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

Physician #1:  The patient is a 53-year-old recurrently depressed male said to be refractory to all treatments over the past six years. He refuses ECT based on concerns of significant cognitive loss, which he fears could lead to job loss. He has been treated on an inpatient basis twice and apparently has been unresponsive to varied pharmacologic treatments. It is unclear if he has had a full MAOI trial. The patient has requested authorization and coverage for vagus nerve stimulation (VNS) therapy. The Health Plan has denied his request on the basis that the efficacy of VNS remains unproven.Upon review of the submitted clinical evidence it is not entirely clear that the patient is treatment resistant since a full ECT trial has not been attempted. Even if the patients condition is truly refractory to treatment, VNS is not likely to be of clinical benefit. Based upon the evidence available to date, VNS remains unproven as there are inadequate well-controlled, blinded studies establishing the benefits, length of improvement, and potential safety issues of VNS.For the reasons 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.Physician #2:  This patient is a 53-year-old male with a long-standing history of recurrent depression apparently resistant to multiple trials of various medications and combinations of medications. He has not undergone treatment with electroconvulsive therapy (ECT) due to concerns regarding memory loss and his ability to continue working. He has been hospitalized twice. The patient is reported to be verbalizing suicidal ideations. His provider has recommended vagus nerve stimulation (VNS) therapy, which has been denied by the Health Plan as an experimental/investigational treatment.Although there is sufficient evidence to support the use of VNS therapy for treatment of serious, unrelenting, non-medication responsive depression, it does not appear VNS in medically warranted in this clinical setting. Review of the submitted clinical information does not demonstrate that MAOIs have been tried. Furthermore, ECT should be attempted prior to consideration of VNS therapy. Although the patient has concerns with ECT, its safety and efficacy is well documented. Moreover, VNS therapy is not without risk as anesthesia/surgery is required for placement of the VNS device. As such, ECT is the next appropriate step in the treatment of this patients depression. 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 53-year-old male with a diagnosis of major depression, recurrent, who is currently receiving Lamictal, Cymbalta and Ativan. The patient has suffered from major depression for an unclear duration and has experienced crying spells, anxiety, sleep disturbances, poor concentration, lack of energy and motivation, and social isolation. His wife echoes this history. In the past he has received Lithium (though eventually developed Lithium toxicity) Ritalin, Neurontin, and Remeron, with either a lack of sustained response and/or intolerable side effects. His psychiatrist indicates vagus nerve stimulation (VNS) therapy is the only viable option for the patient. No other history of his affective disorder has been provided. Electroconvulsive therapy (ECT) has not been recommended; it appears the patients wife is concerned about potential memory loss with ECT.Notes of relevance include the following:May 2005: Doing fairly well, neurontin manages his anxiety.November 2005: Wants to sleep all day. Will add Lamictal to regimen (also on Seroquel 300 mg, Cymbalta 120 mg, and Ativan 1 mg bid).December 2005: Patient is doing better. Is on 100 mg of Lamictal. Is doing more around the house. Will now increase Lamictal to 150 mg (also on Cymbalta 120 mg, Seroquel 200 mg, and Ativan 1 mg bid).At issue in this case is whether VNS therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Based upon the documentation provided, it is not clear if the patient is suffering from a unipolar versus bipolar illness, though given the use of mood stabilizers, there was evidently some consideration of his experiencing the latter. In any event, it is rather presumptive to assume that other medications are not likely to be effective. To name but a few, a tricyclic, a monoamine oxidase inhibitor (MAOI) or a serotonin noradrenaline reuptake inhibitor (SNRI) are other viable options to consider. Additionally, concerns over long-term memory loss with ECT are unfounded. The literature on ECT actually suggests an improvement in cognitive functions longitudinally, given the cognitive impairments induced by depression itself. Finally, the submitted documentation indicates the patient has responded at least somewhat to the increased Lamictal. Thus, it appears more substantive pharmacologic dosing should be considered. All told, there is no merit to considering VNS therapy prior to pursuing conventional treatment for this patient. This is particularly true in light of the modest benefits associated with VNS therapy.As 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.