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. 2020 Sep 14;5(3):182-223.
doi: 10.1159/000511209. eCollection 2020 Sep-Dec.

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
Affiliations

Bringing Greater Accuracy to Europe's Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology

Denis Horgan et al. Biomed Hub. .

Abstract

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.

Keywords: Biomarkers; Cancer plan; Companion diagnostics; Comprehensive genomic profiling; Diagnostic tests; Million European Genome; Molecular diagnostics; Personalised healthcare; Public health; Reimbursement challenges.

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Conflict of interest statement

Benjamin Horbach is a Roche employee and has stock options in Roche. Stephen Hall is a Novartis employee and has stock options in Novartis. Benjamin Gannon is a Myriad Genetics employee and has stock options in Myriad. Rocio Varea Menendezis Eli Lilly employee and has stock options in Eli Lilly. Sarah Mee is an AstraZeneca employee and has stock options in AstraZeneca. Susana Banerjee receives grants from Astrazeneca, GSK & Honoraria − Astrazeneca/MSD, Amgen, Clovis, GSK, Mersana, Seattle Genetics, Merck Sereno, Genmab, Roche, Immunogen.

Figures

Fig. 1
Fig. 1
Evaluating the current biomarker testing landscape could improve Europe-wide access by identifying and targeting barriers.
Fig. 2
Fig. 2
European Commission's Beating Cancer Plan.
Fig. 3
Fig. 3
Main areas of barriers.
Fig. 4
Fig. 4
Index of barriers to PM in Europe [99].
Fig. 5
Fig. 5
Involving every stakeholder group is necessary to improve access to testing in the EU.
Fig. 6
Fig. 6
Matrix of the E-Health Data Solutions.
Fig. 7
Fig. 7
Revision of the EU medical devices legislation. Adopted on April 5, 2017, publication in OJ-EU, May 5, 2017.
Fig. 8
Fig. 8
Minimum testing: drivers, problems, objectives, inputs, results and impact.
Fig. 9
Fig. 9
VODI − value of diagnostic information.
Fig. 10
Fig. 10
Tackling the unmet needs in access to biomarkers testing.
Fig. 11
Fig. 11
Multi-stakeholder engagement, pragmatism and focus to secure improvement.
Fig. 12
Fig. 12
Optimum testing: challenges, objectives, inputs, results and impact.
See this image and copyright information in PMC

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