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 Action for Children
  Allergy UK
  Anaphylaxis UK
  Asthma and Lung UK
  Genetic Alliance UK
  HAE UK
  Immunodeficiency UK
  Jnetics
  NARA - The Breathing Charity
  National Children’s Bureau
  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 Gene and Cell Therapy
  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)
  Maxwellia (tranexamic acid)
  Mylan (tranexamic acid)
  Pharming Group N.V (Ruconest)
  Rivopharm (tranexamic acid)
  Sovereign Medical (tranexamic acid)
  Takeda (Cinryze, lanadelumab)
  Tillomed Laboratories (tranexamic acid)
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
  Cell and Gene Therapy Catapult
  Department of Health, Social Services and Public Safety for 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 Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Asthma, Allergy and Inflammation Research Trust
  British Association for Lung Research
  Cochrane Airways Group
  Cochrane UK
  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
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