Positive Coverage Decision Granted for ReActiv8 Neurostimulation therapy

Mainstay Medical Holdings plc’s ReActiv8 Restorative Neurostimulation therapy is now eligible for health insurance coverage for qualified members when clinically appropriate and medically necessary, Highmark Inc. has decided. Implemented on July 27, the coverage decision specifies that ReActiv8 is the only therapy considered “medically necessary” by the policy when conditions for coverage are met.

Highmark Inc., together with its Blue-branded affiliates, collectively comprises the third-largest overall Blue Cross Blue Shield-affiliated organization in the United States, with nearly 8 million members in Pennsylvania, Delaware, New York, West Virginia, Missouri, and Kansas.

“We are committed to providing our members access to therapies that are clinically proven to improve health outcomes for patients in need,” said Matt Fickie, M.D., senior medical director of Medical Policy for Highmark Inc. “ReActiv8 has proven to be a safe and effective treatment option for patients with intractable chronic low back pain from multifidus dysfunction, with clinical trials also showing reduced opioid use.”

Under its policy, Highmark considers ReActiv8 to be medically necessary for chronic low back pain treatment when various clinical criteria are met, including a lumbar multifidus muscle dysfunction diagnosis and patient selection criteria consistent with U.S. Food and Drug Administration approval guidelines and Mainstay’s clinical trial protocols.

Mechanical chronic low back pain associated with multifidus muscle dysfunction is a distinct and diagnosable condition. Affected patients typically remain symptomatic despite conservative care, including pain medication and physical therapy, and many are not candidates for spine surgery, leaving them with limited treatment options. Positive coverage decisions such as Highmark’s offer treating physicians access to an evidence-based therapy for patients who might otherwise continue to cycle through approaches that do not provide durable relief.

“With Highmark’s decision, ReActiv8 is now available to more than 50 million Blues-affiliated members across the United States,” Mainstay Medical CEO Jason Hannon stated. “We have worked hard to generate robust clinical data demonstrating ReActiv8’s effectiveness and safety. ReActiv8 therapy is distinct from standard peripheral nerve stimulators that provide palliative (temporary) stimulation, and our clinical evidence demonstrates its durable impact across multiple clinical-study and real-world patient populations. Decisions like this one give physicians a safe and effective option for a distinct group of patients whose treatment options have been limited. We look forward to sharing our evidence with other major health plans as we work to expand access for the patients who can benefit from ReActiv8.”

ReActiv8 is an implantable medical device for treating intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction, which may be evidenced by imaging or physiological testing. ReActiv8 candidates are patients with multifidus muscle dysfunction who have failed other forms of therapy (including pain medication and physical therapy) and are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas and is commercially available in the European Economic Area, Australia, the United Kingdom, and the United States.

Mainstay Medical is a medical device company commercializing its implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland, and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.