Coverage for carotid artery stenting in FDA post-approval studies

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The Centers for Medicare and Medicaid Services (CMS) has issued a final National Coverage Determination expanding coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery with stenting to Medicare-eligible participants of a large FDA-mandated post-approval study for a newly approved carotid stent.

This final decision was issued shortly after a 30-day public comment period that followed CMS posting of a draft decision. CMS had posted the draft decision one day after the FDA approved the first carotid artery stenting system, and this final CMS decision came just five weeks after the FDA approval of Guidant’s RX ACCULINK carotid stent system and RX ACCUNET embolic protection system.

“This administration has shown its commitment to improving access to innovative medicine by responding quickly and allowing coverage of Medicare-eligible enrolled in the FDA-required post-approval study,” said CMS Administrator Dr Mark B. McClellan. “We are providing our beneficiaries with access to this important new technology while also expanding the evidence base for future improvements in preventing strokes in high-risk patients.”

“This extremely rapid decision was made possible by excellent communication between CMS, the Food and Drug Administration and the manufacturer of the approved stent,” McClellan said, “and demonstrates the value of this type of interaction.”

Comments received in response to the earlier draft decision were overwhelmingly positive. Most were from medical professional societies that were ultimately in favor of the expanded coverage, but also advocated for mechanisms in place to ensure appropriate use of this technology for the indicated patient population.

CMS believes that carotid stenting in the setting of an FDA post-approval study reasonably assures patient protection through quality monitoring, and can provide Medicare beneficiaries the opportunity to receive the benefits of carotid stents.

The post-approval study will yield additional information that will help doctors target the new device to patients who are most likely to benefit from the procedure, and will develop information about the most appropriate clinical practices to follow with the new device.

Post-approval studies also can provide information on whether the results of earlier clinical trials used for FDA approval can be generalized to other populations, settings, treatment regimens and outcomes.

Before this decision, CMS only covered PTA of the carotid artery concurrent with stent placement in clinical trials being conducted prior to FDA approval (so-called Category B Investigational Device Exemption [IDE] clinical trial). FDA approval of this carotid stenting system means that it is no longer investigational for the approved use. This new coverage decision enables Medicare to pay for carotid stenting performed for these FDA post-approval studies.

CMS is also evaluating a separate request for a broader coverage expansion of PTA of the carotid artery concurrent with stent placement for patients at high risk for carotid endarterectomy (CEA). This coverage determination process, which will involve public comment on a draft coverage decision, will be completed by early 2005.

“As with most medical devices, many important questions remain to be answered about optimal patient selection and how best to use the device after approval by the FDA. The FDA-mandated post-approval study will provide critical information to doctors and patients helping them to make well-informed, individualized decisions about how best to manage their carotid artery disease,” said Dr Sean Tunis, CMS Chief Medical Officer.

“By providing coverage for important technologies while they undergo these additional important clinical studies, CMS is helping to support both innovation and effective, informed use of new medical technologies,” Tunis said.

“We are extremely pleased that the FDA and CMS worked together to enable greater access to this new therapy for Medicare beneficiaries,” said Beverly Huss, President, Endovascular Solutions, Guidant Corporation. “The agencies’ timely action will benefit patients with carotid artery disease by accelerating our understanding of best clinical practices in a variety of settings.”

Guidant has now begun enrollment in CAPTURE (Carotid ACCULINK/ACCUNET Post-Approval Trial to Uncover Rare Events), an FDA-required post-approval study of carotid artery stenting performed by physicians from multiple specialties. The study will utilize Guidant’s carotid stent and embolic protection system.

CAPTURE is part of Guidant’s post-approval study plan that will include at least 1,500 patients receiving Guidant’s FDA-approved ACCULINK carotid stent system and ACCUNET embolic protection system at approximately 150 sites in the United States. The primary endpoint of the study will be a composite of stroke, death and heart attack at 30 days following the carotid stenting procedure.

“For patients who are ineligible or at high risk for traditional surgery, carotid stenting provides a minimally invasive breakthrough therapy to reduce the risk of stroke,” said Beverly Huss. “This additional data on carotid stenting performed by a variety of physicians from across the nation will further advance our knowledge of this important new therapy.”