The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Leqembi (lecanemab), a co-developed Alzheimer’s disease drug by Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB). This development, however, was met with a refusal from the National Institute for Health and Clinical Excellence (NICE), the UK’s national health insurance arbiter, to cover the drug under the National Health Service (NHS).
The MHRA’s approval targets the early stages of Alzheimer’s disease, authorizing Leqembi for patients with one or no copies of the apolipoprotein E4 gene (ApoE4). The MHRA’s endorsement positions the drug as “the first treatment for Alzheimer’s disease licensed for use in Great Britain that shows some evidence of efficacy in slowing the progression of the disease.”
Contrastingly, NICE’s draft guidance determined that “The benefits of the new Alzheimer’s drug lecanemab are too small to justify the costs.” Although acknowledging Leqembi’s ability to slow disease progression by 4 to 6 months, NICE’s assessment considered the costs of the drug, which requires bi-weekly infusions and intensive side effect monitoring, to exceed the benefits. Had NICE approved reimbursement, approximately 70,000 patients would have been eligible for treatment under the NHS.
This decision follows closely on the heels of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issuing a negative opinion on Leqembi’s marketing authorization application (MAA) for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD. The CHMP cited potential safety concerns and insufficient evidence of treatment benefits as the basis for their decision.- Flcube.com
