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

Provisional Schedule

Expected publication 06 July 2022

Project Team

Project lead Daniel Davies

Email enquiries

External Assessment Group Kleijnen Systematic Reviews Ltd

Stakeholders

Companies sponsors Zogenix International
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Dravet Syndrome UK
  Epilepsy Action
Professional groups Association of British Neurologists
  British Paediatric Neurology Association
  Epilepsy Nurses Association
  Royal College of Physicians
Associated public health groups None
Comparator companies GW Pharma (cannabidiol)
  Janssen (topiramate)
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 Health Specialised Services Committee
Relevant research groups None

Timeline

Key events during the development of the guidance:

Date Update
31 May 2022 - 14 June 2022 Final draft guidance: 1109
02 March 2022 Due to operational reasons, consultation of the ACD will be delayed. Further updates will be provided detailing the next steps in the process
20 January 2022 Committee meeting: 2
04 March 2021 Committee meeting: 1
21 January 2021 The forthcoming committee discussion of the above technology appraisal scheduled to take place on 4th February has been rescheduled due to operational issues. The Technology Appraisal committee discussion will now take place on Thursday 4 March 2021.
26 June 2020 Fenfluramine for treating Dravet syndrome was due to pause , however the topic will now continue on the original timelines and will no longer pause. The timelines are subject to staff capacity and the ongoing management of the COVID-19 situation and we will continue to review our plans and update our stakeholders accordingly.
02 June 2020 Invitation to participate
09 April 2020 Topic update: this appraisal has not been defined as therapeutically critical (please follow the link titled rapid guidelines and evidence summaries within the yellow banner at the top of the page for information on recent changes to the way we work). 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 updates as and when this information becomes clear.
31 January 2020 - 28 February 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 2
04 October 2019 The company have asked NICE to reschedule this appraisal again to better align with the regulatory process and NICE has agreed to this request. We anticipate that the appraisal will now re-start in Spring 2020.
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 our processes and methods, please see our CHTE processes and methods manual