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

Provisional Schedule

Committee meeting: 2 15 January 2025
Expected publication 26 March 2025

Project Team

Project lead Louise Jafferally

Email enquiries

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 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
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
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
23 October 2024 - 20 November 2024 Draft guidance
10 July 2024 Following the update about licensing on 11 June, the anticipated publication date for this appraisal has been changed to TBC and will be updated once there is more clarity about when the licence is expected.
03 July 2024 Committee meeting: 1 (private meeting)
11 June 2024 The appraisal committee meeting for donanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease, will go ahead on 3 July 2024 as previously advised. However, this will need to be a private meeting of the committee, without public observers. The reason the meeting needs to be in private is that we have received an update that the licence from the MHRA may not be granted by 3 July. NICE’s technology appraisal committees can only make recommendations on medicines licensed by the MHRA. So, it would not be appropriate for NICE to discuss the donanemab data in public or release any recommendations that pre-empt the MHRA decision.
21 November 2023 Invitation to participate
07 August 2023 Please note that at the request of the company, the timelines for this appraisal have been revised to allow them to develop a robust and comprehensive submission; the appraisal is now anticipated to begin in late November 2023.
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