Ohio Insurer Covering Spiration Valve System for Severe Emphysema

Medical Mutual of Ohio now covers Spiration Valve System (SVS), Olympus‘ minimally invasive therapy for eligible patients with severe emphysema, a progressive form of chronic obstructive pulmonary disease (COPD).

“This decision by Medical Mutual will provide expanded access to this critical therapy that significantly reduces lung hyperinflation associated with severe emphysema, and is durable over time,” Jason Stienecker, MD, pulmonary division chief at Lima Memorial Health System in Lima, Ohio, said in a press release.

The SVS is an umbrella-shaped device, whose tubes — called endobrachial valves — are positioned in specific airways to drive air into healthier regions of the lungs, diverting it away from diseased areas that risk becoming overinflated due to the stiffening of damaged lung tissue.

By enabling healthier portions of the lungs to work more effectively, this device is expected to improve patients’ quality of life by lessening their sense of breathlessness and helping them to accomplish more in their daily lives.

The U.S. Food and Drug Administration (FDA) approved the SVS in 2018 as a minimally invasive treatment for people with severe emphysema, based on positive results from the EMPROVE trial (NCT01812447).

Data from this study showed SVS led to significant improvements in lung function, as measured by forced expiratory volume in one second, over six months of use. This improvement appeared to be stable, lasting for at least one year.

Trial investigators also observed significant improvements in lobe volume reduction — a measure of air trapped inside the lungs — and patients’ overall health. The SVS device also relieved hyperinflation and shortness of breath.

Several other U.S. insurers also cover the SVS under applicable policies. These include Highmark and Health Care Service Corporation, both licensees of the Blue Cross and Blue Shield Association, as well as Aetna and Humana, Olympus reported in its release.

A physician can determine a person’s eligibility for SVS treatment through a computed tomography (CT) scan of their chest and the SeleCT screening tool, a computational algorithm that analyzes CT images.

The SVS was designated a “standard of care option” by the Global Initiative for Chronic Obstructive Lung Disease earlier this year, having received an “A” grade from that organization. The FDA also had designated it a  breakthrough device.

“Spiration Valve treatment can lead to truly meaningful improvements in patients who achieve sustainable clinical outcomes such as improvements in lung function and quality of life,” Stienecker said.