CMS Revisits Funding Vagus Nerve Stimulation for Depression

Deborah Brauser

June 20, 2018

The US Centers for Medicare & Medicaid Services (CMS) may reverse its long-standing policy of not covering vagus nerve stimulation (VNS) for treatment-resistant depression (TRD) – or at least consider reversing itself, according to a new national coverage analysis (NCA) tracking sheet posted by the agency.

Although CMS granted coverage of VNS for patients with refractory partial-onset seizures "for whom surgery is not recommended or for whom surgery has failed" in 1999 in its Medicare National Coverage Determinations (NCD) manual, it decided in 2007 that there was "insufficient evidence" for showing that VNS was necessary for treating TRD. This resulted in the organization deciding that this particular indication should remain uncovered.

However, CMS has opened a new NCA that may lead to their reconsidering section C, paragraph 2 of section 160.18 of the manual, which deals with Medicare coverage of the procedure for TRD.

The organization is also soliciting public comments on their website until June 29 "and is particularly interested in [hearing about] clinical studies and other scientific information relevant to the topic under review."

The recent activity came about after the agency accepted a formal reconsideration request signed by two vice presidents of LivaNova, manufacturer of the VNS Therapy system.

"The company is encouraged that CMS has taken this initial step, which may provide access to this important therapy for TRD that has been a Medicare non-covered indication for more than a decade," the manufacturer stated in a press release.

"A significant body of new evidence has emerged showing that the addition of VNS Therapy is effective in reducing symptoms in patients with TRD," it adds.

New Data

The VNS Therapy system includes a programmable electronic pulse generator and an electrical lead, which are both surgically implanted. It was approved by the US Food and Drug Administration in July 2005 to treat TRD. It's also been indicated for treating chronic or recurrent depression in adult patients in Europe.

The company reports that more than 4000 patients with TRD were implanted with VNS between July 2005 and May 2007, when the procedure was covered by several payers. However, all commercial payers stopped covering this indication following the 2007 NCD issued by CMS.

In its reconsideration request, the manufacturer noted five points under the heading, "New evidence supports that VNS therapy has a treatment benefit for Medicare beneficiaries with TRD."

These include new epidemiology data, notice that the American Psychiatric Association published two documents after 2007 in favor of using VNS to treat TRD, new evidence on the mechanism of action for the treatment, and two literature reviews in which beneficial results were reported.

These literature reviews included findings from the D-21 Dosing and D-23 TRD Registry studies. Results from the former were published in Brain Stimulation in 2013.

D-21 included 331 patients with TRD who were randomly assigned to receive one of three doses of VNS therapy. During the 22-week acute phase, all groups met the primary assessment endpoint of significant change from baseline score on the Inventory of Depressive Symptomatology–Clinician Administered test. Continued improvement was also shown during the additional 28-week long-term phase.

These patients "showed significant improvement at study endpoint compared with baseline, and the effect was durable over one year," Carla Monacelli, vice president of government affairs and market access for LivaNova, and Bryan D Olin, PhD, senior vice president of the company's Clinical, Quality, and Regulatory Department, write in the new reconsideration request letter.

"Valuable Addition"

The D-23 Registry open-label study included 495 patients with TRD who received adjunctive VNS therapy and 301 patients with TRD who received treatment as usual. The VNS group had significantly greater 5-year cumulative rates of response (67.6% vs 40.9%) and remission (43.3% vs 25.7%).

These results were presented at the American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting before being published in the American Journal of Psychiatry in 2017.

"Insurers have not been very receptive to covering it, but we are hopeful that these kinds of data will convince them that this is a very valuable addition and that it should by a covered service," lead author of D-23 Registry Scott Aaronson, MD, Sheppard Pratt Health System, told Medscape Medical News at the ASCP meeting.

"Carefully designed, prospective studies, such as the large, multicenter VNS Therapy studies described in this request...should be sufficient to reconsider coverage" of the treatment for TRD, Monacelli and Olin wrote in their letter.

November 30 is the proposed decision memo due date, reports CMS. The expected NCA completion date is February 28, 2019.

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