Suggested remit: To appraise the clinical and cost effectiveness of histamine dihydrochloride with interleukin-2 within its marketing authorisation for maintenance treatment of acute myeloid leukaemia.
- Status:
- In progress
- Technology type:
- Medicine
- Decision:
- Prioritised
- Prioritisation programme:
- Medicines evaluation
- Rationale:
- Prioritisation Board agreed that all 4 criteria of the highly specialised technology framework were not met (see NICE-wide topic prioritisation: the manual) and that therefore the treatment should be routed to the technology appraisals programme.
- Process:
- STA Standard
- ID number:
- 1627
Provisional Schedule
- Draft guidance:
- 30 April 2026 - 22 May 2026
- Committee meeting: 2:
- 10 June 2026
- Expected publication:
- 05 August 2026
Project Team
- Project lead
- Kate Moore
Email enquiries
If you have any queries please email TACommD@nice.org.uk
- External Assessment Group:
- School of Health and Related Research (ScHARR), University of Sheffield
Stakeholders
- Companies sponsors
- Brancaster Pharma
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Blood Cancer UK
- Professional groups
- Association of Cancer Physicians
- Cancer Research UK
- Royal College of Physicians
- Royal College of Radiologists
- Associated public health groups
- None
- Comparator companies
- Bayer (sorafenib) (confidentiality agreement signed, participating)
- Pfizer (cytarabine) (confidentiality agreement signed, participating)
- Accord Healthcare (cytarabine, sorafenib) (confidentiality agreement not signed, not participating)
- Bristol Myers Squibb (azacitidine) (confidentiality agreement not signed, not participating)
- Daiichi Sankyo (quizartinib) (confidentiality agreement not signed, not participating)
- Hospira UK (cytarabine) (confidentiality agreement not signed, not participating)
- Jazz Pharmaceuticals (cytarabine) (confidentiality agreement not signed, not participating)
- Napp Pharmaceuticals (cytarabine) (confidentiality agreement not signed, not participating)
- Novartis Pharmaceuticals (midostaurin) (confidentiality agreement not signed, not participating)
- Sandoz (sorafenib) (confidentiality agreement not signed, not participating)
- Teva UK (sorafenib) (confidentiality agreement not signed, not participating)
- Thornton & Ross (sorafenib) (confidentiality agreement not signed, not participating)
- Zentiva UK (sorafenib) (confidentiality agreement not signed, not participating)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health - Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- Institute of Cancer Research
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 09 April 2026 | Committee meeting: 1 |
| 09 January 2026 | NICE must unfortunately postpone the first committee discussion for this topic, scheduled for 4 February 2026. We will instead reschedule the first committee discussion to 9 April 2026. - Note added to the project documents |
| 02 July 2025 | Invitation to participate |
| 22 May 2025 - 20 June 2025 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 1627 |
| 22 May 2025 | In progress. Scoping commencing |
| 06 February 2025 | As you will be aware The Department for Health & Social Care has asked NICE to conduct an appraisal of Histamine dihydrochloride with interleukin-2 for maintenance treatment of acute myeloid leukaemia [ID1627] Please note that following on from a request received from the company this appraisal have been scheduled into the work programme and the ap - Note added to the project documents |
| 26 June 2020 | Suspended: The National Institute for Health and Care Excellence (NICE) has been asked to conduct an appraisal of histamine dihydrochloride with interleukin-2 for maintenance treatment of acute myeloid leukaemia ID1627. We have recently invited stakeholders to respond to a written consultation on the draft scope. The company that markets histamine - Note added to the project documents |
| 26 June 2020 | Suspended. _ |
For further information on our processes and methods, please see our CHTE processes and methods manual