CDA | Evidence Driven
CDA | Evidence Driven

vericiguat

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Generic Name:
vericiguat
Project Status:
Complete
Therapeutic Area:
Heart failure
Manufacturer:
Bayer Inc.
Call for patient/clinician input open:
Brand Name:
Verquvo
Project Line:
Reimbursement Review
Project Number:
SR0758-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Bayer requests VERQUVO be reimbursed for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent heart failure decompensation event requiring hospitalization and/or intravenous diuretic therapy. VERQUVO should be used in combination with standard of care therapy for heart failure. Initiation criteria: In adult patients with New York Heart Association (NYHA) II to IV chronic HF Other HF therapies include an angiotensin-converting enzyme inhibitor (ACEi), an angiotensin II receptor antagonist (ARB) or an angiotensin receptor and neprilysin inhibitor (ARNi), a beta-blocker, and if tolerated, a mineralocorticoid receptor antagonist (MRA) VERQUVO should be initiated under the supervision of a healthcare professional who is experienced in the management of HF.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
VERQUVO (vericiguat) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent heart failure decompensation event requiring hospitalization and/or intravenous diuretic therapy. VERQUVO should be used in combination with standard of care therapy for heart failure.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open15-Sep-22
Call for patient/clinician input closed04-Nov-22
Clarification:

- Patient input submission received from HeartLife Foundation and Heart function clinic Vancouver General Hospital, St Paul's Hospital

Submission received14-Oct-22
Submission accepted28-Oct-22
Review initiated31-Oct-22
Draft CADTH review report(s) provided to sponsor for comment19-Jan-23
Deadline for sponsors comments31-Jan-23
CADTH review report(s) and responses to comments provided to sponsor09-Mar-23
Expert committee meeting (initial)22-Mar-23
Draft recommendation issued to sponsor10-May-23
Draft recommendation posted for stakeholder feedback18-May-23
End of feedback period02-Jun-23
Final recommendation issued to sponsor and drug plans14-Jun-23
Final recommendation posted30-Jun-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)28-Jun-23
CADTH review report(s) posted30-Aug-23

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : August 30, 2023