SMC accepts VAZKEPA®▼(icosapent ethyl) to help reduce the risk of heart attacks and strokes for patients in Scotland1

SMC accepts VAZKEPA®▼(icosapent ethyl) to help reduce the risk of heart attacks and strokes for patients in Scotland¹

Icosapent ethyl has been accepted by the SMC for restricted use within NHSScotland, as secondary prevention in adult statin-treated patients at high cardiovascular risk who have elevated fasting triglycerides (≥ 1.7 mmol/L), LDL-C levels >1.04 mmol/L and ≤ 2.60 mmol/L, and established CVD.¹

London, UK August 07, 2023 – Amarin today announced the Scottish Medicines Consortium (SMC) has accepted the restricted use of icosapent ethyl 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 hospitalisation); coronary or other arterial revascularisation procedures; coronary heart disease; ischaemic stroke; or peripheral arterial disease.¹

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 (CV) 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

Professor Adrian Brady, Consultant Cardiologist at Glasgow Royal Infirmary, said: “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.”

Amarin is working with Health Boards across Scotland to secure formulary inclusion and ensure that as many of the eligible population will be able to have access to icosapent ethyl by the end of 2023.

Scott Curley, Amarin’s UK & Ireland General Manager, said: “The introduction of icosapent ethyl to the Scottish Healthcare System marks an important milestone in reducing CVD.

“As a Scotsman whose family has felt the suffering and pain caused by this devastating disease, I have been focused on ensuring eligible patients in Scotland have access to icosapent ethyl, as they do in England, Wales, and Northern Ireland. Scotland’s death rates from heart and circulatory disease are higher than in the rest of the UK. The SMC’s acceptance of icosapent ethyl will help to reduce the risk of CV events amongst a high proportion of patients across Scotland, and the impact this disease has on them and their families. Amarin is committed to working with the Scottish Health Board Formulary Committees to make this additional treatment option available to the appropriate patients with CVD as soon as possible.”

VAZKEPA offers an innovative therapy for patients with CVD, and the results of the REDUCE-IT Trial demonstrate the benefits of its use for optimising the outcomes of patients at high risk of CV events, on top of standard of care with statins.^5,6

The REDUCE-IT Trial, which randomised 8,179 statin-treated patients over an average of 4.9 years, demonstrated that treatment with icosapent ethyl compared to placebo resulted in a 25% relative reduction in the risk of future major adverse CV events (a composite of CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or hospitalisation for unstable angina), a 4.8% absolute risk reduction with a number needed to treat to avoid one event of 21; p < 0.001, HR 0.75 (95% CI, 0.68-0.83).⁵

The most frequently reported adverse reactions associated with Vazkepa were bleeding, peripheral oedema, atrial fibrillation or flutter, constipation, musculoskeletal pain, gout, eructation, and rash. Contraindications to VAZKEPA include; Hypersensitivity to the active substance or to any of the excipients, allergies to soya, peanut; and hereditary fructose intolerance (HFI). Special warnings and precautions include; Allergy to fish/shellfish, hepatic impairment, atrial fibrillation/flutter, and bleeding. Please refer to the SmPC for full information regarding adverse events, contraindications, special warnings, and precautions for VAZKEPA before prescribing.⁷

References

1. Scottish Medicines Consortium. Icosapent Ethly (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.
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.
5. Bhatt DL, Steg PG, Miller M et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019; 380(1):11-22.
6. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy After Acute Coronary Syndromes. N Engl J Med. 2015;372(25):2387-97.
7. VAZKEPA (icosapent ethyl) Summary of Product Characteristics (April 2022) https://www.medicines.org.uk/emc/product/12964/smpc. Accessed August 2023.