Last Updated : January 22, 2018
Details
FilesGeneric Name:
Irinotecan Liposome
Project Status:
Complete
Therapeutic Area:
Metastatic Pancreatic Cancer
Manufacturer:
Shire Canada
Brand Name:
Onivyde
Project Line:
Reimbursement Review
Project Number:
PC0107-000
NOC Status at Filing:
Pre NOC
Strength:
4.3 mg/mL
Tumour Type:
Gastrointestinal
Indications:
Metastatic Pancreatic Cancer
Funding Request:
For the treatment of metastatic adenocarcinoma of the pancreas in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in adult patients who have been previously treated with gemcitabine-based therapy
Pre Noc Submission:
Yes
Sponsor:
Shire Canada
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:
As per Section 4.1.1 subsection a) of the pCODR Procedures, the timeline of the review was temporarily stopped pending rescheduling of the Checkpoint Meeting, as per the request of Shire Canada Inc.
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 22, 2018