1 Recommendations

1.1 Pembrolizumab with axitinib is not recommended, within its marketing authorisation, for untreated advanced renal cell carcinoma in adults.

1.2 This recommendation is not intended to affect treatment with pembrolizumab plus axitinib 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 includes pazopanib, tivozanib or sunitinib. Also, cabozantinib is recommended for patients with intermediate or poor-risk cancer as defined by the International Metastatic Renal Cell Carcinoma Database Consortium. Nivolumab with ipilimumab and avelumab with axitinib cannot be comparators in this appraisal because they are not established practice. Nivolumab with ipilimumab is recommended through the Cancer Drugs Fund (and so not routinely commissioned) and avelumab with axitinib is currently being appraised by NICE.

Clinical trial evidence shows that pembrolizumab with axitinib is more effective than sunitinib for people with untreated renal cell carcinoma, but it is uncertain if there is a long-term benefit. This means the cost-effectiveness estimates are uncertain.

Uncertainties in the clinical evidence would not be resolved through data collection in the Cancer Drugs Fund. So, pembrolizumab with axitinib is not recommended for use in the fund.

Pembrolizumab with axitinib does not meet NICE's criteria to be a life-extending treatment at the end of life. The cost-effectiveness estimates are higher than what NICE normally considers an acceptable use of NHS resources. Therefore, pembrolizumab with axitinib is not recommended.