documentation, we are making this decision because… there is not yet evidence meeting the criteria for reconsideration.” If Leqembi received full FDA approval, CMS said, it may consider giving it broader coverage.
CMS would cover about 85% of eligible Leqembi patients, while the VA and commercial insurers would also play a sizable role.
With the VA’s decision to cover the drug for eligible veterans, that leaves Eisai and Biogen waiting on a potential full FDA approval to make more gains.
“Eisai looks forward to sharing additional high-quality data as it becomes available and to continuing discussions with the VA as the company prepares for the FDA’s potential conversion of Leqembi’s accelerated approval to a traditional approval,” Eisai said in a statement. “Eisai is proud of and humbled by the opportunity to support U.S. veterans.”
All eyes continue to be on Leqembi for news related to its accessibility, including its cost for insurers and patients.
Earlier in March, the U.S. drug pricing watchdog Institute for Clinical and Economic Review (ICER) estimated Leqembi’s cost-effectiveness was somewhere between $8,900 and $21,500 per year — significantly lower than its current list price of $26,500. ICER noted Leqembi’s list price doesn’t line up with its value because while the drug has shown promise in slowing cognitive decline, it carries safety risks like brain swelling and bleeding.
“Currently available evidence is rated as promising but inconclusive to determine whether lecanemab provides a net health benefit over supportive care,” ICER said.
Similar concerns bubbled up during Aduhelm’s launch, ultimately resulting in increased scrutiny on the FDA’s accelerated approval pathway, which some experts consider not rigorous enough in determining which drugs get fast-tracked. FDA commissioner Robert Califf has highlighted the need to revamp the pathway, and improve how the agency deems drugs to be clinically beneficial to patients.
