Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic Obstructive Pulmonary Disease
Treatment: Zephyr Valve Procedure
The insurer denied the Zephyr Valve Procedure.
The determination is upheld.

The patient is a former smoker with symptomatic chronic obstructive pulmonary disease (COPD), high resolution computed tomography (HRCT) that demonstrates centrilobular emphysema a six-minute walk test distance of 214 meters, and a forced expiratory volume in one second (FEV1) of 21%, residual volume (RV) of 238% of predicted, diffusing capacity of the lungs for carbon monoxide (DLCO) of 57% predicted while he is on maximal medical therapy. His current treatment includes Trelegy Ellipta, ProAir, Singular, Daliresp, ipratropium-albuterol nebulizer, Brovana, Yupelri and Budesonide.
At issue is whether the Zephyr Valve Procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The proposed health service or treatment, endobronchial valve device, is not likely to be more beneficial than any standard treatment or treatments for the insured'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 United States (US) 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 Medical Research Council (MRC) dyspnea score greater than or equal to (>=) 2, FEV1 between 15 and 45 percent predicted, total lung capacity (TLC) >=100 percent predicted, residual volume (RV) >=175 percent predicted, DLCO >=20 percent predicted and a six-minute walk distance (6MWD) between 100 and 500 meters.
A key step in evaluation of potential patients is high-resolution computed tomography (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.
Per the clinical information provided, the patient has a diagnosis of symptomatic chronic obstructive pulmonary disease (COPD), an HRCT that demonstrates centrilobular emphysema, a six-minute walk test distance of 214 meters, and an FEV1 of 21%, RV of 238% of predicted, DLCO of 57% predicted while he is on maximal medical therapy. However, there is no documentation that the patient completed a full course of pulmonary rehabilitation, a total lung capacity (TLC) >=100 percent predicted, or an HRCT measuring lobar volumes to determine the amount of emphysematous destruction of each lobe. Therefore, based on the clinical documentation provided and per the current literature regarding optimal candidates for the Zephyr valve for lung volume reduction, the proposed health service or treatment endobronchial valve device is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.