The unexploited potential of biomarker testing in Oncology

Today's guest blog was authored by Denis Horgan, PhD, LLM, MSc, BCL, Executive Director of European Alliance for Personalised Medicine, and Chief Editor of Public Health Genomics

Europe is missing out on major opportunities to help patients suffering from cancer and other serious conditions. 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 in many cancers, but also in an ever-wider range of conditions. But development is impeded by data deficiencies, and lack of policy alignment on standards, approval – particularly the role of real-world evidence in the approval process – and reimbursement.

The acute nature of the problem is compellingly illustrated by the challenges facing the development and use of tumour agnostic therapies. Here, the lack of preparedness to take advantage of this innovative approach to cancer therapy is sharply exposed.

Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests. We should also 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industrial competitiveness and innovation requires an appropriate policy framework – starting with an update to outdated recommendations.

Gaps, and need for action

The uncertainty around access, funding and uptake of biomarkers based on molecular diagnostics has a direct negative influence on investment decisions, further hampering progress and the integration of innovation as set out in our recent publication. The disproportionate attention is striking. Diagnostics account for less than 2% of total healthcare spending, but they influence 60% of clinical decision making. Current policy in Europe –particularly with respect to reimbursement – fails to take this into account, and urgently needs updating.

It is not just the coronavirus pandemic that has given new prominence to health in EU policy, although it has imparted additional impetus. The EU was already conscious of the twin perils of sub-optimal health services becoming unsustainable in the face of demographic change and spiralling chronic disease, and of the EU losing out at a global level to scientific innovation, on which its prosperity largely depends.  

Collaboration is the key for success

Recent signals could justify guarded hopes of an improved environment. There have been demonstrations of broad support for EU initiatives such as its Beating Cancer Plan or its Cancer Mission, and the 1 Million Genome initiative (which 23 European countries have signed up to, including Germany) within the broader framework of the EU Health Data Space. Additionally, the EU institutions have made numerous declarations, before and during the coronavirus crisis, that suggest a growing recognition of the need to innovate at the level of both policymakers and the health community. The renewed attention to disparities in cancer care and access across Europe is also driving new assessments of obstacles and new pursuits of solutions and promoting greater networking and collaboration among cancer institutions.

But nothing will happen by accident. Constructive change to the health care context could ensure better use of new technologies in testing, in diagnosis and in treatment of cancer, through development and use of biomarkers and the advanced treatments – such as personalised medicine – that they enable. But this will result only from vigorous debate among all stakeholders, and agreement on recommendations of a technical and political nature that will result in a better deal for patients and a more sustainable approach to healthcare.

 

 

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