Keytruda for Melanoma Adjuvant Treatment – Details

Details

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Generic Name:
Pembrolizumab
Project Status:
Complete
Therapeutic Area:
Melanoma Adjuvant Treatment
Manufacturer:
Merck Canada
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0168-000
NOC Status at Filing:
Pre NOC
Strength:
25 mg / mL and 50 mg / vial
Tumour Type:
Skin & Melanoma
Indications:
Melanoma Adjuvant Treatment
Funding Request:
For adjuvant treatment of Stage III melanoma  patients following resection ; for re-treatment of patients upon loco-regional or distant recurrence more than 6 months following completed adjuvant course of KEYTRUDA®
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:

‡ 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.