REDWOOD CITY, Calif.--(BUSINESS WIRE)--Pulmonx Corporation, a leader in diagnostic and therapeutic pulmonary device technologies, announced today that its Zephyr® Valve has received positive coverage from Humana® under its new endobronchial valve (EBV) coverage policy. Humana, a national health insurer in the United States covers more than 10 million members. This decision, together with an earlier positive coverage decision by Aetna®, means that the Zephyr Valve is now an available treatment option for over 30 million Americans with commercial insurance. The Zephyr Valve is a less invasive treatment option for severe emphysema (COPD) that has been shown to deliver life-changing benefits to COPD patients without the risk of major surgery. Clinical benefits include improved quality of life, less shortness of breath, and the ability to be more active.1
“Following FDA’s approval of the Zephyr Valve as a ‘breakthrough device', we are thrilled to see a positive coverage policy by another major payer,” states Glen French, President and Chief Executive Officer of Pulmonx. “This policy decision shows a true commitment by Humana to bring the most advanced treatment options to its members. The Zephyr Valve has been shown in numerous published clinical trials to improve pulmonary function, exercise capacity, shortness of breath, and quality of life of patients with severe emphysema.”1,2,3
Under its new coverage policy, Humana specifically names the Zephyr Valve being covered for qualifying patients. The Zephyr Valves are placed in a single bronchoscopic procedure with no incision. The procedure carries much less risk than surgical options including lung volume reduction surgery (LVRS) and lung transplantation.
“Patients with severe emphysema (COPD) suffer from breathlessness and often very poor quality of life, and until the availability of the Zephyr Valve, had few treatment options that did not involve major surgery,” said Dr. Mark Dransfield, Medical Director of the University of Alabama at Birmingham Lung Health Center. “As a physician who manages patients with COPD, I am very pleased to see Humana offer its members access to this treatment option that can provide meaningful life-improving benefits long-term without the risks of major surgery.”
During the procedure, an average of four Zephyr Valves are placed in the airways to block off a diseased portion of the lung, which is thereby reduced in size. Reducing hyperinflation and preventing air from getting trapped in the diseased parts of the lung allows the healthier lung tissue to expand and take in more air. This results in patients being able to breathe easier and have less shortness of breath.1 Patients treated with the Zephyr Valves have reported immediate relief and the ability to go back to doing everyday tasks with greater ease.
More on the Zephyr Valves
The Zephyr Valve was approved by the FDA in June 2018 through an expedited review because, according to FDA, it “represents a breakthrough technology as the device offers bronchoscopic lung volume reduction without surgery and its associated risks. This device offers a significant, clinically meaningful advantage over the current standard of care and therefore, its availability is also in the best interest of patients.”4 Since 2007 more than 15,000 patients have been treated with the Zephyr Valve worldwide. The Zephyr Valve treatment is included in emphysema treatment guidelines issued by leading health organizations worldwide, including the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the UK’s National Institute for Health and Care Excellence (NICE).
More about COPD and Emphysema
More than 15 million Americans suffer from COPD, and 3.5 million of those patients have emphysema.5 Despite taking the best available medications, over one million emphysema patients suffer symptoms of hyperinflation, where air becomes trapped in the lungs and prevents fresh air from entering the lungs, thereby causing severe shortness of breath. Breathing becomes inefficient and patients must work very hard just to breathe – making normal activities, like walking, eating, or even bathing difficult. There are few treatment options for most patients with emphysema and there is no cure. Until now, the only other options for these patients were highly invasive treatments such as lung volume reduction surgery or lung transplantation.
About Pulmonx Corporation
Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is the world leader in interventional pulmonology diagnostics, planning tools, and treatments for obstructive lung disease. For more information, visit www.MyLungsMyLife.com
HUMANA coverage policy:
1 Am J Respir Crit Care Med Vol 198, Iss 9, pp 1151–1164, Nov
2 Kemp S et al. Am J Resp Crit Care Med 2017; (196)12: 1535-1543
3 Valipour et al. Am J Respir Crit Care Med. 2016; Vol 194, Iss 9, pp 1073-1082 and Data on file at Pulmonx
4 PMA P180002: FDA Summary of Safety and Effectiveness Data. June 29, 2018. https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180002B.pdf.
5 American Lung Association. Trends in COPD (Chronic Bronchitis and Emphysema): Morbidity and Mortality. March 2013.