Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1:  The patient is a 30-year-old female with a diagnosis of depression. The patients provider indicates the patient has been tried on multiple medications without lasting benefit. The patient and her provider are requesting authorization for vagus nerve stimulation (VNS) therapy. The Health Plan has denied this request indicating VNS therapy is investigational and therefore, not a covered benefit.To date, VNS remains a highly controversial treatment for refractory depression. There are no valid, controlled, double-blind, research centered and clinically based reproducible studies showing that VNS is any better than sham treatment. VNS is not a part of established principles of health care practice as of this date for the management of refractory depression.  VNS remains an experimental, controversial and unproven procedure at this time. It has not been accepted by the psychiatric community as routine treatment in the management of refractory depression. For these reasons, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Physician 2:  The patient is a 30-year-old female with apparently a 10-year history of depression. Trials of certain medications have been less than successful. It does not appear the patient has been treated with tricyclics, monoamine oxidase inhibitors (MAOIs) or electroconvulsive therapy (ECT). Her provider has recommended vagus nerve stimulation therapy, which the Health Plan has denied on the basis that it is experimental.Based upon the information submitted for review, it does not appear the patient has treatment refractory depression. There are multiple standard therapies that are likely to be effective for this patient including tricyclics, MAOIs and ECT. Vagus nerve stimulation remains experimental at this time and is not likely to be effective in this clinical setting. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3:  The patient is a 30-year-old woman who was first diagnosed with major depression 10 years ago. She has been followed by her current psychiatrist since 2004. The submitted records indicate the patient has been depressed frequently over the past decade and nearly continuously for the past two years. Her treatment since 2004 has consisted of psychotherapy and trials of many anti-depressants (primarily SSRIs). In addition, anxiolytics, one or two mood stabilizers, and an atypical antipsychotic have been used. The patient has apparently been too depressed to work at times and a chronic pain disorder and morbid obesity have complicated her mood disorder with significant somatic preoccupation. There is no evidence of a suicide attempt, but she has suicidal ideation. The patient has never been admitted for psychiatric hospitalization. In late 2005 the patients psychiatrist determined that her depression was treatment resistant and recommended vagus nerve stimulation (VNS) therapy. The Health Plan has denied coverage for VNS therapy on the basis that it is considered investigational in nature.Based upon the information provided, it appears there are a number of viable options that would have to be tried before one can conclude that the patients depression is treatment resistant. These options include longer antidepressant trials than those documented in late 2004 when her antidepressant was changed almost monthly, standard augmentation strategies using more than one anti-depressant at a time and/or lithium, Buspar, Cytomel or psychostimulants, MAOIs, tricyclic antidepressants, ECT and a course of cognitive behavioral therapy and/or dialectical behavioral therapy. Until these options have been tried, it cannot be established that the patient has treatment refractory depression. Even if her condition proves to be refractory to treatment, there is inadequate evidence that VNS therapy is superior to available standard therapies. Despite FDA approval of VNS, the efficacy studies to date have not yielded unequivocal data in support of VNS over placebo. When VNS was approved by the FDA in July 2005, it concluded a process that was marked by two reversals of the decision. Final approval was met with surprise by many psychiatrists and the controversy has continued. The source of the controversy lies with the efficacy data. The FDA requires two randomized, double-blind, placebo-controlled trials that prove a proposed treatment is statistically superior to placebo. In the case of the VNS approval, both of these pivotal studies had serious design and methodology problems that left many scientists wondering what the data actually meant.The National Psychiatric community has not yet embraced VNS as part of the usual standard of care for severe depression. The American Psychiatric Association has stated, While VNS has been studied over the past five years, evidence is not yet sufficient to recommend its use in routine clinical practice.VNS treatment is not indicated for this patient, as the submitted records do not establish that her depression is treatment resistant. Furthermore, the efficacy of the therapy has not been proven. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.