CENTER VALLEY, Pa. , June 10, 2021 /PRNewswire/ -- Olympus today announced that Blue Cross Blue Shield of North Carolina (Blue Cross NC) updated their coverage policy to include the Spiration® Valve System for patients suffering from severe emphysema, a form of COPD (Chronic Obstructive Pulmonary Disease). The Spiration Valve System provides an alternative minimally invasive treatment that has been shown to improve lung function and reduce breathlessness for eligible patients who are suffering from the debilitating symptoms of severe emphysema.
Blue Cross NC is an independent licensee of the Blue Cross and Blue Shield Association, covering over 3.8 million lives across 5 states: North Carolina , South Carolina , Virginia , Florida , and Georgia . The effective date of the policy covering the Spiration Valve System is April 1, 2021 .
This follows similar coverage decisions by Highmark and Health Care Service Corporation, leading licensees of Blue Cross and Blue Shield Association. Aetna and Humana also cover the Spiration Valve System under similar policies.
"This decision by Blue Cross NC will provide expanded access to this critical therapy that significantly reduces lung hyperinflation associated with severe emphysema, and is durable over time," said Abhijit Raval , MBBS, MD, FCCP, Pulmonologist at AnMed Health Medical Center in Anderson, South Carolina . "Treatment with the Spiration Valves can lead to truly meaningful improvements in patients who achieve sustainable clinical outcomes such as improvements in lung function and quality of life."
Spiration Valve System
- Supported by positive clinical, safety, and effectiveness data from the EMPROVE i and REACH ii clinical trials and 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
- Designated as a standard of care option for patients suffering from severe emphysema according to the 2021 report from the Global Initiative for Chronic Obstructive Lung Disease (GOLD), which gives its highest "A" evidence rating for Bronchoscopic Lung Volume Reduction (BLVR) using endobronchial valves. According to the report, this evidence rating is based on data and results from several randomized clinical trials involving a substantial number of patients, including those treated with the Spiration Valve System. iii
During the minimally invasive BLVR procedure with the Spiration Valve, umbrella-shaped endobronchial 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 the Spiration Valve, patients suffer from less breathlessness and have improved lung function 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,iv,v 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
For information about Olympus' the Spiration Valve System offerings, 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
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. 2019;200(11):1354-1362, 2019.
ii Wang G, Li S, Wang C, et. al. The REACH study, a randomized controlled trial assessing the safety and effectiveness of the Spiration Valve System endobronchial therapy for severe emphysema: 12 month follow-up results. European Respiratory Journal. 2017; 50(61); DOI: 10.1183/1393003.congress-2017.OA1465
iii 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 .
iv 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.
v Herth FJF, Slebos DJ, Criner GJ, et al. Endoscopic Lung Volume Reduction: An Expert Panel Recommendation - Update 2019. Respiration. 2019;97(6):548-557.
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SOURCE Olympus Medical Systems Group