Biomarkers and patients’ access to personalized oncology drugs in Europe
Heinz Zwierzina, CDDF Managing Director

Biomarkers can be objectively measured and evaluated as indicators of normal or pathogenic biological processes or of pharmacologic response to therapeutic interventions. As such biomarkers hold great potential to predict clinical outcomes and define a personalised treatment strategy. Given the complexity of the neoplastic process, in most instances a single marker cannot offer the necessary sensitivity and specificity. Therefore research is now focussed on the development of multiplexed assays that screen multiple genes and proteins at the same time.

The need for collaboration among all stakeholders

Regulatory challenges, the hurdles to achieve reimbursement, and access to clinical data are all barriers that will need to be further addressed by all stakeholders to achieve widespread use of biomarkers in clinical practice in future.

The Cancer Drug Development Forum (CDDF, www.cddf.org) recognizes the complex issues of integrating biomarker development into innovative oncology drug development. It organizes and encourages multi-stakeholder meetings and workshops among academia, pharmaceutical industry, regulatory authorities, health technology assessors, patient organisations as well as payers to address these challenges.

Health Technology Assessment (HTA) and patient access

From the healthcare system perspective, access to biomarkers that define the patients that may or may not respond to therapy will be crucial to improve treatment standards and efficiency of care.

At a European level, there is a need to promote research and development in biomarkers, adapt regulatory frameworks to the specificities of new health technologies, and harmonise HTA across Member States. At the national level, there is a need to train healthcare professionals and patient advocates on the importance of biomarker testing, and to adapt reimbursement frameworks to the specificities of new health technologies. Lack of consistent HTA processes across Europe create a barrier to entry for novel diagnostics because they require a significant additional investment from diagnostics companies to navigate the payer landscape.

The Way ahead

The close collaboration between the Cancer Drug Development Forum (CDDF) and the European Cancer Patient Coalition (ECPC) aims to raise awareness and educate patients/policy makers regarding biomarkers and personalised medicine. Biomarker testing holds value for facilitating faster diagnosis, a targeted personalised treatment plan, and avoid wasting resources on ineffective treatments.


For more information about the Personalised Medicine Awareness Month 2018 and to download the Campaign Action Toolkit, available in 12 languages, please visit: ecpc.org//personalisedmedicine2018