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 09 April 2025
Expected publication 25 June 2025

Project Team

Project lead Louise Jafferally

Email enquiries

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 None
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
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Nonr

Timeline

Key events during the development of the guidance:

Date Update
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