To appraise the clinical and cost-effectiveness of Venetoclax in combination with azacitidine within its marketing authorisation for acute myelogenous leukaemia
 
Status In progress
Process STA 2018
ID number 1564

Provisional Schedule

Committee meeting: 1 14 September 2021
Expected publication 24 November 2021

Project Team

Project lead Louise Jafferally

Email enquiries

Evidence Review Group / Assessment Group Health Economics Research Unit and Health Services Research Unit, University of Aberdeen

Consultees

Companies sponsors AbbVie (venetoclax)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Leukaemia Care
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians

Commentators

Comparator companies Jazz Pharmaceuticals (cytarabine) (confidentiality agreement signed, participating)
  Pfizer (cytarabine) (confidentiality agreement signed, participating)
  Celgene (azacitidine) (confidentiality agreement signed, participating)
  Accord Healthcare Ltd (azacitidine, cytarabine) (confidentiality agreement not signed, not participating)
  Dr Reddy’s Laboratories (UK) Ltd (azacitidine) (confidentiality agreement not signed, not participating)
  Seacross Pharmaceuticals Ltd (azacitidine) (confidentiality agreement not signed, not participating)
  Hospira UK (cytarabine) (confidentiality agreement not signed, not participating)
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
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
11 January 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of venetoclax with a hypomethylating agent or low dose cytarabine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable. Please note that following on from a request from the company, the timelines for this appraisal have been revised and technical engagement is now anticipated to begin in mid June 2021.
02 November 2020 Invitation to participate
02 November 2020 In progress. Topic is in progress.
17 September 2020 - 08 October 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
17 September 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of Venetoclax with a hypomethylating agent or low dose cytarabine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable For information, this appraisal has been rescheduled to allow the company to include important data to be presented in their submission. Therefore, this appraisal will be removed from the NICE’s reporting targets for timelines and the company accepts that this drug will not be eligible to receive interim CDF funding from the date of marketing authorisation. The appraisal is now anticipated to begin during late October 2020 when we will write to you about how you can get involved.
17 September 2020 Proposed. Topic is in progress
18 March 2020 The Department for Health and Social Care has asked NICE to conduct an appraisal of venetoclax with a hypomethylating agent or low dose cytarabine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable. Following advice received from the company, the timelines for this appraisal are currently to be confirmed. A further update on timelines will be available in due course.
21 June 2019 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of venetoclax with a hypomethylating agent or low dose cytarabine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during mid- March 2020 when we will write to you about how you can get involved.
25 April 2019 - 24 May 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
09 May 2019 In progress. Referred 31 July 2017

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