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

Rhea-AI Summary

Amarin Corporation announced pricing and reimbursement updates for VAZKEPA in the Netherlands and Italy. The Dutch Ministry of Health has approved VAZKEPA for national reimbursement to reduce the risk of cardiovascular events in statin-treated patients with established cardiovascular disease and elevated triglycerides. In Italy, AIFA has issued a decision to not reimburse VAZKEPA at this time.

Positive

• The approval and reimbursement of VAZKEPA in the Netherlands will allow Amarin to begin efforts to commercialize the drug in September.
• Approximately 1.7 million people in the Netherlands suffer from cardiovascular disease, and the approval of VAZKEPA provides an important new treatment option for them.
• In Italy, cardiovascular diseases are responsible for 35.8% of all deaths, and Amarin is disappointed with the decision to not reimburse VAZKEPA.
• Amarin is continuing to engage with AIFA to secure a positive pricing outcome and ensure access to VAZKEPA in Italy.

Negative

• The negative decision by AIFA in Italy could impact the potential market for VAZKEPA in the country.

– 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.

“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.

About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.

Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of U.S. securities laws, including, but not limited to, expectations regarding the Dutch approval of VAZKEPA for national reimbursement and the market potential in that territory;  the negative decision on pricing in Italy, and Amarin’s plan to continue seeking pricing and reimbursement in that country; Amarin’s continued efforts to advance its pricing and reimbursement discussions in a number of other European markets;  and beliefs about the overall world-wide market potential and success of VASCEPA/VAZKEPA generally. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the year ended December 31, 2022. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.

Availability of Other Information About Amarin 
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (amarincorp.gcs-web.com), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin Contact Information
Investor Inquiries:
Jordan Zwick
Amarin Corporation plc
IR@amarincorp.com

Media Inquiries:
Mark Marmur
Amarin Corporation plc
PR@amarincorp.com

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¹ https://www.hartstichting.nl/hart-en-vaatziekten/cijfers-hart-en-vaatziekten
² Prevenzione Italia 2021. Un update del Documento di consenso e raccomandazioni per la prevenzione cardiovascolare in Italia
(https://www.siprec.it/prevenzione-italia-2021/)

FAQ

What is the approval status of VAZKEPA in the Netherlands?

The Dutch Ministry of Health has approved VAZKEPA for national reimbursement to reduce the risk of cardiovascular events in statin-treated patients with established cardiovascular disease and elevated triglycerides.

How many people in the Netherlands suffer from cardiovascular disease?

Approximately 1.7 million people in the Netherlands suffer from cardiovascular disease.

What is the decision of AIFA regarding VAZKEPA in Italy?

AIFA has issued a decision to not reimburse VAZKEPA at this time.

What percentage of deaths in Italy are caused by cardiovascular diseases?

Cardiovascular diseases are responsible for 35.8% of all deaths in Italy.

What is Amarin's response to the decision by AIFA?

Amarin is disappointed with the decision and is continuing to engage with AIFA to secure a positive pricing outcome and ensure access to VAZKEPA in Italy.