Suggested remit: To appraise the clinical and cost effectiveness of norucholic acid within its marketing authorisation for treating primary sclerosing cholangitis.
- Status:
- Awaiting development
- 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:
- 6583
Provisional Schedule
- Committee meeting:
- 12 January 2027
- Expected publication:
- 29 April 2027
Project Team
- Project lead
- Emily Richards
Email enquiries
If you have any queries please email scopingta@nice.org.uk
Stakeholders
- Companies sponsors
- Dr Falk Pharma (norucholic acid)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Addenbrookes Liver Transplant Association
- Black Health Agency
- Bladder and Bowel Community
- Bowel Cancer UK
- British Liver Trust
- Colostomy UK
- Gene People
- Genetic Alliance UK
- GUTS UK
- IA: Ileostomy and Internal Pouch Group
- IBDrelief
- Liver4Life
- LIVErNORTH
- PSC Support
- South Asian Health Foundation
- Specialised Healthcare Alliance
- Professional groups
- Association of Coloproctology for Great Britain and Ireland
- Association of Surgeons of Great
- Britain and Ireland
- British Association for the Study of the Liver
- British Geriatrics Society
- British Liver Nurses Association
- 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
- UK-PSC
- Associated public health groups
- Public Health Wales
- UK Health Security Agency
- Comparator companies
- Dr Falk Pharma (ursodeoxycholic acid)
- Glenmark Pharmaceuticals (ursodeoxycholic acid)
- Grindecks Kalecks (ursodeoxycholic acid)
- Strides Pharma (ursodeoxycholic acid)
- Wockhardt (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
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Scottish Society of Gastroenterology
- Welsh Government
- Relevant research groups
- Cochrane Hepato-Biliary Group
- Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group
- Cochrane UK
- Foundation for Liver Research
- Genomics England
- MRC Clinical Trials Unit
- National Institute for Health Research
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 19 June 2026 | Awaiting development. Following on from advice received from the company, timelines for this appraisal are to be confirmed whilst the company confirm their regulatory filing plans. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes. |
| 08 June 2026 | Invitation to participate |
| 09 March 2026 - 08 April 2026 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
| 09 March 2026 | In progress. Scoping commenced. |
| 02 October 2025 | Note added to the project documents |
| 15 May 2025 | 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