2021, Volume 28, Supplement 2: Inclisiran▼ – its clinical position in lipid management

September 2021

Sponsorship statement

This sponsored supplement was initiated and funded by Novartis Pharmaceuticals UK Ltd. Editorial control was retained by the authors and editors, however, Novartis reviewed the supplement for technical accuracy and compliance with relevant regulatory requirements. Leqvio® (inclisiran) prescribing information is available on the Novartis website: https://www.health.novartis.co.uk/sites/health.novartis.co.uk/files/inclisiran-pi.pdf

Adverse Event Reporting:
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via uk.patientsafety@novartis.com or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com

If you have a question about the product, please contact Medical Information on 01276 698370 or by email at medinfo.uk@novartis.com

Job code: 133819
Date of preparation: September 2021

Abstract

Articles in this supplement Cardiovascular disease: the state of the nation, and the NHS Long Term Plan Conversations on cholesterol: evaluating the role of LDL-cholesterol reduction in ASCVD New opportunity for cholesterol lowering: inclisiran Inclisiran: testing a population health management methodology to implement a novel lipid treatment...

| View
Cardiovascular disease: the state of the nation, and the NHS Long Term Plan

September 2021 Br J Cardiol 2021;28(suppl 2):S3–S6

Cardiovascular disease: the state of the nation, and the NHS Long Term Plan

Shahed Ahmad, Xenophon Kassianides, Simon Thackray

Abstract

Cardiovascular disease (CVD) is the leading cause of death globally and even in developed nations poses a significant health, social and economic burden. CVD has been identified as a key target by the UK government, Public Health England, NHS England and NHS Improvement. In an effort to tackle CVD, the NHS Long Term Plan has created specific targets in reduction of mortality through CVD risk prevention, with guidance on the importance of collaborative action between stakeholders. COVID-19 has undoubtedly caused huge disruptions in healthcare delivery; however, the front against CVD remains united and lessons have been learnt through the management of this pandemic. With growing support from national organisations, there are reasons for optimism....

| View
Conversations on cholesterol: evaluating the role of LDL-cholesterol reduction in ASCVD

September 2021 Br J Cardiol 2021;28(suppl 2):S7–S12

Conversations on cholesterol: evaluating the role of LDL-cholesterol reduction in ASCVD

Chris J Packard

Abstract

There is now abundant evidence that apolipoprotein-B containing lipoproteins, low-density lipoprotein (LDL) in particular, are implicated in the causation of atherosclerosis, and are, therefore, prime targets in the prevention of atherosclerotic cardiovascular disease (ASCVD). The relationship between LDL and ASCVD risk appears continuous and graded, even down to very low levels of LDL cholesterol (LDL-C). Based on the ‘lower-is-better’ therapeutic paradigm, recent guidelines have set aggressive goals for LDL-C in very-high-risk patients. Using well-established and novel lipid-lowering therapies, we have the ability routinely to achieve the aggressive goals set out in the guidelines. However, to attain this outcome in the majority of patients, combination therapy would need to become the rule rather than the exception....

| View
New opportunity for cholesterol lowering: inclisiran

September 2021 Br J Cardiol 2021;28(suppl 2):S13–S18

New opportunity for cholesterol lowering: inclisiran

Julia Brandts, Kausik K Ray

Abstract

Inclisiran is a first-in-class lipid-lowering agent that recently gained European marketing authorisation. This small-interfering RNA lowers hepatic proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis by using the intrinsic cellular pathway of RNA interference. In pooled analysis of phase III trials, this approach has been shown to achieve an average low-density lipoprotein cholesterol (LDL-C) reduction of approximately 50% with an infrequent maintenance dosing regimen of two injections per year following initial doses at day one and day 90. Three phase III trials found inclisiran to be effective and generally well tolerated among patients at high risk of cardiovascular events because of established atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolaemia, or other high-risk conditions, like diabetes or high (i.e. ≥20%) 10-year risk estimated through a risk calculator. Here we review inclisiran’s mode of action, phase III clinical trial evidence, indication and potential impact on patient management....

| View
Inclisiran: testing a population health management methodology to implement a novel lipid treatment

September 2021 Br J Cardiol 2021;28(suppl 2):S19–S22

Inclisiran: testing a population health management methodology to implement a novel lipid treatment

Samantha Dixon, Linda Rootkin, Tracey Vell

Abstract

Cardiovascular disease (CVD) is an area that places a large burden on both the NHS and society, and is one of the health conditions most strongly associated with health inequalities. This has been recognised by the NHS Long Term Plan and identified as a clinical priority. Within the context of the Long Term Plan and CVD prevention strategies, Novartis Pharmaceuticals announced plans to collaborate with NHS England to tackle the burden of CVD in the UK. The focus of this collaboration is to provide inclisiran, a novel treatment for dyslipidaemia, for secondary prevention atherosclerotic cardiovascular disease (ASCVD) patients in primary care through a population-level agreement. Population health management represents a proactive approach to managing the health and wellbeing of a population and aims to incorporate the total care needs, costs and outcomes of the population. It is a move away from the provision of reactive, demand-led care, and it is recognised that primary care has a clear role to play within population health management strategies. A population health model should be implemented in primary care to access an entire population locally. To test a proposed population health model of system delivery for inclisiran, Novartis and Health Innovation Manchester are running the VICTORION-SPIRIT study – which uses implementation research methodology – with 900 patients recruited across Greater Manchester general practices. The study aims to understand healthcare system challenges and enablers for implementation. It will assess the proposed implementation processes together with the efficacy and safety of inclisiran in a primary care setting. Implementation research provides appropriate methodology to assess the implementation of inclisiran in a primary care setting as part of a population health management approach. The outcomes of this research can be used to elucidate appropriate patient identification approaches, system barriers and enablers and the efficacy and safety of inclisiran in a primary care setting in the UK....

| View