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

Project Team

Project lead Shonagh D'Sylva

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 England
  Welsh Government
Patient carer groups Asthma UK
Professional groups Association of Respiratory Nurse Specialists
  British Thoracic Society
  Royal College of Physicians

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies AstraZeneca (benralizumab)
  GlaxoSmithKline (mepolizumab)
  Novartis (omalizumab)
  Teva (reslizumab) (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

Timeline

Key events during the development of the guidance:

Date Update
07 May 2021 - 28 May 2021 Appraisal consultation: 2
21 April 2021 Following discussions with the company, NICE is unpausing this topic. We will be releasing an appraisal consultation document (ACD) that will provide the detail of the appraisal committee discussion and preliminary recommendation and anticipate publishing this document on the NICE website week commencing 11 May 2021. We are seeking to schedule this appraisal back to committee following this consultation and will update stakeholders of that date in due course.
12 November 2020 Committee meeting: 2
09 July 2020 In progress. In progress
09 July 2020 Dupilumab for treating severe asthma has now been rescheduled into the work programme. The second committee discussion of dupilumab for treating severe asthma will take place on committee on Thursday 12 November 2020. The topic webpage will be updated with the new timelines and expected publication date in due course. The new timelines are subject to staff capacity and the ongoing management of the COVID-19 situation and we will continue to review our plans and update our stakeholders accordingly.
05 May 2020 Schedule affected by COVID-19. Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
09 March 2020 - 30 April 2020 Appraisal consultation: 1
02 April 2020 Topic update: this appraisal has not been defined as therapeutically critical (please follow the link titled rapid guidelines and evidence summaries within the yellow banner at the top of the page for information on recent changes to the way we work). The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide updates as and when this information becomes clear.
11 February 2020 Committee meeting: 1
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