Lecanemab Licensed in Great Britain but NICE Says No to NHS Funding

The split outcome illustrates the two separate tests a new medicine must pass in the UK: regulatory approval on safety, quality and efficacy, and a health technology assessment of whether it represents value for money for the health service.

The terms of the licence

According to the MHRA's announcement, the authorisation was granted to Eisai and covers adults in the early stages of Alzheimer's disease who have one or no copies of the apolipoprotein E4 (ApoE4) gene. The Commission on Human Medicines advised that the benefit risk balance was not favourable in people with two copies, who faced a higher risk of amyloid related imaging abnormalities, and that ApoE4 testing should be carried out before treatment. Use is contraindicated in patients on anticoagulants or with cerebral amyloid angiopathy diagnosed on MRI.

Treatment is given by intravenous infusion every two weeks in a healthcare setting. Initiation will be through a central registration system under a controlled access programme, and a controlled post-authorisation safety study will follow its use in routine practice.

Why NICE did not recommend it

NICE said lecanemab slows progression from mild to moderate Alzheimer's disease by on average 4 to 6 months, but that the costs of fortnightly hospital infusions, intensive monitoring for side effects and the drug itself mean it is not a cost effective use of limited NHS funding. It noted that the trial reported outcomes only after 18 months, leaving a lack of evidence on long-term effects. NICE estimated that around 70,000 adults in England would have been eligible.

What happens next

The public consultation on the draft guidance closes on 20 September 2024, and the NICE committee will consider responses at a second meeting later in the year before reaching final recommendations. For manufacturers of disease-modifying therapies in neurology, the lecanemab decisions show that a marketing authorisation does not guarantee NHS access, and that evidence on long-term outcomes and the cost of delivery will weigh heavily in any appraisal.

Sources

• GOV.UK (MHRA): Lecanemab licensed for adult patients in the early stages of Alzheimer's disease
• NICE: Benefits of new Alzheimer's treatment lecanemab are too small to justify the cost to the NHS