Advice

following a full submission assessed under the end of life medicine process:

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

Indication under review: In combination with platinum and fluoropyrimidine based chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS≥10.

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

In a phase III study, pembrolizumab in combination with chemotherapy was associated with significantly improved progression-free survival and overall survival compared with chemotherapy alone.

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

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
pembrolizumab (Keytruda)
SMC ID:
SMC2420
Indication:

In combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD‑L1 with a CPS ≥10.

Pharmaceutical company
Merck Sharp & Dohme Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Restricted
Date advice published
09 May 2022