To appraise the clinical and cost effectiveness of fenfluramine within its marketing authorisation for treating Dravet syndrome.
 
Status In progress
Process STA 2018
ID number 1109

Provisional Schedule

Committee meeting: 1 28 August 2019
Expected publication 20 November 2019

Project Team

Project lead Jeremy Powell

Email enquiries

Evidence Review Group / Assessment Group Kleijnen Systematic Reviews Ltd

Consultees

Companies sponsors Zogenix International
Others Department of Health and Social Care
  NHS Central London CCG
  NHS England
  NHS West Leicestershire CCG
  Welsh Government
Patient carer groups Brain and Spine Foundation
  Disability Rights UK
  Dravet Syndrome UK
  Epilepsy Action
  Epilepsy Society
  Joint Epilepsy Council
  Leonard Cheshire Disability
  Muslim Council of Britain
  Neurological Alliance
  S.T.A.B.L.E (Supporting those affected by Lifelong Epilepsy)
  South Asian Health Foundation
  Specialised Healthcare Alliance
  SUDEP Action
  The Brain Charity
  Young Epilepsy
Professional groups Association of British Neurologists
  British Neuropathological Society
  British Paediatric Neurology Association
  Epilepsy Nurses Association
  Epilepsy Society
  Institute of Neurology
  International League Against Epilepsy UK
  Neuromodulation Society of UK and Ireland
  Primary Care Neurology Society
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Paediatrics and Child Health
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  United Kingdom Clinical Pharmacy Association

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord Healthcare (clobazam, topiramate)
  Atnahs Pharma UK (clobazam)
  Aurobindo Pharma - Milpharm (topiramate)
  Biocodex (stiripentol)
  Desitin Pharma (sodium valproate)
  Janssen (topiramate)
  Martindale Pharma (clobazam)
  Mylan (topiramate)
  Rosemont Pharmaceuticals (clobazam)
  Sandoz (topiramate)
  Sanofi (clobazam, sodium valproate)
  Thame Laboratories (clobazam)
  Wockhardt UK (sodium valproate)
  Zentiva (sodium valproate)
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
  Department of Health, Social Services and Public Safety for Northern Ireland
  Epilepsy Wales
  Healthcare Improvement Scotland
  Medicines and Healthcare Products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  Neurological Alliance of Scotland
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Wales Neurological Alliance
  Welsh Health Specialised Services Committee
Relevant research groups British Neurological Research Trust
  Cochrane Epilepsy Group
  Epilepsy Research UK
  MRC Clinical Trials Unit
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
04 January 2019 Invitation to participate
03 January 2019 In progress, The appraisal was referred to NICE.
26 July 2018 - 23 August 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance