Suggested remit: To appraise the clinical and cost effectiveness of lecanemab 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 4043

Provisional Schedule

Expected publication 05 February 2025

Project Team

Project lead Louise Jafferally

Email enquiries

External Assessment Group Kleijnen Systematic Reviews Ltd

Stakeholders

Companies sponsors Eisai, Biogen (lecanemab)
Others Department of Health and Social Care
  NHS England
  UCL Dementia Research Centre
  Welsh Government
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
Associated public health groups None
Comparator companies 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)
  Eisai (donepezil) (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)
  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 Health Specialised Services Committee
Relevant research groups Cambridge Public Health
  LifeArc
  Research Institute of the Care of Older People

Timeline

Key events during the development of the guidance:

Date Update
06 November 2024 Committee meeting: 2
06 November 2024 Declaration of interests
22 August 2024 - 20 September 2024 Draft guidance
09 May 2024 Committee meeting: 1 (private meeting)
30 April 2024 Following the update about licensing on 10 April, 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.
10 April 2024 The appraisal committee meeting for ID4043 lecanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease, will go ahead on 9 May 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 9 May. 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 lecanemab data in public or release any recommendations that pre-empt the MHRA decision.
28 September 2023 Invitation to participate
11 August 2023 Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late September 2023. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
21 March 2023 - 20 April 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 4043
21 March 2023 In progress. Scoping commencing
01 February 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
06 December 2022 As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of lecanemab for treating early Alzheimer's disease. 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 August 2023.

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