European Stakeholders call on the EU to deliver on the ambitions of Europe’s Beating Cancer Plan by increasing access to genomic testing

In June 2024, the Cancer Patients Europe, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), the European Society of Pathology and Lung Cancer Europe (LuCE) published a joint statement on increasing access to genomic testing, delivering on the ambitions of Europe’s Beating Cancer Plan.

Over the past 10 years, clinical practice in cancer has evolved at a rapid pace, leading to increased uptake of precision medicine and development of advanced diagnostics that allow for large-scale, high-quality genetic and genomic profiling of cancer patients.[1] Today, for many patients we have the technological capability to deliver the right treatment at the right dose, to the right patient, at the right time. However, despite the rapid pace of innovation in this field, a vast number of cancer patients from all over Europe who would benefit from genomic testing still do not have access to advanced diagnostics.[2]

With Europe’s Beating Cancer Plan[3] in 2021, the EU committed to “leave no stone unturned to take action against cancer” and signalled the beginning of a new era in cancer prevention and care, where, with EU level support, patients will have access to high-quality screening, treatments and the latest state-of-the-art technologies.

In its report on Europe’s Beating Cancer Plan, the European Parliament recognises the lack of reimbursement of genomic testing as a major barrier for patients’ access to the latest most innovative therapies and calls on Member States to increase access for patients in all age groups to advanced diagnostics by earmarking financing and creating clear pathways for fast and efficient reimbursement.[4]

We welcome this political commitment, as genomic testing facilitates earlier diagnosis of disease, improves the prognosis of disease outcome and enables targeted therapeutic interventions based on an unprecedented understanding of the underlying molecular characteristics of patients. With widespread adoption, the potential is enormous to derive exponential benefit for healthcare systems alongside more targeted and efficient use of resources.

The value of knowing: In addition to improved outcomes for patients, genomic testing can also increase patients’ confidence that they have been recommended the right treatment for their cancer. For example, genomic analysis can help identify those patients who may not benefit from systemic adjuvant chemotherapy and so avoid unnecessary toxicity and related decrease in quality-of-life. Conversely, identifying patients who may benefit from systemic adjuvant chemotherapy can make them more confident that undergoing this additional treatment is the right decision for them. However, too often patients who could benefit from genomic testing are not informed about their options and do not receive genomic testing.[5]

The potential for healthcare system savings: Genomic testing has, in separate studies, been shown to help decrease costs for healthcare systems, by eliminating prescription of unsuitable therapies, lowering resource utilisation, lowering costs for adverse event management and reducing costs for severe disease management.[6],[7],[8]

Specific actions from European governments and EU institutions will be needed in order to support the evolving ecosystem for advanced diagnostics: Member States must invest in an R&D ecosystem that fosters development, encourages innovation and facilitates the uptake of advanced diagnostics, while at the EU level, specific and clear regulatory pathways for advanced diagnostics are needed. Member States must also develop clear pathways for fast and efficient reimbursement and facilitate the integration of advanced diagnostics into clinical practice, to ensure access for patients.[9]

Specific actions must include:

• Enhanced consistency in national approaches to reimbursement of and access to genomic testing in Europe, along with establishment of new EU recommendations on genomic testing to facilitate concrete policy action at Member State level.[10]
• A recognition that unclear value assessment approaches for diagnostic tests lead to delays in the integration of testing into clinical practice. Reimbursement must reflect the added value of genomic testing to ensure sufficient funding and laboratory, or inpatient tariffs must be adjusted to cover innovative tests.[11]

One of the  main vehicles to help deliver on the political commitment of Europe’s Beating Cancer Plan will be the CAN.HEAL project (2022-2024), which aims to establish recommendations for initiatives to be incorporated  into the EU health system that will further improve access of individuals and patients to prevention, diagnosis and treatment of cancer through personalised medicine. At the Member State level, some countries have taken a leading role in adoption of advanced diagnostics, with national genomic plans, such as the “Plan France médecine génomique 2025” in France, and “DNPM” in Germany.  Over time, these initiatives will contribute to increased uptake of genomic testing – however the speed of adoption is lagging behind that of other regions. Further action at EU level is needed to encourage uptake of genomic testing in the clinic, with prioritisation of funding and reimbursement of innovative advanced diagnostics.

As European stakeholders representing the continuum of cancer care from patients, clinicians, pathologists to developers, we call on the EU and its Member States to support wider access to genomic testing and deliver on the aims of Europe’s Beating Cancer Plan.

Call to action

The time for the EU to act is now, to ensure that the existing access pathways are suitable for delivering advanced diagnostics to patients across Europe, and to issue clear guidance and support to the Member States, to support wider uptake of genomic testing in national healthcare systems.

Together, we:

1. Call on the European Parliament to follow-up on its resolution on Europe’s Beating Cancer Plan, by facilitating dialogue with the stakeholder community to explore proposed recommendations and issuing concrete guidance for the Member States to reduce inequalities by supporting wider access to genomic testing with a European Parliament resolution.
2. Call on the Council to develop a Council recommendation on genomic testing, to issue Union-wide guidance for the Member States, as has been done for cancer screening. Screening and early detection must be accompanied by the equal opportunity for genomic testing to support disease prognosis, therapy selection and cancer care.
3. Call on the European Commission to ensure the regulatory pathways for advanced diagnostics are developed, in collaboration with stakeholders, to prevent further delays in delivery of innovative genomic testing techniques on the horizon.

 

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[1] Normanno et al (2022): “Cancer Biomarkers in the era of precision oncology: Addressing the needs of patients and health systems. Seminars in Cancer Biology. 84:293-301

[2] Normanno et al (2022): “Access and quality of biomarker testing for precision oncology in Europe” European Journal of Cancer. 176:70-77

[3] COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Europe’s Beating Cancer Plan COM/2021/44 final

[4] European Parliament resolution of 16 February 2022 on strengthening Europe in the fight against cancer – towards a comprehensive and coordinated strategy (2020/2267(INI))

[5] Cancer Patients Europe (2022): myC Genomics and breast cancer European patient survey

[6] Berdunov V, et al. (2022): Journal of Medical Economics Dec 31;25(1):591-604

[7] Lux MP, et al. (2018): The Breast. Feb 1;37:89-98

[8] de Jongh FE, et al. (2022): International Journal of Breast Cancer. Sep 22

[9] EUCOPE (2021): “Developing an advanced diagnostics ecosystem in Europe: A proposal for change

[10] European Cancer Organisation (2022) “Put to the Test: Empowering Genomics to Improve Cancer Care and Patient Lives

[11] IQN Path, ECPC & EFPIA: (2021): “Unlocking the potential of precision medicine in Europe”