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icosapent ethyl

Last Updated: August 26, 2020
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 cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to: established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor.

Submission Type: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: July 16, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 acceptedJuly 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 plansJanuary 16, 2020
Embargo period endedFebruary 28, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaMay 20, 2020
Clarification:

- Deferred to June 17, 2020 CDEC meeting

CDEC recommendation sent to sponsor and drug plansJune 24, 2020
Embargo period endedJuly 09, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansJuly 16, 2020
CDEC Final Recommendation postedJuly 20, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedJuly 30, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansAugust 12, 2020
Validation of redacted CADTH review report(s) receivedAugust 19, 2020
Final CADTH review report(s) postedAugust 26, 2020