‘In vitro’ is Latin for ‘in glass’, indicating that IVDs are tests performed on a sample outside their normal biological context. This means that in vitro diagnostics test a sample of tissue or bodily fluid in an effort to diagnose a disease or condition. Classically, these tests are carried out in a test tube or on a laboratory dish, hence the name ‘in vitro’.
This is in contrast to ‘in vivo’ diagnostics, which are carried out in or on the full body and include techniques such as imaging. In the past IVDs were mainly involved in the branch of medicine that deals with the lab examination of samples of body tissue for diagnostic purposes. Today, however, in vitro diagnostic tests do not necessarily have to be carried out in the lab. IVDs can now be performed at the point-of-care (POC) or by individuals themselves at home, e.g. self-monitoring of blood glucose for management of diabetes.
It is well known and accepted 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 perhaps that the true value of IVDs has not yet been realised?
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.
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. Through molecular diagnostics, the industry also contributes to the natural evolution of medicine and more personalised treatment.
Research and Development (R&D) by our industry has led to the creation of many new and innovative IVDs across a wide range of disease areas. However, the sector still faces a glass ceiling when it comes to the uptake and diffusion of IVDs within the NHS.
Currently 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 costs are borne by the innovators, the savings accrue further down the patient pathway.
Use of IVDs can lead to a more effective, rapid and accurate diagnosis, which in turn enables tailored patient care. However, when being commissioned, the benefits of diagnostics are often either misunderstood, or worse, not considered at all.
Currently, the NHS is too inflexible when it comes to adopting new IVD tests. Typically, solutions are still thought of as pharmaceuticals and consideration is not given to how IVDs could be adopted in the system to improve outcomes.
Delivering benefits 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, employing more than 8,000 people, generating annual sales of approximately £850million to the NHS and playing a significant role UK exports; £1.1billion were exported 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 improve patient outcomes, it is vital that steps are taken to increase the adoption of IVDs.
The IVD industry is clear that it wants to continue to grow, develop and innovate, offering benefits for the NHS, economy, and most importantly, patients.
While the IVD sector is already making a significant difference in these areas, we have identified five priority areas that need to be addressed in order for us to be able to build on our success:
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.
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.
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.
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.
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: https://www.bivda.org.uk/The-IVD-Industry/The-Value-of-IVDs