Suggested remit - To appraise the clinical and cost effectiveness of gilteritinib within its marketing authorisation for treating relapsed or refractory positive acute leukaemia
Status In progress
Process STA 2018
ID number 1484

Provisional Schedule

Committee meeting: 2 02 June 2020

Project Team

Project lead Kate Moore

Email enquiries

Evidence Review Group / Assessment Group School of Health and Related Research (ScHARR), University of Sheffield


Companies sponsors Astella Pharma Ltd (gilteritinib)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Bloodwise
  Leukaemia Care
Professional groups Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists


Comparator companies Bristol-Myers Squibb Pharmaceuticals Ltd (hydroxycarbamide) – confidentiality agreement signed
  Pfizer (cytarabine, idarubicin) – confidentiality agreement signed
  Accord Healthcare Ltd (cytarabine, fludarabine, idarubicin,) – confidentiality agreement not signed
  Actavis (fludarabine) – confidentiality agreement not signed
  Amgen (filgrastim) – confidentiality agreement not signed
  Celgene (azacitidine)
  Hospira UK (cytarabine, fludarabine, filgrastim) – confidentiality agreement not signed
  Medac UK (hydroxycarbamide) – confidentiality agreement not signed
  Napp Pharmaceuticals (cytarabine) – confidentiality agreement not signed
  Sandoz (fludarabine, filgrastim) – confidentiality agreement not signed
  Teva (fludarabine) – confidentiality agreement not signed
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research


Key events during the development of the guidance:

Date Update
15 January 2020 - 05 February 2020 Appraisal consultation
21 January 2020 The company (Astellas) has informed NICE that they intend to submit additional information in response to the Appraisal Consultation Document. Therefore, additional time will be needed by NICE to consider this information. The appraisal committee meeting will be rescheduled into the work programme and the updated appraisal committee meeting date will be communicated in due course.
05 April 2019 Invitation to participate
05 April 2019 In progress, Committee C appraisal
15 February 2019 - 15 March 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance