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Do a Google™ search on VNS Therapy and you will find 285,000 results. Conversely, a Google™ search on Zoloft® will net results well over 14 million. Many, if not all of us in the mental health community have heard of, or have experience with the popular antidepressant, which will be going generic this year. But how many of us have heard of VNS Therapy? Or Cyberonics, the Houston based company that received FDA approval July 15th, 2005 for long-term adjunctive treatment for patients 18 years of age or older with chronic or recurrent treatment-resistant depression?
The National Institute of Mental Health says that in any given year 9.5 percent of the population, or 26 million Americans, suffer from a depressive illness. While the economic impact of this illness is high, the emotional impact cannot be quantified. As professionals in the mental health community let’s continue to educate the consumer, to let them know that their feelings of depression and the pain that is attached is many times treatable. And for those 4.4 million consumers who are considered to be treatment resistant the feeling of despair is often overwhelming and can lead to suicide. For these patients, the ones who may have tried four courses or more of medication but still fail to adequately respond, now is the time to educate yourselves, and your clients about vagus nerve stimulation, (VNS Therapy).
For some patients VNS Therapy is truly a savior, much like some treatment resistant schizophrenic patients look upon clozapine. However, let’s not compare apples to oranges. While both treatments can yield significant clinical results VNS Therapy produces only a few moderate side affects. And VNS Therapy is not handicapped by a black box warning for increased risk of suicide like the antidepressant class of medications.
In doing research for this two-piece article we spoke with several psychiatrists, nurses, and even a few consumers. The clinicians we spoke with were all working within an outpatient setting, excluding one psychiatrist that worked in research. The overwhelming consensus is a positive one. Most possessed an attitude of excitement that there may be an alternative solution in fighting treatment resistant depression as opposed to poly-pharmacy. Some still posed questions ranging from how the therapy worked, how to identify the appropriate patients, or yet, making sure that the patient has insurance that will cover the ninety-minute outpatient procedure. Cyberonics is continually working to educate the mental health community on the VNS Therapy.
This is not some new fangled technology. The first VNS device was implanted into a human in 1988. According to Cyberonics, more than 32,000 patients in 24 countries have experience using VNS Therapy. Although, most experience has been attributed to VNS Therapy for its epilepsy indication. According to the Cyberonics website VNS Therapy is the first and only FDA-approved treatment for their specific illness. However, as of November 2005, only 300 patients with treatment resistant depression have gone through the maze of insurance approval to receive VNS Therapy.
(http://www.fda.gov/cdrh/mda/docs/p970003s050.html)
Article: Vagus-nerve stimulation of benefit in epilepsy. (Lancet, 1999), Search Vagus in lexis-nexis.
Robert P. (“Skip”) Cummins, Cyberonics’ Chairman of the Board and Chief Executive Officer proclaims, “All Americans with TRD should have access to VNS Therapy for its FDA-approved indication”. Cummins goes on to say, “Although over 85 different third party payers, including 19 different Blue Cross/Blue Shield plans, United Healthcare, CIGNA, Aetna, Humana and several regional Medicare carriers have to date granted at least one American with TRD access to VNS Therapy. Several State Medicaid programs now have the same coverage policy for both epilepsy and depression, all Americans with TRD do not yet have the same immediate, universal access to VNS Therapy that Americans with pharmaco-resistant epilepsy have had for at least the past five years”. This problem, however, is something Mr. Cummins and his staff, is diligently working on improving.
And for the early adopters, those willing to forge ahead for the benefit of the patient Cyberonics has put together an incredible education tool www.vnstherapy.com. While the highlights of this site are too many to list it is important to note that Cyberonics arms you with a cache of resources to successfully maneuver through patient identification, to patient insurance coverage information and even provides access to detailed information for surgeons.
Cyberonics is a unique entity in the medical device field. They are proud to announce the fact that they produce only one product, the VNS Therapy System. This might explain how they are doing such a fabulous job educating the mental health community, aligning themselves with consumer advocacy groups like the National Alliance of the Mentally Ill, (NAMI), and supplying the community with very comprehensive marketing and educational pieces. Mr. Cummins reveals his company’s upcoming marketing strategies, ”we plan to educate over 5,000 psychiatrists and VNS surgeons in fiscal 2006 and so far our regional education and training programs have been largely oversubscribed. In terms of TRD coverage, coding and reimbursement, with AMA’s approval of the VNS programming codes for use in TRD, the remaining challenge is obtaining case-by-case and regional and national coverage”.
Let’s not forget that they are giving back to the community as well. This was evidenced by the announcement of their indigent care program noted in a recent press release in January. Cyberonics will provide up to 200 VNS Therapy Systems per year over a five-year period in this program to qualified patients through experienced hospitals and trained psychiatrists.
Check out our next installment that will review the clinical components of VNS Therapy, and take an in depth look at the patient experience. If you are a little apprehensive or left with more questions we highly recommend visiting the www.vnstherapy.com website, or take part in the monthly VNS Therapy teleconference which takes place the first and third Tuesday of every month at 8:00 pm ET. The toll free number is 1-866-598-9336.