Embedding innovation in clinical practice to improve patient care across cardiovascular disease

A Bayer 2023 Cardiovascular Exchange Summit post-meeting report

The following expert faculty members have received an honorarium for participating at the meeting

Faculty member	Affiliation
Professor Amitava Banerjee	Professor of Clinical Data Science, Institute of Health Informatics, University College London; Consultant Cardiologist, University College London Hospitals and Barts Health NHS Trust
Professor Sir Mark Caulfield	Professor of Clinical Pharmacology, Queen Mary University of London & Vice-Principal for Health for Queen Mary’s Faculty of Medicine and Dentistry
Professor Keith Fox	Professor of Cardiology, University of Edinburgh & British Heart Foundation Professor of Cardiology (Emeritus)
Dr Matt Kearney	Executive Director for Cardiovascular Health, UCL Partners
Professor Kamlesh Khunti	Professor of Primary Care Diabetes and Vascular Medicine, University of Leicester
Professor Vijay Kunadian	Professor of Interventional Cardiology, Newcastle University and Honorary Consultant Interventional Cardiologist, Freeman Hospital Newcastle upon Tyne Hospitals NHS Foundation Trust
Dr Guy Lloyd	Consultant Cardiologist, Barts Heart Centre and Honorary Secretary; British Cardiovascular Society
Dr Kieran McCafferty	Consultant Nephrologist, Barts Health NHS Trust; Honorary Senior Lecturer, Queen Mary University of London; Barts Health NIHR CRF Clinical Director; UKKRC CKD and Diabetes Co-Chair
Professor Nicholas S Peters	Professor of Cardiology & Head of Cardiac Electrophysiology, Imperial College, London
Mr Piers Ricketts	Chief Executive of Eastern AHSN
Professor Ganesh Subramanian	Clinical Associate Professor, University of Nottingham; Consultant in Stroke Medicine, Nottingham University Hospitals NHS Trust
Dr Clare Taylor	Academic General Practitioner, Nuffield Department of Primary Care Health Sciences, University of Oxford
Professor Raj Thakkar	GP, Buckinghamshire, CKD Representative & President of the PCCS
Key: AHSN = Academic Health Science Networks (now known as Health Innovation Network; CKD = chronic kidney disease; CRF = Cardiovascular Research Foundation; GP = general practitioner; NHS = National Health Service; NIHR = National Institute for Health and Care Research; PCCS = Primary Care Cardiovascular Society; UCL = University College London; UKKRC = United Kingdom Kidney Research Consortium

The following external authors were involved in the generation and approval of this report

LCW Consulting Bayer medical team Bayer acknowledges that the workshop feedback outlined in the report has been contributed to by delegates in attendance at the meeting who were not paid an honorarium. The Bayer medical team have medicolegally reviewed the document for compliance with the Association of the British Pharmaceutical Industry Code of Practice and for technical accuracy.

The Bayer Cardiovascular Exchange Summit 2023 was organised by Bayer in collaboration with the British Cardiovascular Society (BCS) and the Primary Care Cardiovascular Society (PCCS), providing a forum for the exchange of knowledge and experience from generalists and specialists across cardiovascular disease (CVD) management. The meeting focused on how innovation and leadership could be used to drive change within the National Health Service (NHS) for the benefit of patients, population health and the wider NHS. Key areas where innovation could transform CVD management and NHS service provision were explored and are summarised in this report:

• A holistic approach to CVD prevention and management, and patient empowerment
• Delivering co-ordinated and patient-centred care: innovative models of working
• Innovations in licensing and life science regulation
• Embedding innovation within clinical practice

Innovations in healthcare are being developed at pace and both healthcare professionals (HCPs) and payers need to adapt and embrace new medicines, technologies and services, embedding them into clinical pathways. Barriers that delay the availability of these tools need to be addressed and full use should be made of the enablers that exist to ensure innovations are available to all who could benefit from them. CVD pathways need to be transformed at a system level, addressing inequalities and regional disparities and with greater integration between primary and secondary care. Patients should be at the heart of all new healthcare innovations and should be considered at every step of developmental and regulatory pathways.

