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Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy

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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 NHS before this guidance was published. People having treatment outside of 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

Pembrolizumab for previously treated locally advanced or metastatic urothelial carcinoma was recommended for use in the Cancer Drugs Fund in technology appraisal 519. This appraisal reviews the evidence collected after pembrolizumab became available through the Cancer Drugs Fund.

Treatment for this indication includes docetaxel or paclitaxel. Clinical trial evidence shows that pembrolizumab significantly improves overall survival compared with docetaxel and paclitaxel.

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.

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. Even when pembrolizumab is offered with its agreed discount, the most plausible cost-effectiveness estimate remains above what NICE normally considers acceptable for end-of-life treatments. Therefore, pembrolizumab is not recommended.

Because pembrolizumab has already been available through the Cancer Drugs Fund for locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy, it may not remain in the Cancer Drugs Fund for this indication once the guidance review has been completed.