Remibrutinib for treating chronic spontaneous urticaria inadequately controlled by H1-antihistamines [ID6356]

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

Provisional Schedule

Committee meeting: 1:

13 August 2026

Expected publication:

22 October 2026

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

Professional groups

British Association of Dermatology

 

Clinical Immunology Professional Network

Comparator companies

A Menarini Farmaceutica Internazionale SRL (bilastine) (not participating)

 

Advanz Pharma (methotrexate) (not participating)

 

Amarox (montelukast) (not participating)

 

Astellas Pharma (tacrolimus) (not participating)

 

Aurobindo Pharma – Milpharm (bilastine, cetirizine hydrochloride, montelukast) (not participating)

 

The Boots Company (cetirizine hydrochloride, fexofenadine hydrochloride, loratadine, ranitidine) (not participating)

 

Bristol laboratories (cetirizine hydrochloride) (not participating)

 

Brown and Burk (acrivastine, loratadine, levocetirizine dihydrochloride) (not participating)

 

Celltrion Healthcare UK (omalizumab) (not participating)

 

Cipla EU (cetirizine hydrochloride, fexofenadine hydrochloride, methotrexate) (not participating)

 

Chiesi (tacrolimus) (not participating)

 

Dexcel Pharma (ciclosporin) (not participating)

 

Dr Reddy’s Laboratories (cetirizine hydrochloride, fexofenadine hydrochloride, montelukast) (not participating)

 

Flamingo Pharma UK (cetirizine hydrochloride, loratadine) (not participating)

 

Haleon UK trading (cetirizine hydrochloride, fexofenadine hydrochloride) (not participating)

 

Hospira (methotrexate) (not participating)

 

Glenmark Pharmaceuticals (desloratadine, levocetirizine dihydrochloride, montelukast) (not participating)

 

Krka (desloratadine, montelukast) (not participating)

 

Leo Laboratories (tacrolimus) (not participating)

 

McNeil products (acrivastine, cetirizine hydrochloride) (not participating)

 

Medac Pharma (methotrexate) (not participating)

 

Medley Pharma (cimetidine) (not participating)

 

Morningside Healthcare (methotrexate) (not participating)

 

Mylan (ciclosporin, desloratadine, nizatidine) (not participating)

 

Nordic Pharma (methotrexate) (not participating)

 

Novartis Pharmaceuticals (ciclosporin, omalizumab) (not participating)

 

Novumgen (levocetirizine dihydrochloride) (not participating)

 

Opella Healthcare (fexofenadine hydrochloride) (not participating)

 

Organon Pharma (desloratadine, montelukast) (not participating)

 

Orion Pharma (methotrexate) (not participating)

 

Pinewood Healthcare (cetirizine hydrochloride, loratadine) (not participating)

 

Ranbaxy (UK) a Sun Pharmaceutical Company (ciclosporin, loratadine, montelukast) (not participating)

 

Reckitt Benckiser Healthcare (ranitidine) (not participating)

 

Rivopharm (desloratadine, montelukast) (not participating)

 

Roche Products (mycophenolate mofetil) (not participating)

 

Rosemont Pharmaceuticals (cimetidine, methotrexate, mycophenolate mofetil) (not participating)

 

Sandoz (methotrexate, montelukast, tacrolimus) (not participating)

 

Santen (ciclosporin) (not participating)

 

Sigma Pharmaceuticals PLC (cetirizine hydrochloride) (not participating)

 

Teva Pharma B.V. (mycophenolate mofetil) (not participating)

 

Tillomed Laboratories (mycophenolate mofetil) (not participating)

 

UCB pharma (cetirizine hydrochloride, levocetirizine dihydrochloride) (not participating)

 

Wockhardt (cetirizine hydrochloride) (not participating)

 

Zentiva (fexofenadine hydrochloride) (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 Group

 

Scottish Medicines Consortium

 

Welsh Government

Timeline

Key events during the development of the guidance:

For further information on our processes and methods, please see our CHTE processes and methods manual