Scottish Medicines Consortium Accepts VAZKEPA® (icosapent ethyl) to Help Reduce Cardiovascular Risk for Patients in Scotland(1)

Rhea-AI Summary

Amarin Corporation plc (NASDAQ:AMRN) announces SMC acceptance of VAZKEPA® for reimbursement in Scotland for secondary prevention in high-risk statin-treated patients with established cardiovascular disease. The innovative treatment option aims to reduce the risk of subsequent cardiovascular events.

Positive

• VAZKEPA® acceptance by the Scottish Medicines Consortium is a significant achievement for Amarin Corporation, enabling patient access to an innovative treatment option in Scotland.
• The acceptance of icosapent ethyl, a highly purified omega-3 fatty acid, provides an additional treatment option for high-risk cardiovascular patients, addressing an important unmet medical need.
• Amarin's focus on working with Health Boards across Scotland to ensure formulary inclusion and access to VAZKEPA® by the end of 2023 demonstrates a commitment to patient care and outcomes.

Negative

• None.

-- VAZKEPA® (icosapent ethyl) accepted by the Scottish Medicines Consortium (SMC) for restricted use within NHSScotland, as secondary prevention in adult statin-treated patients at high cardiovascular risk¹ --

-- VAZKEPA® already commercially available in England, Wales, and Northern Ireland where NICE recommended its reimbursement and use across the National Health Service (NHS) in July 2022 --

-- Amarin now working with Health Boards across Scotland to secure formulary inclusion and ensure eligible population access to VAZKEPA® by end of 2023 --

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announces that the Scottish Medicines Consortium (SMC) has accepted VAZKEPA® (icosapent ethyl) for reimbursement with a Patient Access Scheme* for secondary prevention in patients treated with a stable dose of statins, low-density lipoprotein (LDL) cholesterol levels >1.04mmol/L and ≤2.60mmol/L, raised fasting triglycerides (≥1.7mmol/L) and with established cardiovascular disease (CVD) defined as a history of any of the following: acute coronary syndrome (ACS) such as myocardial infarction (MI) or unstable angina needing hospitalization; coronary or other arterial revascularization procedures; coronary heart disease; ischaemic stroke; or peripheral arterial disease.¹

“The acceptance of icosapent ethyl, an innovative active substance comprising a highly purified omega-3 fatty acid (eicosapentaenoic acid greater or equal to 96%), will provide healthcare professionals in Scotland with an additional treatment option to be considered for eligible patients who are at high risk of a subsequent CV event, such as a second heart attack or stroke. This represents an important step forward in the fight against CVD in Scotland,” said Professor Adrian Brady, Consultant Cardiologist at Glasgow Royal Infirmary.

CVD is a significant issue for patients and HCPs in Scotland.^2-4 While current therapies can help to reduce the risk of a first or recurrent major cardiovascular event, there are still at least 10,000 hospital admissions for heart attacks each year, which equates to 1 every 50 minutes, with heart and circulatory diseases causing nearly 18,000 (28%) deaths annually in Scotland.³ What’s more, CVD costs NHS Scotland around £800 million each year, with a wider estimated cost to the economy of £1.8 billion.^3,4

“The SMC’s acceptance and reimbursement of VAZKEPA® is an important development for patients at high cardiovascular risk in Scotland, who will now have access to an innovative treatment option to improve their outcomes. Our UK team will now be focused on working with health boards to secure formulary inclusion and make VAZKEPA® available to these patients as quickly as possible,” said Patrick Holt, President and CEO of Amarin. 

Amarin is working with Health Boards across Scotland to secure formulary inclusion and ensure that as many patients as possible among the eligible population will have access to VAZKEPA® by the end of 2023.

The Company 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.

*Patient Access Schemes are confidential pricing agreements proposed by pharmaceutical companies to enable patient access to new medicines and treatments.  The Patient Access Scheme Assessment Group (PASAG) reviews and advises NHSScotland on the feasibility of proposed schemes for implementation. It operates separately from SMC. 

References

1. Scottish Medicines Consortium. Icosapent Ethyl (SMC2602). https://www.scottishmedicines.org.uk/medicines-advice/icosapent-ethyl-vazkepa-ft-resub-smc2602/. Accessed August 2023.
2. National Institute for Health and Care Excellence. Clinical Knowledge Summary. CVD risk assessment and management: What is the impact of CVD? May 2023. https://cks.nice.org.uk/topics/cvd-risk-assessment-management/background-information/burden-of-cvd/. Accessed August 2023.
3. British Heart Foundation. Scotland Factsheet. BHF. February 2023. https://www.bhf.org.uk/-/media/files/for-professionals/research/heart-statistics/bhf-cvd-statistics-scotland-factsheet.pdf. Accessed August 2023 (from the UK).
4. British Heart Foundation. The CVD Challenge in Scotland. 2018. https://www.bhf.org.uk/for-professionals/healthcare-professionals/data-and-statistics/the-cvd-challenge/the-cvd-challenge-in-scotland. Accessed August 2023. 

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 which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the acceptance and reimbursement of VAZKEPA in Scotland; the effect of Amarin’s entry into Scotland and its continued efforts to expand into other key international markets; and the overall potential and future success of VASCEPA (marketed as VAZKEPA in Europe) and Amarin generally. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further 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 full year ended 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

FAQ

What is the significance of SMC's acceptance of VAZKEPA® for Amarin Corporation?

The SMC's acceptance of VAZKEPA® is a significant achievement for Amarin Corporation, enabling patient access to an innovative treatment option in Scotland.

What is the purpose of VAZKEPA® in Scotland?

VAZKEPA® is aimed at providing an additional treatment option for high-risk cardiovascular patients in Scotland, addressing an important unmet medical need.

How is Amarin working to ensure patient access to VAZKEPA® in Scotland?

Amarin is working with Health Boards across Scotland to secure formulary inclusion and ensure access to VAZKEPA® by the end of 2023, demonstrating a commitment to patient care and outcomes.