Suggested remit: To appraise the clinical and cost effectiveness of donanemab within its marketing authorisation for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease.

Status:
In progress
Technology type:
Medicine
Decision:
Selected
Reason for decision:
Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process:
STA Standard
ID number:
6222

Project Team

Project lead
Kate Moore

Email enquiries

If you have any queries please email TACommD@nice.org.uk


External Assessment Group:
Southampton Health Technology Assessment Centre (SHTAC), University of Southampton

Stakeholders

Companies sponsors
Eli Lilly and Company (donanemab)
Others
Department of Health and Social Care
 
NHS England
 
UCL Dementia Research Centre
Patient carer groups
Alzheimer’s Research UK
 
Alzheimer's Society
 
Dementia UK
Professional groups
Association of British Neurologists
 
British Nuclear Medicine Society
 
College of Mental Health Pharmacy
 
Faculty of Public Health
 
Royal College of Physicians
 
Royal College of Psychiatrists
 
Royal College of Radiologists
 
UK Clinical Pharmacy Association
Associated public health groups
None
Comparator companies
Eisai (donepezil) (confidentiality agreement signed, participating)
 
Accord Healthcare (donepezil, memantine) (confidentiality agreement not signed, not participating)
 
Accord-UK (donepezil, galantamine, memantine) (confidentiality agreement not signed, not participating)
 
Aspire Pharma (galantamine) (confidentiality agreement not signed, not participating)
 
Aurobindo Pharma – Milpharm (donepezil, galantamine) (confidentiality agreement not signed, not participating)
 
Cipla (donepezil) (confidentiality agreement not signed, not participating)
 
Dr Reddy’s Laboratories (galantamine, memantine, rivastigmine) (confidentiality agreement not signed, not participating)
 
Fontus Health (galantamine) (confidentiality agreement not signed, not participating)
 
Genus Pharmaceuticals (memantine) (confidentiality agreement not signed, not participating)
 
Glenmark Pharmaceuticals (memantine) (confidentiality agreement not signed, not participating)
 
Kent Pharma (rivastigmine) (confidentiality agreement not signed, not participating)
 
Krka UK (memantine, rivastigmine) (confidentiality agreement not signed, not participating)
 
Lundbeck (memantine) (confidentiality agreement not signed, not participating)
 
Lupin Healthcare (memantine) (confidentiality agreement not signed, not participating)
 
Mylan (donepezil, memantine, rivastigmine) (confidentiality agreement not signed, not participating)
 
Novartis Pharmaceuticals (rivastigmine) (confidentiality agreement not signed, not participating)
 
Ranbaxy, a Sun Pharmaceutical Company (donepezil) (confidentiality agreement not signed, not participating)
 
Rosemont Pharmaceuticals (donepezil, memantine, rivastigmine) (confidentiality agreement not signed, not participating)
 
Sandoz (galantamine, rivastigmine) (confidentiality agreement not signed, not participating)
 
Takeda (galantamine) (confidentiality agreement not signed, not participating)
 
Thame Laboratories (galantamine) (confidentiality agreement not signed, not participating)
 
Zentiva (memantine, galantamine) (confidentiality agreement not signed, not participating
General commentators
All Wales Therapeutics and Toxicology Centre
 
British National Formulary
 
Department of Health, Social Services and Public Safety for Northern Ireland
 
Healthcare Improvement Scotland
 
Medicines and Healthcare products Regulatory Agency
 
NHS Wales Joint Commissioning Committee
 
Scottish Medicines Consortium
 
Welsh Government
Relevant research groups
Cambridge Public Health
 
National Institute for Health Research
 
Research Institute for the Care of Older People

Timeline

Key events during the development of the guidance:

Date Update
20 March 2026 Appeal decision
15 October 2025 Appeal
01 October 2025 Note - Note added to the project documents
19 June 2025 - 03 July 2025 Final draft guidance
14 May 2025 Committee meeting: 3
06 March 2025 - 27 March 2025 Draft guidance: 2
06 March 2025 Note added to the project documents
15 January 2025 Committee meeting: 2
15 January 2025 Declaration of interests
23 October 2024 - 20 November 2024 Draft guidance
10 July 2024 Note added to the project documents
03 July 2024 Committee meeting: 1 (private meeting)
11 June 2024 Note - Note added to the project documents
21 November 2023 Invitation to participate
07 August 2023 Note - Note added to the project documents
01 June 2023 - 29 June 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6222
31 March 2023 In progress. DHSC referral received
12 December 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

For further information on our processes and methods, please see our CHTE processes and methods manual