NICE has issued a draft guideline recommending against venetoclax with rituximab as a treatment option for adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). The treatment did not meet the criteria for inclusion in the Cancer Drugs Fund (CDF).
The guidelines committee considered evidence from the MURANO trial of venetoclax plus rituximab compared with bendamustine plus rituximab which found that median progression-free survival (PFS) was significantly longer with venetoclax plus rituximab compared with bendamustine plus rituximab (HR 0.17; 95% CI 0.11-0.25; P
An unanchored matched-adjusted indirect comparison (MAIC) carried out to allow an indirect comparison of venetoclax plus rituximab with ibrutinib and idelalisib plus rituximab was flawed and could not be used to draw conclusions.
With uncertainty around the clinical data, estimates of cost-effectiveness could not be calculated.
Consequently, the draft guidance says venetoclax with rituximab cannot be recommended for routine use in the NHS. In addition, the treatment did not meet the criteria for inclusion in the CDF.
The draft guidance is open to consultation until 16 November 2018. The NICE appraisal committee meeting again on 27 November 2018 to consider the feedback received along with any new information.