A new study published in the New England Journal of Medicine (NEJM) assessing the performance of US and EU regulatory and reimbursement authorities finds the US actually exceeds several of its EU counterparts when it comes to providing expeditious market access to medical devices.
The study comes just a single day after the publication of a similar article in the The Public Library of Science called for further research on the medical device review processes of the US and EU.
The article, "Patient Access to Medical Devices-A comparison of US and European Review Processes," opens with a common, industry-supported premise: The US is slower to approve medical devices than its EU counterparts, to the ultimate detriment of patients.
A full review of the data reveals a more complicated narrative, write authors Saptarshi Basu and John Hassenplug, both employees at the US Food and Drug Administration's (FDA) Office of the Commissioner.
The issue is not that FDA is faster at reviewing devices, write Basu and Hassenplug-it's not, as the European Conformity (CE) marking process asks much less of its sponsors than does FDA's premarket approval (PMA) or 510(k) substantial equivalence processes.
Reimbursement as an Extended Review Process
Instead, Basu and Hassenplug point to the EU's reimbursement processes as being a related barrier to accessing patients.
"A review of the data, using appropriate end points, suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four largest European markets (Germany, France, Italy, and Britain) - largely because patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States," write the authors.
While the US has a federal reimbursement system in the form of the Centers for Medicaid and Medicare Services (CMS), its decisions apply only to the Medicare and Medicaid programs it is charged with overseeing. Even when its time to decision is taken into account, the US is still substantially faster than its Italian, French and German counterparts. Britain, meanwhile, was estimated to edge out the US by a handful of months.
The US edge comes largely in the speed of its reimbursement decisions. The authors highlighted the Stratos LV-T implantable pacemaker as an example. Approved in France, Italy and the US, the product was approved for reimbursement in the US in 14 months. France approved the device for reimbursement in 37.7 months, while Italy took 73.4 months to approve it. Though the countries could exhibit wide ranges in approval speeds-Italy approved a vascular stent graph in as little as two months, for example-the US was more predictable and within a narrower and shorter range of approval times.
"Using this information, we determined that the time it takes to bring innovative, high-risk devices to patients in the United States is similar to or shorter than that in the top four European markets," wrote Basu and Hassenplug. The authors noted previous assessments were unfair in that they did not compare "equivalent standards in terms of… the end points of the process and the key end point of market access."
In other words, though the EU's initial device review process may be less restrictive, countries may still "require additional data on the device's safety and effectiveness, as well as on cost-effectiveness" -information the US front-loads into its review process.