Dear Readers,

We are now entering the fourth year of FDA's final approval of vagus nerve stimulation to treat major depressive disorder.

Cyberonics continues to execute on its previously announced plan to focus primarily on the epilepsy market. From February 22nd 2008 to April 25th, a total of twenty-seven patients in the United States were implanted with the VNS Therapy System^TM for depression. That is about one patient for every two states. Cyberonics continues to seek a financial partner or joint venture for a new depression clinical study.

• The Twilight Zone - Reimbursement Purgatory
• Show Me the Money - A 2008 Nissan Maxima, Fully Loaded
• Back to the Future - Polypharmacy
• Medscape/WebMd - Interview with Charles B. Nemeroff, MD, PhD
• Next Issue - Depression Plan Announcement

The Twilight Zone – Reimbursement Purgatory

I think that universal reimbursement for non-pharmacological based treatments (excluding ECT and psychotherapy) such as VNS, TMS, FEAST, and DBS is many years away. Below is a painful reminder of Medicare's National Coverage Determination for vagus nerve stimulation (VNS):

"CMS (Centers for Medicare and Medicaid Services) believes almost all correctly identified depressed patients can be successfully treated for depression" [HELLO?]

"CMS has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression. Accordingly, we are issuing the following national coverage determination:

Vagus nerve stimulation is not covered for treatment resistant depression."*

* Source: CMS Decision Memo for VAGUS NERVE Stimulation for Treatment of Resistant Depression (TRD) - May 4, 2007

Comment: I hope that I am completely wrong. There has to be a better way.
 

Show Me the Money – A 2008 Nissan Maxima, Fully Loaded

I am frequently asked "how much does the procedure cost?" It varies state-by-state, city-by-city and hospital by hospital. My best guess is that the VNS Therapy System^TM costs about the same as a 2008 Nissan Maxima, fully-loaded and including a GPS.

With the introduction of the newest generator, the Demipulse^TM, the cost of the device will rise during the next 12 months.
 

Back to the Future – Polypharmacy

The good news is that the past five years has produced many well designed clinical trials using combinations of drugs to produce evidence-based efficacy. This has enabled psychiatrists to make better informed decisions when prescribing multiple medications. So please don't ever give-up.

If your prescribing psychiatrist is not familiar with the latest published studies in the medical literature, I would send him back to the research library. The polypharmacy route can be a drag (been there, done that). However, evidence-based strategies can help mitigate that process and potentially improve your response to the treatment. Please see below interview with Charles B. Nemeroff, MD, PhD
 

Medscape/WebMd – Expert Interview with Charles B. Nemeroff, MD, PhD

Below is a portion of a short interview with one of the nation's leading psychiatric experts in treating resistant depression using pharmacologic options.

Medscape Psychiatry & Mental Health. 2008; ©2008 Medscape
Posted 07/08/2008

Pharmacologic Options for Treatment-Resistant Depression:
An Expert Interview with Charles B. Nemeroff, MD, PhD

Dr. Nemeroff is a leading researcher in the field of mood disorders. He is the Reunette W. Harris Professor and Chairman of the Department of Psychiatry and Behavioral Sciences at the Emory University School of Medicine in Atlanta, Georgia. On behalf of Medscape, Randall F. White, MD, asked Dr. Nemeroff for an update on managing treatment-refractory depression (TRD).

Medscape: Can you briefly outline the pharmacologic strategies for managing TRD?

Dr. Nemeroff: We have 2 main pharmacologic approaches: switching and augmentation.

In switching, most practitioners choose a medication with a different mechanism of action from the first one. For example, if a patient had not responded to an SSRI, the doctor might choose:

1. A serotonin-norepinephrine reuptake inhibitor (such as Effexor, Cymbalta or Serzone); and
2. An atypical antidepressant such as bupropion (Welbutrin), mirtazapine (Remeron) , or nefazodone (Serzone) ; or a monoamine oxidase (MAO) inhibitor or tricyclic antidepressant.

The augmentation strategy includes either augmentation with an agent that in and of itself is not an antidepressant but can enhance the effects of the antidepressant, or combining the initial antidepressant with a second antidepressant.

This is not without some ambiguity because, for instance, quetiapine (Seroquel) is a second-generation antipsychotic (SGA) that actually has antidepressant properties of its own. Be that as it may, the traditional strategies are thyroid hormone (T3), 25-50 micrograms daily, and lithium.

Medscape: The second-generation antipsychotics (SGAs) show promise in TRD. Which ones have been studied and what does the latest research tell us about their usefulness?

Dr. Nemeroff: My research team published a report in Neuropsychopharmacology, Mahmoud and colleagues published a study late last year, and our group together with the Brown University group conducted a third study that is now in press. All 3 studies show that risperidone (Risperdol) is effective in TRD to a greater or lesser extent.

**This activity is supported in part by an unrestricted grant from Bristol-Myers Squibb.
 

Next Issue

I will probably write the next issue of the VagusNerveStimulation.com Bulletin when Cyberonics announces a plan for its depression business unit. The two publicly disclosed options are:

1. Possible transfer to stand-alone entity, and
2. Seeking of a financial partner for plan execution

In addition to depression, there are several on-going studies involving the vagus nerve to treat:

• Obesity
• Fibromyalgia
• Chronic migraine
• Brain injuries

Keep your kewl this summer.

I wish you all the best in your treatment plans.

Kindly,

Charles E. Donovan, III
Implanted April 4, 2001
www.VagusNerveStimulation.com
"Keeping Patients Informed"