Inspire Medical Systems Inc, a medical technology company that makes an implantable therapy for obstructive sleep apnea (OSA) and is focused on the development and commercialization of minimally invasive solutions for patients with the sleep disorder, reports that the Blue Cross Blue Shield Association’s (BCBSA) Evidence Street issued a positive assessment of Inspire therapy to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield (BCBS) companies.

The report summarized that sufficient evidence exists to determine that hypoglossal nerve stimulation results in a meaningful improvement in the net health outcome for patients meeting the following selection criteria, which are based on information from clinical study populations and clinical expert opinion:

  • age ? 22 years in adults, or adolescents with Down’s syndrome (age 10 to 21 years); and
  • diagnosed moderate to severe OSA (with less than 25% central apneas); and
  • CPAP failure or inability to tolerate CPAP; and
  • body mass index ? 35 kg/m2 in adults; and
  • favorable pattern of palatal collapse.

“This positive assessment demonstrates the strength of the clinical evidence for Inspire therapy and is an important step forward in securing coverage from health insurance providers in the BCBS affiliate network,” says Tim Herbert, president and CEO of Inspire Medical Systems, in a release. “This positive Evidence Street assessment for Inspire therapy will provide us with key support in our ongoing discussions with BCBS companies that relate to positive coverage decisions in the future. The positive review further validates the benefits of Inspire therapy, and we continue to believe that our growing body of clinical and real-world data will be the basis for additional coverage decisions by other major health plans, as well as provide support to centers in obtaining individual prior authorization approvals.”

The BCBSA’s Evidence Street platform provides health care decision-makers easy access to impartial medical evidence reviews for devices, diagnostics, and pharmaceuticals and was created to make BCBSA’s evidence review process of medical technologies and therapies more transparent, efficient, and comprehensive. BCBSA collects and analyzes available peer-reviewed evidence, then synthesizes that data and ascertains if the evidence is sufficient or insufficient to determine the effect on health outcomes.

The BCBSA’s Evidence Street does not determine whether each of the 36 BCBS companies nationwide cover a medical technology. However, it provides BCBS companies with evidence-based opinions that the BCBS companies often consider in their decisions.