The White Paper is based on the new concept of “complementary diagnostics”, defining tests using biomarkers for the purposes of risk assessment, diagnosis, prognosis, monitoring, and guiding therapeutic decisions.  This broad definition encompasses companion diagnostics.

The OHE team, also including Bernarda Zamora and Jorge Mestre-Ferrandiz of OHE, and also collaborating with the EPEMED Steering Committee of Emmanuelle Benzimra, Daniel Lesteven, Ralph Riley, Iain Miller, Joseph Ferrara, Juliette Plun-Favreau, Peter Kapitein, Veronique Bendien and Peter Collins, conducted an extensive review of the medical and health economics literature on the “value of knowing” that is generated by complementary diagnostics.  The Report also includes a landscape review of case studies of European health technology assessment agencies evaluating a range of complementary diagnostics.

The White Paper presents a more comprehensive framework for considering the value contribution of complementary diagnostics.  Going beyond the usual focus on health gain and cost savings, the framework highlights the value to the patient of having greater certainty of treatment benefit.  The Paper also identifies several other sources of value related to information, including real option value, the value of hope and scientific spillovers.   The Report ends with several policy recommendations in areas including evidentiary standards and reimbursement for diagnostics.  Garrison commented: “Our OHE team and the EPEMED Steering Committee hope that this research and White Paper will stimulate an important dialogue between diagnostic manufacturers, health technology assessment bodies and payers about a broader concept of value that would promote R&D, by appropriately rewarding innovation in complementary diagnostics.”