Suggested remit: To appraise the clinical and cost effectiveness of donidalorsen within its marketing authorisation for preventing hereditary angioedema attacks.
- 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:
- 6457
Provisional Schedule
- Committee meeting: 1:
- 08 April 2026
- Expected publication:
- 18 June 2026
Project Team
- Project lead
- Leena Issa
Email enquiries
If you have any queries please email [email protected]
Stakeholders
- Companies sponsors
- Otsuka Pharmaceuticals (donidalorsen)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Allergy UK
- Anaphylaxis Campaign
- Asthma and Lung UK
- Genetic Alliance UK
- HAE UK
- Immunodeficiency UK
- NARA- The Breathing Charity
- South Asian Health Foundation
- Specialised Healthcare Alliance
- UK Primary Immune-deficiency Patient Support Charity (UKPIPS)
- Professional groups
- • Association for Respiratory Technology and Physiology
- • Association of Genetic Nurses & Counsellors
- Association of Paediatric Emergency Medicine
- British Geriatrics Society
- British Paediatric Allergy, Immunity and Infection Group (BPAIIG)
- British Paediatric Respiratory Society
- British Skin Foundation
- British Society for Allergy & Clinical Immunology
- British Society for Genetic Medicine
- British Society for Haematology
- British Society for Immunology
- British Thoracic Society
- BSI Clinical Immunology Professional Network (BSI-CIPN)
- ILD-IN: Interstitial Lung Diseases Interdisciplinary Network
- Immunology and Allergy Nurses Group
- National Heart and Lung Institute
- Neonatal and Paediatric Pharmacists Group
- Primary Care Respiratory Society UK
- Royal College of General Practitioners
- Royal College of Nursing
- Royal College of Paediatrics & Child Health
- Royal College of Pathologists
- Royal College of Physicians
- Royal Pharmaceutical Society
- Royal Society of Medicine
- Royal Society of Medicine - Allergy and Immunology Section
- UK Clinical Pharmacy Association
- UK Forum on Haemoglobin Disorders
- Associated public health groups
- Public Health Wales
- UK Health Security Agency
- Comparator companies
- BioCryst Pharmaceuticals (berotralstat)
- CSL Behring (berinert, garadacimab)
- Pharming Group N.V (ruconest)
- Takeda (cinryze, lanadelumab)
- 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
- Hospital Information Services – Jehovah’s Witnesses
- Medicines and Healthcare products Regulatory Agency
- National Association of Primary Care
- National Pharmacy Association
- NHS Confederation
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- Asthma, Allergy and Inflammation Research Trust
- British Association for Lung Research
- Cochrane Airways Group
- David Hide Asthma and Allergy Research Centre
- Genomics England
- MRC Clinical Trials Unit
- National Institute for Health Research
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 28 August 2025 | Invitation to participate |
| 30 April 2025 - 30 May 2025 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6457 |
| 30 April 2025 | In progress. Scoping commenced. |
| 12 December 2024 | Referral |
| 08 July 2024 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
| 08 July 2024 | Topic selection |
For further information on our processes and methods, please see our CHTE processes and methods manual