Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 55-year-old woman with a diagnosis of major depressive disorder that appears unamenable to psychopharmacological treatment and psychological treatment. The submitted records do not indicate whether the patient has received ECT. The patient and her psychiatrist are requesting authorization for vagus nerve stimulation (VNS) therapy. The Health Plan has denied their request on the basis that VNS remains experimental/investigational.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 55-year-old female diagnosed with major depressive disorder, recurrent without psychosis. She has received limited benefit from multiple treatments. The patient has not had a positive response to several anti-depressants (more than four) and combinations of psychotropic medications. She has requested authorization for vagus nerve stimulation therapy, which the Health Plan has denied.The Health Plans denial is correct. Vagus nerve stimulation remains experimental at this time and is not likely to be effective in this clinical setting. Furthermore, based on the records provided, it does not appear she has been treated with monoamine oxidase inhibitors (MAOIs) or ECT. Thus, there are alternative standard therapies available that are likely to be more efficacious than vagus nerve stimulation therapy, which remains clinically unproven. Accordingly, 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 55-year-old woman who states that she has been depressed since childhood. She has been in formal psychiatric treatment for many of her adult years, carrying a diagnosis of chronic, recurrent major depression. Her treatment has consisted of psychotherapy and extensive use of medications. Medication trials have included anti-depressants from most classes (not MAOIs), mood stabilizers, antipsychotics, sedative-hypnotics and benzodiazepines. The records provided do not document a trial of electroconvulsive therapy (ECT). In July 2005 the patient was hospitalized for stabilization of depression. She has suicidal ideation and remains depressed. The patient and her psychiatrist are seeking authorization for vagus nerve stimulation (VNS) therapy. The Health Plan has denied this request on the basis that VNS therapy is investigational for the treatment of refractory depression.Review of the submitted clinical information indicates the patient has suffered from recurrent depression for years. However, it does not appear the patient has exhausted standard treatments. A trial of MAOIs and ECT would be the next appropriate step in the treatment of this patients depression. At this time, there is no clear evidence to indicate that VNS will be any more useful than the standard therapies that remain available.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 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.