Generic 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
Details
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.