Single table 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.[1]^,[2]
• In clinical trials, over 80% of CVD patients do not reach guideline-recommended cholesterol goals despite taking moderate to high intensity statins.[3]
• NUSTENDI^®▼ (bempedoic acid / ezetimibe) fixed dose combination is an oral treatment combining two complementary ways of reducing cholesterol in a once-daily tablet.[4]

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:[5]

• 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

“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.[7] 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.[8]

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."

– ENDS –

About NUSTENDI^®

Bempedoic acid / ezetimibe is an oral treatment which combines two complementary ways of reducing cholesterol in a once-daily tablet.

Bempedoic acid / ezetimibe fixed dose combination tablet is indicated for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:⁴

• in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe,
• alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,
• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without a statin.

The most commonly reported adverse reactions for bempedoic acid / ezetimibe fixed dose combination tablet are hyperuricaemia and constipation.⁴

Full summary of product characteristics is available at www.medicines.org.uk.

About NILEMDO^®

Bempedoic acid is a first-in-class, oral, once-daily treatment with a novel mechanism of action, which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.[9] Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.⁹

Bempedoic acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:⁹

• In combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
• Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

The most commonly reported adverse reactions for bempedoic acid are hypercuricaemia, pain in extremity and anaemia.⁹

Full summary of product characteristics is available at www.medicines.org.uk.

Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid in the European Economic Area, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories.

About Daiichi Sankyo

Daiichi Sankyo UK Ltd is a UK affiliate company with corporate origins in Japan. We create and supply innovative products to help the NHS to deliver better patient care in the fields of cardiovascular disease and oncology. 

Our company was founded in 2006 through the merger of Japanese companies Daiichi and Sankyo in Europe. With a rich legacy of scientific expertise dating back more than 100 years, we are the pioneer behind leading pharmaceuticals that have contributed to the improvement of countless lives across the world.

Our mission is to contribute to the enrichment of quality of life through the discovery and delivery of innovative medicines that address diverse and unmet medical needs.

We are committed to providing innovation that demonstrates value and supports the NHS in its delivery of sustainable high-quality care, enabling efforts to reduce health inequalities and unwarranted variations and which puts the patient at the heart of the service. For further information please visit the Daiichi Sankyo UK website: https://www.daiichi-sankyo.co.uk/

Social media channels:

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Contact

Alistair Gordon (UK)

Daiichi Sankyo UK Ltd.

Government Affairs and Corporate Communications Manager

 +44 7591 953 681

Alistair.Gordon@daiichi-sankyo.co.uk

References

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

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

[3] 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.

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

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

[6] 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.

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

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

[9] EMC. NILEMDO® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11743/smpc Last accessed October 2021.