Biogen and Eisai’s Leqembi has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency for Alzheimer’s disease, but a negative opinion from the local cost-effectiveness watchdog means widespread coverage is uncertain.
The reimbursement challenge could add another speed bump to the already-slow global rollout of Leqembi, which is still a long way from achieving its blockbuster ambitions.
On Thursday, the UK’s health agency approved Leqembi for slowing progression of mild cognitive impairment or mild dementia in adults with Alzheimer’s disease.
The thumbs-up marks a welcome change for Eisai and Biogen after the drug was rejected by the European Medicines Agency in a surprise decision in July. The EMA said Leqembi’s risks do not outweigh its benefits, especially in light of the potential for amyloid-related imaging abnormalities (ARIA) such as brain swelling and bleeding. The drugmakers said they will seek a reexamination of the negative opinion from the Committee for Medicinal Products for Human Use.
However, the MHRA approval does not guarantee coverage of Leqembi by the UK’s NHS, which is the biggest payer in the country. That is down to the National Institute for Health and Care Excellence, which published a separate draft guidance on Thursday that leans against reimbursing the drug. Around 70,000 adults in England would have been eligible for NHS treatment with Leqembi, according to NICE.
The guidance is now open for public consultation until Sept. 20, after which responses will be evaluated before it issues a final recommendation. Eisai said in its own release that it is working with NICE, the Scottish Medicines Consortium and the NHS to make Leqembi available “as soon as possible.”
It is not unusual for an MHRA approval to be followed by a negative opinion from NICE, Janet Beal, health economics and market access managing analyst at GlobalData, told Endpoints News in an email. But, in the majority of cases, renegotiation of prices or further evidence submitted by drugmakers tends to result in a NICE recommendation, she added.
NICE said that the high costs of Leqembi in terms of intravenous infusions in the hospital, and the need for vigilant monitoring of side effects combined with its limited efficacy, means it’s not good value for the taxpayer. Leqembi infusions take around an hour and are given every two weeks. Patients must also be monitored for ARIA events through an MRI scan prior to their fifth, seventh and 14th infusions, according to the drug’s label.
In Leqembi’s Phase 3 trial, 12.6% of treated patients had signs of brain swelling and 17.3% had signs of brain bleeding. The drug’s ability to delay cognitive decline by four to six months was described by NICE as “meaningful” but “small.” The watchdog also said there was limited evidence on the drug’s long-term efficacy beyond the 18 months covered by clinical trials.
Leqembi has a list price of $26,500 per year in the US. If NICE recommends NHS coverage, it would be sold at an undisclosed discount. But for now, Leqembi will become available in the much smaller private market in the UK.
Leqembi won FDA accelerated approval in January 2023, converted to full approval in July, but driving sales has proven a major challenge. Back in April, Biogen CEO Chris Viehbacher described launching Leqembi in the US as “extraordinarily difficult” because providers are dealing with a lot of change.
Leqembi is also approved in mainland China, Japan, Hong Kong, South Korea, Israel and the United Arab Emirates.
Editor’s note: This article and its headline was updated to add more context.