Amarin Corp Plc (AMRN)

[veni vidi vici]

Canadian Review Timeline

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

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

Source: https://cadth.ca/icosapent-ethyl