CADTH | Evidence Driven
CADTH | Evidence Driven

Besponsa for Acute Lymphoblastic Leukemia – Details

Details

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Generic Name:
Inotuzumab Ozogamicin
Project Status:
Complete
Therapeutic Area:
Acute Lymphoblastic Leukemia (ALL)
Manufacturer:
Pfizer Canada Inc.
Brand Name:
Besponsa
Project Line:
Reimbursement Review
Project Number:
PC0121-000
NOC Status at Filing:
Pre NOC
Strength:
0.9 mg/vial
Tumour Type:
Leukemia
Indications:
Acute Lymphoblastic Leukemia (ALL)
Funding Request:
For the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Pre Noc Submission:
Yes
Sponsor:
Pfizer Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
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
pERC Meeting:
Final Recommendation Issued:

Files

Provincial Funding Summary View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – pERC Final Recommendation Final Recommendation July 6, 2018 View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – Final Clinical Guidance Report Guidance Reports July 6, 2018 View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – Final Economic Guidance Report Guidance Reports July 6, 2018 View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – pERC Initial Recommendation Initial Recommendation May 3, 2018 View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – PAG Feedback on pERC Initial Recommendation Feedback July 6, 2018 View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – Manufacturer Feedback on pERC Initial Recommendation Feedback July 6, 2018 View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – Clinician Feedback on Initial Recommendation Feedback July 6, 2018 View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – Patient Group COI Declarations COI Declarations July 6, 2018 View PDF
Inotuzumab Ozogamicin (Besponsa) Acute Lymphoblastic Leukemia – Clinician COI Declarations COI Declarations July 6, 2018 View PDF

‡ 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 : July 23, 2018