Suggested remit: To appraise the clinical and cost effectiveness of acalabrutinib and venetoclax with or without obinutuzumab within its marketing authorisation for previously untreated chronic lymphocytic leukaemia.
 
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 6232

Provisional Schedule

Committee meeting: 1 03 February 2026
Expected publication 22 April 2026

Project Team

Project lead Leena Issa

Email enquiries

Stakeholders

Companies sponsors AstraZeneca UK (acalabrutinib)
Others Department of Health and Social Care
  NHS England
Patient carer groups African Caribbean Leukaemia Trust
  Anthony Nolan
  Black Health Agency for Equality
  Blood Cancer UK
  Cancer 52
  Cancer Black Care
  Chronic Lymphocytic Leukaemia Support Association
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Kevin Kararwa Leukaemia Trust
  Leukaemia Cancer Society
  Leukaemia Care
  Leukaemia UK
  Lymphoma Action
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
  WMUK
Professional groups Association of Anaesthetists
  Association of Cancer Physicians
  Association of Surgeons of Great Britain and Ireland
  British Blood Transfusion Society
  British Geriatrics Society
  British Institute of Radiology
  British Oncology Pharmacy Association
  British Psychosocial Oncology Society
  British Society for Haematology
  British Society of Blood and Marrow Transplantation and Cellular Therapy
  British Society of Interventional Radiology
  British Transplantation Society
  Cancer Research UK
  NHS Blood and Transplant
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK CLL forum
  UK Oncology Nursing Society
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies AbbVie (venetoclax)
  Accord (bendamustine, fludarabine)
  Aspen (chlorambucil)
  Baxter Healthcare (cyclophosphamide)
  BeOne Medicines UK (zanubrutinib)
  Celltrion Healthcare UK (rituximab)
  Dr Reddy’s Laboratories (bendamustine)
  Gilead Sciences (idelalisib)
  Johnson & Johnson Innovative Medicine (ibrutinib)
  Pfizer (rituximab)
  Roche (obinutuzumab, rituximab)
  Sandoz (cyclophosphamide, rituximab)
  Sanofi (fludarabine)
  Seacross Pharmaceuticals (bendamustine)
  Zentiva (bendamustine)
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health - Northern Ireland
  Healthcare Improvement Scotland
  Hospital Information Services –Jehovah’s Witnesses
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Confederation
  NHS Wales Joint Commissioning Committee
  Scottish Medicines Consortium
  Welsh Government
Relevant research groups Cochrane Haematological Group
  Genomics England
  Institute of Cancer Research
  Leukaemia Busters
  Lymphoma Research Trust
  MRC Clinical Trials Unit
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
15 July 2025 Invitation to participate
15 May 2025 The Department for Health & Social Care has asked NICE to conduct an appraisal of Acalabrutinib with venetoclax with or without obinutuzumab for untreated chronic lymphocytic leukaemia [ID6232]. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-July 2025. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
21 January 2025 - 18 February 2025 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6232
21 January 2025 In progress. Scoping commencing
16 December 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