LivaNova touts CMS trial clearance for vagus nerve depression treatment system

LivaNova (NSDQ:LIVN) said on Wednesday that the U.S. Centers for Medicare & Medicaid Services finalized a National Coverage Decision for LivaNova’s Vagus Nerve Stimulation Therapy for treating treatment-resistant depression.

The London-based company said that the modified NCD will enable Medicare coverage for VNS therapy through the Coverage with Evidence Development framework when offered through a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up of at least 1 year.

“As part of our commitment to improving the lives of patients around the world, LivaNova requested that CMS formally reconsider coverage for VNS Therapy for Treatment-Resistant Depression. We applaud CMS for taking this considerable step to provide increased access to treatment through Coverage with Evidence Development. We are pleased that CMS has expanded the potential beneficiaries of this therapy by including patients with bipolar disorder, an important and underserved patient population. Further, CMS expanded its research questions to include response to treatment, providing a much better gauge of benefit in this very ill patient population. Overall, this decision will help the large number of people who suffer from TRD receive access to an affordable, potentially life-altering treatment option,” CEO Damien McDonald said in a press release.

The change will also cover replacement of the VNS therapy device, LivaNova said, and includes the possibility to extend the study to a prospective longitudinal study.

LivaNovas said it plans to submit a clinical study protocol to CMS for a new 500-person trial of the device, with enrollment slated to begin during the third quarter of this year and expected to take as long as 18 months.

“Not only does the science support that VNS for TRD works, but we have seen first-hand the profound impact it has on the lives of patients. We have implanted more than 80 TRD patients with VNS devices, many of whom were on Medicare disability and completely incapacitated by their depressive illness, oftentimes for years or decades. With VNS treatment, we have seen them go on to lead productive lives, in most cases, the effects of the treatment are sustained—unlike most antidepressant treatments in TRD. This treatment is highly effective and significantly changes, and may even save, lives,” Dr. Charles Conway of the Washington University Center for Advancement of Research in Resistant Mood and Affective Disorders said in a prepared statement.

“Medicare coverage for TRD patients is critical. Depression is the leading cause of disability in the U.S. patients with TRD are often younger than the typical Medicare beneficiary and will likely become eligible for Medicare as a result of disability, not age. We believe that TRD is an area of high unmet medical need and an area where LivaNova can make a difference and improve the lives of patients,” neuromodulation GM Edward Andrle said in prepared remarks.

Last November, CMS proposed a launch of a clinical trial of the VNS system to explore its ability to treat Treatment-Resistant Depression.