For IVDs, the concept of value and how it is measured is different from that of therapeutic medical devices or pharmaceuticals. IVDs are complex interventions which can provide information on a wide range of different outcomes, depending on the contextual factors and the perspective taken. IVDs can deliver:
- Improved clinical benefits for patients
- Societal gains of early detection and prevention of disease progression
- Value of knowing for individual patients
- Economic savings and resource efficiencies for healthcare institutions and health systems
- Improved patient management by healthcare providers
Essentially, the information resulting from diagnostic testing provides value by enabling users to make decisions on the expected best course of action with less uncertainty.
Results of in vitro testing influence as many as 70% of clinical decisions, while IVDs account for just 0.8% of total healthcare expenditure. When IVDs are reimbursed, the decision is typically based on the cost of the test kit itself, the equipment that analyses the sample (usually large laboratory machines) and the cost of staff performing the analysis, rather than on the value they bring. The reimbursement of IVDs varies widely across the continent, from €3.6 (Romania) to €43.5 (Switzerland) per capita per annum, which leads to large inequalities of access. Therefore, there is a major need for a new evaluation framework, that recognises the comprehensive value of diagnostic information.
At MedTech Europe we support the idea that the full value of diagnostic information should be captured, taking account of what matters to patients, society and to all other players involved in healthcare delivery. Assessors and decision-makers on funding and reimbursement should consider the full breadth of value that diagnostic information can provide, including:
- From a patient perspective: direct/indirect impact on relevant outcomes;
- From a health system perspective: impact on use of resources by different actors, in different healthcare pathways and settings, and over time.
If the full potential of diagnostic information is explored, MedTech Europe believes societal and individual health outcomes will improve in a sustainable way. To achieve that, it is necessary to define relevant and pragmatic assessment methods, which build the basis for rewarding the value of diagnostic information. Such assessment would go beyond technological criteria and would comprise multiple dimensions of value and multiple outcome measures, relevant for medical decision making.
Since 2015 MedTech Europe has been part of an international group of experts who published the VODI Concept. Our shared goal is to bring VODI from concept to reality.