CR3 News Magazine 2021 VOL 3: MAY - MEDICAL ISSUE: SURVIVING | Page 39

Biomarkers insufficiently used

Biomarkers are still largely unknown by cancer patients and are insufficiently used by physicians, according to a survey conducted by the European Cancer Patient Coalition (ECPC) and the European Alliance for Personalised Medicines (EAPM) to measure patient awareness on biomarkers across Europe, as part of an ongoing commitment to improve cancer patients’ treatment outcomes.

Physicians use diagnostic tests for various levels of clinical decision support (i.e. to confirm a diagnosis, to estimate prognosis, or to make a therapy selection, etc.). Poor patient knowledge surrounding diagnostic technologies and biomarkers, and lack of reimbursement for biomarker testing in many European countries creates an obstacle for improving cancer patients’ clinical outcomes.

What are biomarkers?

A biomarker is1 any substance, structure, or process that can be measured in the body or its products and influence or predict the incidence or outcome or disease. Biomarkers are also used for disease prognosis, the patient likelihood of responding to a given treatment, to monitor treatment response but also throughout the cancer drug discovery process.

Examples of biomarkers include everything from pulse and blood pressure measurements through basic chemistries to more complex laboratory tests of blood and other tissues.

What do patients know about biomarkers?

Despite the interest in ensuring optimized treatments are administered to patients, at the right time, results of the survey show that 30% of respondents are not familiar with the concept of biomarkers and 60% of respondents would not have been proposed a biomarker testing by their oncologist.

Differences also exist in testing time for biomarkers test ranging from 5 to 30+ days for the same test in different countries.

Information to patients

The survey also suggests that the relationship between patients and their oncologists can be improved as more time is required to inform patients about the challenges and benefits of biomarkers testing. 70% of respondents said that their doctor did not provide them with sufficient information.

Recommendations for policy makers

The results of this survey are a useful resource to improve clinical outcomes for cancer patients through better utilization of biomarker testing, and extends from prevention and screening technologies, through to diagnosis, treatment and follow-up. The EU can play an important role to improve patients’ and clinicians understanding the use of biomarkers throughout the patients’ treatment journey and to facilitate a better regulatory framework to accelerate access to biomarker testing.

What can be done?

Increase biomarker literacy: Health authorities, physicians and patient groups need to improve awareness regarding genetic testing. Communication focused upon access to testing and how it can aid in patient care provides an important opportunity to engage patients in managing their health as active partners and inform them about break-through developments in medical technologies.

Improve access: The development of biomarker-based diagnostics can facilitate faster diagnosis and treatment. For this to happen, diagnostics tests need to be integrated in the clinical setting and be affordable and available to all patients.

Adapting the regulatory framework: The regulatory and reimbursement processes must be adapted to the specificities of new technologies. Hospitals and other clinical settings have to adapt to respond to some of its challenges such as quality and assurance of the diagnosis or data privacy. In addition, a better integration of diagnostic regulations into therapeutic (i.e. drug) regulatory frameworks could improve the reimbursement and access of biomarker tests.

About the survey

As part of a campaign to raise awareness about the use of biomarkers across Europe, a survey was conducted among ECPC member organisations in a joint effort by the ECPC and the European Alliance for Personalized Medicine (EAPM). The electronic/phone survey, conducted between April – June of 2016, gathered 150 answers from various cancer patients/survivors.

Benefits of using biomarkers

For patients they can improve the risk-benefit profile of new and existing drugs, providing optimized therapy selection in a timely manner, to increase the likelihood of response;

For the industry they can improve the efficiency and speed of the drug development process;

For healthcare providers they can offer optimized targeted treatment selection, avoid medical errors and reduce adverse reactions to medicinal products2;

For healthcare systems biomarkers can serve as navigation tools, ensuring that the right patient gets the right treatment at the right time. They are part of a comprehensive movement towards personalized medicine and can help to reduce treatment costs, increase patient response, while ensuring efficient use of scarce health care resources3. This is an integral aspect to the sustainability of future healthcare economics.

[1]WHO. Environmental Health Criteria 237. Principles for evaluating health risks in children associated with exposure to chemicals. WHO, 2006

[2] Use of ‘-omics’ technologies in the development of personalised medicine, European Commission, 2013

[3]Deverka PA, Vernon J, McLeod HL., Economic opportunities and challenges for pharmacogenomics, Annu Rev Pharmacol Toxicol. 2010

How much do you know about biomarkers?

Sept 2016

Continued on page 40 ...

39