The Value of Diagnostic information (VODI) in Heart Failure – Recognising Value Beyond ‘Beats-Per-Minute’

Bernarda Zamora presented at the virtual event entitled ‘Value of Diagnostic Information in Heart Failure’, which was organised by Roche Diagnostics. The panel, composed of six experts representing a range of stakeholders across Europe, shared their insights and perspectives on the Value of Diagnostic Information (VODI), and explored policies and changes that need to be made to capture the outcomes of diagnostic information in heart failure treatment and management.

On 16 November 2020, Bernarda Zamora presented at the virtual event Value of Diagnostic Information in Heart Failure, which was organised by Roche Diagnostics. This event continued the efforts of the Value of Diagnostic Information (VODI) platform towards the promotion and implementation of the VODI concept developed through stakeholders’ discussions with MedTech Europe. The panel, composed of six experts representing a range of stakeholders across Europe, shared their insights on the Value Of Diagnostic Information and explored policies and changes that need to be made to better measure the value of diagnostic information in heart failure (HF) treatment and management.

HF is a common and complex syndrome where the heart becomes too weak or stiff to pump enough blood through the body. The health and economic burden of HF is large and well-documented. One in five people can expect to be diagnosed with HF at some point in their lives, facing survival rates worse than major cancers, and being the most common cause of hospital admissions in people over the age of 65. Early diagnosis has an important impact both on improving survival rates and on reducing the direct and indirect costs of HF care to health systems and society. However, common symptoms between HF and other diseases make it challenging for healthcare professionals to confirm or rule out HF. Diagnostic information is needed to diagnose HF timely and accurately, and this is facilitated by in vitro diagnostics (IVDs), such as the blood test N-terminal pro-brain natriuretic peptide (NT-proBNP).

The VODI framework outlines how to define and measure the value of outcomes created by IVDs, and how to incorporate this information into decision-making processes. The VODI concept was introduced by the panel moderator, Mr Ed Harding, Network Director of the Heart Failure Policy Network, followed by presentations from Ms Sophie Marie Meiser, Manager of Market Access and Economic Policies at MedTech Europe, and Bernarda Zamora, Senior Economist at the Office of Health Economics. They stipulated the challenge that exists to appropriately measure and reward the value generated by IVDs, as derived from information used by healthcare professionals in decision-making. In contrast to therapeutics, this value is not observed as a direct clinical benefit and it must be captured through the ‘value chain’ triggered by healthcare professionals with the diagnosis, that spills over to patients, healthcare providers, healthcare systems and society overall. To overcome this challenge, the VODI framework is designed to be holistic: it accounts for the full range of potential benefits of diagnostic testing, beyond the traditional clinical and health economic domains. This is essential to recognise, measure, fully leverage and reward the benefits of diagnostics for patients, health systems, and society.

Source: Wurcel et al. 2019.

Healthcare professionals were represented at the panel by Professor Yigal M Pinto of the Heart Centre at the Academic Medical Centre in The Netherlands, and by Ms Carys Barton, Heart Failure Nurse Consultant at Imperial College Healthcare NHS Trust and Chair of the British Society for Heart Failure Nurse Forum. Both stressed the importance of more and earlier diagnosis. For example, 40% of HF patients that are hospitalised in the UK display symptoms that should have triggered earlier investigations. With better use of NT-proBNP testing in primary care, hospitalisation can be avoided through timely diagnosis of HF and initiation of guideline-recommended therapies, and selection and optimisation of complex treatment choices. To capture the clinical benefit, it is important to measure clinical endpoints along the patient pathway. While new treatments have demonstrated considerable survival benefits in clinical trials, it is much more difficult to determine treatment benefit in real-world settings. The effect of diagnostic tests such as NT-proBNP should be measured in clinical endpoints including hospital admission rate as well as survival.

Patients’ views were brought forward by Mr Nick Hartshorne-Evans, Founder and Chief Executive of the Pumping Marvellous Foundation in the UK. Patients’ testimonies expressed how delayed diagnosis or misdiagnosis of HF has had a detrimental impact on their psychological wellbeing, quality of life and employment of people first experiencing symptoms of HF. People living with HF have reported increased levels of stress, anxiety, and depression due to delays in their diagnostic process. Moreover, there is a lack of awareness of IVDs tests. The measurement of biomarkers relevant to HF, such as NT-proBNP and others, ideally as part of routine blood tests at a one-stop HF clinic, would contribute to increasing the awareness of signs and symptoms of HF among the public and healthcare professionals.

A view from the industry and the healthcare system was presented by Professor Damien Gruson, Head of Lab, Cliniques universitaires Saint-Luc, Belgium; and Member of the European Commission’s Expert Panel on Effective Ways of Investing in Health. In particular, he stressed the importance of point-of-care devices and new laboratory testing services in primary care that can support the timely diagnosis of HF. The use of point-of-care devices, notably, has been valuable during the COVID-19 pandemic by enabling real-time monitoring of HF patients. The information generated by these devices, coupled with clinical data, can further improve diagnosis and better characterise a person’s HF. This would support the delivery of personalised HF care and treatment, which may lead to improved cardiovascular outcomes and potentially generate substantial cost savings.

The panel session ended with a discussion of questions and comments raised by attendees, including several suggestions for incentivising the use of diagnostics in HF. The panel concluded that:

1. Increasing awareness among healthcare professionals of the VODI along the HF care pathway is the first step to trigger the value chain;
2. Implementation should be facilitated by funding support and reimbursement of high-value diagnostics tests, including tests in primary care; and
3. The information collected from real-world data should be shared and analysed, which would require investments in information-technology systems that currently sit in silos.

Related Research:

Wurcel V, Cicchetti A, Garrison L, Kip M, M, A, Koffijberg H, Kolbe A, Leeflang M, M, G, Merlin T, Mestre-Ferrandiz J, Oortwijn W, Oosterwijk C, Tunis S, Zamora B. 2019. The Value of Diagnostic Information in Personalised Healthcare: A Comprehensive Concept to Facilitate Bringing This Technology into Healthcare Systems. Public Health Genomics. 22, pp. 8-15. doi: 10.1159/000501832