Bringing Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology
Authors: Horgan Denis , Ciliberto Gennaro , Conte Pierfranco , Baldwin David , Seijo Luis , Montuenga Luis M. , Paz-Ares Luis , Garassino Marina , Penault-Llorca Frederique , Galli Fabrizia , Ray-Coquard Isabelle , Querleu Denis , Capoluongo Ettore , Banerjee Susana , Riegman Peter , Kerr Keith , Horbach Benjamin , Büttner Reinhard , Van Poppel Hein , Bjartell Anders , Codacci-Pisanelli Giovanni , Westphalen Benedikt , Calvo Fabien , Koeva-Balabanova Jasmina , Hall Stephen , Paradiso Angelo , Kalra Dipak , Cobbaert Christa , Varea Menendez Rocio , Maravic Zorana , Fotaki Vassiliki , Bennouna Jaafar , Cauchin Estelle , Malats Nuria , Gutiérrez-Ibarluzea Iñaki , Gannon Benjamin , Mastris Ken , Bernini Chiara , Gallagher William , Buglioni Simonetta , Kent Alastair , Munzone Elisabetta , Belina Ivica , Van Meerbeeck Jan , Duffy Michael , Sarnowska Elżbieta , Jagielska Beata , Mee Sarah , Curigliano Giuseppe 
Published: September 2020

Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. This paper sets out the potential of biomarker testing, the unfolding precision and range of possible diagnosis and prediction, and the many obstacles to adoption. It offers case studies of biomarker testing in breast, ovarian, prostate, lung, thyroid and colon cancers, and derives specific lessons as to the potential and actual use of each of them. It also draws lessons about how to improve access and alignment, and to remedy the data deficiencies that impede development. And it suggests solutions to outstanding issues – notably including funding and the tangled web of obtaining reimbursement or equivalent coverage that Europe’s fragmented health system implies. It urges a European evolution towards an initial minimum testing scenario, which would guarantee universal access to a suite of biomarker tests for the currently most common conditions, and, further into the future, to an optimum testing scenario in which a much wider range of biomarker tests would be introduced and become part of a more sophisticated health system articulated around personalised medicine. For exploiting genomics to the full, it argues the need for a new policy framework for Europe. Biomarker testing is not an issue that can be treated in isolation, since the purpose of testing is to improve health. Its use is therefore always closely linked to specific health challenges and needs to be viewed in the broader policy context in the EU and more widely. The paper is the result of extensive engagement with experts and decision makers to develop the framework, and consequently represents a wide consensus of views on how healthcare systems should respond from push and pull factors at local, national and cross-border and EU level. It contains strong views and clear recommendations springing from the convictions of patients, clinicians, academics, medicines authorities, HTA bodies, payers, the diagnostic, pharmaceutical and ICT industries, and national policy makers.