following a full submission considered under the end of life and orphan equivalent process:
pembrolizumab (Keytruda®) is not recommended for use within NHSScotland.
Indication under review: as monotherapy, for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS)≥10.
In an open label, non-comparative phase II study of adults with advanced / metastatic urothelial cancer who had no previous treatment for advanced / metastatic disease and who were ineligible for first line cisplatin based therapy, treatment with pembrolizumab was associated with an objective response in 47% of patients with strongly positive PD-L1 expression (CPS≥10).
The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice337KB (PDF)
- Medicine name:
- pembrolizumab (Keytruda)
- SMC ID:
- As monotherapy for the treatment of locally advanced or metastatic or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy (first line)
- Pharmaceutical company
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full submission
- Not recommended
- Date advice published:
- 10 September 2018