LivaNova
(Nasdaq: LIVN)
this week announced it submitted a request to the Centers for Medicare and Medicaid Services to reconsider national coverage for its Vagus Nerve Stimulation (VNS) Therapy in patients with unipolar treatment-resistant depression (TRD).
The request is backed by a new series of peer-reviewed publications from the RECOVER clinical study, as well as recently released 24-month top-line data showing durable and increasing benefit for patients receiving VNS Therapy.
LivaNova said the newly submitted materials fulfill the agency’s Coverage with Evidence Development (CED) requirements by providing publicly accessible results on pre-specified primary and secondary endpoints. The company’s submission includes five published or accepted articles and new data showing that VNS-treated patients maintained a median durability of benefit of more than 80% at two years.
“We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,” said LivaNova Chief Innovation Officer Ahmet Tezel. “Our follow-on analyses of the RECOVER unipolar data demonstrate that symptoms alone may not be the sole source upon which to gauge the clinical impact of treatment. Instead, symptoms, function, and quality of life taken together present a more complete picture of treatment effectiveness. We are eager to review this powerful data with CMS during the reconsideration process.”
The RECOVER trial enrolled 493 adults with unipolar TRD who had previously failed four or more antidepressant treatments. The company said that from months 12 to 24, the proportion of patients with clinically meaningful benefit increased from 40.2% to 51.6%.
Researchers also reported a statistically significant improvement in suicidality metrics in VNS-treated patients, with separation from control observed as early as three months. While not included in the initial CMS filing, LivaNova plans to provide those findings to the agency following peer-reviewed publication.
The company’s VNS Therapy is FDA-approved and CE-marked for chronic or recurrent depression in adults who have not responded to multiple treatments.
