TRD Societal Cost Can Sway US Payer On VNS Coverage Decision

LivaNova is counting on CMS paying more than lip service to the value-based agenda as it assesses coverage decisions for Vagus Nerve Stimulation (VNS) for the treatment of resistant depression over the coming months. In many ways it is a test for both parties.

The dominant theme during LivaNova PLC's second quarter earnings call on August 1 – once updates on Japanese approval and reimbursement for the sutureless aortic heart valve (Perceval), TMVR trials (ongoing) and the ImThera OSA trial (paused) were delivered – was current efforts to seek US coverage for Vagus Nerve Stimulation (VNS) for treatment of resistant depression (TRD).

The UK-headquartered group is seeking "adequate patient access" to the therapy for TRD sufferers, who are defined as patients who have tried four or more treatments and failed.After 11 years of the current US national coverage decision, the positive news for LivaNova has been the renewed attention given to VNS by the Centers for Medicare & Medicaid Services (CMS), which in May released a

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