Suggested remit: To appraise the clinical and cost effectiveness of ganaxolone within its marketing authorisation for treating seizures caused by CDKL5 deficiency disorder (CDD) in people aged 2 years and over.
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Status
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In progress
|
|
Technology type
|
Medicine
|
|
Decision
|
Awaiting decision
|
| Process |
TA
|
| ID number |
3988
|
Project Team
| Project lead |
Jeremy Powell |
Email enquiries
Stakeholders
| Companies sponsors |
Orion Pharma (ganaxolone) |
| Others |
Department of Health and Social Care |
| |
NHS England |
| |
Welsh Government |
| Patient carer groups |
CDKL5 UK |
| Professional groups |
Association of British Neurologists |
| |
Epilepsy Nurses Association |
| |
Royal College of Physicians |
| |
UK Clinical Pharmacy Association |
| Associated public health groups |
Public Health Wales |
| |
UK Health Security Agency |
| Evidence review group |
PenTAG Health Technology Assessment |
| 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 |
National Institute for Health Research |
|
Date
|
Update
|
|
17 September 2024
|
Appeal |
|
12 August 2024 - 27 August 2024
|
Final draft guidance |
|
11 May 2024
|
Declaration of interests |
|
11 April 2024
|
Declaration of interests |
|
11 April 2024
|
Committee meeting: 3 |
|
31 October 2023
|
The company has identified an error in the evidence for this appraisal, which they consider may affect the committee’s considerations. NICE is investigating this issue. While we investigate, the final draft guidance is withdrawn, and the appeal period is suspended. |
|
06 September 2023
|
Committee meeting: 2 |
|
02 August 2023 - 23 August 2023
|
Draft guidance |
|
06 July 2023
|
Committee meeting: 1 |
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14 November 2022
|
Topic selection |
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25 August 2022
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Invitation to participate |
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28 March 2022 (14:00)
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Scoping workshop |
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31 January 2022 - 28 February 2022
|
Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
|
24 November 2021
|
In progress |
For further information on our processes and methods, please see our CHTE processes and methods manual