New technology review process: the laparoscopic adjustable gastric band.

The Interregional New Technologies Committee (INTC) is one evaluation route for new medical technologies or technologies with expanded indications within Kaiser Permanente (KP). The primary focus of the INTC is to consider all available published evidence on a particular technology, surgical technique, or implantable device for a specific clinical indication and provide a recommendation on the sufficiency of the evidence for determining net medical benefit to Permanente Medical Group leaders and Kaiser Foundation Health Plan management throughout KP Regions. This iterative process provides an objective, evidence-based assessment to inform decision making by physicians and support the most appropriate care for KP members. This overview illustrates the INTC process and how it supports clinical decision making using implantation of laparoscopic adjustable gastric bands (LAGBs) as an example. In February 2011, the US Food and Drug Administration (FDA) approved lowering the acceptable body mass index for the Lap-Band from 35 to 30 kg/m(2) for patients with at least one comorbid condition. It is difficult to find published studies on medical technologies that have been recently approved by the FDA. The manufacturer often submits clinical data to the FDA, but details are frequently not publicly available at the time of approval. The LAGB example demonstrates the complex issues addressed by the INTC, particularly when there is some evidence of short-term improvement in outcomes with a medical device but little if any confirmation of long-term safety or effectiveness.