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 Selected
Process STA Standard
ID number 1627

Provisional Schedule

Committee meeting: 1 04 February 2026
Expected publication 22 April 2026

Project Team

Project lead Kate Moore

Email enquiries

External Assessment Group Liverpool Reviews and Implementation Group, University of Liverpool

Stakeholders

Companies sponsors Brancaster Pharma
Others Department of Health and Social Care
  NHS England
Patient carer groups African Caribbean Leukaemia Trust
  Anthony Nolan
  Black Health Agency for Equality
  Blood Cancer UK
  Cancer 52
  Cancer Black Care
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Kevin Kararwa Leukaemia Trust
  Leukaemia Cancer Society
  Leukaemia Care
  Leukaemia UK
  Lymphoma Action
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
  WMUK
Professional groups Association of Anaesthetists
  Association of Cancer Physicians
  Association of Surgeons of Great Britain and Ireland
  British Association of Surgical Oncology
  British Blood Transfusion Society
  British Geriatrics Society
  British Institute of Radiology
  British Oncology Pharmacy Association
  British Psychosocial Oncology Society
  British Society for Haematology
  British Society of Blood and Marrow Transplantation and Cellular Therapy
  British Society of Interventional Radiology
  British Transplantation Society
  Cancer Research UK
  NHS Blood and Transplant
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal College of Surgeons
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK CLL Forum
  UK Oncology Nursing Society
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Clinigen Healthcare (interleukin-2)
  Accord Healthcare (cytarabine, sorafenib)
  Bayer (sorafenib)
  Bristol Myers Squibb (azacitidine)
  Daiichi Sankyo (quizartinib)
  Hospira UK (cytarabine)
  Jazz Pharmaceuticals (cytarabine)
  Napp Pharmaceuticals (cytarabine)
  Novartis Pharmaceuticals (midostaurin)
  Pfizer (cytarabine)
  Sandoz (sorafenib)
  Teva UK (sorafenib)
  Thornton & Ross (sorafenib)
  Zentiva UK (sorafenib)
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
  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 Haematological Group
  Genomics England
  Institute of Cancer Research
  Leukaemia Busters
  Lymphoma Research Trust
  MRC Clinical Trials Unit
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
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 appraisal is now anticipated to begin during early July 2025 when we will write to you about how you can get involved.
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 dihydrochloride have ceased to engage with NICE regarding this appraisal. NICE have therefore taken the decision to suspend this topic from the work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes. If you have any comments or concerns please contact the project manager for this appraisal Emily Richards on (44 (0)161 413 4070 or via email on emily.richards@nice.org.uk)
26 June 2020 Suspended. _

For further information on our processes and methods, please see our CHTE processes and methods manual