UK’s NHS Likely to Block Eli Lilly’s Donanemab for Alzheimer’s, Following Leqembi Rejection

The UK’s National Health Service (NHS) is poised to block the use of another Alzheimer’s treatment, Eli Lilly and Co’s donanemab, mirroring its recent rejection of Biogen Inc’s Leqembi by the National Institute for Health and Care Excellence (NICE). While donanemab demonstrated greater efficacy in slowing cognitive decline compared to lecanemab, experts believe it will face a similar fate due to safety concerns and its high price tag.

Donanemab showcased its potential to slow Alzheimer’s progression by 35%, surpassing lecanemab’s 27% effectiveness. However, clinical trials also unveiled significant risks. Notably, one in three patients experienced brain bleeds, and one in four developed brain swelling. These conditions, linked to amyloid-related imaging abnormalities, occurred at twice the rate observed with lecanemab, according to a Telegraph report, raising serious doubts about donanemab’s approval by the Medicines and Healthcare Products Regulatory Agency (MHRA), even though both drugs have received approval in the United States.

The cost of donanemab, projected to be even higher than lecanemab, presents another substantial hurdle. NICE previously cited lecanemab’s annual cost—between £50,000 and £100,000 per patient—as a major factor in its rejection. Considering that donanemab’s price is estimated to be roughly 25% higher, NICE’s decision to reject the drug appears increasingly likely. The organization is unlikely to reverse its stance, particularly after setting a precedent with lecanemab.

Last week, Biogen’s lecanemab became the first treatment for early Alzheimer’s disease (mild cognitive impairment and mild dementia due to Alzheimer’s) that targets an underlying cause of the disease to be authorized in a European country. Despite this approval, the National Institute for Health and Care Excellence (NICE), in its draft guidance, stated that “benefits of the new Alzheimer’s drug lecanemab are too small to justify the costs.”

LLY stock is currently down 0.31% at $949.80 during the premarket session on Monday. This news comes after Biogen and Eisai’s popular Alzheimer’s drug Leqembi is seeing slow adoption. The reasons behind this slow adoption are being investigated.

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