June 23, 2020
Spiration Valve System, which has been demonstrated to improve quality of life for patients suffering from severe emphysema, a form of COPD (Chronic Obstructive Pulmonary Disease)i has received an expansion of insurance coverage. The news was reported by Olympus.
Both Aetna and Humana now provide coverage for eligible patients to receive minimally invasive bronchoscopic lung volume reduction (BLVR) treatment.
Spiration Valves are small, umbrella-shaped endobronchial valves placed into airways using a bronchoscope with the goal of blocking air from flowing into diseased parts of the lungs where it can remain trapped, causing hyperinflation. Once in place, the valves redirect air away from hyperinflated parts of the lungs allowing healthier lung tissue to expand and function more effectively. As a result, patients may breathe easier and experience improvement in quality of life.i
Patient selection is the first step to determining which patients could benefit from this procedure. A decade of clinical studies has shown that patient selection is one of the most important factors in predicting a positive response to BLVR.ii,iii,iv Physicians use a quantitative computed tomography (QCT)-based patient screening tool, called SeleCT®, to determine if a patient is a suitable candidate for Spiration Valve treatment.
“Before endobronchial valves such as the Spiration Valve were FDA approved, the only option for patients on maximum medical management was major surgery, which comes with significant risks,” said Dr. Gerard Criner, Professor of Medicine and Chair of the Department of Thoracic Surgery and Medicine at Temple University. “With significant evidence now in place for endobronchial valve treatment, we can now offer patients a choice in treatment options.”
BLVR using endobronchial valves such as the Spiration Valve is now supported as a standard of care for patients suffering from severe emphysema according to the 2020 report from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) report, which upgraded the evidence level rating for BLVR with endobronchial valves to its highest “A” rating. According to the report, this evidence rating is based on results from randomized clinical trials with data from several clinical trials involving a substantial number of patients, including those treated with the SVS.v
GOLD’s Global Strategy for Diagnosis, Management and Prevention of COPD report is used by healthcare professionals worldwide in establishing their strategies for managing and preventing COPD, a disease that impacts almost 16 million people in the U.S.vi The report is reviewed and revised annually by leading physicians in the field of COPD.v
i Criner GJ, Delage A, Voelker K, et al. Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve Sysetm (EMPROVE): A Multicenter, Open-Label, Randomized, Controlled Trial. Am J Respir Crit Care Med. 2019;200(11):1354-1362. doi: 10.1164/rccm.201902-0383OC.
ii Sciurba FC, Ernst A, Herth FJF, et al. A randomized study of endobronchial valves for advanced emphysema. New England Journal of Medicine 2010;363(13):1233-1244. doi:10.1056/NEJMoa0900928.
iii Schuhmann M, Raffy P, Yi Y, et al. CT predictors of response to endobronchial valve lung reduction treatment: Comparison with Chartis. American Journal of Respiratory and Critical Care Medicine 2015;191(7):767-774. doi:10.1164/rccm.201407-1205OC.
iv Herth FJF, Slebos DJ, Criner GJ, Shah PL. Endoscopic Lung Volume Reduction: An Expert Panel Recommendation – Update 2017. Respiration 2017;94(4):380-388. doi:10.1159/000479379.
v Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for Diagnosis, Management and Prevention of COPD 2020 Report. Retrieved from: https://goldcopd.org/gold-reports/. Accessed November 12, 2019.
vi Basics About COPD. CDC.gov. https://www.cdc.gov/copd/basics-about.html. Published July 19, 2019. Accessed May 27, 2020.