following a full submission:
donanemab (Kisunla®) is not recommended for use within NHSScotland.
Indication under review: for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
In a randomised, double-blind, phase III study, donanemab reduced cognitive and functional decline associated with early Alzheimer’s disease compared with placebo at 76 weeks.
The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
The submitting company has indicated their intention to make a resubmission.
Medicine details
- Medicine name:
- donanemab (Kisunla)
- SMC ID:
- SMC2687
- Indication:
for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (APOE4) heterozygotes on non-carriers.
- Pharmaceutical company
- Eli Lilly and Company Ltd
- BNF chapter
- Central nervous system
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 12 May 2025