Overview
Evidence-based recommendations on venetoclax (Venclyxto) with obinutuzumab for untreated chronic lymphocytic leukaemia in adults.
Is this guidance up to date?
Next review: For recommendation 1.1: December 2023
Next review: For recommendation 1.2: More evidence on venetoclax with obinutuzumab in people with untreated chronic lymphocytic leukaemia who do not have a 17p deletion or TP53 mutation for whom fludarabine plus cyclophosphamide and rituximab or bendamustine plus rituximab is suitable is being collected until the final analysis of the CLL13 study is available. After this, NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.
Commercial arrangement
There is a managed access agreement, which includes a patient access scheme, for venetoclax. Contact pricing@abbvie.com for details.
There is a simple discount patient access scheme for obinutuzumab. Contact welwyn.rx_bdop@roche.com for details.
Guidance development process
How we develop NICE technology appraisal guidance
Your responsibility
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.