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

Committee meeting 09 May 2025
Expected publication 30 July 2025

Project Team

Project lead Vonda Murray

Email enquiries

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
  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