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Draft guidance consultation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 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 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. Treatments for mild dementia caused by Alzheimer's disease include an acetylcholinesterase inhibitor (donepezil hydrochloride, galantamine or rivastigmine). Donanemab would be used at the same time as current treatments at these stages of Alzheimer's disease.

Evidence from clinical trials suggests that cognitive function continues to worsen over time with donanemab added to current treatment, but at a slower rate than with placebo. But there is not enough evidence on the long-term effects of donanemab.

There are substantial uncertainties in the economic model, including:

  • the treatment-effect estimates

  • the mortality risk associated with Alzheimer's disease

  • how long the effects of donanemab last after stopping treatment

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

  • the infusion costs for donanemab.

Because of the uncertainties, it is not clear what the most likely cost-effectiveness estimate is for donanemab. But it is likely to be above what NICE normally considers an acceptable use of NHS resources. So, donanemab is not recommended for routine use.

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