Devices Reimbursement

 News Release - January 18, 2021

New Treatment for Severe Emphysema Now Covered Under Highmark Blue Cross Blue Shield

Spiration ® Valve System COPD Treatment Available to Highmark Blue Cross Blue Shield Members in Delaware, Pennsylvania, and West Virginia

CENTER VALLEY, Pa., Jan. 18, 2021 -- (Healthcare Sales & Marketing Network) -- Olympus announced that Highmark Blue Cross Blue Shield (BCBS) updated its coverage policy to include the Spiration® Valve System for eligible patients suffering from severe emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD). This coverage provides a minimally invasive treatment alternative for eligible patients.

Highmark is a nationally recognized industry leader in developing up-to-date policy guidelines for safe and effective medical technologies. It is an independent licensee of the Blue Cross and Blue Shield Association, and the fourth-largest overall Blue Cross Blue Shield-affiliated organization, with over 5 million members in Delaware, West Virginia, and Pennsylvania. For more information, visit: https://www.highmarkblueshield.com/home/

For information about Olympus Spiration® Valve System, visit these dedicated websites:

• For doctors: https://svs.olympusamerica.com/healthcare-professionals
• For patients and their families: https://svs.olympusamerica.com/patients-and-family
• Full prescriptive information: https://svs.olympusamerica.com/prescriptive-information

"This expanded coverage for endobronchial valve treatment is great news for patients who suffer from the debilitating symptoms of severe emphysema," said Dr. Gerard Criner, Professor of Medicine and Chair of the Department of Thoracic Surgery and Medicine at Temple University. "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."
   

Spiration® Valve System

• Supported by positive clinical, safety, and effectiveness data from clinical trials and real-world evidence reported by leading U.S. and global researchers.
• Designated as an FDA 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
• Supported as a standard of care for patients suffering from severe emphysema according to the 2021 report from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) report, which gives its highest "A" evidence rating for Bronchoscopic Lung Volume Reduction (BLVR) using endobronchial valves.

During the minimally invasive BLVR procedure with the Spiration® Valve System, umbrella-shaped endobronchial lung valves are positioned in selected airways. The valves allow air to flow in only one direction, preventing air from flowing into the diseased part of the lung and redirecting air to healthier lung tissue. The treatment relieves the hyperinflation of the diseased portions of the lungs and allows healthier parts of the lungs to expand and function more effectively. With improved breathing, patients suffer less breathlessness and fatigue and, as a result, may be able to 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,iii To determine if a patient is eligible for Spiration® Valve treatment, physicians use a completely non-invasive patient screening tool called SeleCT® and the patient's computerized tomography (CT) scan. This selection method, using criteria validated in the EMPROVE trial, does not require more invasive patient selection methods.i

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 www.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.

Source: Olympus

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