The outputs from the Bayer Cardiovascular Exchange Summit 2023 provide valuable insights into how innovation can be used to transform the management of CVD, representing perspectives from stakeholders including HCPs working across primary and secondary care, as well as patient representatives.

Introduction

In an era of rapid technological advancement and evolving healthcare needs, the National Health Service (NHS) needs to embrace innovation, integrating new technologies, evidence-based practices, and novel approaches into clinical workflows to ensure consistent high-quality care and optimised patient outcomes. Building on the success of the 2022 Cardiovascular Exchange Summit,¹ the 2023 Bayer Cardiovascular Exchange Summit provided a forum for the exchange of ideas and experiences from primary care generalists and secondary care specialists with an interest in cardiovascular (CV) medicine, as well as patient representatives. They explored how innovation and leadership could be used to drive change within the NHS for the benefit of patients. The two-day meeting was organised in partnership with the British Cardiovascular Society (BCS) and the Primary Care Cardiovascular Society (PCCS), with an expert faculty spanning cardiovascular, renal and stroke multidisciplinary teams.

The meeting addressed key areas where innovation could play a vital role in transforming cardiovascular disease (CVD) management and NHS service provision:

• A holistic approach to CVD prevention and management, and patient empowerment
• Delivering co-ordinated and patient-centred care: Innovative models of working
• Innovations in licensing and life science regulation
• Embedding innovation within clinical practice

Members of the speaking faculty shared their experience and examples of best practice during plenary sessions, providing background context and setting the scene for further, in-depth conversations during workshops and panel discussions in which delegates shared their own ideas and experiences, discussing how innovation could be used to transform pathways and services within the NHS. The multidisciplinary nature of the audience allowed voices to be heard from across primary and secondary care and different disciplines, including patient perspectives, providing a valuable insight into how innovations are being and could be adopted across the spectrum of CV care services within the NHS.

Both the BCS and PCCS are committed to working in partnership with patients, the pharmaceutical industry and relevant organisations with aligned strategic aims to identify the current challenges in CVD management within the NHS and to identify solutions to address these.

This report summarises the key messages from the meeting.

A holistic approach to CVD prevention and management, and patient empowerment

Growing evidence suggests that cardiovascular (CV), renal and metabolic (CVRM) conditions, such as heart failure, chronic kidney disease (CKD), inflammation, thrombosis and diabetes, are intertwined (figure 1). Therefore, there is a need for a holistic approach to patient care.^2–9 Both the mechanisms of these conditions and their risk factors need to be understood to identify high-risk patients and provide optimal care.

There needs to be a shift towards a preventative health system

The risk factors for CVD are well established and understood (figure 2). Many of these are modifiable, presenting the opportunity for people to reduce their CV risk through early and proactive lifestyle and pharmacological interventions.^10,11 However, many patients with CVD or risk factors for CVD remain undiagnosed or sub-optimally treated.¹² The 2019 NHS Long Term Plan states that CVD ‘is the single biggest area where the NHS can save lives over the next 10 years.’ Identifying undetected hypertension and hypercholesterolaemia, and consequent optimisation of blood pressure and cholesterol levels is outlined within the Long Term Plan as a key strategy to achieve the ambition of preventing 150,000 heart attacks, strokes and dementia cases over the 10-year period.¹³

Hypertension is the number one risk factor globally for mortality and affects 15 million people in the UK, of which around 4.8 million remain undiagnosed.^12,14 Blood pressure control is often achievable, and technological advances such as home blood pressure monitoring can empower patients to take control of blood pressure management.¹⁵ However in England, around 30% of patients with hypertension are not optimally treated.¹⁶ If even 80% of people with hypertension were optimally managed, around 14,000 heart attacks and strokes and over 4,400 deaths would be prevented in just three years, with savings to the NHS of around £150 million. Similarly, a large number of CV events and deaths could be saved with associated cost savings to the NHS, if cholesterol levels were optimised in patients with established CVD.¹⁷ This is recognised in the 2023/24 Quality and Outcomes Framework (QOF), which includes two indicators to ensure that all patients with established CVD or CKD receive optimal treatment to reduce levels of low-density lipoprotein cholesterol (LDL-C).¹⁸

