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dapagliflozin

Last Updated: July 29, 2020
Result type: Reports
Project Number: SR0642-000
Product Line: Common Drug Review

Generic Name: dapagliflozin

Brand Name: Forxiga

Manufacturer: AstraZeneca Canada Inc.

Indications: Heart failure with reduced ejection fraction

Manufacturer Requested Reimbursement Criteria1: For the treatment of heart failure (HF) with reducedejection fraction in patients with New York Heart Association (NYHA) class II,III, or IV HF to reduce the risk of cardiovascular (CV) death, hospitalizationfor heart failure and urgent heart failure visit, and to improve heart failuresymptoms, if the following clinical criteria are met: Reduced left ventricular ejection fraction (LVEF) ( 40%). As an adjunct to standard of care therapy, such as astable dose of an angiotensin-converting enzyme inhibitor (ACEi) or anangiotensin II receptor antagonist (ARB), a beta blocker and an aldosteroneantagonist (if tolerable).

Submission Type: New

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 sponsorSeptember 03, 2020
Expert committee meeting (initial)September 16, 2020
Draft recommendation issuedSeptember 28, 2020
To
September 30, 2020