Suggested remit: To appraise the clinical and cost effectiveness of remibrutinib within its marketing authorisation for treating chronic spontaneous urticaria that is inadequately controlled by H1-antihistamines.
- 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:
- 6356
Project Team
- Project lead
- Jeremy Powell
Email enquiries
If you have any queries please email TACommB@nice.org.uk
Stakeholders
- Companies sponsors
- Novartis Pharmaceuticals (remibrutinib)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Allergy UK
- South Asian Health Foundation
- Specialised Healthcare Alliance
- Professional groups
- British Association of Dermatologists
- British Dermatological Nursing Group
- British Geriatrics Society
- British Skin Foundation
- British Society for Allergy & Clinical Immunology
- British Society for Cutaneous Allergy
- British Society for Immunology
- Primary Care Dermatology Society
- Royal College of General Practitioners
- Royal College of Nursing
- Royal College of Pathologists
- Royal College of Physicians
- Royal Pharmaceutical Society
- Royal Society of Medicine
- UK Clinical Pharmacy Association
- Associated public health groups
- Public Health Wales
- UK Health Security Agency
- Comparator companies
- Celltrion Healthcare UK (omalizumab)
- Cipla EU (cetirizine hydrochloride, fexofenadine hydrochloride, methotrexate)
- Chiesi (tacrolimus)
- Dexcel Pharma (ciclosporin)
- Dr Reddy’s Laboratories (cetirizine hydrochloride, fexofenadine hydrochloride, montelukast)
- Flamingo Pharma UK (cetirizine hydrochloride, loratadine)
- Haleon UK trading (cetirizine hydrochloride, fexofenadine hydrochloride)
- Hospira (methotrexate)
- Glenmark Pharmaceuticals (desloratadine, levocetirizine dihydrochloride, montelukast)
- Krka (desloratadine, montelukast)
- Leo Laboratories (tacrolimus)
- McNeil products (acrivastine, cetirizine hydrochloride)
- Medac Pharma (methotrexate)
- Medley Pharma (cimetidine)
- Morningside Healthcare (methotrexate)
- Mylan (ciclosporin, desloratadine, nizatidine)
- Nordic Pharma (methotrexate)
- Novartis Pharmaceuticals (ciclosporin, omalizumab)
- Novumgen (levocetirizine dihydrochloride)
- Opella Healthcare (fexofenadine hydrochloride)
- Organon Pharma (desloratadine, montelukast)
- Orion Pharma (methotrexate)
- Pinewood Healthcare (cetirizine hydrochloride, loratadine)
- Ranbaxy (UK) a Sun Pharmaceutical Company (ciclosporin, loratadine, montelukast)
- Reckitt Benckiser Healthcare (ranitidine)
- Rivopharm (desloratadine, montelukast)
- Roche Products (mycophenolate mofetil)
- Rosemont Pharmaceuticals (cimetidine, methotrexate, mycophenolate mofetil)
- Sandoz (methotrexate, montelukast, tacrolimus)
- Santen (ciclosporin)
- Sigma Pharmaceuticals PLC (cetirizine hydrochloride)
- Teva Pharma B.V. (mycophenolate mofetil)
- Tillomed Laboratories (mycophenolate mofetil)
- UCB pharma (cetirizine hydrochloride, levocetirizine dihydrochloride)
- Wockhardt (cetirizine hydrochloride)
- Zentiva (fexofenadine hydrochloride)
- 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 Group
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- British Skin Foundation
- Cochrane Skin Group
- Genomics England
- MRC Clinical Trials Unit
- National Institute for Health Research
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 02 October 2025 | Invitation to participate |
| 07 July 2025 - 04 August 2025 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6356 |
| 07 July 2025 | In progress. Scoping commenced. |
| 13 September 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