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Amarin Received Positive Recommendation from UK National Institute for Health and Care Excellence for Reimbursement of VAZKEPA

Amarin Corporation plc (NASDAQ: AMRN) today announces that the UK's National Institute for Health and Care Excellence (NICE) is recommending icosapent ethyl (marketed under the brand name VAZKEPA®) for reimbursement and use across the National Health Servi...

Benzinga · 06/10/2022 06:03
Amarin Corporation plc (NASDAQ:AMRN) today announces that the UK's National Institute for Health and Care Excellence (NICE) is recommending icosapent ethyl (marketed under the brand name VAZKEPA®) for reimbursement and use across the National Health Service (NHS) in England and Wales to reduce the risk of cardiovascular (CV) events in adult statin-treated patients at high cardiovascular risk who have elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]), LDL-C levels >1.04 mmol/L (and ≤ 2.60 mmol/L) and established cardiovascular disease (eCVD), at a price of £144.21 per 120 soft capsules (i.e. 30-day supply; equivalent of approximately 170 EUR or 181 USD*).1,2 "We are extremely pleased with today's positive recommendation by NICE," said Karim Mikhail, president and chief executive officer. "This is another important step forward in successfully executing our European growth strategy, and considering that the UK has historically served as a reference market with regard to Health Technology Assessments, it is a major step toward unlocking the company's multi-billion-dollar revenue opportunity outside of the U.S.**" Cardiovascular disease ranks as one of the UK's leading causes of death3. More than six million people live with cardiovascular disease in England, costing the NHS around £7.4 billion each year3,4. VAZKEPA represents an important scientific innovation for reducing cardiovascular risk in eligible patients across England and Wales, supported by the clinical data from the landmark REDUCE-IT® cardiovascular outcome study5. The Final Appraisal Document (FAD) is part of NICE's Health Technology Appraisal (HTA) process aimed at making recommendations on both the clinical and cost effectiveness of medicines and treatments in England to help ensure that the NHS uses its resources fairly and cost-effectively. Today's FAD represents the NICE appraisal committee's draft final guidance related to the use of icosapent ethyl within the NHS in England. NICE's final guidance is expected to be published on the 13th of July 2022, after which all local NHS formularies are expected to make the product available within 3 months. Based on a collaboration with the Welsh Government and the All Wales Medicines Strategy Group (AWMSG), the final NICE guidances will also apply to Wales and be implemented across the NHS in Wales. "This positive recommendation is the outcome of many months of constructive scientific discussions with multiple stakeholders and a detailed systematic review of clinical and economic evidence," commented Laurent Abuaf, senior vice president and president Amarin Europe. "Following Sweden, this is now the second Health Technology Assessment in Europe that recognizes the potential value of VAZKEPA for strengthening cardiovascular care in England and Wales, following a very rigorous clinical and economic evaluation process. We look forward to working with all relevant stakeholders in the NHS to offer this important new treatment option to eligible cardiovascular patients across these countries in the UK." In parallel, Amarin continues to progress well with its reimbursement discussions in the other 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