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.
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.
 
Status Suspended
Decision Selected
Process STA 2018
ID number 3763

Project Team

Project lead Louise Jafferally

Email enquiries

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
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