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 TACommC@nice.org.uk
Stakeholders
- Companies sponsors
- Otsuka Pharmaceuticals (donidalorsen)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- HAE UK
- Professional groups
- BSI Clinical Immunology Professional Network (BSI-CIPN)
- Royal College of Pathologists
- Royal College of Physicians
- Associated public health groups
- None
- Comparator companies
- BioCryst Pharmaceuticals (berotralstat) (confidentiality agreement signed, participating)
- Takeda (cinryze, lanadelumab) (confidentiality agreement signed, participating)
- CSL Behring (berinert, garadacimab) (confidentiality agreement not signed, not participating)
- Pharming Group N.V (ruconest) (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
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- None
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