Keytruda for Advanced Non-Small Cell Lung Carcinoma (First Line) – Details

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Generic Name:
Pembrolizumab
Project Status:
Complete
Therapeutic Area:
Advanced non-small cell lung carcinoma (first line)
Manufacturer:
Merck Canada Inc.
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0101-000
NOC Status at Filing:
Pre NOC
Strength:
50mg vial
Tumour Type:
Lung
Indications:
Non-Small Cell Lung Carcinoma (First Line)
Funding Request:
For previously untreated patients with metastatic NSCLC whose tumours express PD-L1 and who do not harbor a sensitizing EGFR mutation or ALK translocation. Funding is being requested for patients with a TPS (Tumour Proportion Score) of PD-L1 ≥50%.
Pre Noc Submission:
Yes
Sponsor:
Merck Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Not Granted
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
Clarification:
The Manufacturer has advised that Category 2 submission requirements for a pre-NOC submission will not be available to complete the submission for a June pERC meeting date. An updated target date for the pERC meeting has been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements.
pERC Meeting:
Final Recommendation Issued:

‡ 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.