Patients should feel engaged and take ownership of their condition(s)

Early identification of people with risk factors for CVD and understanding their risk profiles can enable healthcare professionals (HCPs) to co-develop an individualised care plan with them. HCPs can support patients to understand the value and purpose of minimising their risk and the potential benefits and harms of the treatments offered to them. Patient education is key to engagement and adherence. Providing patients with the information and tools to change their behaviour and lifestyle, while tailoring treatment according to the individual patient’s needs and preferences in line with the National Institute for Health and Care Excellence (NICE) guidance,¹⁹ will help them take ownership of their condition and adhere to the treatments agreed with their HCPs. However, this requires time and the NHS is currently struggling with staff shortages.²⁰

Secondary prevention is crucial for the prevention of further CVD events. Aggressive treatment should be offered to lower blood pressure and LDL-C levels, along with antithrombotic and antidiabetic therapies for those who would benefit from them.²¹ Both new and established therapies that have been shown to reduce CV death, all-cause mortality and strokes which are approved by NICE need to be used more effectively across the UK to provide individualised care. There needs to be a particular focus on pro-actively identifying and managing patients with frailty (including dementia) or those in the last year of life, given that over-medicalisation can cause harm.

Inequalities and disparities need to be understood, addressed and resourced to make CVD healthcare more equitable

Late diagnosis, suboptimal treatment and unwarranted variation in the management of high-risk conditions for CVD is widespread and entrenched within the NHS.²² CVD is a major driver of health inequalities, accounting for around a fifth of the life-expectancy gap between the most- and least-deprived areas of England.²³ It is critical to acknowledge that usually silent high-risk CVDs are hard to manage in real-world general practice, with complexity, multimorbidity and time pressures being the norm. Demand in primary care is overwhelming, with little spare capacity; contracts and incentives are not aligned to evidence. Therefore, pathways need to be transformed at a system level and made simpler, with inequalities and regional disparities addressed.

Digital technologies are increasingly being used for diagnosis and management of CVD

Culture and innovations for the diagnosis and monitoring of CVD and its risk factors have an important role in the future of CVD prevention. Advances in digital technologies, including wearable devices, provide opportunities to identify and treat asymptomatic patients at an early stage and can demonstrate value and cost-effectiveness, reducing the dependency on HCPs and also the need for more costly interventions as the condition progresses.²⁶ Artificial intelligence (AI)-powered tools are also proving to be increasingly valuable, building in treatment components and linking to pathways.^27,28 However, the processes to purchase and adopt technologies in the NHS needs urgent review. Furthermore, the medical workforce needs to be enabled to embrace these innovations and be upskilled on the use of digital technology, while ensuring patients who lack digital literacy are not disadvantaged.

Delivering co-ordinated and patient-centred care: innovative models of working

HCPs need to work in partnership with patients, viewing them as a whole person rather than just a person with a single disease

Many patients with CVD have several other long-term conditions (multiple long-term conditions or multimorbidity) and, therefore, do not follow simple algorithmic pathways. Policy changes are needed to facilitate integrated care between primary and secondary care settings, with a focus on patient-centred, personalised care, considering frailty, multi-morbidity and polypharmacy.

