Eisai will have an unprecedented third attempt to convince experts at UK medicines cost-effectiveness assessor NICE that the NHS should fund its Biogen-partnered Alzheimer's disease therapy Leqembi.

卫材将有史以来第三次尝试说服英国药品成本效益评估机构 NICE 的专家，让 NHS 为该公司与渤健合作的阿尔茨海默病治疗药物 Leqembi 提供资金。

The company confirmed this morning that NICE has taken the 'unusual decision' to hold a third appraisal committee meeting as part of its ongoing evaluation of Leqembi (lecanemab), which was turned down last year by NICE in

公司今天早上证实，NICE已做出“不寻常的决定”，在其对Leqembi（lecanemab）持续评估的过程中召开第三次评审委员会会议。该药物去年被NICE拒绝。

draft guidance

草案指南

published just ahead of the drug's approval by the Medicines and Healthcare products Regulatory Agency (MHRA).

在药品和健康产品监管局（MHRA）批准该药物之前不久发布。

The UK approved the drug for treating mild cognitive impairment and mild dementia due to Alzheimer's in adult patients who have one or no copies of the APOE4 gene mutation (heterozygotes or non-carriers), which is a risk factor for the disease. These patients are thought to be at lower risk of amyloid-related imaging abnormalities (ARIA) – including brain swelling and bleeding – than people with two copies of the APOE4 gene variant..

英国已批准该药物用于治疗患有轻度认知障碍和因阿尔茨海默病引起的轻度痴呆的成年患者，这些患者携带一个或未携带APOE4基因突变（杂合子或非携带者），这是该疾病的风险因素。这些患者被认为比携带两个APOE4基因变异的人出现与淀粉样蛋白相关的影像学异常（ARIA）——包括脑肿胀和出血——的风险更低。

In its draft guidance, NICE said that there was a 'small but meaningful' benefit with Leqembi in these patients – a four to six-month delay in cognitive decline – but added that there was also little evidence of its long-term effects beyond 18 months.

在草案指南中，NICE表示，Leqembi 对这些患者有“小但有意义”的益处——认知能力下降延迟四到六个月——但补充说，几乎没有证据表明其超过 18 个月的长期效果。

The agency also said the cost of treatment with Leqembi, from the drug itself as well as the need for regular infusions and intensive monitoring for side effects, was too high to justify its modest benefits. A second draft guidance document also arrived at similar conclusions.

该机构还表示，使用Leqembi治疗的成本过高，包括药物本身的费用以及定期输液和对副作用进行密切监测的需求，其带来的效益相对有限，难以证明其高昂成本的合理性。第二份草案指南也得出了类似的结论。

'Eisai welcomes the opportunity for a second consultation period as a positive step forward in its ongoing dialogue with NICE to support medicine access for eligible patients,' said the company, adding that NICE's panel will 'need to consider significant changes to current diagnostic and treatment pathways to support management of early Alzheimer's disease (AD) patients.'.

“卫材欢迎第二次咨询期的机会，认为这是与NICE持续对话中的积极一步，以支持符合条件的患者获得药物，”该公司表示，并补充说NICE的小组将“需要考虑对当前诊断和治疗途径进行重大改变，以支持早期阿尔茨海默病（AD）患者的管理。”

The

The

second consultation period

第二次咨询期

has already begun and will conclude on 27th March, with the date of the third appraisal committee meeting scheduled for 14th May and a final decision due around 23rd July.

已经开始，并将于3月27日结束，第三次评估委员会会议定于5月14日举行，最终决定预计在7月23日左右做出。

Nick Burgin, president of global value and access at Eisai EMEA, said: 'We recognise that introducing a new class of medicine is not always straightforward; substantial changes are needed to improve Alzheimer's disease management and lecanemab is just one part of the bigger picture.'

卫材欧洲、中东和非洲地区全球价值与准入总裁尼克·伯金表示：“我们认识到，引入一类新药并非总是那么简单；为了改善阿尔茨海默病的管理，需要进行实质性的改变，而lecanemab只是其中的一部分。”

Biogen's UK and Ireland managing director, Kylie Bromley, added: 'There is a critical need for innovative treatments to slow the progress of early Alzheimer's disease and preserve the identity and independence of those impacted for as long as possible. While the additional delay is disappointing news for this community, we are encouraged that the dialogue to secure reimbursement for lecanemab will continue.'.

渤健英国和爱尔兰董事总经理克ylie·布罗姆利补充说：「对于减缓早期阿尔茨海默病的进展，并尽可能长时间地保护受影响者身份和独立性，创新治疗手段有着迫切的需求。尽管额外的延迟对该群体来说是令人失望的消息，但我们感到鼓舞的是，确保lecanemab报销的对话将会继续。」

In the UK, Eisai and Biogen co-promote Leqembi, with Eisai distributing the product as the marketing authorisation holder (MAH).

在英国，卫材和渤健共同推广Leqembi，卫材作为上市许可持有人（MAH）负责分销该产品。

Eisai said recently that Leqembi sales were around $196 million in the first nine months of its current fiscal year and it expects to hit the full-year target of around $280 million for the drug.

卫材最近表示，Leqembi 在其当前财政年度的前九个月销售额约为 1.96 亿美元，预计该药物将实现全年约 2.8 亿美元的目标。