Suggested remit: To appraise the clinical and cost effectiveness of efanesoctocog alfa within its marketing authorisation for treating and preventing bleeding episodes in people of any age with previously treated Haemophilia A.
Status
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In progress
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Technology type
|
Medicine
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Decision
|
Selected
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Reason for decision
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Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
|
Process |
STA Standard
|
ID number |
6170
|
Project Team
Email enquiries
External Assessment Group |
Kleijnen Systematic Reviews Ltd |
Stakeholders
Companies sponsors |
Swedish Orphan Biovitrum |
|
(efanesoctocog alfa) |
Others |
Department of Health and Social Care |
|
NHS England |
Patient carer groups |
Gene People |
Professional groups |
Royal College of Pathologists |
|
Royal College of Physicians |
|
UK Haemophilia Centre Doctors’ Organisation |
Comparator companies |
Bio Products Laboratory (factor VIII) (confidentiality agreement not signed, not participating) |
|
Biotest (factor VIII) (confidentiality agreement not signed, not participating) |
|
CSL Behring UK (factor VIII) (confidentiality agreement signed, participating) |
|
Novo Nordisk (factor VIII, turoctocog alfa pegol) (confidentiality agreement signed, participating) |
|
Octopharma (factor VIII, simoctocog alfa) (confidentiality agreement signed, participating) |
|
Pfizer (moroctocog alfa) (confidentiality agreement signed, participating) |
|
Roche (emicizumab) (confidentiality agreement signed, participating) |
|
Takeda UK (octocog alfa, rurioctocog alfa pegol, susoctocog alfa) (confidentiality agreement signed, participating) |
General commentators |
All Wales Therapeutics and Toxicology Centre |
|
British National Formulary |
|
Department of Health, Social Services and Public Safety for Northern Ireland |
|
Haemophilia Scotland |
|
Healthcare Improvement Scotland |
|
Medicines and Healthcare products Regulatory Agency |
|
Scottish Medicines Consortium |
|
Welsh Government |
|
Welsh Health Specialised Services Committee |
Date
|
Update
|
07 August 2024
|
Committee meeting |
07 August 2024
|
Declaration of interests |
17 May 2024 - 10 June 2024
|
Draft guidance |
04 April 2024
|
Committee meeting |
15 March 2024
|
Efanesoctocog alfa has not yet received regulatory approval, so the committee meeting on 4 April 2024 will be held in private. |
31 August 2023
|
Invitation to participate |
27 July 2023
|
Please note that following on from information received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin during mid-August 2023, when we will write to you about how you can get involved. |
22 May 2023 - 20 June 2023
|
Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6170 |
13 October 2022
|
In progress. DHSC referral received |
11 August 2022
|
Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
For further information on our processes and methods, please see our CHTE processes and methods manual