Last Updated : January 11, 2018
Details
FilesGeneric Name:
Midostaurin
Project Status:
Complete
Therapeutic Area:
Acute Myeloid Leukemia
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Rydapt
Project Line:
Reimbursement Review
Project Number:
PC0108-000
NOC Status at Filing:
Pre NOC
Strength:
25 mg
Tumour Type:
Leukemia
Indications:
Acute Myeloid Leukemia
Funding Request:
In combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML)
Pre Noc Submission:
Yes
Sponsor:
Novartis Pharmaceuticals Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse
Clarification:
The timeline of the review was temporarily stopped as of July 27, pending receipt of updated economic information from the submitter. The documents were received, and the submission resumed on August 17.
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 11, 2018