Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: This patient is a 57-year-old male diagnosed with depression who reports there has been no significant improvement in his illness over a nine-year course of treatment. His provider notes he is refractory to standard treatments as evidenced by the failure of various antidepressants, psychostimulants, combinations of antidepressants and mood stabilizers and atypical antipsychotics.  It is also noted that he cannot tolerate high doses of his two current medications, Remeron and Effexor. One course of ECT was not helpful and efforts by the patient to help himself, e.g., cognitive approaches, mindfulness, etc. have also failed to elevate his mood.  Hence, the patient is asking for authorization of vagus nerve stimulation (VNS) therapy. The Health Plan considers the therapy experimental/investigational and has denied coverage.Treatment resistant depression is defined by the failure of four antidepressants to relieve depressive symptoms. On a national level many experienced and prudent clinicians found the FDAs July 2005 approval of VNS for the treatment of this type of depression to have been hasty and premature. