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  • Question on Consultation

    a. Has all of the relevant evidence been taken into account?

  • Question on Consultation

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

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

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    d. 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?

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1 Recommendations

1.1

Donanemab is not recommended, within its marketing authorisation, for treating mild cognitive impairment or 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 donanemab 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

Donanemab 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 donanemab 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). Donanemab could be used at the same time as usual treatments at these stages of Alzheimer's disease.

Evidence from clinical trials suggests that people having donanemab 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 also some evidence that the effects of donanemab continue after treatment is stopped.

There is a high level of uncertainty in the economic model. But the most plausible cost-effectiveness estimate for donanemab is much higher than what NICE considers an acceptable use of NHS resources. Donanemab 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 monthly infusions in hospital and intensive monitoring for side effects). So, donanemab is not recommended for routine use.

Because donanemab is not cost effective and the uncertainties would not be addressed in a period of managed access, it is not recommended with managed access.