NEW YORK – The UK National Institute for Health and Care Excellence on Thursday issued two updated draft guidances recommending against making Eisai and Biogen's Leqembi (lecanemab) and Eli Lilly's Kisunla (donanemab) available to Alzheimer's patients in England.
NICE maintains that cost and evidence gaps remain for both of the beta-amyloid-targeting drugs and has opened the new draft guidances for Leqembi and Kisunla for public comment through March 27. An independent NICE committee will consider the responses, including possible new evidence or commercial proposals from the sponsors, before issuing final draft recommendations.
The independent committee last year determined that Leqembi and Kisunla showed too little benefit to justify their cost to the National Health Service. Committee members had requested additional data from the sponsors for their respective drugs, but after assessing the additional evidence, NICE affirmed its initial determination that the drugs were not cost-effective.
During the public comment period, NICE is seeking stakeholder feedback on the committee's conclusions regarding managed access agreements, under which patients can access for a time promising treatments that are not yet routinely recommended due to uncertain clinical or cost considerations while sponsors collect additional data. However, according to NICE, data presented so far suggest neither drug would provide enough benefit to justify the resources required to provide it even under such an arrangement.
The list price for Leqembi is £275 ($355) for a 200 milligram solution and £545 ($705) for a 500 milligram solution, with a recommended dosing schedule of 10 milligrams per kilogram administered biweekly. Following NICE's initial decision to not recommend Leqembi, Alzheimer's patient advocacy groups urged the institute to change its position, arguing that without NICE's backing the treatment, with a £20,000 annual cost, will be out of reach to most. The list price for Kisunla, which is dosed monthly, is confidential, according to NICE.
In the US, where both Leqembi and Kisunla are approved for treating Alzheimer's, Leqembi has a list price of $26,500 per year and Kisunla costs $32,000 per year.
After considering public comments to the present recommendation, NICE will publish the final draft guidances for Leqembi and Kisunla in July.