CDA | Evidence Driven
CDA | Evidence Driven

Blincyto for MRD-positive B-cell precursor ALL — Details

Details

Files
Generic Name:
Blinatumomab
Project Status:
Complete
Therapeutic Area:
MRD+ ALL Resubmission
Manufacturer:
Amgen Canada Inc
Brand Name:
Blincyto
Project Line:
Reimbursement Review
Project Number:
PC0204-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Strength:
38.5 mcg
Tumour Type:
Leukemia
Indications:
Minimal Residual Disease (MRD)-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (BCP ALL)
Funding Request:
Patients with Philadelphia chromosome-negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
Sponsor:
Amgen Canada Inc
Submission Date:
Submission Deemed Complete:
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

Blinatumomab (Blincyto) MRD+ BCP ALL – pERC Final Recommendation Final Recommendation October 29, 2020 View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – Final Economic Guidance Report Guidance Report October 29, 2020 View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – Final Clinical Guidance Report Guidance Report October 29, 2020 View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – pERC Initial Recommendation Initial Recommendation September 3, 2020 View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – PAG Feedback on Initial Recommendation Feedback View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – Manufacturer Feedback on Initial Recommendation Feedback October 29, 2020 View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – Patient Advocacy Group Feedback on Initial Recommendation Feedback October 29, 2020 View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – Clinician Feedback on Initial Recommendation Feedback October 29, 2020 View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – Patient Advocacy Group COI Declarations COI Declarations View PDF
Blinatumomab (Blincyto) MRD+ BCP ALL – Clinician COI Declarations COI Declarations October 29, 2020 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 : November 17, 2020