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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Draft guidance consultation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 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 having placebo (both added to current treatment). There is a lack of evidence on the long-term effects.

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

  • how changes in a person's condition are modelled over time

  • the infusion costs for lecanemab.

The cost-effectiveness estimates for lecanemab are also uncertain, but they are all much higher than what NICE considers an acceptable use of NHS resources. Lecanemab is not good value for the NHS. This is because the benefit it provides is relatively small, but the cost for providing it is high (including fortnightly infusions in hospital and intensive monitoring for side effects). So, lecanemab is not recommended for routine use.

Because lecanemab is unlikely to be cost effective and because of significant uncertainties that would not be addressed in a period of managed access, it is not recommended with managed access.

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