Advice

Following a full submission assessed under the end of life and orphan medicine process:

pembrolizumab (Keytruda®) is accepted for restricted use within NHS Scotland.

Indication under review: as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.

In a phase III study of patients with measurable urothelial carcinoma with progressive disease on or after platinum based chemotherapy, treatment with pembrolizumab was associated with a statistically significant improvement in overall survival when compared with investigator’s choice of single agent chemotherapy.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

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Medicine details

Medicine name:
pembrolizumab (Keytruda)
SMC ID:
1291/18
Indication:
As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
Pharmaceutical company
MSD
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Restricted
Date advice published:
12 February 2018