The Value of IVDs

THE VALUE OF IVDs

What is an IVD?

‘In vitro’ is Latin for ‘in glass’. IVDs are tests performed on a sample taken from the body to diagnose a disease or condition. Samples can include blood, urine, or tissues. Classically, these tests were carried out in a test tube or on a laboratory dish, hence the name ‘in vitro’. While this term might seem old-fashioned in the post-COVID world, where most of us are accustomed to home testing with lateral flow devices, it is well understood within the life science and healthcare worlds.

IVDs vary from sophisticated technologies performed in clinical laboratories by highly-trained scientists to simple self-tests conducted by the public. IVDs can be performed at the point-of-care (POC), within clinical settings, or by individuals themselves at home, for example self-monitoring of blood glucose for management of diabetes.

 

The Statistic

The Statistic

The life sciences sector almost always uses the statistic that approximately 70% of clinical decisions are influenced by the use of in vitro diagnostics. Comparatively, approximately less than 1% of the NHS budget is dedicated to the uptake of new and innovative IVD products. Why is this? Could it be that the true value of IVDs has not yet been realised?

The Statistic

The Statistic

In vitro diagnostics (IVDs) are an essential part of the NHS. They are used to both enable diagnosis and to rule out causes of ill health. They are also used to monitor, screen and assess people for any potential health problems they might have. Increasingly, they also allow people with chronic disease to manage their own conditions.

Benefits

IVDs are a key tool for clinicians in assessing what is causing a patient’s illness or symptoms. They allow clinicians to prescribe the most effective or appropriate treatment, and to avoid prescribing inappropriate treatment – for example antibiotics for a viral infection.

Through the use of data, genetic sequencing of test samples, and molecular diagnostics, IVDs contribute to the natural evolution of medicine and more personalised treatment.

Effectively used, IVDs help to reduce hospital stays, support patients to look after their own health and release resources for use elsewhere in the NHS, resulting in a healthier population and stronger economic growth. Moving diagnostics tests from within healthcare settings to non-traditional settings can reduce the burden on the NHS and shorten clinical pathways. The evolution of IVDs to be less invasive can lead to higher uptake, key in areas such as the early diagnosis of cancer.

Tackling antimicrobial resistance (AMR) – where the microorganisms which cause disease (including bacteria, viruses, fungi and parasites) can no longer be treated by antimicrobial medicines – is a key priority for the NHS, one of the World Health Organisation’s top ten threats, and is seen by the UK as a risk comparable to climate change. IVDs provide one of the key solutions to this issue by allowing accurate diagnosis and suitable treatment.

Delivering the benefits

Delivering better outcomes for patients and the NHS is at the heart of the IVD industry. However, it should be acknowledged that the industry also makes a valuable contribution to the UK economy and plays a significant role in UK exports; £1.1billion worth of IVDs were exported from the UK in 2013. We are determined that the sector will continue to thrive in the UK post-Brexit, but in order for the industry to grow and continue to improve patient outcomes, it is vital that steps are taken to increase the adoption of IVDs.

The COVID-19 pandemic drove a step-change in diagnostic innovation and awareness. It is essential that this impetus is maintained outside of industry. The UK government’s 100 Day Mission is a key part of pandemic preparedness, to ensure IVDs are available to respond to future pandemics in this time frame. This will require investment, engagement, and preparedness from the UK government and BIVDA are working closely to support this.

The increased use of IVDs, including moving diagnostics from traditional settings, is key to unlocking NHS performance. This includes innovative tests and operating models, faster and better procurement, and a more efficient regulatory regime. BIVDA is heavily involved in each of these areas.

Where do we go from here?

  • Securing a more effective NHS by increasing the adoption of IVDS
    The adoption of innovative IVD tests within the NHS is still taking too long. Typically, widespread adoption of new diagnostic tests takes approximately 10 years. Over the coming months, the Government will be implementing the recommendations of the Accelerated Access Review (AAR) and the Life Sciences Industrial Strategy. We hope this will provide a vital stepping-stone to faster adoption, so that patients of the future have access to the right IVDs, at the right time. However, it is also vital that IVDs receive the same status as medicines, specifically by making it mandatory that positive NICE Diagnostics Guidance is funded and implemented within 90 days.
  • Playing a leading role in overcoming global health challenges
    The importance of IVDs in overcoming the challenge of antimicrobial resistance (AMR) cannot be overstated. While the widespread use of broad-spectrum antibiotics has helped to create multi-drug resistant strains of bacteria, greater adoption of IVDs would lead to a reduction in cases of unnecessary antibiotic prescribing by reducing time to appropriate treatment decision and allowing for a more targeted use of therapy against infection. Understanding of the beneficial role IVDs have to play in this area is increasing among both clinicians and policymakers. To build on this progress, BIVDA wants the Government to work in conjunction with industry and NHS England to ensure extensive use of IVD tests to support the prescribing of antibiotics in both primary and secondary care and prevent over-prescribing and unnecessary treatment.
  • Securing a new mechanism for funding of IVDS
    A key factor that limits the wider adoption of IVDs is the way the NHS budget works. The budget for testing and general pathology in the NHS is separated from the rest of the budget for a medical pathway. This can often provide a disincentive to introduce cost-saving and potentially life-saving new tests because while the up-front and ongoing tests are borne by the innovators, the savings accrue further down the patient pathway. BIVDA is calling on the Government to introduce a funding mechanism, which does not disincentive the uptake of IVDs, thereby encouraging the NHS to increase the adoption of IVDs and enabling better patient access to diagnostics.
  • Guaranteeing patient access to molecular diagnostics
    Advances in personalised medicines have helped to transform the way we understand and treat health conditions in the UK today. Patient access to these treatments is reliant on the availability of appropriate molecular diagnostics tests. However, the availability of molecular diagnostic tests is variable due to a fragmented commissioning structure. In oncology, some progress has been made to overcome this challenge. For example, NHS Improvement introduced a clear mechanism for funding an initial six specific molecular tests for cancer within the 2016/17 National Tariff Payment System (NTPS). However, this is only part of the solution. BIVDA calls on the Government to work with NHS England to introduce a national commissioning framework for molecular diagnostics, starting in oncology, ensuring widespread patient access to such tests and allowing more patients to benefit from personalised treatments.
  • Establishing a new relationship with the EU
    The UK’s membership of the EU affects many of the regulations that shape the environment in which the IVD sector operates. As the UK negotiates a new relationship with the EU, it is vital to ensure that the UK environment for IVDs and life sciences as a whole remains as attractive as possible, for the benefit of the NHS, UK economy and most importantly, patients. We strongly urge the Government to align with the EU IVD Regulation and, if possible, retain Notified Body and Competent Authority status to allow the EU or UK authorities to mutually accept devices lawfully marketed in other territories, and ensure the UK market is open for business for countries that conform to regulations other than CE marking. It is also important that UK IVD companies are able to continue recruiting skilled students and professionals from across the globe.

The Value of IVDs (BIVDA’s eight page report which examines how IVDs are delivering value for patients, the NHS and the UK economy) is available to download from the BIVDA website.- The Value of IVDsThe Value Story Case Studies

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