Last Updated : April 18, 2016
Details
FilesGeneric Name:
Blinatumomab
Project Status:
Complete
Therapeutic Area:
Acute Lymphoblastic Leukemia
Manufacturer:
Amgen Canada Inc.
Brand Name:
Blincyto
Project Line:
Reimbursement Review
Project Number:
PC0064-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Strength:
38.5 µg (mcg) vial
Tumour Type:
Leukemia
Indications:
Acute Lymphoblastic Leukemia
Funding Request:
For the treatment of 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 advised that Category 2 submission requirements for a pre-NOC submission were not available to complete the submission for a December 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. A confirmed pERC meeting date is posted as all pre-NOC submission requirements have been met
Final Recommendation Issued (target date):
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 : April 18, 2016