Suggested remit: To appraise the clinical and cost effectiveness of tralokinumab within its marketing authorisation for treating moderate to severe atopic dermatitis.
 
Status Discontinued
Decision Selected
Process TA
ID number 3734

Project Team

Project lead Shonagh D'Sylva

Email enquiries

External Assessment Group BMJ Technology Assessment Group (BMJ-TAG), BMJ

Stakeholders

Companies sponsors Leo Pharma (tralokinumab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups National Eczema Society
Professional groups British Association of Dermatologists
  Royal College of Physicians
Associated public health groups None
Comparator companies GlaxoSmithKline (alitretion)
  Novartis Pharmaceuticals (ciclosporin, mycophenolate mofetil)
  Pfizer (methotrexate)
  Sanofi (dupilumab)
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 None

Timeline

Key events during the development of the guidance:

Date Update
05 August 2021 Due to significant capacity challenges NICE has paused the development of the Single Technology Appraisals for [ID3768] abrocitinib for treating moderate to severe atopic dermatitis in people aged 12 and over, [ID3733] Upadacitinib for treating moderate to severe atopic dermatitis in people aged 12 and over and [ID3734] Tralokinumab for treating moderate to severe atopic dermatitis. All 3 topics will be appraised together as a Multiple Technology Appraisal under [ID3960].
05 August 2021 Discontinued
04 August 2021 Schedule affected by COVID-19. We are continuing to face significant capacity challenges and will be delaying the development of tralokinumab for treating moderate to severe atopic dermatitis [ID3734]. This topic will now be considered as part of a multiple technology appraisal [ID3960]. We anticipate that it will be considered by the technology appraisal committee in March 2022.
09 February 2021 Invitation to participate
05 October 2020 The Department for Health and Social Care has asked NICE to conduct an appraisal of tralokinumab for treating moderate to severe atopic dermatitis. 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 early February 2021. 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 submission.
05 October 2020 In progress. Topic is in progress
22 July 2020 - 19 August 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