The National Institute for Health and Care Excellence (NICE) has taken the decision not to recommend nivolumab for locally advanced unresectable or metastatic urothelial carcinoma in adults who have had platinum-containing therapy.
In its final appraisal determination, NICE states that, although the drug has been studied in a clinical trial, it has not been directly compared with other treatments and it is unclear how effective nivolumab is compared with current clinical practice.
The clinical-effectiveness evidence for nivolumab comes from CheckMate 275 and CheckMate 032 phase 2 single-arm trials which included 270 patients with locally advanced unresectable or metastatic urothelial carcinoma (CheckMate 275) and 78 patients with carcinoma of the renal pelvis, ureter, bladder, or urethra (CheckMate 032). It was estimated that the most plausible incremental cost-effectiveness ratio (ICER) for nivolumab would be somewhere between £58,791 per quality-adjusted life-year (QALY) gained (versus paclitaxel) and £78,869 per QALY gained (versus docetaxel), above what NICE normally considers to be acceptable for end-of-life treatments.
NICE says there was substantial uncertainty because the model used a simulated treatment comparison, and the ICER could be considerably higher in real life. Because neither data collection from clinical practice or the ongoing trials would resolve the identified uncertainty, the agency determined that nivolumab is not suitable for use within the Cancer Drugs Fund.
