Last Updated : January 24, 2023
Details
FilesGeneric 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:
- 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 open | March 09, 2022 |
| Call for patient/clinician input closed | April 29, 2022 |
| Clarification: - Patient input submission received from the HeartLife Foundation | |
| Submission received | April 06, 2022 |
| Submission accepted | April 21, 2022 |
| Review initiated | April 22, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | July 07, 2022 |
| Deadline for sponsors comments | July 18, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | August 12, 2022 |
| Expert committee meeting (initial) | August 24, 2022 |
| Draft recommendation issued to sponsor | September 06, 2022 |
| Draft recommendation posted for stakeholder feedback | September 15, 2022 |
| End of feedback period | September 29, 2022 |
| Final recommendation issued to sponsor and drug plans | October 14, 2022 |
| Final recommendation posted | November 01, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 28, 2022 |
| CADTH review report(s) posted | January 20, 2023 |
Files
Last Updated : January 24, 2023