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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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Draft guidance consultation

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1 Recommendations

1.1

Lecanemab is not recommended, within its marketing authorisation, for treating mild cognitive impairment and mild dementia due to Alzheimer's disease in adults who are apolipoprotein (APO) E4 heterozygotes or non-carriers.

1.2

This recommendation is not intended to affect treatment with lecanemab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

Why the committee made these recommendations

Current treatment for mild cognitive impairment caused by Alzheimer's disease is best supportive care, and for mild dementia caused by Alzheimer's disease includes an acetylcholinesterase inhibitor (donepezil hydrochloride, galantamine or rivastigmine). Lecanemab could be used at the same time as current treatments at these stages of Alzheimer's disease.

Evidence from a clinical trial suggests that people having lecanemab continue to have worsening cognitive function over time, but at a slower rate than people on placebo (both added to current treatment). There is a lack of evidence on the long-term effects.

There are substantial uncertainties in the economic model, such as:

  • how changes in a person's condition are modelled over time, including when they stop treatment

  • the infusion costs for lecanemab.

Although there are uncertainties with the cost effectiveness estimates, all of the cost-effectiveness results seen by the committee are considerably above what NICE considers an acceptable use of NHS resources. So, lecanemab cannot be recommended for routine use.

NICE has asked the company and NHS England to provide some additional information to address the uncertainties. The committee will consider this information and other stakeholder comments at a second meeting.