The value of a diagnostic solutions is contextual and based on the insights they generate to support various decisions in the care continuum. What are the comprehensive value drivers and how we could articulate them to Payers, Providers and Patients?
There are several value frameworks aiming to assess the value of life science products, but Advanced Medical Technology Association (AdvaMed) approach is specifically designed for diagnostic tests. Here is a short summary of the guiding principles and key value drivers:
AdvaMedDx’s Approach for Effective Value Assessment
Source: A Framework for Comprehensive Assessment of the Value of Diagnostic Tests, AdvaMed, 2017
Key principles:
Apply broad array of patient centric value drivers from various perspectives (Comprehensiveness principle)
Utilize appropriate range of available evidence, reflecting test type and potential risks-benefits (Evidentiary principle)
Consider reporting direct and indirect costs incurred and avoided over timeframe appropriate for the test (Cost principle)
Account for immediate and longer-term test impact and patient benefits in representative patient populations (Specificity principle)
Include quantified estimates as well as qualitative analyses as appropriate (Flexibility principle)
Incorporate multiple stakeholders’ perspectives (Engagement principle)
Disclose why the assessment was initiated, who was involved, its purpose, and the decision-making process (Transparency principle)
Update assessments regularly to keep up with the rapid technological and clinical changes (Relevancy principles)
Value drivers can come from four major sources:
Clinical impact: clinical utility and health outcomes associated with the diagnostic technology. The test needs to measure accurately and reliably the analyte/biomarker of interest (analytical validity); detect, predict the outcomes of interest in a patient population (clinical validity) and inform an appropriate clinical decision (clinical utility). Improved patient safety, tolerability, compliance and physical and psychological wellbeing shall be also taken into account.
Non clinical patient impact breaks down to patient experience, and patient economics, such as proximity of test delivery, reduced follow-up visits, repeat procedures, improved care plan compliance and reduced burden on care givers.
Care delivery revenue, and cost impact mostly refer to quality of care metrics and more efficient resource utilization (e.g. readmissions; follow-ups, length of stay, wait times)
Public and population impact refer to macro implications mainly from population health, burden of disease, patient and caregiver productivity perspectives.
The European trade association, MedTech Europe has also developed a similar concept, Value of Diagnostic Information (VODI), which also emphasizes the importance of contextual factors, perspective taken and multidimensional value elements.
These specific frameworks are essential tools to drive holistic value assessments for diagnostic solutions.
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