Suggested remit: To appraise the clinical and cost effectiveness of omaveloxolone within its marketing authorisation for treating Friedreich’s ataxia in people 16 years and over.
 
Status In progress
Technology type Medicine
Decision Awaiting decision
Process STA Standard
ID number 6423

Provisional Schedule

Committee meeting: 1 04 June 2025
Expected publication 13 August 2025

Project Team

Project lead Jeremy Powell

Email enquiries

External Assessment Group Peninsula Technology Assessment Group (PenTAG), University of Exeter

Stakeholders

Companies sponsors Biogen (omaveloxolone)
Others Department of Health and Social Care
  NHS England
  NHS Genomic Network of Excellence
  NHS Genomic Medicine Service
Patient carer groups Ataxia UK
  Beacon
  Brain and Spine Foundation
  Brain Charity
  Cardiomyopathy UK
  Diabetes UK
  Gene People
  Genetic Alliance UK
  Neurological Alliance
  Scoliosis Support & Research
  South Asian Health Foundation
  Specialised Healthcare Alliance
Professional groups Association of British Neurologists
  British Association of Neuroscience Nurses
  British Geriatrics Society
  British Neuropathological Society
  British Society for Blood and Marrow Transplantation
  British Society of Rehabilitation Medicine
  Chartered Society of Physiotherapy
  Institute of Neurology
  National Neurosciences Advisory Group
  Primary Care and Community Neurology Society
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Occupational Therapists
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  UK Clinical Pharmacy Association
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies None
General commentators All Wales Inherited Metabolic Disease Service
  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
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  Neurological Alliance of Scotland
  NHS Confederation
  Scottish Medicines Consortium
  Wales Neurological Alliance
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Brain Research UK
  Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group
  Genomics England
  MRC Clinical Trials Unit
  National Hospital for Neurology and Neurosurgery
  National Institute for Health Research
  Oxford Ataxia Centre
  Oxford-Harrington Rare Disease Centre
  Paediatric Ataxia Centre, National Hospitals for Neurology and Neurosurgery
  Sheffield Children’s Centre
  The London Ataxia Centre, National Hospitals for Neurology and Neurosurgery
  The Sheffield Ataxia Centre, Department of Neurology, Royal Hallamshire Hospital
  UCL Queen Square Institute of Neurology

Timeline

Key events during the development of the guidance:

Date Update
24 October 2024 Invitation to participate
23 October 2024 Topic routing was discussed at the NICE Prioritisation Board in September 2024. The Board concluded that the topic was suitable for a Technology Appraisal. Please see HST checklist on the project documents tab for further details.
12 July 2024 - 09 August 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6423
12 July 2024 In progress. Scoping commenced.
24 June 2024 This appraisal has been referred to NICE and is due to begin late October 2024.
12 October 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
12 October 2023 Topic selection

For further information on our processes and methods, please see our CHTE processes and methods manual