The National Institute for Health and Care Excellence said there were uncertainties with both the clinical evidence and the economic modeling provided.
Clinical trial evidence does suggest that Venclyxto (venetoclax) plus rituximab boosts progression free survival compared with bendamustine plus rituximab, but the latter combination is now “rarely used”, it noted.
Also, indirect comparisons of the regimen with the current standard of care, ibrutinib (AbbVie/Johnson & Johnson’s Imbruvica), “have limitations, so no firm conclusions can be drawn about the size of the benefit for venetoclax plus rituximab”.
Therefore, it was concluded that Venclyxto could not be recommended either for routine NHS use or for inclusion in the Cancer Drugs Fund.
“We are disappointed with the outcome of the draft decision, however this is not the final step in the appraisal and we are pleased NICE has recognised that venetoclax plus rituximab could be an important treatment option with an acceptable safety profile,” said Jérôme Bouyer, general manager, AbbVie UK.
“We are also pleased to learn that patient experts would welcome a therapy with a fixed treatment duration in this setting. We remain committed to ensuring that patients with relapsed or refractory CLL have access to an important chemotherapy-free option.”…