Suggested remit: To appraise the clinical and cost effectiveness of risankizumab within its marketing authorisation for treating moderately to severely active ulcerative colitis in people who have had an inadequate response, lost response, or were intolerant to conventional therapy, one or more biologic therapies, or a JAK inhibitor.
 
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 Cost Comparison Standard
ID number 6209

Project Team

Project lead Jeremy Powell

Email enquiries

External Assessment Group Bristol Technology Assessment Group, University of Bristol

Stakeholders

Companies sponsors AbbVie (risankizumab)
Others Department of Health and Social Care
  NHS England
Patient carer groups Crohn’s and Colitis UK
Professional groups Royal College of Physicians
  UK Clinical Pharmacy Association
Associated guideline groups NICE - National Guideline Centre
Comparator companies Abbvie (adalimumab, upadacitinib) (CAU signed- participating)
  Amgen (adalimumab) (CAU not signed- not participating)
  Biogen Idec (adalimumab, infliximab) (CAU not signed- not participating)
  Bristol-Myers Squibb Pharmaceuticals (ozanimod) (CAU not signed- not participating)
  Celltrion Healthcare UK (adalimumab, infliximab) (CAU not signed- not participating)
  Eli Lilly and Company (mirikizumab) (CAU not signed- not participating)
  Frezenius Kabi (adalimumab) (CAU not signed- not participating)
  Galapagos Biotech (filgotinib) (CAU not signed- not participating)
  Janssen-Cilag (ustekinumab) (CAU signed- participating)
  Merck, Sharp and Dohme, UK (golimumab, infliximab) (CAU not signed- not participating)
  Pfizer (infliximab, tofacitinib, etrasimod) (CAU not signed- not participating)
  Sandoz (adalimumab, infliximab) (CAU not signed- not participating)
  Takeda UK (vedolizumab) (CAU signed- participating)
Evidence review group National Institute for Health Research Health Technology Assessment Programme (NETSCC)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
05 September 2023 Invitation to participate
07 June 2023 - 05 July 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6209
14 February 2023 In progress. DHSC referral received
18 November 2022 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