Suggested Remit: To appraise the clinical and cost effectiveness of venetoclax with obinutuzumab within its marketing authorisation for untreated chronic lymphocytic leukaemia.
 
Status In progress
Process STA 2018
ID number 1402

Project Team

Project lead Louise Jafferally

Email enquiries

Evidence Review Group / Assessment Group Warwick Evidence, Warwick Medical School, University of Warwick

Consultees

Companies sponsors AbbVie (venetoclax)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Chronic Lymphocytic Leukaemia Support Association
  Leukaemia CARE
  Lymphoma Action
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

Commentators

Comparator companies Roche Products (obinutuzumab, rituximab) (CAU form received, participating)
  AHH Pharmaceuticals (chlorambucil) (CAU form not received, not participating)
  Accord Healthcare (bendamustine, fludarabine) (CAU form not received, not participating)
  Actavis UK (fludarabine) (CAU form not received, not participating)
  Aspen (chlorambucil) (CAU form not received, not participating)
  Baxter Healthcare (cyclophosphamide) (CAU form not received, not participating)
  Dr Reddy’s Laboratories (bendamustine) (CAU form not received, not participating)
  Gilead Sciences (idelalisib) (CAU form not received, not participating)
  Janssen-Cilag (ibrutinib) (CAU form not received, not participating)
  medac (bendamustine) (CAU form not received, not participating)
  Napp Pharmaceuticals (bendamustine, rituximab) (CAU form not received, not participating)
  Sandoz (cyclophosphamide, fludarabine, rituximab) (CAU form not received, not participating)
  Sanofi (fludarabine) (CAU form not received, not participating)
  Seacross Pharmaceuticals (bendamustine) (CAU form not received, not participating)
  Zentiva (bendamustine) (CAU form not received, 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
  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
27 January 2020 The appraisal timelines for this Topic have been rescheduled to allow the company to include newly available data to be presented in updated submission documentation. The appraisal committee meeting has been rescheduled and the updated appraisal timelines will be communicated in due course.
08 October 2019 The deadline for submissions is now Tuesday 29 October 2019.
07 August 2019 Invitation to participate
22 May 2019 - 20 June 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
21 March 2017 In progress, Topic referred

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