Value of Diagnostic Tests When Treatment Is Not Optimal?

ISSUE: The cost-effectiveness of diagnostic tests hinges on their ability to correctly diagnose a condition and guide appropriate treatment, which is expected to improve clinical outcomes. How might diagnostic tests be valued for conditions that lack optimal treatment? Many infectious diseases provide good examples – e.g. norovirus, rhinovirus, bacterial vaginosis. There are currently no treatment options for norovirus and rhinovirus. Despite antibiotics being available for bacterial vaginosis, symptom persistence/recurrence rates are high. For these conditions where improvements in clinical outcomes may not be achieved through treatment, how is the value of diagnostic information (VODI) perceived? How does the valuation criteria differ for diagnostics intended for conditions with good treatment options? Does disease severity affect the perceived value? The aims of this issue panel are: 1) to use infectious disease examples to explore more complex relationships between treatment effectiveness and diagnostic value across multiple perspectives; 2) explore different value parameters for diagnostics and how these may be captured in cost-effectiveness analysis.

OVERVIEW: The moderator will present a 10-minute overview of the issue. Each panel member will then have 10 minutes to present their perspective. This will include the concept of VODI and how VODI supports broader value assessment of diagnostics beyond treatment outcomes; clinician perspective on the real-world clinical and economic benefits of molecular diagnostics for infectious diseases; and payer perspective on current priorities and considerations for diagnostic reimbursement. After the presentations, the moderator will summarise and pull out the key themes and consider wider applicability to additional disease areas before a 20-minute panel discussion with audience participation. It’s expected that researchers and manufacturers in the diagnostic tests field and payers would benefit from this discussion.