How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

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

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

Draft guidance consultation

Open for comments Open until   Request commenting lead permission

We have updated this service so that members of the same organisation can now collaborate on a joint online response.

Read our blog to learn more.

1 Recommendations

1.1

Lecanemab is not recommended, within its marketing authorisation, for treating mild cognitive impairment and mild dementia caused by Alzheimer's disease in adults who are heterozygous for apolipoprotein E4 or do not have the gene.

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.

What this means in practice

Lecanemab is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because the available evidence does not suggest that lecanemab is value for money in this population.

Why the committee made these recommendations

Usual treatment for mild cognitive impairment caused by Alzheimer's disease is best supportive care. For mild dementia caused by Alzheimer's disease, it includes an acetylcholinesterase inhibitor (donepezil hydrochloride, galantamine or rivastigmine). Lecanemab could be used at the same time as the usual 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 this is at a slower rate than in people having placebo (both added to usual treatment). There is a lack of evidence on the long-term effects.

There is a high level of uncertainty in the economic model. Also, the most plausible cost-effectiveness estimate for lecanemab is much higher than what NICE considers an acceptable use of NHS resources. 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 not cost effective and because of uncertainties that would not be addressed in a period of managed access, it is not recommended with managed access.