Last Updated : September 8, 2017
Details
FilesGeneric Name:
Blinatumomab
Project Status:
Complete
Therapeutic Area:
Acute Lymphoblastic Leukemia (pediatric)
Manufacturer:
Amgen Canada Inc.
Brand Name:
Blincyto
Project Line:
Reimbursement Review
Project Number:
PC0099 -000
Performance Metric:
Achieved
Strength:
38.5mcg vial
Tumour Type:
Leukemia
Indications:
Pediatric Acute Lymphoblastic Leukemia (ALL)
Funding Request:
For the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL)
Pre Noc Submission:
Yes
Sponsor:
Amgen 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 had initially advised that Category 2 submission requirements for a pre-NOC submission would not be available to complete the submission for a June pERC meeting date. An updated target date for the pERC meeting had 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:
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 : September 8, 2017