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
- Gene People
- Genetic Alliance UK
- Haemophilia Society
- Immunodeficiency UK
- South Asian Health Foundation
- Specialised Healthcare Alliance
- Professional groups
- Association of Genetic Nurses & Counsellors
- British Blood Transfusion Society
- British Geriatrics Society
- British Paediatric Allergy, Immunity and Infection Group
- British Society for Genetic Medicine
- British Society for Haematology
- Haemophilia Chartered Physiotherapists Association
- Haemophilia Nurses Association
- Neonatal and Paediatric Pharmacists Group
- Royal College of General Practitioners
- Royal College of Nursing
- Royal College of Paediatrics & Child Health
- Royal College of Pathologists
- Royal College of Physicians
- Royal Pharmaceutical Society
- Royal Society of Medicine
- UK Clinical Pharmacy Association
- UK Forum on Haemoglobin Disorders
- UK Haemophilia Centre Doctors’ Organisation
- Associated public health groups
- Public Health Wales
- UK Health Security Agency
- Comparator companies
- Bio Products Laboratory (factor VIII)
- CSL Behring UK (factor VIII)
- Grifols UK (factor VIII)
- Novo Nordisk (factor VIII: eptacog alfa, turoctocog alfa pegol)
- Octopharma (factor VIII: simoctocog alfa)
- Pfizer (factor VIII: moroctocog alfa)
- Roche (emicizumab)
- Swedish Orphan Biovitrum (efanesoctocog alfa, factor VIII: efmoroctocog alfa)
- Takeda (factor VIII: octocog alfa, susoctocog alfa)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- Allied Health Professionals Federation
- Board of Community Health Councils in Wales
- British National Formulary
- Care Quality Commission
- Department of Health - Northern Ireland
- Haemophilia Northern Ireland
- Haemophilia Scotland
- Haemophilia Wales
- Healthcare Improvement Scotland
- Hospital Information Services - Jehovah's Witnesses
- Medicines and Healthcare products Regulatory Agency
- National Association of Primary Care
- National Pharmacy Association
- NHS Confederation
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- Cochrane Haematology
- Genomics England
- MRC Clinical Trials Unit
- National Institute for Health Research
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 | Note - 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