Suggested remit: To appraise the clinical and cost effectiveness of garadacimab within its marketing authorisation for preventing acute attacks of hereditary angioedema.
- Status:
- In progress
- Technology type:
- Medicine
- Decision:
- Awaiting decision
- Process:
- STA Standard
- ID number:
- 6394
Provisional Schedule
- Committee meeting: 2:
- 12 August 2025
- Expected publication:
- 23 October 2025
Project Team
- Project lead
- Leena Issa
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Peninsula Technology Assessment Group (PenTAG), University of Exeter
Stakeholders
- Companies sponsors
- CSL Behring (garadacimab)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- HAE UK
- Professional groups
- British Society for Immunology
- Royal College of Pathologists
- Royal College of Physicians
- Immunology and Allergy Nurses Group
- Associated public health groups
- None
- Comparator companies
- BioCryst Pharmaceuticals (berotralstat) (confidentiality agreement signed, participating)
- CSL Behring (Berinert) (confidentiality agreement signed, participating)
- Takeda (Cinryze, lanadelumab) (confidentiality agreement signed, participating)
- Maxwellia (tranexamic acid) (confidentiality agreement not signed, not participating)
- Mylan (tranexamic acid) (confidentiality agreement not signed, not participating)
- Pharming Group N.V (Ruconest) (confidentiality agreement not signed, not participating)
- Rivopharm (tranexamic acid) (confidentiality agreement not signed, not participating)
- Sovereign Medical (tranexamic acid) (confidentiality agreement not signed, not participating)
- Tillomed Laboratories (tranexamic acid) (confidentiality agreement not signed, not participating)
- 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
- 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 |
|---|---|
| 02 July 2025 - 23 July 2025 | Draft guidance: 1 |
| 11 June 2025 | Committee meeting |
| 05 March 2025 | After receiving the external assessment report, NICE has assessed the evidence submissions and report to decide how this appraisal will progress. This appraisal will continue as a single technology appraisal and progress to technical engagement before preparation for the committee meeting in June 2025. |
| 05 September 2024 | Invitation to participate |
| 28 June 2024 - 26 July 2024 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6394 |
| 28 June 2024 | In progress. Scoping commencing |
| 14 November 2023 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
| 09 November 2023 | Topic selection |
For further information on our processes and methods, please see our CHTE processes and methods manual