Perspective
Patient Access to Medical Devices — A
Comparison of U.S. and European Review Processes
Saptarshi Basu, M.P.A., and John C.
Hassenplug, M.Sc.
Interview with Dr. Rita Redberg on
the approval process for medical devices in the United States and in Europe.
(23:44)
The U.S. process for approving
innovative, high-risk medical devices has been criticized for taking longer
than the European approval process.1 This contention is often used to support the argument that the
Food and Drug Administration (FDA) should lower its standards for approving
medical devices, since a slow approval process is delaying Americans' access to
innovative and lifesaving technology. But 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)2 — largely
because patient access is generally delayed until reimbursement decisions are
made, which often takes substantially longer in Europe than in the United
States.
To compare the United States and
Europe fairly on this front, three criteria must be considered: the level of
device innovation, equivalent start and end points, and patient access as
defined by time to reimbursement. First, we focused on innovative, high-risk
devices because in the United States 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. Furthermore,
previous studies have shown that lower-risk devices achieve market access in a
similar amount of time in the United States and in Europe.
Second, an accurate comparison of
time to market access requires measurement of the total time that elapses
between application submission and market access. Previous studies have
compared the chronologic dates of application submission and market access, but
the date an application is submitted varies from country to country.
Third, 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. Previous
comparisons of the U.S. and European systems have used the approval date to
measure process duration, but innovative, high-risk devices don't reach a
market where most patients can benefit from them immediately after gaining regulatory
approval, though they may be accessible to patients who can afford to pay out
of pocket. Rather, there is a second level of review through which public or
private insurers decide whether and at what price they will pay for a device.
Generally, public systems take longer than private insurers to make
reimbursement decisions, and significantly more Europeans than Americans have
public insurance. Two thirds of the U.S. population is covered by private
health insurance, whereas only a fifth receives publicly funded reimbursement,
primarily administered by the Centers for Medicare and Medicaid Services (CMS).
For both private and public systems
in the United States, the pathway to patient access to a device starts with the
submission of an application to the FDA. The FDA reviews innovative, high-risk
devices for safety and effectiveness (clinical benefit) under the premarket
approval (PMA) process, and information on the duration of reviews is publicly
available. In fiscal year 2011, the FDA approved 40 applications for PMA. The
average review time was 13.1 months, with 8.4 months attributed to FDA review
time, and 4.7 months to the time the agency waits for the sponsor to address
deficiencies in the application (“sponsor time”).3 CMS provides reimbursement for the majority of devices when
they earn FDA approval. For a limited number of devices each year, however, CMS
conducts a national coverage determination in response to external requests for
validation or for devices that have limited or conflicting evidence of clinical
benefit. This process averaged 8.6 months over the past 5 fiscal years.4 Although it is difficult to obtain
data on how long private insurers take to make coverage decisions, anecdotal
information from private insurers suggests that decisions are made within a few
weeks to a few months after FDA approval, depending on the amount and quality
of evidence of clinical benefit.
In Europe, by contrast, most of the
27 member countries of the European Union (EU) have publicly financed health
care systems; such systems cover approximately four fifths of the populations
of the four largest device markets. All EU countries require devices to first
obtain a Conformité Européenne (CE) marking, which refers to a symbol shown on
products that indicates market approval throughout the EU. The CE marking
process is conducted by for-profit, third-party “notified bodies” that have
been accredited by a member country to assess device safety and performance but
do not evaluate effectiveness (which requires more clinical data). Although
publicly available data are limited, anecdotal information from notified bodies
suggests that the process takes 1 to 3 months, excluding sponsor time.
Most European patients do not have
access to innovative, high-risk devices as soon as the devices receive a CE
marking. Each country must first make a decision about reimbursement, a process
that varies substantially among countries.5 Though a CE 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.
In France, a centralized body makes
reimbursement decisions after assessing the safety and effectiveness of
individual devices. Reimbursement decisions in Italy are devolved to the various
regions, and Britain and Germany conduct broader assessments of device types or
procedures, rather than of individual devices. Typically, innovative devices
not covered under an existing diagnosis-related group (DRG) require review
under the lengthier Health Technology Assessment process, which assesses
safety, clinical benefit, and cost-effectiveness. Government-provided
information on time to reimbursement varies by country. Estimated time frames
are an average of 71.3 months in Germany, a range of 36.0 to 48.0 months in
France, a range of 16.4 to 26.3 months in Italy, and an estimated 18 months in
Britain.
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 (see figure
Missing
graphic: Comparison of Time to Market in Premarket Approval and
Reimbursement Processes.
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.
To further illustrate this point, we
compared the time to approval for five innovative, high-risk medical devices
available in France, Italy, and the United States (see table
Missing graphic: Comparison of Time to Market Access
for Five Innovative Devices in France, Italy, and the United States.
These case studies indicate that the
average time to market access for these devices was 26.3 months in France, 30.8
months in Italy, and 15.3 months in the United States.
These numbers may not fully capture
the reasons why a device reaches the market more quickly in one country than in
another and do not reflect experiences with all innovative, high-risk devices.
However, unless one uses equivalent standards in terms of the level of risk,
the start and end points of the process, and the key end point of market
access, accurate comparisons cannot be made.
Disclosure
forms provided by the authors are
available with the full text of this article at NEJM.org.
This article was published on August
1, 2012, at NEJM.org.
SOURCE INFORMATION
From the Office of Planning, Office of the Commissioner,
Food and Drug Administration, White Oak, MD.
