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

If you have any queries please email [email protected]

Stakeholders

Companies sponsors
AstraZeneca UK (acalabrutinib)
Others
Department of Health and Social Care
 
NHS England
Patient carer groups
Blood Cancer UK
 
Chronic Lymphocytic Leukaemia Support Association
 
Leukaemia Care
 
Leukaemia UK
 
Lymphoma Action
Professional groups
Association of Cancer Physicians
 
British Society for Haematology
 
Cancer Research UK
 
Royal College of Physicians
 
Royal College of Radiologists
 
UK CLL forum
Associated public health groups
None
Comparator companies
AbbVie (venetoclax) (confidentiality agreement signed, participating)
 
BeOne Medicines UK (zanubrutinib) (confidentiality agreement signed, participating)
 
Johnson & Johnson Innovative Medicine (ibrutinib) (confidentiality agreement signed, participating)
 
Pfizer (rituximab) (confidentiality agreement signed, participating)
 
Accord (bendamustine, fludarabine) (confidentiality agreement not signed, not participating)
 
Aspen (chlorambucil) (confidentiality agreement not signed, not participating)
 
Baxter Healthcare (cyclophosphamide) (confidentiality agreement not signed, not participating)
 
Celltrion Healthcare UK (rituximab) (confidentiality agreement not signed, not participating)
 
Dr Reddy’s Laboratories (bendamustine) (confidentiality agreement not signed, not participating)
 
Gilead Sciences (idelalisib) (confidentiality agreement not signed, not participating)
 
Roche (obinutuzumab, rituximab) (confidentiality agreement not signed, not participating)
 
Sandoz (cyclophosphamide, rituximab) (confidentiality agreement not signed, not participating)
 
Sanofi (fludarabine) (confidentiality agreement not signed, not participating)
 
Seacross Pharmaceuticals (bendamustine) (confidentiality agreement not signed, not participating)
 
Zentiva (bendamustine) (confidentiality agreement not signed, not participating)
General commentators
All Wales Therapeutics and Toxicology Centre
 
British National Formulary
 
Department of Health - Northern Ireland
 
Healthcare Improvement Scotland
 
Medicines and Healthcare products Regulatory Agency
 
NHS Wales Joint Commissioning Committee
 
Scottish Medicines Consortium
 
Welsh Government
Relevant research groups
Institute of Cancer Research

Related links

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