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icosapent ethyl

Last Updated: July 10, 2019
Result type: Reports
Project Number: SR0619-000
Product Line: Common Drug Review

Generic Name: icosapent ethyl

Brand Name: Vascepa

Manufacturer: HLS Therapeutics

Indications: Ischemic events in statin-treated patients

Manufacturer Requested Reimbursement Criteria1: To reduce the risk of ischemic cardiovascular events (death due to cardiovascular event, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and unstable angina) in statin-treated patients with elevated triglycerides and other risk factors such as: established cardiovascular disease, or at high risk for cardiovascular disease.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  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 postedMay 17, 2019
Patient group input closedJuly 09, 2019
Clarification:

- No patient input submission received

Submission receivedJune 17, 2019
Submission accepted for reviewJuly 02, 2019
Review initiatedJuly 03, 2019
Draft CADTH review report(s) sent to applicantSeptember 17, 2019
Comments from applicant on draft CADTH review report(s) receivedSeptember 26, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to applicant and drug plansDecember 02, 2019
To
December 04, 2019