Nivolumab for adjuvant treatment of invasive urothelial cancer at high risk of recurrence

1.1 Nivolumab is recommended as an option for the adjuvant treatment of muscle-invasive urothelial cancer that is at high risk of recurrence after radical resection in adults whose tumours express PD-L1 at a level of 1% or more. It is recommended only if:

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

Radical resection (surgery) aims to remove all traces of the cancer. Adjuvant treatment aims to reduce the risk of the cancer returning after resection. Standard care for muscle-invasive urothelial cancer that is at high risk of recurrence after radical resection is adjuvant treatment with platinum‑based chemotherapy or best supportive care.

Clinical trial evidence shows that adjuvant treatment with nivolumab reduces the risk of the cancer coming back compared with placebo. However, it is uncertain whether nivolumab increases how long people live because this data is not available yet. An indirect treatment comparison of nivolumab with platinum‑based chemotherapy is also highly uncertain.

The company did not provide cost-effectiveness estimates comparing nivolumab with platinum‑based chemotherapy. The most likely cost-effectiveness estimates for nivolumab compared with best supportive care are uncertain. But, these estimates are within what NICE usually considers an acceptable use of NHS resources when platinum‑based chemotherapy is not a suitable option. So, adjuvant treatment with nivolumab is recommended only if platinum‑based adjuvant chemotherapy is not suitable.