The National Institute for Health and Care Excellence (NICE) have issued a final decision not to recommend the pembrolizumab plus axitinib combination as a first-line treatment for advanced kidney cancer, despite it’s proven effectiveness at prolonging the life of kidney cancer patients.

In their Final Appraisal Document (FAD) released today, NICE stated that there was uncertainty about the long-term benefits of the pembrolizumab plus axitinib combination. NICE also made the decision the combination is too expensive to be prescribed for NHS patients.

Pembrolizumab is an immunotherapy and axitinib is a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) which act by boosting the immune system and interfering with the growth of the tumour, respectively. The combination has been shown to extend progression-free and overall survival compared with standard treatment with sunitinib. However, overall survival data remain immature.

The combination was approved for untreated advanced RCC by the European Medicines Agency in September 2019 and is available in the USA and Canada.

KCSN was a consultant for the NICE health technology appraisal of pembrolizumab plus axitinib, and have been heavily involved in the submission of a proposal for the Appraisal Consultation Document (ACD) and the appeal against the decision made in the ACD not to recommend the combination for first-line treatment of advanced RCC.

Rose Woodward said “This is really disappointing news for patients and their families. We know that without biomarkers for kidney cancer, patients and clinicians need access to the widest possible choice of effective treatments. If we continue to deny patients access to clinically effective drugs throughout the kidney cancer pathway, then our cancer survival rates will always lag behind that of other countries, and this is unacceptable. Kidney cancer patients in the UK already have one of the worst 5 year survival rates in Europe.

If you have any concerns about this disappointing news, please get in touch with Rose or Julia at the KCSN.

See the pembrolizumab/axitinib FAD on the NICE website here