Amarin Provides Pricing & Reimbursement Updates for VAZKEPA (icosapent ethyl) in The Netherlands and Italy

– Dutch Ministry of Health Approves VAZKEPA (icosapent ethyl) for National Reimbursement to Reduce the Risk of Cardiovascular Events in Patients with Established Cardiovascular Disease –

– Italy’s AIFA Pricing & Reimbursement Committee (CPR) Issues Negative Decision on VAZKEPA; Follows Positive Scientific Assessment by the Italian Scientific Technical Committee (CTS) –

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced pricing and reimbursement updates for VAZKEPA (icosapent ethyl) in the Netherlands and Italy.

In the Netherlands, the Dutch Ministry of Health has approved VAZKEPA (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients with established cardiovascular disease and elevated triglycerides (≥ 1,7 and ≤ 5,6 mmol/l). The national reimbursement will now allow Amarin to begin efforts to commercialize VAZKEPA across the Netherlands in September.

Cardiovascular disease (CVD) is a substantial issue in the Netherlands with ~1.7 million people suffering from the disease. Every day, approximately 100 people die of CVD and approximately 640 CVD patients are admitted to hospital¹, significantly impacting patients, their families and the Dutch healthcare system.

“With the approval and reimbursement of VAZKEPA in the Netherlands, Dutch cardiovascular patients and physicians now have access to an important new treatment option to reduce cardiovascular risk and improve health outcomes,” said Patrick Holt, President and CEO of Amarin. “Today’s approval is a testament to the strength of VAZKEPA’s scientific data and evidence from the REDUCE-IT study, which included more than 1,600 Dutch patients across more than 40 clinical trial sites in the Netherlands.”

In Italy, AIFA has issued a decision to not reimburse VAZKEPA at this time. The decision follows a positive scientific assessment issued by the Italian Scientific Technical Committee (CTS), support through positive interactions with Italian healthcare professionals and collaborative negotiations with the Italian authorities to reach an appropriate price for VAZKEPA. Amarin is continuing to engage with AIFA on all possible options – including a resubmission - to secure a positive pricing outcome and ensure access to VAZKEPA in the interest of patients across Italy.