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European Groups Find Inequitable Access to Quality Cancer Biomarker Testing

NEW YORK – The International Quality Network for Pathology (IQN Path), the European Cancer Patient Coalition (ECPC), and the European Federation of Pharmaceutical Industries and Associations (EFPIA) on Tuesday released a report detailing inequities in the quality and accessibility of cancer biomarker testing in the EU and the UK and recommending policy solutions to overcome these barriers.

The report is based on research conducted throughout 2020 and was jointly funded by IQN Path, ECPC, and EFPIA, as well as industry and academic partners. The groups administered surveys to 141 laboratory managers and 1,665 patients, conducted 58 in-depth interviews with laboratory managers, physicians, and payors, and interrogated a wide swath of secondary sources.

The research explored how a selection of key biomarkers tests performed across seven metrics: laboratory access, test availability, test reimbursement, test order rate, quality scheme participation, laboratory accreditation, and test turnaround time. Tests included in the analysis gauged PD-L1 expression and mismatch repair deficiency or microsatellite instability, and assessed the following genes: BRCA1/2, EGFR, NTRK, BRAF, KRAS/ NRAS, HER2, ALK. The research also looked at next-generation sequencing hotspot tests of up to 50 genes, targeted panels, NGS panels encompassing more than 50 genes, and liquid biopsy assays.

In terms of access, the report identified variability across the EU. Northern and Western countries generally performed better than Southern, Central, and Baltic countries, the survey found.

In 15 out of 28 countries, there was a lag time of at least one year between when biomarker-based therapies were approved for reimbursement and when associated tests to identify these biomarkers became available. After targeted therapies received approval from the European Medicines Agency, moreover, it took anywhere from 127 days to 823 days — in Germany and Poland, respectively — for patients to gain access to the drugs.

In 13 countries, fewer than 75 percent of biopsies from eligible patients were tested for biomarkers. The report also detailed a lack of standardized value criteria for new biomarker tests and described how some countries' reimbursement codes are based on cost or technology rather than value. Laboratory infrastructure and referral pathways varied regionally, too, as did public funding for biomarker testing, physician and patient education about testing, and laboratory participation in external quality assessments.

To address these inequities, the groups recommended establishing processes for simultaneous approval of targeted therapies and their associated biomarker tests, and said that these therapies and tests should become available to patients as a package. Importantly, they called on health systems to establish a system of test value assessment, dedicate budgets for biomarker testing, and require that all laboratories pursue external quality assessments and ISO accreditation.

Further recommendations include establishing regional testing centers and ensuring that education and training is available for physicians, pathologists, payors, policy makers, and patient advocacy groups. The groups also encouraged centralized clinico-genomic data collection and horizon scanning for future testing needs.

In the longer term, the groups urged standardizing approaches to developing tests, including those used in clinical trials, as well as establishing testing infrastructure through lab networks, sharing data collected across Europe, and standardizing EU- and UK-wide best practices.

Finally, IQN Path, ECPC, and EFPIA called for establishing precision medicine task forces on both the country- and Europe-wide levels to implement these recommendations.

"It is … a matter of urgency to provide physicians and health systems with the biomarker testing infrastructures and processes required in order to deliver the benefits of these therapeutic advances to patients," Nathalie Moll, EFPIA's director, said in a statement about the report. "This study is a strong first step in that direction and we look forward to working with all stakeholders in the health and policy space to make this a reality."