Last Updated : September 22, 2021
Details
FilesGeneric Name:
Decitabine-Cedazuridine
Project Status:
Complete
Therapeutic Area:
Myelodysplastic Syndromes (MDS)
Manufacturer:
Taiho Pharma Canada, Inc.
Brand Name:
Inqovi
Project Line:
Reimbursement Review
Project Number:
PC0228-000
Tumour Type:
Leukemia
NOC Status at Filing:
Post NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Tumour Type:
Leukemia
Indications:
Myelodysplastic Syndromes (MDS)
Funding Request:
INQOVI (decitabine and cedazuridine) is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.
Review Status:
Notification to Implement Issued
Date NOC Issued:
Sponsor:
Taiho Pharma Canada, Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 22, 2021