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

Physician 1:  The patient is a 46-year-old female with a diagnosis of bipolar disorder that has not been amenable to standard treatment. 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 conditions such as bipolar disorder. 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 the patients condition. 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 bipolar disorder. 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:  This case involves the treatment of a 46-year-old woman with a long-standing history of bipolar disorder. She has had both manic and depressive episodes, but the depression is described as treatment-resistant and most burdensome. It has led to a number of psychiatric hospitalizations and several suicide attempts. Treatment has consisted of medication trials of antidepressants (mostly serotonergic drugs), several mood stabilizers, an antipsychotic, and one psychostimulant. These medications failed to give lasting relief.In 2003 the patient began a long course of electroconvulsive therapy (ECT). Over the next two years she received nearly 50 treatments (both acute and maintenance). The treating psychiatrist described ECT as very helpful. The patient also agreed that ECT helped but, despite this, she was inconsistently compliant with maintenance treatments due to difficult logistics and memory loss. The records indicate that when she was treated with ECT in mid-2005 she experienced no memory loss.Throughout 2006 the patients depression has apparently waxed and waned. Chronic knee pain (requiring narcotic analgesics) has added to her discomfort, and she has had trouble sleeping at times. There were no documented psychiatric admissions or suicide attempts in 2006. She remains depressed at this time. The patient and her psychiatrist have requested authorization for vagus nerve stimulation (VNS) therapy, which the Health Plan has denied.Of concern in this case is the patients poor compliance with ECT in the face of its acknowledged helpfulness. ECT was, and is, a viable option for this patient. Additionally, there is no documentation that antidepressant augmentation strategies have been systematically tried (other than one stimulant) or that MAOIs or tricyclic antidepressants have been used. A combination of Remeron and Effexor once used in the past was found to be helpful, and as such, would be appropriate to try again.Although the patient and her psychiatrist are hopeful that VNS will provide lasting benefit in the treatment of the patients condition, there is little efficacy data to suggest that this would be the case or that VNS would be more beneficial than 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 bipolar disorder. 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 46-year-old female with a long history of bipolar disorder. She has been treated over the years on multiple medications including antidepressants, antipsychotics, mood stabilizers, and combinations thereof. She has had a positive response to electroconvulsive therapy (ECT), but problems with follow-up treatments occurred due to distance. Apparently, there have been no trials of MAOI medications. The patients provider has recommended vagus nerve stimulation therapy, which the Health Plan has denied on the basis that it is experimental/investigational.Based upon the information submitted for review, the patient has not exhausted standard therapies for the treatment of bipolar disorder. It does not appear the patient has tried MAOI medications. Furthermore, the patient actually benefited from ECT but decided to discontinue the therapy. Vagus nerve stimulation remains experimental at this time and is not likely to be superior to standard modalities 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.