empagliflozin

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Generic Name:
empagliflozin
Project Status:
Complete
Therapeutic Area:
Heart failure
Manufacturer:
Boehringer Ingelheim Canada Ltd.
Call for patient/clinician input open:
Brand Name:
Jardiance
Project Line:
Reimbursement Review
Project Number:
SR0726-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of heart failure in patients with New York Heart Association (NYHA) class II, III, or IV. To be used as an adjunct to standard of care therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Jardiance is indicated in adults, as an adjunct to standard of care therapy for the treatment of chronic heart failure.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 openMarch 09, 2022
Call for patient/clinician input closedApril 29, 2022
Clarification:

- Patient input submission received from the HeartLife Foundation

Submission receivedApril 06, 2022
Submission acceptedApril 21, 2022
Review initiatedApril 22, 2022
Draft CADTH review report(s) provided to sponsor for commentJuly 07, 2022
Deadline for sponsors commentsJuly 18, 2022
CADTH review report(s) and responses to comments provided to sponsorAugust 12, 2022
Expert committee meeting (initial)August 24, 2022
Draft recommendation issued to sponsorSeptember 06, 2022
Draft recommendation posted for stakeholder feedbackSeptember 15, 2022
End of feedback periodSeptember 29, 2022
Final recommendation issued to sponsor and drug plansOctober 14, 2022
Final recommendation postedNovember 01, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 28, 2022
CADTH review report(s) postedJanuary 20, 2023