Suggested remit: To appraise the clinical and cost effectiveness of Beremagene geperpavec within its marketing authorisation for treating skin wounds assocatied with dystrophic epidermolysis bullosa.
 
Status In progress
Technology type Medicine
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Further information The topic routing was re-considered by the Topic Selection Oversight Panel (TSOP) in September 2023. The panel concluded that the topic should remain routed to the Technology Appraisal (TA) work programme. Please see project documents for further details. The timelines for the evaluation are to be confirmed.
Process STA Standard
ID number 3959

Provisional Schedule

Committee meeting: 1 03 September 2025
Expected publication 29 January 2026

Project Team

Project lead Jeremy Powell

Email enquiries

External Assessment Group School of Health and Related Research (ScHARR), University of Sheffield

Stakeholders

Companies sponsors Krystal Biotech Inc (beremagene geperpavec)
Others Department of Health and Social Care
  NHS England
Patient carer groups Anthony Nolan
  Beacon
  Changing Faces
  Cure EB
  DEBRA UK
  Gene People
  Genetic Alliance UK
  Let’s Face It
  South Asian Health Foundation
  Specialised Healthcare Alliance
Professional groups Counsellors
  Association of Paediatric Emergency Medicines
  British Association of Dermatologists
  British Dermatological Nursing Group
  British Geriatrics Society
  British Society for Cutaneous Allergy
  British Society for Gene and Cell Therapy
  British Society for Genetic Medicine
  British Society for Paediatric and Adolescent Dermatology
  British Trauma Society
  National Diagnostic Epidermolysis Bullosa Laboratory
  Neonatal and Paediatric Pharmacists Group
  Primary Care Dermatology Society
  Royal College of Emergency Medicine
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Paediatrics & Child Health
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society of Tissue Viability
  St John's Institute of Dermatology
  Surgical Dressing Manufacturers Association
  UK Clinical Pharmacy Association
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Chiesi (Birch bark extract)
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Cell and Gene Therapy Catapult
  Department of Health- Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups University Hospitals Birmingham, Adult Epidermolysis Bullosa Service
  Birmingham Women’s and Children’s Hospital, Epidermolysis Bullosa Service
  British Skin Foundation
  Centre of Evidence-based Dermatology, University of Nottingham
  Cochrane Skin Group
  Dermatrust
  Genomics England
  Great Ormond Street Children’s Hospital, London, Dermatology
  Guy’s and St Thomas’ Hospital, London, Dermatology
  Health Services Research Unit, Department of Public Health, University of Oxford
  Skin Inflammation Genetics Group, King’s College London
  MRC Clinical Trials Unit
  National Institute for Health Research
  Wounds UK

Timeline

Key events during the development of the guidance:

Date Update
10 February 2025 Invitation to participate
02 December 2024 - 16 December 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
02 December 2024 In progress. We consulted on the draft scope for this appraisal in 2022. The appraisal was paused but is now restarting. To ensure that the scope is up to date we are now holding a short second consultation.
15 January 2024 The topic routing was re-considered by the Topic Selection Oversight Panel (TSOP) in September 2023. The panel concluded that the topic should remain routed to the Technology Appraisal (TA) work programme. Please see project documents for further details. The timelines for the evaluation are to be confirmed.
11 January 2024 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
11 January 2024 Topic selection
28 July 2023 Following a routing challenge raised by the company, regarding the Topic Selection Oversight Panel (TSOP) decision to route Beremagene Geperpavec as a Technology Appraisal, the start of this evaluation is delayed. The timelines for the evaluation will be confirmed once TSOP have reviewed the challenge.
14 June 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
14 June 2023 Topic selection
14 June 2023 Topic selection. Routing update
19 January 2023 (14:00) Scoping workshop
09 November 2022 - 07 December 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
20 May 2022 In progress. Scoping commencing

For further information on our processes and methods, please see our CHTE processes and methods manual