Enfortumab vedotin with pembrolizumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic urothelial cancer in adults when platinum-based chemotherapy is suitable.
Enfortumab vedotin with pembrolizumab can only be used if the companies provide them according to their commercial arrangements.
What this means in practice
Enfortumab vedotin with pembrolizumab must be funded in the NHS in England for the condition and population in the recommendation, if it is considered the most suitable treatment option. It must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that enfortumab vedotin with pembrolizumab provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
For untreated unresectable or metastatic urothelial cancer when platinum-based chemotherapy is suitable, usual treatment is platinum-based chemotherapies (carboplatin or cisplatin, both with gemcitabine). This is followed by avelumab as maintenance treatment if the cancer has not got worse.
Clinical trial evidence shows that enfortumab vedotin with pembrolizumab increases how long people have before their cancer gets worse and how long they live compared with usual treatment.
Despite some uncertainties in the economic evidence, when considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, enfortumab vedotin with pembrolizumab can be used.