Personalised care provides people with choice and control over the way their care is planned and delivered, empowering them to make decisions. Care should be based on what matters to the patient and their individual strengths and needs.²⁹ Self-management, supported by education can help empower patients with CV, metabolic and renal diseases to take ownership of their conditions. Furthermore, patient advocacy and support groups, patient steering groups and digital technologies, such as healthcare apps, can help to involve patients in their own care, empowering them to make changes to their lifestyle and improve adherence to treatments (figure 3).^30–32

Clinical pathways for CVD diagnosis and management need to be transformed at a system level and made simpler

Around-the-clock integrated working between primary and secondary care HCPs, across disciplines, and between patients and HCPs is essential for the provision of personalised care for patients, especially for those with complex comorbidities, to ensure continuity of care.³⁶ Integrated working can streamline and transform CVD patient pathways, improving both patient-centred care and patient outcomes.²²

HCPs need to identify where change is needed within clinical pathways and embrace new ways of working to provide sustainable high-quality personalised care for all patients. They should break away from working in silos and instead work in partnerships, taking full advantage of innovations and enablers that can help transform pathways. Health Innovation Networks (HINs, formerly Academic Health Science Networks, AHSNs) work with healthcare organisations and businesses to support the adoption and spread of innovation within the NHS to improve services for patients, enable NHS efficiencies and support economic growth. Over 2.3 million patients have benefitted from HIN programmes to date, including those with CVD.

Therapeutic inertia exists in CVD management and needs to be addressed

Once patients have been identified and are being treated for CVD, it is important to ensure they are followed up regularly and remain optimally managed. Therapeutic inertia is usually described as the failure to advance therapy when appropriate to do so, but also includes the failure to de-intensify therapy when appropriate, for example in frailty or last year of life, when the harms associated with therapies may outweigh the benefits. HCPs, patients and the healthcare system can all contribute to therapeutic inertia (figure 4).^48,49

Measures including education for HCPs, adherence to guidelines (but tailored to the individual e.g. those with frailty), development of quality measures, effective use of information systems, contractual enablers, demand management, adoption of value-based medicine and motivation and support for patients around self-management and adherence may all help combat therapeutic inertia.^51,52 Furthermore, empowering pharmacists and nurses to initiate and intensify treatment may also be an effective approach to mitigate therapeutic inertia.⁵³

Innovations in clinical research, licensing and life science regulations

The process by which innovations and clinical trial findings are implemented into clinical practice and embedded into patient care pathways needs to be accelerated

Clinical trials provide the data and evidence needed to demonstrate that new innovations are beneficial for patients. However, the cohorts of those trialled and the applicability to real-world settings need to be considered; there can be long delays in embedding these innovations into clinical practice and making them available for use within the NHS. The NHS Long Term Plan set out ambitions to speed up the pipeline for developing innovations and the adoption of innovation into ‘business-as-usual’ within the NHS, to enable proven and affordable new techniques and technologies reach patients faster and to reduce variation.¹³ There are a number of schemes in place to fast-track the licensing of new medicines and technologies, including the Innovative Licensing and Access Pathway (ILAP),⁵⁴ the Early Access to Medicines Scheme (EAMS)⁵⁵ and the Accelerated Access Collaborative (AAC).⁵⁶ These aim to provide patients with faster access to innovations, based on a balance of risks and benefits and for conditions where there is a clear and urgent unmet need. In addition, there are opportunities for international regulatory collaborations. The Access Consortium aims to provide accelerated access to high-quality medicines by maximising international cooperation and reducing duplication through work-sharing initiatives.⁵⁷ Conversely, the International Recognition Procedure (IRP) will allow medicines approved in Australia, Canada, Europe, Japan, Switzerland, Singapore and the USA that meet certain criteria to undergo a fast-tracked Medicines and Healthcare Products Regulatory Agency (MHRA) review to obtain and/or update UK marketing authorisations.⁵⁸

Research should be embedded within clinical care and can encourage collaboration and the integration of primary and secondary care

Access to clinical research should be facilitated for patients and routinely embedded in clinical care. Research can provide income to bolster increasingly strained NHS budgets with commercial sponsors often paying for nurses, doctors and drugs, benefitting more than just the patients taking part in the trial, and can also help in the recruitment and retention of staff and boost staff morale.⁵⁹ There is also evidence that hospitals with a greater level of research funding have lower patient mortality rates.⁶⁰ Patient experience of clinical research is generally positive, with those who participate potentially benefitting from access to treatments they may otherwise have not been eligible for. They also receive continuity of care with the same HCPs, frequent and high-quality contact with HCPs, and clear explanations. Furthermore, patients feel they are making a contribution and helping others.^59,61 However, there is inequality in access to research for patients across the UK.⁶² This needs to be addressed to enable all patients to access appropriate clinical trials and drugs, and to ensure that patient samples are representative of the patient population. Every patient should be considered a potential research participant and efforts should be made to ensure patients want to take part in clinical research.

