Single tablet cholesterol-lowering combination accepted for NHS use in Scotland

Single tablet cholesterol-lowering combination accepted for NHS use in Scotland

• High blood cholesterol increases the risk of cardiovascular disease (CVD), which was the leading cause of death in Scotland in 2020, equating to nearly 50 people every day.[i]^,[ii]
• In clinical trials, over 80% of CVD patients do not reach guideline-recommended cholesterol goals despite taking moderate to high intensity statins.[iii]
• NUSTENDI^®▼ (bempedoic acid / ezetimibe) fixed dose combination is an oral treatment combining two complementary ways of reducing cholesterol in a once-daily tablet.[iv]

UXBRIDGE, UK, (11 October 2021) – Daiichi Sankyo is pleased to announce that the Scottish Medicines Consortium (SMC) has today accepted bempedoic acid / ezetimibe fixed-dose combination tablet,⁴ for treating patients in Scotland with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet for use in patients who are:[v]

• Statin intolerant or for whom a statin is contraindicated and
• Where ezetimibe alone does not appropriately control LDL-C (low-density lipoprotein cholesterol) and
• Where proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are not appropriate.

The SMC has previously accepted bempedoic acid for restricted use in combination with ezetimibe for this indication. Bempedoic acid / ezetimibe provides a single tablet alternative to bempedoic acid plus ezetimibe.⁵

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.⁵

This medicine provides a single tablet alternative to taking bempedoic acid and ezetimibe as separate tablets. Bempedoic acid was recommended by the SMC earlier this year and marked the first oral cholesterol-lowering treatment to be made available to Scottish patients in over 18 years.[vi]

Today’s SMC Advice means eligible patients will now have access to a single-tablet therapy that combines two complementary ways of reducing cholesterol, while helping to reduce pill burden associated with multiple medications.

“The SMC’s recommendation means that bempedoic acid and ezetimibe can now be prescribed together in a fixed-dose combination, providing two complementary ways of reducing LDL-C,” commented Professor Adrian Brady, Honorary Professor, University of Glasgow and Consultant Cardiologist, Glasgow Royal Infirmary. “This once-daily formulation can contribute to improving medication management and helping to alleviate pill burden, a common challenge in cardiovascular care. The use of multiple medications can become overwhelming for some CVD patients, leading to low treatment adherence and contributing to poorer clinical outcomes. Today’s announcement therefore provides another option for those who require additional therapies to reach their LDL-C goals.”

There are an estimated 700,000 people living with heart and circulatory diseases in Scotland and just over a quarter of related deaths are associated with high LDL-C.² As part of its Heart Disease Action Plan 2021, the Scottish Government has highlighted the need to tackle risk factors, such as high cholesterol, as a key priority to minimise preventable heart disease and stroke.[vii] Cholesterol is often referred to as a “hidden risk factor” due to it not carrying any typical signs or symptoms, highlighting the importance of testing.[viii]

Manuel Reiberg, Managing Director, Daiichi Sankyo UK said: "This approval by the SMC marks an important step for patients, their physicians and the health system. At Daiichi Sankyo, our aim is to help reduce the impact of CVD and to tackle the biggest population health challenges. We are proud that we can now bring this option to areas of high unmet need and we remain committed to partnering with and supporting the CVD patient community in Scotland and the rest of the UK."

[i] NHS. Cardiovascular Disease. Available at: https://www.nhs.uk/conditions/cardiovascular-disease/ Last accessed October 2021.

[ii] British Heart Foundation. Scotland Factsheet. 2020. Available at: https://www.bhf.org.uk/what-we-do/our-research/heart-statistics Last accessed October 2021.

[iii] Fox KM, et al. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving
   high- or moderate-intensity statins. Clin Res Cardiol 2018; 107: 380–388.

[iv] EMC. NUSTENDI® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11744/smpc Last accessed October 2021.

[v] SMC. Medicine advice: Detailed Advice Document. Bempedoic acid / Ezetimibe (Nustendi) SMC ID: SMC2406.

[vi] SMC. Medicines advice. Ezetimibe (Ezetrol) SMC ID: 61/03. Available at: https://www.scottishmedicines.org.uk/medicines-advice/ezetimibe-ezetrol-fullsubmission-6103/. Last accessed October 2021.

[vii] Scottish Government. Heart Disease Action Plan 2021. Available at: https://www.gov.scot/publications/heart-disease-action-plan/ Last accessed October 2021.

[viii] British Heart Foundation. High Cholesterol – Causes, Symptoms & Treatments. Available at: https://www.bhf.org.uk/informationsupport/risk-factors/high-cholesterol. Last accessed October 2021.