1.1 Nivolumab is not recommended, within its marketing authorisation, for treating locally advanced unresectable or metastatic urothelial carcinoma in adults who have had platinum-containing therapy.
1.2 This recommendation is not intended to affect treatment with nivolumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Treatment options for people with locally advanced unresectable or metastatic urothelial carcinoma who have had platinum-containing therapy are limited. They are usually offered docetaxel, paclitaxel and best supportive care.
Nivolumab has been studied in a clinical trial, but it has not been directly compared with other treatments. So it is not clear how effective nivolumab is compared with current clinical practice.
Nivolumab meets NICE's criteria to be considered a life-extending treatment at the end of life. The committee agreed that the assumptions incorporated in the evidence review group's (ERG's) revised base case were mostly consistent with its preferred assumptions. The committee agreed that the most plausible incremental cost-effectiveness ratios (ICERs) were somewhere between the ERG's estimates of £58,791 per quality-adjusted life year (QALY) gained (compared with paclitaxel) and £78,869 per QALY gained (compared with docetaxel), above what NICE normally considers to be acceptable for end-of-life treatments. There was substantial uncertainty because the model used a simulated treatment comparison, so the ICER could be considerably higher. Therefore nivolumab could not be recommended for routine use in the NHS for locally advanced, unresectable or metastatic urothelial cancer after platinum-containing chemotherapy.
Because neither data collection from clinical practice or the ongoing trials would resolve the identified uncertainty, nivolumab is not suitable for use within the Cancer Drugs Fund for people with unresectable or metastatic urothelial cancer after platinum-containing therapy.