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
- Draft guidance:
- 30 July 2025 - 20 August 2025
- Committee meeting: 2:
- 10 September 2025
- Expected publication:
- 05 November 2025
- Expected publication:
- 05 November 2025
Project Team
- Project lead
- Kate Moore
Email enquiries
If you have any queries please email [email protected]
- 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
- British Liver Trust
- Gene People
- The PBC Foundation
- Professional groups
- British Association for the Study of the Liver
- British Hepatology Pharmacy Group
- Royal College of Physicians
- Associated public health groups
- None
- Comparator companies
- Ipsen (elafibranor) (confidentiality agreement signed, participating)
- ADVANZ Pharma (ursodeoxycholic acid, obeticholic acid) (confidentiality agreement not signed, not participating)
- Dr. Falk Pharma UK (ursodeoxycholic acid) (confidentiality agreement not signed, not participating)
- Galen (ursodeoxycholic acid) (confidentiality agreement not signed, not participating)
- Glenmark Pharmaceuticals Europe (ursodeoxycholic acid) (confidentiality agreement not signed, not participating)
- Strides Pharma UK (ursodeoxycholic acid) (confidentiality agreement not signed, not participating)
- Wockhardt UK (ursodeoxycholic acid) (confidentiality agreement not signed, not participating)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health - Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Scottish Society of Gastroenterology
- Welsh Government
- Relevant research groups
- None
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 09 July 2025 | Committee meeting: 1 |
| 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