Suggested remit: To appraise the clinical and cost effectiveness of ivosidenib (with azacitidine) within its marketing authorisation for untreated IDH1-positive acute myeloid leukaemia when intensive induction chemotherapy is unsuitable.
 
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 6198

Provisional Schedule

Expected publication 04 June 2024

Project Team

Project lead Leena Issa

Email enquiries

External Assessment Group Peninsula Technology Assessment Group (PenTAG), University of Exeter

Stakeholders

Companies sponsors Servier Laboratories (ivosidenib)
Others Department of Health and Social Care
  NHS England
Patient carer groups Blood Cancer UK
  Leukaemia Care
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
Comparator companies AbbVie (venetoclax) (confidentiality agreement signed, participating)
  Accord Healthcare (azacitidine, cytarabine) (confidentiality agreement not signed, not participating)
  Bristol Myers Squibb (azacitidine) (confidentiality agreement not signed, not participating)
  Celgene (azacitidine) (confidentiality agreement not signed, not participating)
  Dr Reddy’s Laboratories (UK) (azacitidine) (confidentiality agreement not signed, not participating)
  Hospira UK (cytarabine) (confidentiality agreement not signed, not participating)
  Jazz Pharmaceuticals (cytarabine) (confidentiality agreement signed, participating)
  Mylan (azacitidine) (confidentiality agreement not signed, not participating)
  Pfizer (cytarabine) (confidentiality agreement not signed, not participating)
  Sandoz (azacitidine) (confidentiality agreement not signed, not participating)
  Seacross Pharmaceuticals (azacitidine) (confidentiality agreement not signed, not participating)
  Tillomed (azacitidine) (confidentiality agreement not signed, not participating)
  Zentiva (azacitidine) (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
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
03 April 2024 Committee meeting: 2
28 February 2024 - 20 March 2024 Draft guidance
06 February 2024 Committee meeting
04 July 2023 Invitation to participate
16 May 2023 - 14 June 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
16 May 2023 In progress. Scoping commenced
25 October 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