Suggested remit: To appraise the clinical and cost effectiveness of aducanumab within its marketing authorisation for treating mild cognitive impairment (MCI) in early Alzheimer’s disease.
Following on from information provided to NICE by the company in December 2021, the appraisal of Aducanumab for treating mild cognitive impairment and mild dementia caused by Alzheimer's disease [ID3763] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
- Status:
- Discontinued
- Decision:
- Selected
- Process:
- TA
- ID number:
- 3763
Project Team
- Project lead
- Louise Jafferally
Email enquiries
If you have any queries please email TATeam4@nice.org.uk
- External Assessment Group:
- Warwick Evidence, Warwick Medical School, University of Warwick
Stakeholders
- Companies sponsors
- Biogen (aducanumab)
- Others
- Department of Health and Social Care
- NHS England
- Welsh Government
- Patient carer groups
- Alzheimer’s Research UK
- Alzheimer’s Society
- Professional groups
- Association of British Neurologists
- Royal College of Physicians
- Royal College of Psychiatrists
- UK Clinical Pharmacy Association
- Associated guideline groups
- National Guideline Alliance
- Associated public health groups
- None
- Comparator companies
- Eisai Ltd (donepezil) (confidentiality agreement signed, participating)
- Novartis Pharmaceuticals UK Ltd (rivastigmine) (confidentiality agreement signed, participating)
- Accord Healthcare Ltd (donepezil, memantine) (confidentiality agreement not signed, not participating)
- Accord-UK Ltd (donepezil, galantamine, memantine) (confidentiality agreement not signed, not participating)
- Aspire Pharma Ltd (galantamine) (confidentiality agreement not signed, not participating)
- Aurobindo Pharma – Milpharm Ltd (donepezil, galantamine) (confidentiality agreement not signed, not participating)
- Beacon Pharmaceuticals / Kent Pharma UK Ltd (rivastigmine) (confidentiality agreement not signed, not participating)
- Cipla EU Ltd (donepezil) (confidentiality agreement not signed, not participating)
- Dr Reddy’s Laboratories (UK) Ltd (galantamine, memantine, rivastigmine) (confidentiality agreement not signed, not participating)
- Fontus Health Ltd (galantamine) (confidentiality agreement not signed, not participating)
- Genus Pharmaceuticals (memantine) (confidentiality agreement not signed, not participating)
- Glenmark Pharmaceuticals Europe Ltd (memantine) (confidentiality agreement not signed, not participating)
- Healthcare Pharma Ltd (memantine) (confidentiality agreement not signed, not participating)
- Lundbeck Ltd (memantine) (confidentiality agreement not signed, not participating)
- Lupin Healthcare (UK) Ltd (memantine) (confidentiality agreement not signed, not participating)
- Mylan (donepezil, memantine, rivastigmine) (confidentiality agreement not signed, not participating)
- Ranbaxy (UK) Ltd a Sun Pharmaceutical Company (donepezil) (confidentiality agreement not signed, not participating)
- Rosemont Pharmaceuticals Ltd (donepezil, memantine, galantamine, rivastigmine) (confidentiality agreement not signed, not participating)
- Sandoz Ltd (galantamine, rivastigmine) (confidentiality agreement not signed, not participating)
- Takeda UK Ltd (galantamine) (confidentiality agreement not signed, not participating)
- Thame laboratories (galantamine) (confidentiality agreement not signed, not participating)
- Zentiva (galantamine) (confidentiality agreement not signed, not participating)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- Alzheimer’s Scotland
- 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
- None
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 18 July 2023 | Discontinued. Following on from information provided to NICE by the company in December 2021, the appraisal of Aducanumab for treating mild cognitive impairment and mild dementia caused by Alzheimer's disease [ID3763] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued. |
| 22 December 2021 | Suspended. On 16 December 2021, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for aducanumab (Aduhelm), a medicine intended for the treatment of Alzheimer’s disease. Consequently the first appraisal committee discussion of this topic has been cancelled and NICE has suspended the appraisal. |
| 08 July 2021 | Invitation to participate |
| 19 March 2021 | In progress. Topic is in progress |
| 16 November 2020 (14:00) | Scoping workshop |
| 22 September 2020 - 20 October 2020 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
For further information on our processes and methods, please see our CHTE processes and methods manual