Article in New England Journal of Medicine Compares U.S., European Device Review Processes
A commentary in The New England Journal of Medicine challenges the argument put forth by medical device manufacturers and some lawmakers that U.S. companies are at a competitive disadvantage against their European counterparts because of the approval process here.
In fact, the article argues that “it takes the same amount of time or less” for patients in the United States “to gain access to innovative, high-risk medical devices” than it does for patients in Europe’s four largest markets—Germany, France, Italy, and Great Britain.
The article, “Patient Access to Medical Devices—A Comparison of U.S. and European Review Processes,” was written by Saptarshi Basu and John C. Hassenplug, and appears in the Aug. 9 edition of the journal.
For years, U.S. device makers and their allies have pushed for changes in how the U.S. Food and Drug Administration (FDA) reviews applications for new medical devices and approves them for market. They say the European approval process is far more streamlined and efficient, the end result being that patients abroad have quicker access to state-of-the-art and sometimes life-saving devices.
But the authors of the Journal commentary say that comparing the time it takes to win government approval for a device doesn’t give the full picture. Equally, if not more, important they say is the time devoted to considering reimbursement decisions.
The authors argue that a more telling comparison between the U.S. and European markets would be to consider the entire “pathway to patient access,” including “a second level of review” during which public or private insurers decide if and how much they will pay for a device.
“Patient access should be equated with the availability of reimbursement, rather than with device approval because broad patient access to a new device doesn’t occur until reimbursement by a national or third-party payer is available,” the authors wrote.
Why then does that part of the process take longer in Europe?
“Generally, public systems take longer than private insurers to make reimbursement decisions, and significantly more Europeans than Americans have public insurance,” they wrote.
Still, FDA officials have conceded they can do better in how they review applications for medical devices, and in January 2011 announced a series of reforms aimed at improving the “predictability, consistency, and transparency” of agency policies and processes.
Posted: August 14, 2012