following a full submission:

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

Indication under review: as monotherapy for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults.

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

In an open-label, phase III study, pembrolizumab monotherapy was associated with significantly improved progression-free survival compared with investigator’s choice of chemotherapy in patients with metastatic MSI-H/dMMR colorectal cancer.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

Medicine details

Medicine name:
pembrolizumab (Keytruda)

As monotherapy for the first‑line treatment of metastatic microsatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) colorectal cancer in adults.

Pharmaceutical company
Merck Sharp & Dohme Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Date advice published
13 September 2021