Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 31-year-old female who is requesting authorization for vagus nerve stimulation (VNS) treatment for major depression. The patient has not shown sustained improvement with conventional anti-depressants and electroconvulsive (ECT) therapy. The Health Plan has denied the patients 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 31-year-old woman who has been treated for depression since 2002, initially by her primary care physician and since 2003 by a primary psychiatrist and several consulting psychiatrists. She carries a diagnosis of major depression, severe and she is currently felt to have treatment-resistant depression (TRD). In addition, it is now felt that her depression (and its treatment) is complicated by a dysthymic disorder and an obsessive-compulsive personality style.At present, the patient is taking Clozaril and Zoloft and continuing in psychotherapy. Her attending psychiatrist feels that vagus nerve stimulation (VNS) is the only modality left for the patient. The Health Plan has denied authorization for VNS therapy on the basis that it has not been shown to be effective for treatment of the patients condition.At present, the patient is taking Clozaril and Zoloft and continuing in psychotherapy. Her attending psychiatrist feels that VNS is the only modality left for the patient. It could be argued that another course of ECT is indicated before giving up on that modality, though, the concern raised about the usefulness of biological treatment for this patient does remain.The use of VNS in this context is investigational. There is nothing about the patients clinical history to suggest that VNS would be any more effective for her than the available standard treatment. 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 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.Physician 3:  The patient is a 31-year-old female with a long-standing history of depression, deemed severe Major Depression, probable Dysthymic Disorder, and Obsessive-Compulsive personality style. She is currently treated with Clozaril and Zoloft following more than a dozen ECT treatments, most of them with bilateral lead placement.  The patient was felt to have initially improved to some degree from ECT but was later considered to ultimately not have improved.  Prior courses of medications included Lexapro, Marplan, Zyprexa, Prozac, Lamictal, nortriptyline, Effexor, and Lithium with a variety of supplements, ranging from Provigil, SAMe, and Mirapex. She could not tolerate some of the medications, though often used in low dosage, or experienced no benefit from them. She also had a consultation with a psychiatrist who felt that Bipolar Disorder could not be entirely ruled out. The patient is seeking authorization for vagus nerve stimulation therapy. The Health Plan considers the therapy experimental and thus has denied coverage.Review of the submitted clinical information reveals uncertainty as to the true, operative diagnosis of the patient.  Though she had been deemed to suffer from Major Depression, as in a Unipolar type, there was consideration by one of the consulting psychiatrists of her possibly suffering from a Bipolar-spectrum disorder. Her treating psychiatrist noted her to have been clearly hypomanic at one point. Another issue has to do with the various dosages of medications with which she was treated.  For example, she often took such small amounts of medications, e.g., Prozac 15 mg or Zyprexa 1.25 mg, that it would be impossible for her to achieve any benefit from those medications.  A confounding factor may have been the dosing of Lithium. Finally, there is also a disparity between the constant concern of her treating psychiatrist as to her suicidality and her actual level of function.  There were clear periods in which, though she felt depressed and was seen as negative, she had a relatively high level of function.  At least some of what she reported as bleak and hopeless did not particularly match up with her actual level of function. It is also of note that the ECT psychiatrist felt that no further ECT was indicated both because of the relatively paltry level of response as well as underlying character pathology.  All told, the patient has not exhausted more conventional medical treatments for her depression. Furthermore, the patients failure to respond to multiple ECT treatments makes it very unlikely that she will benefit from VNS placement.  As such, there is no clinical indication for VNS therapy in the treatment of this treatment.  Based upon the information set forth above, 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.