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| Project Number | PC0204-000 |
|---|---|
| Brand Name | Blincyto |
| Generic Name | Blinatumomab |
| Strength | 38.5 mcg |
| Tumour Type | Leukemia |
| Indication | 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% |
| Review Status | Complete |
| Pre Noc Submission | No |
| NOC Date | December 19, 2019 |
| Manufacturer | Amgen Canada Inc |
| Sponsor | Amgen Canada Inc |
| Submission Date | January 20, 2020 |
| Submission Deemed Complete | February 3, 2020 |
| Submission Type | Initial |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | February 3, 2020 |
| Check-point meeting | April 9, 2020 |
| pERC Meeting | August 20, 2020 |
| Initial Recommendation Issued | September 3, 2020 |
| Feedback Deadline ‡ | September 18, 2020 |
| pERC Reconsideration Meeting | October 15, 2020 |
| Final Recommendation Issued | October 29, 2020 |
| Notification to Implement Issued | November 13, 2020 |
| Therapeutic Area | MRD+ ALL Resubmission |
| Recommendation Type | Reimburse with clinical criteria and/or conditions |
‡ 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.
