In June, the European Parliament voted for a resolution aimed at improving the current legislative framework for medical devices, calling on the European Commission (EC) to shift to a “system of pre-market authorization for certain categories of medical devices, including, at least, medical devices of class IIb and III.” Class IIb includes all non-invasive devices intended for modifying the biological or chemical composition of blood or other body liquids, while Class III devices are specifically intended to control, diagnose, monitor, or correct a defect of the heart or central circulatory system. Since then, we have been tuned in to the ongoing debate surrounding the contents of the Commission’s next proposal to revise the EU medical device directives.
The proposal, scheduled for release in late September, is expected to address the Parliament’s request via a new pre-market scrutiny mechanism to ensure the “highest quality” of Notified Body assessment for high risk devices. Member States of the EU already control a pre-market conformity assessment process for Class III devices (the highest risk of three possible classifications), with similar objectives to the FDA’s pre-market approval (PMA) process. Under the proposed mechanism, however, member states would be able to review, scrutinize, and comment on assessments performed by Notified Bodies, provided the assessment meets certain criteria, such as:
- High-risk (Class III) devices;
- Devices that represent public health concerns;
- “Novel” technologies (a category yet to be defined);
- Files from Notified Bodies with a history of significant discrepancies
Under supervision of the EC, a committee of Member States’ experts would determine whether to exercise the mechanism. The scrutiny process would have to be called for within 15 days of receipt of a new application, and the committee would have 90 days to scrutinize the file after the Notified Body submits its preliminary assessment. Within the first 60 days, the committee could request supplemental information from the Notified Body. In total, the mechanism could add 3-6 months to the approval process. Many fear that such a delay would not only increase manufacturer’s time to commercialization, but also slow innovation in the EU and hinder patient access to novel technologies.
The Existing PMA Process in the United States
In the United States, the Food and Drug Administration (FDA) controls a pre-market approval (PMA) process for Class III devices, the highest risk of three possible classifications. The PMA process is lengthy, expensive, and complex. No formal application exists, though some guidance is available through the FDA. In addition to user fees, extensive clinical evidence must be prepared for the submission, and surveys indicate that each month costs companies upwards of $740,000.
The PMA process is also time-consuming. In February, the GAO found that the FDA met deadlines for original PMAs in only four out of seven years, and for expedited reviews in just two out of seven. Original PMAs were delayed an average of 627 days in 2008, nearly 36% longer than in 2003. A portion of the delay is “sponsor time,” or time taken for the sponsor to provide additional information. We calculate that between 2003 and 2008, sponsor time in original PMA submission went up 44.6%, versus a 25.1% rise in agency time. This, however, may simply be evidence of an increasingly complex process that demonstrates no significant increase in patient safety.
The FDA system has long been fraught with challenges, receiving significant criticism from actors within the United States such as the GAO. It is therefore with caution that we approach a proposal for increased review of high-risk devices in the EU.
Implications for Market Access
Historically, medical device approvals in the EU have been met with less bureaucracy and greater transparency. The delegation of control to Notified Bodies allows the process to move along more quickly. The scrutiny mechanism, we expect, will cause an indeterminate delay which hopefully will not rival that of the FDA.
Some claim that the delays in the PMA process are offset by other factors – namely, time to reimbursement. FDA analysts recently argued that time to market access for Class III devices is shorter in the United States because of prompt coverage and reimbursement of the devices upon FDA approval, compared with waits of anywhere from 16.4 to 71.3 months for health technology assessments in the EU.
This assessment, however, fails to fully comprehend the European and US reimbursement and funding systems. We have seen many examples of slow device uptake by insurers in the United States. For example, although cochlear implants have been available in the US since 1970s, the nation’s largest private insurer did not routinely cover them until 2009, and Medicare issued a National Coverage Determination only as recently as 2005.
Indeed, most devices in the US are available upon approval, but this can also be true in the EU. In markets with bundled payments, the physician or hospital often decides what approved devices to use, at times pre-empting the reimbursement process. Additionally, national systems in the EU may not provide reimbursement immediately upon receipt of CE marking, but special payment and in some cases individuals paying out-of-pocket or with supplemental private insurance can gain access. Increasing the delay for some devices by augmenting traditional review with the scrutiny mechanism could change this paradigm – for the worse. Implementation of policies similar to the FDA’s PMA process puts the European marketplace for medical devices at risk for decreased innovation and reduced patient access to novel technologies.
The authors Gavin Erickson, Jordan Hinahara, and Andrew Marcarelli all work at GfK Bridgehead.
Gfk Bridgehead is a global consultancy with extensive experience in market access, pricing, and reimbursement for medical devices, diagnostics, and pharmaceuticals.