Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 47-year-old female with a diagnosis of major depression. She is now seeking vagus nerve stimulation (VNS) therapy for treatment and management of her depression. She reports her condition has been refractory to treatment to date. The Health Plan has denied authorization for VNS on the basis that it is an experimental treatment and therefore a non-covered benefit. The patient is appealing the Health Plans denial.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 therapy 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 47-year-old female diagnosed with major depressive disorder. The submitted records indicate the patient was treated with multiple psychotic hospitalizations, psychotherapy, electroconvulsive therapy, and multiple trials of antidepressant medications, antipsychotic medications and mood stabilizers in various combinations. The patient has conservative treatment resistant depression with several severe suicide attempts and psychotic episodes. She has received minimal improvement from medications and weekly ECT. The patient wishes to undergo vagus nerve stimulation (VNS) therapy. The Health Plan has denied authorization for the requested therapy on the basis that it is experimental.Although VNS remains investigational and experimental this patient has had more than acceptable trials of standard treatment, all of which have failed. It is not likely that continued attempts at standard treatment will be effective. Given the lack of available treatment options, pursuit of VNS therapy is acceptable in this case. As such, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3:  The patient is a 47-year-old woman who had a history of recurrent depression, suicidality and psychiatric hospitalization that began around the age of 30. The patient reported no formal psychiatric history prior to age 30 but per history her childhood was quite traumatic. The patients mother was described as schizophrenic, and her father was depressed and alcohol dependent. Since then the patient has had a number of overdoses, suicidality and numerous psychiatric admissions. Her diagnosis has been major depression with psychosis. The patient has had numerous medication trials in the past. Currently, she is taking Welbutrin, Lexapro, and Trilafon. In addition, she has had a number of ECT treatments. None of these treatment modalities have cured her symptoms fully, or even for very long. Her treating psychiatrist indicates her depression is refractory. At present, the patient does not work and is constantly wishing to be dead. Her psychiatrist has requested authorization for VNS treatment for her at this juncture, which has been denied by the Health Plan.It is clear from the submitted clinical history that this patient is very ill and badly burdened by her psychopathology. While depression and suicidality have been her cardinal symptoms, a recurrent, and perhaps underlying psychosis is also present. With the family history of schizophrenia it is entirely possible that schizoaffective disorder is the primary diagnosis. Axis II pathology may be complicating the clinical picture as well.Despite this patients need for symptom relief, there is insufficient evidence VNS will be any more effective for her than the standard available treatments. Further attempts at standard therapy could be made including a more aggressive trial of antipsychotics, a return to tricyclic anti-depressants, or monoamine oxidase inhibitors or perhaps more structured types of psychotherapy (cognitive behavioral therapy or dialectical behavioral therapy), possibly in the context of a continuing day treatment program rather than a partial hospitalization program.Furthermore, given the patients easy access to psychosis, there is a risk she would develop delusions concerning the VNS procedure and its side effects (voice alteration).  The more general concern regarding VNS as a treatment modality began with the approval process in early 2005. 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.