NICE has approved venetoclax with rituximab for previously treated relapsed or refractory chronic lymphocytic leukaemia (CLL).
With approximately 3500 new cases of CLL diagnosed each year in the UK, it is estimated that 1000 people will be eligible for venetoclax in the first year.
In September 2018, NICE decided not to recommend venetoclax plus rituximab due to uncertainties in the evidence. However, it now says that, following further data submissions and clarification from the company, the treatment is considered cost-effective.
The main clinical evidence to the support the decision came from the phase 3 MURANO trial which compared venetoclax plus rituximab (n=194) with bendamustine plus rituximab (n=195) in adults with relapsed or refractory CLL.
In the company’s original submission the data came from a May 2017 data cut, with a median follow-up of 23.8 months from starting treatment. In response to consultation, the company presented data from a May 2018 data cut, with a median follow-up of 36 months from starting treatment.
The May 2018 data cut showed that progression-free survival (PFS) was statistically significantly longer with venetoclax plus rituximab than with bendamustine plus rituximab (median not reached vs 16 months; HR 0.16; 95% CI 0.12-0.23; P<0.0001. Overall survival (OS) was longer with venetoclax plus rituximab (HR 0.50; 95% CI 0.30-0.85; P=0.0093).
Although it is uncertain how effective venetoclax is compared with ibrutinib, NICE concluded that venetoclax plus rituximab can be considered a cost-effective use of NHS resources and it is recommended for routine use in the NHS.
