Suggested remit - To appraise the clinical and cost effectiveness of quizartinib within its marketing authorisation for treating relapsed or refractory FLT3-ITD-positive acute myeloid leukaemia.
On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for Quizartinib for treating relapsed or refractory acute myeloid leukaemia. Therefore, this appraisal has been suspended. NICE will continue to monitor any developments and will update stakeholders if the situation changes.
 
Status Suspended
Decision Selected
Process STA 2018
ID number 1325

Project Team

Project lead Louise Jafferally

Email enquiries

Stakeholders

Companies sponsors Daiichi Sankyo (quizartinib)
Others Department of Health
  NHS England
  Welsh Government
Patient carer groups Bloodwise
  Leukaemia CARE
Professional groups Association of Cancer Physicians
  British Society for Haematology
  Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
Comparator companies Pfizer (cytarabine, idarubicin) (confidentiality agreement signed)
  Accord Healthcare Ltd (cytarabine, etoposide, fludarabine, idarubicin, mitoxantrone) (confidentiality agreement not signed)
  Actavis (fludarabine) (confidentiality agreement not signed)
  Amgen (filgrastim)
  Hospira UK (cytarabine, fludarabine, filgrastim) (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
  National Cancer Research Institute
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
18 October 2019 Suspended. On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for Quizartinib for treating relapsed or refractory acute myeloid leukaemia. Therefore, this appraisal has been suspended. NICE will continue to monitor any developments and will update stakeholders if the situation changes.
26 September 2019 Please note that following an update received from the company, the NICE appraisal committee discussion on Wednesday 2 October 2019 has been cancelled and will be rescheduled in due course. NICE will continue to monitor any development and further information regarding the timelines of this appraisal will be available once known.
26 September 2019 In progress. In progress
12 April 2019 Following an update from Daiichi Sankyo UK, the committee date for the appraisal of quizartinib for treating relapsed or refractory acute myeloid leukaemia has been rescheduled to 2 October 2019.
09 November 2018 Invitation to participate
27 June 2018 - 25 July 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
05 December 2017 In progress. DHSC referral received

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