Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Bringing onco-innovation to Europe’s healthcare systems: the unexploited potential of biomarker testing, real world evidence and the potential of Tumour Agnostics. The lesson from BRCA1/2 genetic testing

Version 1 : Received: 12 August 2020 / Approved: 14 August 2020 / Online: 14 August 2020 (04:27:45 CEST)

A peer-reviewed article of this Preprint also exists.

Horgan, D.; Ciliberto, G.; Conte, P.; Curigliano, G.; Seijo, L.; Montuenga, L.M.; Garassino, M.; Penault-Llorca, F.; Galli, F.; Ray-Coquard, I.; Querleu, D.; Riegman, P.; Kerr, K.; Van Poppel, H.; Bjartell, A.; Codacci-Pisanelli, G.; Koeva-Balabanova, J.; Paradiso, A.; Maravic, Z.; Fotaki, V.; Malats, N.; Bernini, C.; Buglioni, S.; Kent, A.; Munzone, E.; Belina, I.; Van Meerbeeck, J.; Duffy, M.; Jagielska, B.; Capoluongo, E. Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine. Cancers 2021, 13, 583. Horgan, D.; Ciliberto, G.; Conte, P.; Curigliano, G.; Seijo, L.; Montuenga, L.M.; Garassino, M.; Penault-Llorca, F.; Galli, F.; Ray-Coquard, I.; Querleu, D.; Riegman, P.; Kerr, K.; Van Poppel, H.; Bjartell, A.; Codacci-Pisanelli, G.; Koeva-Balabanova, J.; Paradiso, A.; Maravic, Z.; Fotaki, V.; Malats, N.; Bernini, C.; Buglioni, S.; Kent, A.; Munzone, E.; Belina, I.; Van Meerbeeck, J.; Duffy, M.; Jagielska, B.; Capoluongo, E. Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine. Cancers 2021, 13, 583.

Journal reference: Cancers 2021, 13, 583
DOI: 10.3390/cancers13030583

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. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions. One of the paradigmatic examples is BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, development is impeded by data deficiencies, and lack of policy alignment on standards, approval – and the role of real-world evidence in the process - and reimbursement. The acute nature of the problem is compellingly illustrated by the particular challenges facing the development and use of tumour agnostic therapies, where the gaps in preparedness for taking advantage of this innovative approach to cancer therapy are sharply exposed. Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving healthcare and winning advantages for Europe's industrial competitiveness and innovation require an appropriate policy framework – starting with an update to outdated recommendations.

Keywords

cancer biomarkers, BRCA1/2, genomics; European recommendation

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