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Amarin Corporation Reports NICE Issues Final Guidance for Reimbursement Making VAZKEPA® (icosapent ethyl) Available Across the NHS in England & Wales

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Amarin Corporation plc (NASDAQ: AMRN) today announced that NICE has issued its final guidance recommending VAZKEPA® (icosapent ethyl) for reimbursement and use across the National Health Service (NHS) in England and Wales to help reduce the risk of major CV events in high-risk statin-treated patients with eCVD, at a price of £144.21 per 120 soft capsules (i.e. 30 day supply; the equivalent of approximately 171 EUR or 172 USD*).

This announcement marks a major milestone for Amarin globally and in the UK, as following final guidance, all local NHS formularies in England and Wales will need to make VAZKEPA available within 90 and 60 days, respectively. Today’s final guidance also further supports the successful execution of Amarin’s European growth strategy, and the Company’s efforts to unlock the multi-billion-dollar revenue opportunities for the product outside of the U.S.**

Karim Mikhail, president and chief executive officer of Amarin said, “Receiving this final guidance from NICE is a significant moment, as it is another important step in our international expansion. Our teams in Europe are working incredibly hard to ensure a successful launch of VAZKEPA, so we can help transform the lives of CV patients across the region and move closer to realizing our bold vision of reaching the day when heart disease is no longer a leading cause of death.”

The publication of the final guidance supports the growing recognition of VAZKEPA’s clinical benefits. It is the last step in the NICE Health Technology Appraisal (HTA) process, used to assess the clinical benefits and cost-effectiveness of medicines and treatments in England to ensure the NHS uses its resources fairly and cost-effectively. Based on the collaborative relationship between the Welsh Government and the All-Wales Medicines Strategy Group (AWMSG), the final NICE guidance will also be implemented across the NHS in Wales, in line with the devolved powers of the Welsh Assembly.

Commenting on today’s news, Laurent Abuaf, senior vice president and president, Amarin Europe said, “We have a once in a generation opportunity to transform the lives of cardiovascular patients across Europe, and today’s announcement regarding NICE’s final guidance will help us realize that mission in one of our key markets. Following the successful completion of the HTA assessment in the UK, and the positive reimbursement guidance, our local teams in every country in Europe will be inspired by how the UK will be prioritizing access to local health economies. Our teams in the UK will of course work tirelessly to make this medicine available across the whole territory in the coming months.”

Off the back of this success, Amarin continues to drive forward reimbursement discussions in other major European markets and remains on track to receive pricing decisions in up to eight countries with plans to launch VAZKEPA in up to six European countries this year.

*Based on exchange rate of EUR and USD as of the date of this release.
** U.S. Dollar


References

1 National Institute for Health and Care Excellence. Final Guidance: Icosapent ethyl with statin therapy for reducing the risk of cardiovascular events in people with raised triglycerides [ID3831]. NICE; 2022. https://www.nice.org.uk/guidance/gid-ta10736/documents/final-appraisal-determination-document. Accessed July 2022.
2 VAZKEPA (icosapent ethyl) Summary of Product Characteristics (April 2022) https://www.medicines.org.uk/emc/product/12964/smpc#gref. Accessed July 2022.
3 Vazkepa® (icosapent ethyl): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf [accessed July 2022]

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