Last Updated : April 15, 2025
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Head and neck squamous cell carcinoma
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0410-000
Call for patient/clinician input closed:
Tumour Type:
Head and Neck
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without platinum-containing chemotherapy and then as monotherapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without platinum-containing chemotherapy and then as monotherapy.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | 31-Jan-25 |
|---|---|
| Call for patient/clinician input closed | 31-Mar-25 |
| Submission received | 18-Mar-25 |
| Submission accepted | 01-Apr-25 |
| Review initiated | 02-Apr-25 |
| Draft CADTH review report(s) provided to sponsor for comment | 18-Jun-25 |
| Deadline for sponsors comments | 27-Jun-25 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 31-Jul-25 |
| Expert committee meeting (initial) | 13-Aug-25 |
| Draft recommendation issued to sponsor | August 25, 2025 To August 27, 2025 |
| Draft recommendation posted for stakeholder feedback | 04-Sep-25 |
| End of feedback period | 18-Sep-25 |
Files
Last Updated : April 15, 2025