On July 15, 2005, Vagus Nerve Stimulation (VNS) Therapy was approved through the Pre-Market Approval Process at the United States Food and Drug Administration (FDA) for use in treatment-resistant depression (TRD). Specifically, the FDA summary of safety and effectiveness stated:
In conclusion, CDRH (Centers for Devices and Radiological Health) believes the PMA applicant has provided reasonable assurance of safety and efficacy based on valid scientific evidence as required by statute and regulation for the approval of a Class III medical device. CDRH has come to this conclusion because the sponsor has provided data that were systematically collected and analyzed which showed significant improvement from baseline over one and two years for a definable subset of the target population, and comparative data against a reasonably matched control which also sustained improvement over time.1
The availability of treatments such as VNS Therapy for TRD is one of the reasons why the United States is a global leader in the healthcare. Achieving FDA approval is a very significant milestone in the advancement of any new treatment, from development through eventual widespread adoption. Evidence supporting VNS Therapy in TRD is valid and the urgent medical necessity for the TRD population is unquestionable. Physicians and patients should expect every payer to approve coverage and reimbursement of VNS Therapy for all those patients with TRD who need it. However, as our health care system evolves and, in the process, succumbs to intense financial pressure, FDA approval alone is no longer adequate to ensure widespread access to important new treatments such as VNS Therapy for TRD. |
