Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Respiratory System. 
Treatment: Surgical Services. 
The insurer denied endobronchial valve device. 
The denial is overturned. 

The patient is a male former smoker with emphysema causing very severe obstructive lung disease with and forced expiratory volume one second (FEV1) of 24.7% - 26.6% of predicted with hyperinflation, air-trapping and a reduced gas diffusion capacity. In addition, his six-minute walk distance was 441.35 meters with a Medical Research Council (MRC) dyspnea score of 2 based on his functional capacity. The high resolution computed tomography (HRCT) documents severe centrilobular emphysema with a destruction score calculation using the StratX system. His current treatment includes Symbicort, Spiriva Respimat, Ventolin HFA and oxygen supplementation. The treating provider has proposed treatment with endobronchial valves. The subject under review is whether the treatment is likely to be more beneficial for this patient than standard therapy for his condition.

The health plan's determination is overturned.

The proposed endobronchial valve device is likely to be more beneficial than any standard treatment or treatments for the patient's life threatening or disabling condition or disease.

The Zephyr valve is an endobronchial valve (EBV) made of a nitinol skeleton and a silicone body with a "duckbill" valve on the proximal end. The U.S. Food and Drug Administration (FDA) has approved the Zephyr Endobronchial Valve System for bronchoscopic implantation in lung regions with little to no collateral ventilation to treat patients with hyperinflation associated with severe emphysema. Based on the inclusion criteria for the pivotal clinical trials, candidate selection for Zephyr EBV placement will include a modified MRC dyspnea score greater than or equal to 2, FEV1 between 15 and 45 percent predicted, total lung capacity (TLC) greater than or equal to 100 percent predicted, residual volume (RV) greater than or equal to 175 percent predicted, diffusing capacity of the lungs for carbon monoxide (DLCO) greater than or equal to 20 percent predicted and a six-minute walk distance (6MWD) between 100 and 500 meters. A key step in evaluation of potential patients is HRCT to measure lobar volumes and determine the amount of emphysematous destruction of each lobe. Multiple studies have demonstrated that Zephyr valve treatment in hyperinflated patients with heterogeneous or homogenous emphysema without collateral ventilation resulted in significant and clinically meaningful benefits in lung function, dyspnea, exercise tolerance, and quality of life, with an acceptable safety profile.

Based on the physician's notes and testing, he has an MRC dyspnea score > 2 based on his functional capacity, FEV1 24.7% - 26.6% of predicted with hyperinflation (TLC 138.9%), air-trapping (RV 175.5%), a reduced gas diffusion capacity (DLCO 45.3%) and a six-minute walk distance of 441.35 meters. In addition, the HRCT demonstrates centrilobular emphysema and has been evaluated for fissure completeness. Therefore, the requested procedure or service Zephyr endobronchial valve placement likely to be of greater benefit for this patient than any other treatment.