The lament that American patients are denied the benefits of novel medical devices available to their European counterparts due to the burdensome, time-consuming regulatory process in the United States does not hold up to scrutiny, according to a Perspective article published online August 1, 2012, ahead of print in the New England Journal of Medicine.

In fact, according to the paper, the upfront delay caused by the rigorous approval standards in the United States is counterbalanced by a speedier time to a reimbursement decision than in European countries. The latter is a more meaningful indicator of widespread access to new devices than regulatory approval per se, contend Saptarshi Basu, MPA, and John C. Hassenplug, MSc, both of the US Food and Drug Administration (FDA).

The authors argue that to compare fairly the situations in Europe and the United States, critics should focus on truly innovative, high-risk devices and examine the entire process, from initial application to the respective regulatory authorities to patient access. Importantly, they say, the latter should be interpreted as broad availability of the device, which is dependent on reimbursement decisions by national or third-party payers. Previous comparisons of device delay between Europe and the United States have used approval solely as the endpoint of the process, a measure relevant only to those few patients who can afford to pay out of pocket for costly new devices.

A second layer of review involves insurer decisions about whether and at what price a new device will be covered. Generally, public insurers are slower to make such decisions than private payers, the authors write. Since far more Europeans than Americans are covered by public insurance, American patients end up waiting about the same or even less time for access to newly approved devices than their European counterparts.

Key Differences in the European, US Systems

In the United States, the regulatory approval process is relatively transparent, the authors note. Taking fiscal year 2011 as a benchmark, they write that the average time for regulatory review, starting with initial premarket approval (PMA) application, was 13.1 months, with 8.4 months devoted to FDA assessment and 4.7 months to sponsors responding to FDA questions and requests.

In general, the Centers for Medicare and Medicaid Services (CMS) provides reimbursement for devices as soon as they gain FDA approval. In some cases, a national coverage determination is made in response to requests for validation or for devices that have limited or conflicting evidence of clinical benefit. Over the past 5 fiscal years, that process has taken an average of 8.6 months. On the other hand, private insurers typically make coverage decisions within weeks to a few months of FDA approval.

In contrast, European Union (EU) countries require that a new device obtain CE mark approval from a private “notified body” (accredited by 1 of the member countries) attesting to safety and performance but not efficacy. Though data are scarce, Basu and Hassenplug say this process takes only 1 to 3 months, excluding any time required for sponsors to respond to requests for more data.

However, even after a device has CE marking, most patients in EU countries must await a decision on reimbursement, and standards for coverage can match or surpass those for FDA approval, the authors write. When innovative devices are not covered under an existing diagnosis-related group (DRG), they typically require a lengthier Health Technology Assessment review, which evaluates safety, clinical benefit, and cost-effectiveness. Estimated time frames for this process range from 71.3 months in Germany to 18 months in Britain.

To illustrate their point, the authors looked at the time to approval for 5 innovative high-risk devices submitted for approval between fiscal years 2002 and 2011. The average time to market access was actually lower in the United States compared with France and Italy (table 1).

Table 1. Comparison of Time to Market Access

^a Time elapsed between submission for CE mark and reimbursement decision.
^b Time elapsed between FDA submission and FDA approval.

Delay Is Real

“In the final analysis, this [article] seems to say that there really isn’t a meaningful lag” in new device availability in the United States vs. Europe, Aaron V. Kaplan, MD, of the Dartmouth-Hitchcock Medical Center (Lebanon, NH), told TCTMD in a telephone interview. “I think that is wrong.

“There should be no doubt in anyone’s mind that the barriers to approval are a lot higher in the United States than in Europe,” he continued. “The question should not be whether [the difference] exists but whether it is appropriate. And it needs to be acknowledged that inappropriate delay to access to an innovative technology is potentially as harmful as approval of a device that does not meet safety and effectiveness standards.”

In fact, for one of the devices the authors cite to make their case, the Taxus Liberté stent (Boston Scientific, Natick, MA), the technology was not available in the United States until more than 2 years after it was approved and covered in France, Dr. Kaplan pointed out.

There is some merit to the authors’ contention that broad access following a coverage decision is the proper parameter for measuring system delay, Dr. Kaplan acknowledged. “But access is really the end of the journey. The question is the pathway for getting there, and [regulatory] approval is an important part of the equation.” In fact, there are some transformative technologies for which the authors’ metric does not hold, he observed, pointing to the example of TAVR, which “had impressive adoption prior to [insurance] coverage by European authorities because the technology was so compelling.”

Moreover, “for the FDA to say that it’s really CMS coverage we should focus on is a flawed notion in that approval is a huge part of [gaining access],” Dr. Kaplan contended. “Having a device available in the United States prior to a coverage decision allows centers to become familiar with it and understand how it can be used outside the context of studies. And that, in turn, allows CMS to make better coverage determinations.”

Argument Out of Step with FDA’s Own Initiatives

Most concerning, said Dr. Kaplan, is that the article “emanates from the FDA commissioner’s office and seems to be discordant” with the direction of its own efforts. Over the past few years, he noted, the agency’s Center for Devices and Radiological Health has acknowledged that delay is an issue and has been working to reduce it with “innovation initiatives,” such as a priority review pathway for bringing pioneering medical devices to market swiftly and safely.

In cardiac cath labs today, American patients lack access to a number of novel devices that are available in Europe, such as the smaller second-generation percutaneous valves, Dr. Kaplan observed. “The conversation should focus on: How do we streamline the processes so that we provide the clinical community with the best technology that has been appropriately demonstrated to be safe and effective?” he said, adding that finding a balance between timely access and rigorous review is difficult but essential.

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