This case study explains the global differences in test reimbursement and reveals that for some tests the laboratories own costs aren't even covered....
Tom Zeitlow provides analysis on the recent report by Frost & Sullivan,’European Genetic Testing and Screening Services Market’.
Two things struck me about a recent report from Frost & Sullivan entitled European Genetic Testing and Screening Services Market . The report found that the European genetic testing and screening services market is poised to take off, driven by the increasing availability of tests covering a wider range of disease areas as testing for genetic diseases has swiftly moved from the laboratory into medical practice, but that reimbursement remains a primary barrier. As Frost & Sullivan Senior Research Analyst, Divyaa Ravishankar, specifically notes, “Varying reimbursement procedures across Europe, however, loom as a major concern to market participants. When samples are being shipped across international boundaries, inadequate reimbursement can result in uneven access to genetic testing services.”
First, it struck me that this report yet again highlights the market shift underway driven primarily by physician demand. As the report noted, “There is a rising interest in predictive testing, which is seen as the highest growth area within genetic testing.” Secondly, it struck me that this demand is again exposing the infrastructure gaps in the EU laboratory market. For more details on this research see http://www.frost.com/prod/servlet/press-release.pag?Src=RSS&docid=263379124
Perhaps we should pose the question, “for whom are these reimbursement infrastructure gaps a problem?” Of course, diagnostic companies introducing new tests are often frustrated by the national reimbursement structures in most markets outside the US and continue to lobby for change. Whilst this serves to address some gaps on some tests it does not really address the underlying enablement of personalized medicine. Cash-strapped EU governments are not ready any time soon to stick their hand up to fund new predictive or molecular tests (particularly as the price tag associated with them is tenfold higher than previous price points). Ask any laboratory manager outside the US at the minute how much time they spend trying to get adequately reimbursed for the time, effort and commitment to introducing new tests and they will likely shock you with their answer.
The correct answer, naturally, is that infrastructure gaps are a problem for multiple stakeholders in a myriad of ways. It is our view that a solution will ultimately involve a pan-EU and coordinated action. A more immediate stopgap solution lies with coordinated actions between pharma, clinicians, diagnostic companies and, of course, laboratorians on a per disease or indication basis. The strident efforts by Roche to ensure quality BRAF testing (regardless of the platform used) outside the US is available and reimbursed whenever Zelboraf will be requested, should not be seen as the obligation only of a diagnostic company with deep pockets, but rather a role model for such coordinated action among all the interested stakeholders.
This level of industrial and organizational collaboration will not happen on its own. Indeed, our own research on cross industry collaboration highlights critical components of collaboration between competitors. Interestingly, it starts with identifying who the winners will be.