Last Updated : November 10, 2021
Details
FilesGeneric Name:
dapagliflozin
Project Status:
Complete
Therapeutic Area:
Heart failure with reduced ejection fraction
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Forxiga
Project Line:
Reimbursement Review
Project Number:
SR0642-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of heart failure (HF) with reduced
ejection fraction in patients with New York Heart Association (NYHA) class II,
III, or IV HF to reduce the risk of cardiovascular (CV) death, hospitalization
for heart failure and urgent heart failure visit, and to improve heart failure
symptoms, if the following clinical
criteria are met:
Reduced left ventricular ejection fraction (LVEF) ( 40%).
As an adjunct to standard of care therapy, such as a
stable dose of an angiotensin-converting enzyme inhibitor (ACEi) or an
angiotensin II receptor antagonist (ARB), a beta blocker and an aldosterone
antagonist (if tolerable).
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Forxiga is indicated in adults, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) to reduce the risk of CV death, hospitalization for heart failure and urgent heart failure visit, and to improve heart failure symptoms.
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 Milestones |
|
|---|---|
| Call for patient input open | March 03, 2020 |
| Call for patient input closed | April 22, 2020 |
| Clarification:
- Patient input submission received from Cardiac Health Foundation of Canada, Heart Failure Support Group of Manitoba and HeartLife Foundation |
|
| Submission received | March 31, 2020 |
| Submission accepted | April 27, 2020 |
| Clarification:
- Submission was not accepted for review on 15 Apr 2020 - Revised category 1 requirements received on 27 Apr 2020 |
|
| Review initiated | April 28, 2020 |
| Draft CADTH review report(s) provided to sponsor for comment | July 29, 2020 |
| Deadline for sponsors comments | August 10, 2020 |
| CADTH responses on draft review report(s) provided to sponsor | November 06, 2020 |
| Clarification:
- Submission temporarily suspended at the request of the sponsor - The temporary suspension of the review has been lifted |
|
| Expert committee meeting (initial) | November 18, 2020 |
| Draft recommendation issued to sponsor | December 02, 2020 |
| End of embargo period | December 16, 2020 |
| Final recommendation issued to sponsor and drug plans | December 23, 2020 |
| Final recommendation posted | January 06, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 14, 2021 |
| CADTH review report(s) posted | March 1, 2021 |
Files
Last Updated : November 10, 2021