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 |
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Final draft guidance: 1109 |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