Appeal type: Experimental/Investigational
Decision: Overturned

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

This is the case of a male patient who suffers from very severe chronic obstructive pulmonary disease (COPD) and hyperinflation. The patient is on maximum inhaled therapy including Symbicort and Spiriva. The patient had pulmonary rehab. The patient continues to have shortness of breath. Pulmonary function testing (PFT) showed post bronchodilator forced expiratory volume one second (FEV1) of 26.6%, total lung capacity (TLC) of 139%, residual volume (RV) of 175%, and diffusing capacity lungs for carbon monoxide (DLCO) of 45%. Computed tomography (CT) of the chest showed upper lobe emphysema. The 6 minute walk test (MWT) was 441 meters (m). The treating provider is seeking to treat the patient with placement of endobronchial valves (EBV).

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 insured's life threatening or disabling condition or disease.

EBV placement is supported by The Global Initiative for Chronic Obstructive Lung Disease (GOLD) and National Institute for Health and Care Excellence (NICE) guidelines for selected patients with hyperinflation associated with severe emphysema. Zephyr EBV placement is approved in the USA.

In the LIBERATE trial, 190 subjects with severe emphysema were randomly assigned to EBV placement or usual care (UC). At 12 months, 48 percent of participants receiving EBV treatment and 17 percent of those receiving usual care had an improvement in FEV1 greater than (>) 15 percent. FEV1, 6 minute walking distance (MWD), dyspnea, and quality of life were all significantly better in the EBV group.

A separate multicenter trial (TRANSFORM) randomly assigned 97 patients with severe heterogeneous emphysema to receive EBV or standard of care (SOC). At six months, there was improvement in residual volume, 6MWD and modified Medical Research Council dyspnea score in the EBV group. The improvement in quality of life was also greater in the EBV group.

Based on the inclusion criteria for the pivotal clinical trials, candidate selection for Zephyr EBV placement will include a modified Medical Research Council dyspnea score > 2, post-bronchodilator FEV1 between 15 and 45 percent predicted, total lung capacity > 100 percent predicted, residual volume > 175 percent predicted, DLCO > 20 percent predicted, and a 6MWD between 100 and 500 m, following supervised pulmonary rehabilitation.

This patient has very severe COPD. The patient is on maximum inhaled therapy. The patient continues to have significant shortness of breath with limitation in the activities of daily living despite pulmonary rehab. The patient continues to have shortness of breath. PFT showed post bronchodilator FEV1 of 26.6%, TLC of 139%, RV of 175%, and DLCO of 45%. The patient's 6 minute walk test was 441 m.

The patient does not have many other options at this stage but to have the endobronchial valves to improve his symptoms and his quality of life.