To appraise the clinical and cost effectiveness of dupilumab within its marketing authorisation for treating severe asthma inadequately controlled with optimised standard therapy.
 
Status In progress
Process STA 2018
ID number 1213

Provisional Schedule

Committee meeting: 1 11 February 2020
Expected publication 06 May 2020

Project Team

Project lead Jeremy Powell

Email enquiries

Evidence Review Group / Assessment Group Southampton Health Technology Assessment Centre (SHTAC), University of Southampton

Consultees

Companies sponsors Sanofi (dupilumab)
Others Department of Health and Social Care
  NHS East Leicestershire and Rutland CCG
  NHS England
  NHS Newcastle Gateshead CCG
  Welsh Government
Patient carer groups Action Against Allergy
  Allergy UK
  Asthma Relief Charity
  Asthma Trust for Asthmatic Children
  Asthma UK
  British Lung Foundation
  Muslim Council of Britain
  NARA – The Breathing Charity
  South Asian Health Foundation
  Specialised Healthcare Alliance
Professional groups Association of Respiratory Nurse Specialists
  British Geriatrics Society
  British Paediatric Respiratory Society
  British Society for Allergy & Clinical Immunology
  British Thoracic Society
  Primary Care Respiratory Society UK
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  UK Clinical Pharmacy Association

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies AstraZeneca (benralizumab)
  GlaxoSmithKline (mepolizumab)
  Novartis (omalizumab)
  Teva (reslizumab)
General commentators Allied Health Professionals Federation
  All Wales Therapeutics and Toxicology Centre
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare Products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Asthma, Allergy and Inflammation Research Trust
  British Association for Lung Research
  Cochrane Airways Group
  MRC Clinical Trials Unit
  National Institute for Health Research
  National Society for Research into Allergy

Timeline

Key events during the development of the guidance:

Date Update
13 June 2019 Invitation to participate
08 October 2018 In progress, Sanofi agrees to commence the appraisal for dupilumab (Dupixent) in patients with moderate to severe asthma from age 12 years upwards (subject to regulatory approval from June 2019 and in accordance with the new NICE process). Sanofi accepts that the revised timelines were agreed at the request of Sanofi (the Manufacturer), and any impact upon the timing of the NICE appraisal of this indication is the responsibility of Sanofi. Dupilumab in asthma is currently under review by the European Medicines Agency (EMA) as a licence extension for dupilumab (Dupixent). The NHS will only be able to commit to funding this medicine for the treatment of patients with moderate to severe asthma once NICE has conducted a Technology Appraisal on this topic.
16 January 2018 (14:00) Scoping workshop (London)
22 November 2017 - 20 December 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance