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
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 posted May 17, 2019 Patient group input closed July 09, 2019 Clarification: - No patient input submission received
Submission received June 17, 2019 Submission accepted for review July 02, 2019 Review initiated July 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 sponsor October 22, 2019 Comments from sponsor on draft CADTH review report(s) received October 31, 2019 CADTH review team's comments on draft CADTH review report(s) sent to sponsor November 29, 2019 Canadian Drug Expert Committee (CDEC) meeting December 11, 2019 CDEC recommendation sent to sponsor and drug plans December 23, 2019 To January 02, 2020