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UK's NICE Recommends Roche's Tecentriq for First-Line PD-L1-Positive Bladder Cancer

NEW YORK – The UK National Institute for Health and Care Excellence on Thursday recommended the National Health Service make Roche's atezolizumab (Tecentriq) available for advanced urothelial cancer patients in England whose tumors express PD-L1 in at least 5 percent of their cancer cells.

Specifically, NICE issued a draft guidance recommending that the PD-L1 inhibitor be available for treatment-naïve bladder cancer patients who cannot receive platinum-based chemotherapy. The committee based its recommendation on additional clinical evidence collected as part of the Cancer Drugs Fund managed access agreement, including results of the Phase III IMvigor130 study and evidence available within the Systemic Anti-Cancer Therapy dataset.

After evaluating this data, NICE deemed that atezolizumab, when used to treat this PD-L1-positive urothelial cancer subpopulation, would be a life-extending treatment at an acceptable cost-effectiveness threshold. The drug's list price is roughly £66,000 ($88,967) annually, but the company has agreed to make atezolizumab available to the NHS at an undisclosed discounted price.

"Today's decision comes after additional clinical evidence was collected as part of a managed access agreement through the Cancer Drugs Fund," Meindert Boysen, deputy chief executive and director of the Center for Health Technology Evaluation at NICE, said in a statement. "I am pleased we were able to not only secure access for people with this form of urothelial cancer in the interim but to now recommend it for routine use in the NHS."

Atezolizumab is approved for the same indication in the US together with Roche's Ventana PD-L1 assay as a companion diagnostic to identify patients eligible for the drug.