- The Department of Veteran Affairs will cover Eisai and Biogen’s new Alzheimer’s treatment Leqembi for veterans in early stages of the disease, becoming the first major U.S. insurer to agree to pay for the medicine following its accelerated approval in January.
- The policy will apply to patients who fit criteria by the Veterans Health Administration and labeling set for the medicine by the Food and Drug Administration, Eisai said Monday. The decision contrasts with Medicare’s policy to limit Leqembi coverage to only patients enrolled in clinical trials until there is more data to demonstrate the therapy’s benefit or it wins a full approval.
- The FDA could grant a full approval for Leqembi as soon as July. Unlike Biogen’s earlier Alzheimer’s drug Aduhelm, which the VA did not cover, Leqembi has more consistent data showing it slows the cognitive decline of the disease as well as removes deposits of a toxic protein called amyloid from patients’ brains.
The VA’s decision comes two months after the FDA granted an accelerated approval for Leqembi and a month after the CMS reiterated its policy restricting coverage of the drug.
The Alzheimer’s Association had asked the CMS to reconsider its stance, but the agency said it hasn’t seen enough data to show the drug meets its standards for coverage, namely that a drug be both “reasonable and necessary,” which differs from the FDA’s “safe and effective” requirements for approval.
The CMS’ policy is far more reaching than the VA’s because its programs cover the vast majority of people with Alzheimer’s in the U.S. The CMS said it would broaden its coverage of Leqembi “on the same day” the FDA converts the drug’s accelerated approval to full approval. Even then, however, coverage would have limitations and come with requirements for additional data-gathering, such as via patient registries.
Last week, the FDA accepted Eisai’s application for traditional approval of Leqembi, which is based on confirmatory study data that showed treatment slowed patients’ physical and mental decline by 27% compared to a placebo. The FDA will also a hold an advisory committee meeting to discuss the application. (Leqembi’s accelerated approval was based on an earlier study in which treatment powerfully removed amyloid from patients’ brains and suggested a clinical benefit.)
Eisai hopes to avoid Biogen’s disastrous launch of Aduhelm by quickly moving to gain a full approval and by pricing Leqembi at $26,500 per year, around half the initial price Biogen set for Aduhelm before it was forced to slash it.
Even if the CMS follows the VA in granting coverage, questions remain about whether targeting amyloid deposits in the brain is sufficient for treating Alzheimer’s. Repeated failures in clinical trials of amyloid-clearing drugs have made insurers and doctors skeptical about their effectiveness and spurred calls to pursue other approaches. The latest failure came last week, when Eli Lilly reported its experimental drug solanezumab failed a large 10-year study, concluding nearly two decades of unsuccessful research on the drug.
Lilly’s other Alzheimer’s drug called donanemab could be the next to win FDA approval should trial data expected this year confirm earlier positive findings.