Bringing Greater Accuracy to Europe's Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology
Denis Horgan 1 , Gennaro Ciliberto 2 , Pierfranco Conte 3 , David Baldwin 4 , Luis Seijo 5 , Luis M Montuenga 6 , Luis Paz-Ares 7 , Marina Garassino 8 , Frederique Penault-Llorca 9 , Fabrizia Galli 10 , Isabelle Ray-Coquard 11 , Denis Querleu 12 , Ettore Capoluongo 13 , Susana Banerjee 14 , Peter Riegman 15 , Keith Kerr 16 , Benjamin Horbach 17 , Reinhard Büttner 18 , Hein Van Poppel 19 , Anders Bjartell 20 , Giovanni Codacci-Pisanelli 21 , Benedikt Westphalen 22 , Fabien Calvo 23 , Jasmina Koeva-Balabanova 24 , Stephen Hall 25 , Angelo Paradiso 26 , Dipak Kalra 27 , Christa Cobbaert 28 , Rocio Varea Menendez 29 , Zorana Maravic 30 , Vassiliki Fotaki 30 , Jaafar Bennouna 31 , Estelle Cauchin 31 , Nuria Malats 32 , Iñaki Gutiérrez-Ibarluzea 33 34 , Benjamin Gannon 35 , Ken Mastris 36 , Chiara Bernini 1 , William Gallagher 37 , Simonetta Buglioni 2 , Alastair Kent 38 , Elisabetta Munzone 39 , Ivica Belina 40 , Jan Van Meerbeeck 41 , Michael Duffy 37 , Elżbieta Sarnowska 42 , Beata Jagielska 42 , Sarah Mee 43 , Giuseppe Curigliano 39
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.
CITATION Biomed Hub. 2020 Sep 14;5(3):182-223. doi: 10.1159/000511209. eCollection Sep-Dec 2020