By Turna Ray
Germany, the UK, and France have the "most favorable markets" in Europe for drug/diagnostic combination products, according to a recent assessment of European reimbursement systems conducted by the Personalized Medicine Coalition.
The report, authored by Susan Garfield of consulting firm Bridgehead International, concluded that "all European countries’ reimbursement infrastructures are limited in their ability to adequately evaluate and rapidly provide access to personalized medicine diagnostics or combined drug and diagnostic products" and recommends that these countries "reassess their evaluation and payment systems to accommodate the growing number of personalized medicine technologies that are being brought to market."
The report ranks European countries' reimbursement infrastructures in terms of their personalized medicine knowhow. For this analysis, Garfield considered whether each nation's current infrastructure supports or inhibits personalized medicine products and whether each system is undergoing changes to accommodate these new technologies. Based on these criteria, 10 countries were scored based on a 40-point scale.
"With this methodology, countries such as Germany, the UK, and France were ranked higher, due in large part to their current reimbursement pathways for combined diagnostics and therapeutics, previous support of other personalized medicine technologies, and their investments in personalized medicine research," the report notes. For example, payors, policymakers, and clinicians in Germany are actively debating how to reform regulations and pricing policies to accommodate personalized treatments.
"Most payors in Germany and in other markets indicate that if the test only provides information for information’s sake then there is little value from the payor perspective," according to the report. "Alternatively, if the test can direct care, then the test has inherent value and will likely be covered if priced appropriately."
"Conversely, countries such as the Netherlands, Finland, and Norway were ranked lower due to their current reimbursement systems’ lack of clear pathways for evaluation and funding for personalized technologies," the report states.
Italy, Sweden, Sweden, Switzerland, and Spain were in the middle of the pack and their systems were found to need "general room for improvement." For example, in Italy, even though a drug may be centrally approved, local governments in the country can limit access to a treatment in a particular region, which makes it difficult for more sophisticated and possibly more expensive personalized products to be consistently available throughout the nation.
Italian "regions are exerting control over purchasing decisions by moving some drugs from the traditional pharmacy channel to the hospital channel," the report states. "Today, there is significant variation among regions in terms of coverage and availability of personalized medicine products."
According to the PMC report, the most salient factor hindering access to personalized medicine throughout European countries is the fact that reimbursement systems aren't designed to incentivize drug/diagnostic codevelopment. While many European nations reimburse for medical products under a single-payor system, they have disjointed processes for how drugs are appraised and how tests are paid for.
Furthermore, the reimbursement system for medical products is disjointed from the regulatory process, which is managed through a centralized body for all European Union nations. "This creates fragmentation in technology evaluation, evidence requirements, and market access for personalized medicine technologies across Europe," the report notes. "As a result, health systems in many countries are failing to appropriately evaluate and pay for personalized medicine technologies."
Since regulatory approval doesn't necessarily square with reimbursement approval, "patients are often deprived of the most advanced drug and diagnostic treatments while health systems bear the costs of outdated trial-and-error approaches to medicine," the report concludes.
According to figures from the European Medicines Agency, the body responsible for reviewing the efficacy and safety of medical products in the EU, approximately 20 percent of the product submissions it has reviewed to date involve the application of genomic data to individualize the administration of treatments. The European Commission, the body responsible for granting approval for drugs, has cleared 13 targeted or personalized medicines that require testing with a companion diagnostic prior to patient administration.
However, the regulatory process for diagnostics is separate from the process for drugs, and much more lenient. Diagnostics can be commercialized as kits after manufacturers affix CE-marking attesting that they meet regulatory requirements. Diagnostics can also be marketed as laboratory-developed tests requiring no CE marking.
The comparatively more stringent regulatory system for drugs often means that a companion test will be available in Europe before the drug is. For example, Roche/Plexxikon's application for Zelboraf, a melanoma drug for patients with BRAF mutations, is currently under review by European regulatory authorities. However, the BRAF companion test kit developed by Roche simultaneously alongside the drug already has CE marking.
After drugs and tests are granted regulatory approval, they are subject to each country's specific technology evaluation and reimbursement systems. National payors evaluate and pay for drugs deemed to improve outcomes and be cost-effective. However, diagnostics are paid for by hospital or lab budgets, or based on code-specific fee schedules.
"Diagnostic reimbursement pathways in many European countries are not as clearly defined or sophisticated as those for drugs," the PMC states in its report. This, on top of the fact that reimbursement criteria for companion tests varies from country to country, has led to inconsistent coverage polices for personalized medicine products.
Citing the example of Herceptin, the breast cancer drug indicated for patients whose tumors overexpress the HER2 protein, the report points out that although the drug is widely covered by national payors in European countries, the companion diagnostic that gauges which patients should receive the drug is not paid for by all payors. The PMC notes that while the HER2 test is publicly funded in the UK, France, Germany, and Italy, in Spain the drug developer must fund patient testing.
The wide variance in the reimbursement system across European nations is often cited as a barrier to market entry for many drug developers and test makers.
The PMC report comes as many drug and test developers are increasingly working together to develop theranostic products, particularly in the oncology space. While some EU national payors have agreed to cover some of these newer personalized medicine products, there is no consistent payment for these drug/test combinations.
And while some larger diagnostics firms developing prognostic tests and companion diagnostics with drug developers are looking to expand into the European market, tackling reimbursement issues country-by-country is a time-consuming and expensive process that is not feasible for the majority of smaller firms.
For example, Myriad Genetics has opened up offices in multiple European countries and is working through reimbursement issues region-by-region for its molecular diagnostic tests, particularly its flagship BRACAnalysis test to gauge the risk of hereditary breast and ovarian cancer. Similarly, Genomic Health has had success gaining reimbursement for its Oncotype DX breast cancer test in multiple European countries.
To remedy these hurdles, the PMC report recommends several changes to the reimbursement systems in European countries to enable faster and more consistent access to personalized drugs, such as improving the coding systems and reimbursement process; enhancing the reimbursement review process for diagnostics so they are as sophisticated as the process for drugs; aligning reimbursement and regulation requirements; and providing clearer guidance for the evidence requirements needed to gain reimbursement coverage in each country.
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