NEJM: FDA is no slower with device approvals than EU counterparts

The conventional wisdom holds that, when it comes to deploying new medical technologies, the U.S. is much slower than Europe’s four largest markets. The conventional wisdom is wrong. So argued the authors of an Aug. 1 New England Journal of Medicine “Perspective” article, basing their case on data showing that reimbursement decisions figure as prominently as regulatory ones in delaying—or expediting—patient access to innovative, high-risk devices.

“[W]e 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 Saptarshi Basu, MPA, and John C. Hassenplug, MSc. “The public (CMS) process in the United States takes approximately as long as those in Italy and Britain, approximately half as long as that in France, and less than a third as long as that in Germany. The difference in time to market access is even greater when it comes to private insurers (covering the majority of the U.S. population), which often make reimbursement decisions within a few months after FDA approval.”

Basu is a graduate fellow at Cornell University’s Institute for Public Affairs. Hassenplug is an operations research analyst with the FDA.

The authors arrived at their conclusions after considering three criteria—device sophistication (in their words, “level of device innovation”), equivalent start and end points, and patient access as defined by time to reimbursement. They explained that they focused their research on innovative, high-risk devices because, in the U.S., such devices “require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries.”

Basu and Hassenplug pointed out that previous studies have shown lower-risk devices reaching patients in similar times windows on both sides of the Atlantic.

“Most European patients do not have access to innovative, high-risk devices as soon as the devices receive a CE marking,” they wrote. “Each country must first make a decision about reimbursement, a process that varies substantially among countries. Though a CE (Conformité Européenne) marking can be granted on the basis of fewer clinical data than are required for FDA approval, European standards for reimbursement are often similar to or higher than those that the FDA imposes for device approval. European countries may require additional data on the device's safety and effectiveness, as well as on cost-effectiveness.”

The authors also noted that, while the numbers they crunch in the NEJM piece may not provide the final word on why devices reach markets more quickly in one country than in another, accurate comparisons cannot be made without the use of equivalent standards for determining levels of risk, the start and endpoints of the submission-to-market process and the key endpoint of market access.