dapagliflozin


( Last Updated : November 10, 2021)
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:

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:
  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 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