Suggested remit: To appraise the clinical and cost effectiveness of etranacogene dezaparvovec within its marketing authorisation for treating moderately severe or severe haemophilia B.
Status
|
In progress
|
Technology type
|
Medicine
|
Decision
|
Selected
|
Process |
TA
|
ID number |
3812
|
Project Team
Email enquiries
External Assessment Group |
Peninsula Technology Assessment Group (PenTAG), University of Exeter |
Stakeholders
Companies sponsors |
CSL Behring (etranacogene dezaparvovec) |
Others |
Department of Health and Social Care |
|
NHS England |
|
Welsh Government |
Patient carer groups |
Haemophilia Society |
Professional groups |
Royal College of Physicians |
|
UK Haemophilia Centre Doctors’ Organisation |
Comparator companies |
Novo Nordisk (eptacog alpha, nonacog beta pegol) |
|
Pfizer (nonacog alfa) |
|
Swedish Orphan Biovitrum (eftrenonacog alfa) |
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
|
13 September 2023
|
Committee meeting: 2 |
02 August 2023 - 23 August 2023
|
Draft guidance |
12 July 2023
|
Committee meeting |
01 November 2022
|
Invitation to participate |
01 November 2022
|
In progress. invitation to participate |
16 September 2022
|
As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of etranacogene dezaparvovec within its marketing authorisation for treating moderately severe or severe haemophilia B.
Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early-November 2022 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-January 2023. |
29 March 2022 (14:00)
|
Scoping workshop |
24 January 2022 - 21 February 2022
|
Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
For further information on our processes and methods, please see our CHTE processes and methods manual