Suggested remit: To appraise the clinical and cost effectiveness of fenfluramine hydrochloride within its marketing authorisation for treating Lennox-Gastaut seizures in people aged 2 and over.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 1651

Provisional Schedule

Expected publication 22 May 2024

Project Team

Project lead Kate Moore

Email enquiries

External Assessment Group Kleijnen Systematic Reviews Ltd

Stakeholders

Companies sponsors UCB (fenfluramine hydrochloride)
Others Department of Health and Social Care
  NHS England
Patient carer groups Tuberous Sclerosis Association
Professional groups British Paediatric Epilepsy Group
  British Paediatric Neurology Association
  Neonatal and Paediatric Pharmacists Group
  Royal College of Physicians
Comparator companies Accord Healthcare – not participating
  Aspire Pharma – not participating
  Atnahs Pharma – not participating
  Aurobindo Pharma – not participating
  Desitin Pharma – not participating
  Eisai – not participating
  Gerot Lannach UK – not participating
  GlaxoSmithKline – not participating
  Glenmark Pharmaceuticals Europe – not participating
  Janssen-Cilag – not participating
  Jazz Pharmaceuticals (cannabidiol)
  Martindale Pharma – not participating
  Mylan – not participating
  Rosemont Pharmaceuticals – not participating
  Sanofi – not participating
  Seacross Pharmaceuticals Ltd – not participating
  Somex Pharma – not participating
  Thame Laboratories – not participating
  Viatris – not participating
  Wockhardt – not participating
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
  Welsh Government

Timeline

Key events during the development of the guidance:

Date Update
06 March 2024 Committee meeting: 2
31 January 2024 - 21 February 2024 Draft guidance
11 January 2024 Committee meeting
08 June 2023 Invitation to participate
25 January 2023 - 22 February 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
25 January 2023 In progress. Scoping commenced
13 May 2020 Schedule affected by COVID-19. Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.

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