1505MO - Improving cancer care through broader access to quality biomarker testing: An IQN Path, ECPC and EFPIA initiative

Background

Predictive biomarkers are essential for selecting the best therapeutic strategy in cancer patients. Yet, the promise of superior treatment outcomes cannot be realised if patients do not have access to high quality biomarker testing. The International Quality Network for Pathology (IQN Path ASBL), the European Cancer Patient Coalition (ECPC) and the European Federation of Pharmaceuticals Industries and Associations (EFPIA) launched an initiative to evaluate the access to and quality of biomarker testing (BMT) across Europe.

Methods

Four access metrics (laboratory access, test availability, test reimbursement, test order rate) and three quality metrics (quality scheme participation, laboratory accreditation, test turnaround time) were applied. Secondary sources included surveys of 141 laboratory managers and of 1.665 patients, and 58 in-depth interviews with laboratory managers, physicians, and payers. The findings were reviewed over a series of meetings by IQN Path, ECPC, EFPIA and key opinion leaders, in order to develop an unbiased view of existing test access barriers and to establish a consensus on critical policy recommendations for immediate, concerted action.

Results

A detailed mapping showed the status of each country according to the applied metrics and six key barriers to BMT were identified in the majority of European countries: 1) Limited availability of precision medicine linked to biomarkers; 2) Unclear value assessment approaches for diagnostic tests; 3) Very diverse laboratory infrastructure, capabilities and referral pathways; 4) Limited availability of public funding to support biomarker testing; 5) Limited stakeholder awareness and education; 6) Inconsistent participation of laboratories in quality assurance schemes.

Conclusions

To address the barriers to high quality BMT, multi-disciplinary and concerted action is needed. Short-term and long-term policy recommendations to address the shortcomings in BMT access would be presented and discussed with the ESMO audience. The project was initiated and financed by IQN Path, ECPC and EFPIA together with a consortium of industry and academic partners, and conducted by L.E.K. Consulting.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

EFPIA and IQN Path.

Funding

EFPIA and IQN Path.

Disclosure

N. Normanno: Financial Interests, Personal, Other, Speaker's fee and/or advisory board: MSD; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Qiagen; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Bayer; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Biocartis; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Illumina; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Incyte; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Roche; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: BMS; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Merck; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Thermo Fisher; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: AstraZeneca; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Sanofi; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Eli Lilly; Financial Interests, Personal, Other, Speaker's fee and/or advisory board: Novartis; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Thermo Fisher; Financial Interests, Institutional, Research Grant: Qiagen; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Biocartis; Financial Interests, Institutional, Research Grant: Illumina; Financial Interests, Institutional, Research Grant: Blueprint; Non-Financial Interests, Personal, Member of the Board of Directors: International Quality Network for Pathology (IQN Path); Non-Financial Interests, Personal, Member of the Board of Directors: Italian Cancer Society (SIC). M. Akkermans: Financial Interests, Personal, Full or part-time Employment: MSD. C. Bedard Pfeiffer: Financial Interests, Personal, Full or part-time Employment: Roche. I. Cattaneo: Financial Interests, Personal, Full or part-time Employment: Novartis. J. Emch: Financial Interests, Personal, Full or part-time Employment: GSK. P. Fivey: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. S. Hall: Financial Interests, Personal, Full or part-time Employment: Novartis. E. Rouleau: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Clovis; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Other, Travel: BMS; Financial Interests, Personal, Other, Travel: AstraZeneca. M. van Meerveld: Financial Interests, Personal, Full or part-time Employment: MSD. All other authors have declared no conflicts of interest.