Last Updated : January 14, 2021
Details
FilesGeneric Name:
Pembrolizumab
Project Status:
Complete
Therapeutic Area:
head and neck squamous cell carcinoma (HNSCC)
Manufacturer:
Merck Canada
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0216-000
NOC Status at Filing:
Pre NOC
Strength:
25 mg/mL
Tumour Type:
Head and Neck
Indications:
Head and Neck Squamous Cell Carcinoma (HNSCC)
Funding Request:
First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression [Combined Positive Score (CPS) ≥ 1] as determined by a validated test.
First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in combination with platinum and fluorouracil (FU) chemotherapy, in adult patients.
Pre Noc Submission:
Yes
Sponsor:
Merck Canada
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:
Files
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
Last Updated : January 14, 2021