In the years to come, Europe is likely to reach an inflection point when it comes to which countries widen reimbursement opportunities for biomarker tests, and which fall behind leading markets. The holy grail of potential parallel reimbursement of precision medicines with corresponding biomarker tests is likely to prove critical for the uptake of many innovative oncology drugs on the horizon. The possibility of lowering access barriers to specialty biomarker products, and the inter-relational benefit for access to precision anti-cancer medicines, understandably piques significant pharmaceutical sector interest.

Access barriers to biomarker tests are strongly present in European markets today, as was recently evidenced in a wide-ranging survey by the European Federation of Pharmaceutical Industries and Associations. The report looks at access time and the extent of access to biomarker tests across Europe. The analysis, written in conjunction with the International Quality Network for Pathology and European Cancer Patient Coalition, ranks each European country, in fairly black and white terms, on a scale of reimbursement access barriers to oncology biomarker testing, based on a cross-country comparison of metrics for test availability, reimbursement, and order rates, among other factors. This is a perfectly accurate way of scoring country-specific merits, although it is possible that early access schemes and other routes to some markets may slightly skew the results too negatively in a few cases. Still, the EFPIA’s conclusions are well justified and a fair evaluation of the survey data.

Large inconsistencies and variations exist in how European countries reimburse biomarker tests for the diagnosis and treatment of cancer. Aggregate performance indicators – examining precision medicine availability versus biomarker testing per European country – reveal that the gulf between countries manifests itself as a geographical split, with northern and western European countries generally investing more in biomarker testing than Eastern European, Southern European, and Baltic countries.

Rapid and continuing advances in biomarker testing are clearly not matched by an even take-up across health systems. EFPIA modeling ranks the top markets as Germany, Denmark, Belgium, Austria, Finland, France, Sweden, Ireland, the Netherlands, and the UK. In comparison, Bulgaria, Romania, Slovakia, Poland, and Latvia conduct a fraction of the amount of biomarker testing. The observation that some countries are missing out on diagnostic testing suggests these countries face future obstacles to improving cancer patients’ clinical outcomes and fully gaining from innovative anti-cancer medications.

Among the factors that could have the most short-term influence toward improving biomarker testing availability is the adoption of dedicated, high-level sources of public funding to support biomarker testing, possible action to link the reimbursement approval of biomarker test with medicine reimbursement (this is not typically the case, or at least it is not done in time-parallel), and work on refining “unclear and inefficient” value assessments for new diagnostic tests. Key contributors to overcoming limited and inconsistent European access to biomarker testing should be based on best practices in those countries that currently have comparatively high biomarker enabling systems. A handful of states have made strides in these areas, with the EFPIA singling out Germany, although even here it identifies room for improvement, noting that while testing is publicly well-reimbursed, the funding sources can vary between biomarkers according to treatment setting, prevalence and novelty. This is not ideal for the introduction of the technology. Another drawback to the approach taken by many European countries is that “unclear and inefficient” value assessments often lead to delays in the integration of testing into clinical practice. Best practices in this area are currently exemplified by Belgium and Scotland whereby key stakeholders are involved in reimbursement approval decisions for biomarker tests also participate in reimbursement approval for medicines, hence ensuring some degree of alignment between the two processes. The other change needed to open up the testing market is the creation of guaranteed budgets, which would probably usually be applied in national hospital settings. This is done in Denmark, with dedicated diagnostic budgets achieving significant success, alongside budgetary review mechanisms that can adapt quickly to higher volumes required or new tests. The UK has also been a pathfinder in this field, by undertaking regular reviews of regional budgets to ensure that diagnostic funding is regularly adjusted to ensure sufficient cover for biomarker testing.

The challenge for the sector is the diverse range of capabilities, organizational architecture and policy approaches to integrating specific biomarker tests into standard treatment that are currently characteristic. Of course, there is no one-size-fits-all model that is suitable for all European markets, but even so, there should be the possibility that early adopters of the technology can drive widespread uptake and slowly remove regional variation and unequal access by developing best practice standards for others to follow. The growing importance of this is clear, with the need for testing, as well as future increases in volume and complexity of the available testing, only set to increase demand.

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