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icosapent ethyl

Last Updated: October 31, 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
Clarification:

- Submission temporarily suspended pending receipt and review of information

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) sent to sponsorOctober 22, 2019
Comments from sponsor on draft CADTH review report(s) receivedOctober 31, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 29, 2019
Canadian Drug Expert Committee (CDEC) meetingDecember 11, 2019
CDEC recommendation sent to sponsor and drug plansDecember 23, 2019
To
January 02, 2020