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Draft guidance consultation

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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 apolipoprotein E4 heterozygotes or non-carriers.

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.

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). Donanemab could be used at the same time as current 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 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, including:

  • the treatment-effect estimates

  • what proportion of people starting donanemab would have mild cognitive impairment or mild dementia caused by Alzheimer's disease

  • the risk of death associated with Alzheimer's disease

  • how long the effects of donanemab last after stopping treatment

  • the health-related quality of life of people with mild cognitive impairment or mild dementia caused by Alzheimer's disease, and their carers

  • the infusion costs for donanemab.

The cost-effectiveness estimates for donanemab are also uncertain, but they are much higher than what NICE considers an acceptable use of NHS resources. Donanemab is not good value for the NHS because the benefit it provides for people with Alzheimer's disease is relatively small but the cost is high for providing it (including monthly infusions in hospital and intensive monitoring for side effects). So, donanemab is not recommended for routine use.

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

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