NICE(UK) positive for Calquence + Venclyxto +/- obinutuzumab for untreated chronic lymphocytic leukaemia – AstraZeneca + AbbVie

NICE(UK): Acalabrutinib plus venetoclax can be used as an option for untreated chronic lymphocytic leukaemia (CLL) in adults.

It can only be used: i) without obinutuzumab, and ii) if the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with acalabrutinib plus venetoclax that was started in the NHS before this guidance was published.

Why the committee made these recommendations: This evaluation only includes acalabrutinib plus venetoclax without obinutuzumab. This is because the company did not include evidence for acalabrutinib plus venetoclax with obinutuzumab in its analysis.

Standard treatment for untreated CLL is:

i) venetoclax plus ibrutinib

ii) venetoclax plus obinutuzumab

iii) acalabrutinib alone, or

iv) zanubrutinib alone.

Acalabrutinib plus venetoclax (without obinutuzumab) has not been directly compared in a clinical trial with standard treatments. It has been indirectly compared with: i) venetoclax plus ibrutinib; ii) venetoclax plus obinutuzumab; and iii) ibrutinib alone, which works in the same way as acalabrutinib alone and which the evidence suggests is similarly effective. The results of these indirect comparisons are uncertain but acalabrutinib plus venetoclax is likely to have similar clinical effectiveness to these treatments. The most likely cost-effectiveness estimates for acalabrutinib plus venetoclax are within the range that NICE considers an acceptable use of NHS resources.