following a resubmission assessed under the end of life and orphan process
pembrolizumab (Keytruda®) is not recommended for use within NHS Scotland.
Indication under review: as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults. This submission relates to use in adults previously treated with ipilimumab.
In a phase II randomised study, pembrolizumab improved progression free survival compared with chemotherapy in patients with advanced melanoma previously treated with ipilimumab and, if BRAF V600 mutant-positive, a BRAF or MEK inhibitor.
The submitting company did not present a sufficiently robust economic analysis and in addition its justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice183KB (PDF)
Medicine details
- Medicine name:
- pembrolizumab (Keytruda)
- SMC ID:
- 1087/15
- Indication:
- As monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults. This submission relates to use in adults previously treated with ipilimumab.
- Pharmaceutical company
- MSD
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Resubmission
- Status
- Not recommended
- Date advice published
- 12 December 2016