CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time.
For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal.

 

Begin main content

dapagliflozin

Last Updated: December 2, 2020
Result type: Reports
Project Number: SR0642-000
Product Line: Reimbursement Review

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

  1. 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.

Key Milestones2

Call for patient input openMarch 03, 2020
Call for patient input closedApril 22, 2020
Clarification:

- Patient input submission received from Cardiac Health Foundation of Canada, Heart Failure Support Group of Manitoba and HeartLife Foundation

Submission receivedMarch 31, 2020
Submission acceptedApril 27, 2020
Clarification:

- Submission was not accepted for review on 15 Apr 2020

- Revised category 1 requirements received on 27 Apr 2020

Review initiatedApril 28, 2020
Draft CADTH review report(s) provided to sponsor for commentJuly 29, 2020
Deadline for sponsors commentsAugust 10, 2020
CADTH responses on draft review report(s) provided to sponsorNovember 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 sponsorDecember 02, 2020
End of embargo periodDecember 16, 2020