Suggested remit: To appraise the clinical and cost effectiveness of denecimig (Mim8) within its marketing authorisation for preventing bleeding episodes in haemophilia A in people 1 year and over.
- Status:
- In progress
- Technology type:
- Medicine
- Decision:
- Selected
- Reason for decision:
- 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:
- 6400
Provisional Schedule
- Committee meeting:
- 07 October 2026
- Expected publication:
- 24 February 2027
Project Team
- Project lead
- Kate Moore
Email enquiries
If you have any queries please email TACommD@nice.org.uk
- External Assessment Group:
- Southampton Health Technology Assessment Centre (SHTAC), University of Southampton
Stakeholders
- Companies sponsors
- Novo Nordisk (Denecimig [Mim8])
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Haemophilia Society
- Professional groups
- British Society for Haematology
- Associated public health groups
- None
- Comparator companies
- Pfizer (factor VIII: moroctocog alfa) (confidentiality agreement signed, participating)
- Roche (emicizumab) (confidentiality agreement signed, participating)
- Swedish Orphan Biovitrum (confidentiality agreement signed, participating)
- Takeda (factor VIII: octocog alfa, susoctocog alfa) (confidentiality agreement signed, participating)
- Bio Products Laboratory (factor VIII) (confidentiality agreement not signed, not participating)
- CSL Behring UK (factor VIII) (confidentiality agreement not signed, not participating)
- Grifols UK (factor VIII) (confidentiality agreement not signed, not participating)
- Novo Nordisk (factor VIII: eptacog alfa, turoctocog alfa pegol) (confidentiality agreement not signed, not participating)
- Octopharma (factor VIII: simoctocog alfa) (confidentiality agreement not signed, not participating)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health - Northern Ireland
- Haemophilia Northern Ireland
- Healthcare Improvement Scotland
- NHS Wales Joint Commissioning Committee
- Relevant research groups
- None
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 09 March 2026 | Invitation to participate |
| 09 March 2026 | In progress. Invitation to participate |
| 19 January 2026 | 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 March 2026 when we will write to you about how you can get involved. - Note added to the project documents |
| 10 December 2025 - 15 January 2026 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6400 |
| 18 December 2025 | Awaiting development. 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 March 2026 when we will write to you about how you can get involved. |
| 10 December 2025 | In progress. Scoping commencing |
| 31 January 2024 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
| 30 January 2024 | Topic selection |
For further information on our processes and methods, please see our CHTE processes and methods manual