Health Care Service Corporation (HCSC) Adds Coverage Policy for Severe Emphysema Treatment

Minimally Invasive Endobronchial Valve COPD Treatment with the Spiration® Valve System Now Available to Blue Cross Blue Shield Members in Illinois, Montana, New Mexico, Oklahoma, and Texas

CENTER VALLEY, Pa., (November 18, 2020) – Olympus announced that Health Care Service Corporation (HCSC) updated their coverage policy to include the Spiration® Valve System for eligible patients suffering from severe emphysema, a form of COPD (Chronic Obstructive Pulmonary Disease). This new coverage provides a minimally invasive treatment alternative for eligible patients.

HCSC is an independent licensee of the Blue Cross and Blue Shield Association and the largest customer-owned health insurer in the U.S. and fifth largest overall, covering more than 16 million lives across 5 states: Illinois, Montana, New Mexico, Oklahoma and Texas. The effective date of the policy covering the Spiration Valves was November 1, 2020. For more information, visit: https://www.hcsc.com/.

“This expanded coverage for endobronchial valve treatment is great news for patients who suffer from the debilitating symptoms of severe emphysema,” said Dr. David Mason of Baylor University Medical Center in Dallas, Texas. “Not being able to breathe really limits the ability of patients to go about their daily lives, and for those who qualify for the treatment, endobronchial valves can make a big difference.”

The Spiration Valve System is supported by positive clinical, safety, and effectiveness data from clinical trials and real-world evidence reported by leading U.S. and global researchers. The Spiration Valve is an FDA-designated breakthrough device that has demonstrated statistically significant and clinically meaningful improvements in lung function, reduction in shortness of breath and improvement in quality of life compared to standard of care medical management.i

During a minimally invasive procedure, called Bronchoscopic Lung Volume Reduction (BLVR), the umbrella-shaped lung valve is positioned in selected airways. These valves only allow air to flow one way, preventing air from flowing into the diseased part of the lung and redirecting air to healthier lung tissue, which can then expand and function more effectively. With improved breathing, patients suffer less breathlessness and fatigue and, as a result, can do more in their daily lives and enjoy an improved quality of life.

Patient selection is a critical first step in determining who qualifies for this treatment. A decade of clinical studies has shown that patient selection is one of the most important factors in predicting a positive response to BLVR.^i,ii,ii To determine if a patient is a suitable candidate for Spiration Valve treatment, physicians use a completely non-invasive patient screening tool called SeleCT® that is based on quantitative computed tomography (QCT) and powered by Artificial Intelligence. This selection method, proven by the outcomes of the EMPROVE trial, makes additional more invasive patient selection methods unnecessary.ⁱ

“For patients with severe emphysema who are medically maximized, treatment options are very limited and carry high clinical burdens,” 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 to positively and meaningfully impact pulmonary function and patients’ quality of life.”

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.^iv

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. The report is reviewed and revised annually by leading physicians in the field of COPD.^v

To learn more about the Spiration Valve System, visit: svs.olympusamerica.com.

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About Olympus
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments. For more information, visit medical.olympusamerica.com.

ⁱ Criner GJ, Delage A, Voelker K, et al., "Improving lung function in severe heterogenous emphysema with the Spiration® Valve System (EMPROVE): a multicenter, open-label, randomized, controlled trial," American Journal of Respiratory and Critical Care Medicine, vol. 200, no. 11, pp. 1354-1362, 2019.

ⁱⁱ 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.

ⁱⁱⁱ Herth FJF, Slebos DJ, Criner GJ, et al.. , "Endoscopic Lung Volume Reduction: An Expert Panel Recommendation - Update 2019.," Respiration, vol. 97, no. 6, pp. 548-557, 2019.

^iv Global Initiative for Chronic Obstructive Lung Disease (GOLD), "2020 Global Strategy for the Diagnosis, Management, and Prevention of COPD," [Online]. Available: https://goldcopd.org/gold-reports/ . [Accessed November 2 2020].

^v Basics About COPD. CDC.gov. https://www.cdc.gov/copd/basics-about.html. Published July 19, 2019. Accessed Nov 2, 2020.