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Bringing onco‐innovation to Europe’s healthcare systems : The potential of biomarker testing, real world evidence, tumour agnostic therapies to empower personalised medicine

Horgan, Denis ; Ciliberto, Gennaro ; Conte, Pierfranco ; Curigliano, Giuseppe ; Seijo, Luis ; Montuenga, Luis M. ; Garassino, Marina ; Penault‐llorca, Frederique ; Galli, Fabrizia and Ray‐coquard, Isabelle , et al. (2021) In Cancers 13(3).
Abstract

Rapid and continuing advances in biomarker testing are not being matched by uptake 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— notably BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, the implementation of genetic testing in clinical routine setting is still challenging. Development is impeded by country‐related heterogeneity, data deficiencies, and lack of... (More)

Rapid and continuing advances in biomarker testing are not being matched by uptake 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— notably BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, the implementation of genetic testing in clinical routine setting is still challenging. Development is impeded by country‐related heterogeneity, 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. We show herein the main issues and proposals that emerged during the previous advisory boards organised by the European Alliance for Personalized Medicine which mainly focus on possible scenarios of harmonisation of both oncogenetic testing and management of cancer patients.

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@article{216a05d8-6c1a-4cd9-8974-e09b7b656e50,
  abstract     = {{<p>Rapid and continuing advances in biomarker testing are not being matched by uptake 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— notably BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, the implementation of genetic testing in clinical routine setting is still challenging. Development is impeded by country‐related heterogeneity, 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. We show herein the main issues and proposals that emerged during the previous advisory boards organised by the European Alliance for Personalized Medicine which mainly focus on possible scenarios of harmonisation of both oncogenetic testing and management of cancer patients.</p>}},
  author       = {{Horgan, Denis and Ciliberto, Gennaro and Conte, Pierfranco and Curigliano, Giuseppe and Seijo, Luis and Montuenga, Luis M. and Garassino, Marina and Penault‐llorca, Frederique and Galli, Fabrizia and Ray‐coquard, Isabelle and Querleu, Denis and Riegman, Peter and Kerr, Keith and Van Poppel, Hein and Bjartell, Anders and Codacci‐pisanelli, Giovanni and Koeva‐balabanova, Jasmina and Paradiso, Angelo and Maravic, Zorana and Fotaki, Vassiliki and Malats, Nuria and Bernini, Chiara and Buglioni, Simonetta and Kent, Alastair and Munzone, Elisabetta and Belina, Ivica and Van Meerbeeck, Jan and Duffy, Michael and Jagielska, Beata and Capoluongo, Ettore}},
  issn         = {{2072-6694}},
  keywords     = {{Biomarkers; Cancers; Europe’s Healthcare Systems; HRD; Oncogenomics}},
  language     = {{eng}},
  number       = {{3}},
  publisher    = {{MDPI AG}},
  series       = {{Cancers}},
  title        = {{Bringing onco‐innovation to Europe’s healthcare systems : The potential of biomarker testing, real world evidence, tumour agnostic therapies to empower personalised medicine}},
  url          = {{http://dx.doi.org/10.3390/cancers13030583}},
  doi          = {{10.3390/cancers13030583}},
  volume       = {{13}},
  year         = {{2021}},
}