1.1 Avelumab is recommended as an option for maintenance treatment of locally advanced or metastatic urothelial cancer that has not progressed after platinum-based chemotherapy in adults, only if:
avelumab is stopped at 5 years of uninterrupted treatment or earlier if the disease progresses and
the company provides avelumab according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with avelumab 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
There are no maintenance treatments routinely available for locally advanced or metastatic urothelial cancer that has responded to platinum-based chemotherapy. Clinical trial evidence shows that if people take avelumab it takes longer for their cancer to get worse, and they live longer than if they have best supportive care.
Avelumab meets NICE's criteria to be considered a life-extending treatment at the end of life. This is because although there are different ways to estimate life expectancy, overall, it is likely that most people who would have been eligible for treatment with avelumab would live on average less than 24 months. The most likely cost-effectiveness estimates are within what NICE usually considers an acceptable use of NHS resources for end of life treatments. So avelumab is recommended, if it is stopped at 5 years or earlier if the disease progreses.