1 Recommendations

1 Recommendations

1.1 Pembrolizumab is not recommended, within its marketing authorisation, for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy.

1.2 This recommendation is not intended to affect treatment with pembrolizumab that was started in the Cancer Drugs Fund before this guidance was published. For those people, pembrolizumab will be funded by the company until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Treatment for previously treated locally advanced or metastatic urothelial carcinoma includes docetaxel or paclitaxel. Clinical trial evidence shows that pembrolizumab significantly improves overall survival compared with docetaxel and paclitaxel. Some evidence has also been collected through the Cancer Drugs Fund.

Atezolizumab is now also a possible treatment. But it was not established clinical practice in the NHS at the time of the original appraisal, so is not included in the scope for this review.

If an active treatment is not tolerated or people choose not to have it, best supportive care is given. No clinical or cost-effectiveness evidence was available for pembrolizumab compared with best supportive care.

Pembrolizumab meets NICE's criteria to be considered a life-extending treatment at the end of life. The most likely cost-effectiveness estimate for pembrolizumab is uncertain. This is because it is not clear which model of overall survival is most appropriate or how long the treatment benefit of pembrolizumab should continue. Even when pembrolizumab is offered with its agreed discount, the most plausible cost‑effectiveness estimate remains higher than what NICE normally considers acceptable for end‑of‑life treatments. Therefore, pembrolizumab is not recommended.

  • National Institute for Health and Care Excellence (NICE)