Generic Name: dapagliflozin
Brand Name: Forxiga
Manufacturer: AstraZeneca Canada Inc.
Therapeutic Area: Heart failure with reduced ejection fraction
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.
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
Project Status: Active
Companion Diagnostics: No
Fee Schedule: Schedule B
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
|Call for patient input open||March 03, 2020|
|Call for patient input closed||April 22, 2020|
- 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|
- 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|
- 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|