NICE gave a negative opinion on AbbVie’s Venclyxta in combination with Roche’s Rituxan, for treating relapsed or refractory chronic lymphocytic leukaemia in adults.
In draft guidance, the committee said that although clinical evidence suggested that venetoclax with rituximab increased how long patients lived before the disease got worse, uncertainties existed about the size of its benefit and its cost-effectiveness compared with ibrutinib, or other treatment options. The watchdog said these “inconsistencies” between the clinical- and cost-effectiveness data in AbbVie's models prevented them from coming up with a “most plausible cost-effectiveness estimate” for Venclexta.
The Venclexta-Rituxan combo won U.S FDA approval this July.
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