Clinical trials should give significant consideration to patient-reported outcome measures (PROMs)

Patients should be at the heart of all new healthcare innovations and should be considered at every step of the developmental and regulatory pathway, from trial design through to regulatory approval. While improving outcomes and mortality is a key focus for any new therapy, it is also important to consider the impact on the patient’s quality of life and their perception of the burden of disease. PROMs are often considered a less important outcome within trial design. However, they can provide important information for patients, families and clinicians, as well as trialists, regulators, commissioners and industry, about the patient’s perception of their own health, including functional status and health-related quality of life. From the patient perspective, the lived experience is extremely important and PROMs are the only way to capture this within a trial.⁶³ PROMs are increasingly being included as end points in clinical trials,^64–67 and are also now being used in health economic modelling and regulatory decision making.^68,69

The MHRA have published guidance around the use of real-world evidence (RWE) in clinical studies and randomised controlled trials to support regulatory submissions.^70,71 Use of RWE, including electronic health records (EHRs), PROMs and disease and patient registries to improve recruitment and aid regulatory decision making could accelerate the development approval processes for new therapies and technologies so they can be made available to patients more quickly. Use of EHRs can provide a large study population from which multiple datasets can be obtained across many different variables and have been used, for example, to identify patterns in CVD risk in selected populations and the impact of the coronavirus disease 2019 (COVID-19) pandemic on CVD services.^72–75 Furthermore, combining EHR data with machine learning identified disease subtypes in both CVD and CKD may inform clinical risk prediction and future trial design.^76,77

Embedding innovation within clinical practice

The embedding of findings from clinical trials into clinical practice and guidelines needs to be accelerated

In order for patients to benefit from new medicines, technologies and services, innovations need to be embraced by both clinicians and payers and embedded into clinical pathways where they are made accessible to all patients who might benefit from them and improve outcomes in the real world. The implementation of new technologies into clinical practice can be challenging, with multiple barriers that delay the availability of these tools for HCPs and patients within the NHS.

Small pilot schemes can be used to demonstrate the effectiveness of innovations; however, these do not always translate to wider implementation. An alternative to pilot schemes is direct implementation of technologies into clinical care.

Appendix

A holistic approach to cardiovascular disease (CVD) prevention and management, and patient empowerment

Delivering co-ordinated and patient-centred care: innovative models of working

Innovations in licensing and life science regulation

Embedding innovation within clinical practice

Acknowledgements

Bayer would like to thank the chairs, faculty and delegates for their opinions, enthusiasm and engagement throughout the meeting.

Professor Kamlesh Khunti is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and the NIHR Leicester Biomedical Research Centre (BRC).

Funding

The creation of this report was funded by Bayer plc.

Conflicts of interest

All faculty members received an honorarium for participating at the meeting.

Professor Kamlesh Khunti has acted as a consultant, speaker or received grants for investigator-initiated studies for Astra Zeneca, Bayer, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Oramed Pharmaceuticals, Pfizer, Roche and Applied Therapeutics.

Professor Vijay Kunadian has received honoraria from Bayer, CSL Behring and Medtronic.

Dr Kieran McCafferty has acted as a consultant or speaker for or received grants from AstraZeneca, Bayer, Fresenius, Oncacare, Napp and Vifor.

Professor Raj Thakkar has acted as a consultant or speaker for AstraZeneca, Abbott, Amgen, Bayer, Boehringer Ingelheim, Daiichi Sankyo and Novartis.

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