Suggested remit: To appraise the clinical and cost effectiveness of guselkumab within its marketing authorisation for treating moderately to severely active ulcerative colitis.
- 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:
- 6237
Provisional Schedule
- Expected publication:
- 28 August 2025
Project Team
- Project lead
- Thomas Feist
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Liverpool Reviews and Implementation Group, University of Liverpool
Stakeholders
- Companies sponsors
- J&J Innovative Medicine (guselkumab)
- Others
- Department of Health and Social Care
- Health Technology Wales (HTW)
- NHS England
- Patient carer groups
- Crohn’s and Colitis UK
- Professional groups
- Royal College of Physicians
- UK Clinical Pharmacy Association
- Associated public health groups
- None
- Comparator companies
- AbbVie (adalimumab, risankizumab, upadacitinib)Confidentiality agreement signed, participating
- Alfasigma UK formerly Galapagos Biotech (filgotinib) Confidentiality agreement not signed, not participating
- Amgen (adalimumab, ustekinumab) Confidentiality agreement not signed, not participating
- Biogen Biosimilars (adalimumab, infliximab) Confidentiality agreement not signed, not participating
- Bristol-Myers Squibb Pharmaceuticals
- (ozanimod) Confidentiality agreement not signed, not participating
- Celltrion Healthcare UK (adalimumab, infliximab, ustekinumab) Confidentiality agreement not signed, not participating
- Eli Lilly (mirikizumab) Confidentiality agreement not signed, not participating
- Frezenius, Kabi (adalimumab) Confidentiality agreement not signed, not participating
- Genus Pharmaceuticals (ustekinumab) Confidentiality agreement not signed, not participating
- Janssen-Cilag (golimumab, infliximab, ustekinumab) Confidentiality agreement not signed, not participating
- Pfizer (etrasimod, infliximab, tofacitinib) Confidentiality agreement not signed, not participating
- Samsung Bioepis UK (ustekinumab) Confidentiality agreement not signed, not participating
- Sandoz (adalimumab, infliximab) Confidentiality agreement not signed, not participating
- Takeda UK (vedolizumab) 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
- Welsh Government
- Relevant research groups
- None
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 15 January 2025 | Invitation to participate |
| 06 September 2024 | Following completion of the scoping process and the NICE Medicines Optimisation Team briefing, it has been confirmed that this appraisal will be routed to the cost comparison process. Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during mid-January 2025 when we will write to you about how you can get involved. |
| 07 May 2024 - 05 June 2024 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6237 |
| 07 May 2024 | In progress. Scoping commenced. |
| 18 January 2023 | 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