Vol. 5 No. 10 (2025)
Reimbursement Recommendations

Pembrolizumab (Keytruda)

decorative image of the issue cover

Published October 22, 2025

Key Messages

  • Canada’s Drug Agency (CDA-AMC) recommends that Keytruda should be reimbursed by public drug plans for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 (combined positive score [CPS] ≥ 1), as determined by a validated test, as neoadjuvant treatment (before surgery) as monotherapy, continued as adjuvant treatment (after surgery) in combination with radiotherapy (RT) with or without cisplatin, and then as monotherapy, if certain conditions are met.
  • Keytruda should only be covered to treat patients aged 18 years or older who have newly diagnosed, locally advanced HNSCC that can be removed by surgery. Their tumours must test positive for PD-L1 (CPS ≥ 1), and they should be in relatively good health (as measured by performance status). Keytruda should not be covered for patients who have more advanced disease (T4b and/or N3 cancer stage or distant spread); cancer outside the mouth, throat, or voice box; or have received prior treatment for head and neck cancer. Exceptions may be made for patients with resectable recurrence more than 6 months after previous treatment.
  • Keytruda should only be reimbursed if it is prescribed by clinicians with expertise in managing head and neck cancer and the cost of Keytruda is reduced.