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

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.

Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options

“…– Aligned reimbursement processes of precision mechanism and subsequent treatment [ 175 , 178 , 179 ] ➤ General: – Use of lists of approved genetic and genomic tests and dedicated technology assessment programme (e.g., “Palmetto”) [ 88 , 107 , 156 , 160 , 171 ] – Regulatory reforms to streamline access to diagnostics, dedicated funding [ 123 ]. – Use of value of information to define who should bear the cost of precision medicine value [ 170 ] – Refinement of value assessment frameworks to include wider economic analyses of direct and indirect costs and benefits, and additional element of value [ 173 , 174 ] Evidence: ➤ Performance-based models: – Inability to obtain accurate/credible data to measure outcomes (related cost barriers to implementing data collection technologies) [ 71 ] – Lack of demonstrable benefit/value [ 10 , 13 , 152 ] – Clear evidence of the clinical utility of diagnostic tests [ 63 , 101 , 120 , 149 , 161 – 163 ] Financial risk: ➤ Performance-based models: – (Increasing) co-payments by patients reduces access/use of treatment [ 72 ] – Affordability issues of PM [ 126 – 128 , 168 ] (even for therapies with proven cost-effectiveness) and costly new therapies (gene/cell/cancer therapies) [ 13 , 126 – 128 , 150 , 152 ] – Future private payers have incentives to avoid patients with accrued liabilities due to past treatment [ 73 ] – Switch to insurance providers to those with a history of coverage [ 10 ] – Distort incentives for payers if the current payer can shift payment disproportionately toward future payers [ 73 ] ➤ Non-risk-sharing (traditional) models: ...…”

“…– Aligned reimbursement processes of precision mechanism and subsequent treatment [ 175 , 178 , 179 ]…”

Identifying the Steps Required to Effectively Implement Next-Generation Sequencing in Oncology at a National Level in Europe

“…As identified during the expert panels, access to NGS can be limited by low awareness among physicians of the availability of biomarker tests and limited knowledge of referral pathways, particularly in rural centers. Physicians also show uncertainty when interpreting and using genomic data to guide treatment; a survey across 19 European countries found 39% of clinicians to be dissatisfied with the conditions of non-small cell lung cancer molecular testing in their country, citing difficulties with understanding results [40]. This is confounded by the differing education of physicians across Europe.…”

American Joint Committee on Cancer’s Staging System for Breast Cancer, Eighth Edition: Summary for Clinicians

“…In many parts of the world, biological markers and multigene panels are not routinely available (23). Also, even in other parts of the world where biomarkers are more accessible, such as Europe, barriers in policy, reimbursement, and regulation have also delayed the widespread adoption of prognostic testing compared to the US (24). Therefore, the continued use of anatomic TNM staging in these regions emphasizes both its relevance and consistent usage.…”