1.1 Nivolumab with ipilimumab is recommended for use within the Cancer Drugs Fund as an option for adults with untreated advanced renal cell carcinoma that is intermediate- or poor-risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria. It is recommended only if the conditions in the managed access agreement for nivolumab with ipilimumab are followed.
1.2 This recommendation is not intended to affect treatment of nivolumab with ipilimumab 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
Current treatment for untreated advanced renal cell carcinoma is usually pazopanib, sunitinib, tivozanib or cabozantinib.
For people with untreated advanced renal cell carcinoma that is at intermediate or high risk of getting worse, the results of a clinical trial (CheckMate 214) show that nivolumab with ipilimumab is more effective than sunitinib in the short term, but its long-term effects are uncertain.
Nivolumab with ipilimumab has the potential to be cost effective, but more evidence is needed to address the clinical uncertainties. Longer-term follow-up of patients in CheckMate 214 would help to address the uncertainties about how long people live, and how long they live without their disease getting worse. Therefore, nivolumab with ipilimumab is recommended for use in the Cancer Drugs Fund for people who have untreated advanced renal cell carcinoma, while the manufacturer of nivolumab and ipilimumab collects further data.