following a full submission assessed under the end of life process:
pembrolizumab (Keytruda®) is accepted for restricted use within NHSScotland.
Indication under review: as monotherapy or in combination with platinum and fluorouracil chemotherapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express programmed cell death ligand-1 (PD-L1) with a combined positive score (CPS)≥1.
SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
Overall survival was longer in patients who received pembrolizumab as monotherapy or in combination with chemotherapy compared with a monoclonal antibody plus chemotherapy in a phase III study in patients with untreated, locally incurable, recurrent or metastatic HNSCC with PD-L1 CPS≥1.
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.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
- Medicine name:
- pembrolizumab (Keytruda)
- SMC ID:
As monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.
- Pharmaceutical company
- Merck Sharp & Dohme Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Date advice published
- 07 September 2020