Suggested remit: To appraise the clinical and cost effectiveness of seladelpar within its marketing authorisation for previously treated primary biliary cholangitis.
 
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
Process STA Standard
ID number 6429

Provisional Schedule

Committee meeting: 1 02 July 2025
Expected publication 10 September 2025

Project Team

Project lead Vonda Murray

Email enquiries

External Assessment Group Peninsula Technology Assessment Group (PenTAG), University of Exeter

Stakeholders

Companies sponsors Gilead Sciences (seladelpar)
Others Department of Health and Social Care
  Health Technology Wales (HTW)
  NHS England
Patient carer groups Addenbrookes Liver Transplant Association
  Black Health Agency
  Bladder and Bowel Community
  British Liver Trust
  Gene People
  Genetic Alliance UK
  GUTS UK
  Haemochromatosis UK
  Liver4Life
  LiverNorth
  Metabolic Support UK
  PBC Foundation
  PSC Support
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Association of Coloproctology of Great Britain and Ireland
  Association of Surgeons of Great Britain and Ireland
  British Association for the Study of the Liver
  British Geriatrics Society
  British Hepatology Pharmacy Group
  British Society of Gastroenterology
  British Transplantation Society
  NHS Blood and Transplant
  Primary Care Society for Gastroenterology
  Royal College of Anaesthetists
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Surgeons
  Royal Pharmaceutical Society
  Royal Society of Medicine
  UK Clinical Pharmacy Association
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies ADVANZ Pharma (ursodeoxycholic acid, obeticholic acid)
  Dr. Falk Pharma UK (ursodeoxycholic acid)
  Galen (ursodeoxycholic acid)
  Glenmark Pharmaceuticals Europe (ursodeoxycholic acid)
  Ipsen (elafibranor)
  Strides Pharma UK (ursodeoxycholic acid)
  Wockhardt UK (ursodeoxycholic acid)
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
  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
  Scottish Society of Gastroenterology
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Cochrane Hepato-Biliary Group
  Genomics England
  Foundation for Liver Research
  MRC Clinical Trials Unit
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
19 November 2024 Invitation to participate
03 September 2024 - 01 October 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6429
03 September 2024 In progress. Scoping commencing
22 April 2024 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

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