CDA | Evidence Driven
CDA | Evidence Driven

andexanet alfa

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Generic Name:
andexanet alfa
Project Status:
Complete
Therapeutic Area:
Reversal of FXa inhibitor anticoagulant effects
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Ondexxya
Project Line:
Reimbursement Review
Project Number:
ST0772-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For adult patients treated with FXa inhibitors(rivaroxaban or apixaban) when rapid reversal ofanticoagulation is needed due to life-threatening oruncontrolled bleeding.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Ondexxya (andexanet alfa) is indicated for adult patientstreated with FXa inhibitors (rivaroxaban or apixaban) whenrapid reversal of anticoagulation is needed due to lifethreateningor uncontrolled bleeding.
Recommendation Type:
Do not reimburse
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open01-Feb-23
Call for patient/clinician input closed27-Mar-23
Clarification:

- Patient input submission received from VTE-COS Patient Partners (members of CanVECTOR)

Submission received02-Mar-23
Submission accepted16-Mar-23
Review initiated20-Mar-23
Draft CADTH review report(s) provided to sponsor for comment08-Jun-23
Deadline for sponsors comments19-Jun-23
CADTH review report(s) and responses to comments provided to sponsor14-Jul-23
Expert committee meeting (initial)26-Jul-23
Draft recommendation issued to sponsor09-Aug-23
Draft recommendation posted for stakeholder feedback17-Aug-23
End of feedback period31-Aug-23
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting22-Nov-23
Final recommendation issued to sponsor and drug plans05-Dec-23
Final recommendation posted21-Dec-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)19-Dec-23
CADTH review report(s) posted08-Mar-24

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : March 8, 2024