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

August 9, 2023 4:06 PM EDT

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.

“In Italy, cardiovascular diseases are responsible for 35.8% of all deaths, exceeding 230,000 cases annually and represent the leading cause of death and hospitalization2,” added Holt. “While we are disappointed with today’s decision, we continue to stand behind the proven therapeutic benefit of our product and we will continue our efforts to ensure patients across Italy have access to VAZKEPA to reduce their cardiovascular risk.”

Amarin continues to advance its pricing and reimbursement discussions in a number of other European markets to drive patient access across the region and will share updates as these become available.

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