Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine

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 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Europe’s industrial competitiveness and innovation require an appropriate policy framework—starting with an update to outdated recommendations.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.

The Homologous Recombination Deficiency Scar in Advanced Cancer: Agnostic Targeting of Damaged DNA Repair

“…For that reason, new protocols for improving the conservation and storage of paraffined samples should be implemented in hospitals. In fact, a systematic and consensus protocol for high-quality minimum biomarker testing is being requested by the scientific community [ 100 ]. These molecular testing recommendations should be offered to all cancer patients for diagnosis and prevention, detailing the type, the technique and the methods of implementation and ensuring adequate training for clinicians to guide the treatment decisions.…”

The tumor-agnostic treatment for patients with solid tumors: a position paper on behalf of the AIOM- SIAPEC/IAP-SIBioC-SIF Italian Scientific Societies

“…The model based on the outsourcing of the HRD test is not sustainable in many countries, to the lack of coverage and the not homogeneous infrastructure of both hospitals and laboratories. Therefore, the only way to overcome these challenges is to harmonize paths in every country or region worldwide (Horgan et al, 2020(Horgan et al, , 2021.…”

“…Therefore, it would be strongly recommended that these tests should be performed at specialized medical institutions (cancer genomic medicine designated core hospitals) that meet the quality requirements. In order to achieve the goal of the implementation, centralization, consolidation and harmonization of large-scale genomic assays will be the key (Horgan et al, 2021).…”

How Can the EU Beating Cancer Plan Help in Tackling Lung Cancer, Colorectal Cancer, Breast Cancer and Melanoma?

“…In addition to putting pressure on individuals, national health and social care systems and state budgets, this disease also affects productivity and economic growth [ 3 , 4 ]. New scientific understanding and new techniques and methodologies are opening up horizons for great improvements in diagnosis and care [ 5 ]. However, take-up is uneven, research needs and potential outstrip currently available resources, manifestly beneficial practices—such as population-level screening for lung cancer—are still not generalised, and the quality of life of patients and survivors is only beginning to be given attention it merits.…”