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 overturned.

The patient has very severe chronic obstructive pulmonary disease (COPD) and hyperinflation. The patient is on maximum inhaled therapy. He is a carbon dioxide (CO2) retainer. He continues to have shortness of breath. Pulmonary function tests (PFT) showed post bronchodilator forced expiratory volume in one second (FEV1) of 21%, residual volume (RV) of 238%, and diffusing capacity of the lungs for carbon monoxide (DLCO) of 57%. The treating provider is requesting the placement of endobronchial valves. A computed tomography (CT) scan of the chest showed upper lobe emphysema. A 6-minute walk test (MWT) was 214 meters. The patient is dyspneic despite Trelegy, Daliresp, Singulair, Brovana, 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 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.
Endobronchial valve (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 endobronchial valve (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 walk 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.
A meta-analysis (Labarca et al) evaluated change in forced expiratory volume in 1 second (FEV1), 6-minute walk test (6MWT), residual volume, modified medical research council (mMRC) and Saint George respiratory questionnaire (SGRQ), all-cause mortality, risk of pneumothorax, and risk of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) after insertion of endobronchial valves. Four randomized controlled trials (RCTs)including 629 subjects were included. The authors found that patients with severe heterogeneous emphysema and hyperinflation endobronchial valve is an alternative that showed an improvement in pulmonary function, quality of life, and dyspnea score with an acceptable risk profile.
Criner et al performed a multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to endobronchial valve with medical management (treatment) or medical management alone (control). The primary efficacy outcome was the difference in mean FEV1 from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV1 responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. Between October 2013 and May 2017, 172 participants (53.5% male; mean age, 67.4 years) were randomized to treatment (number [n]=113) or control (n=59). Mean FEV1 showed statistically significant improvements between the treatment and control groups-between-group difference at 6 and 12 months, respectively. At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. The final authors conclusions were that in patients with severe heterogeneous emphysema, the endobronchial valves shows significant improvement in multiple efficacy outcomes
This patient suffers from very severe COPD and continues to be symptomatic despite maximum medical therapy. The patient has no other medical or surgical option at this stage. Based on above discussion and clinical trials the Zephyr valves are indicated and medically necessary to improve the patient symptoms.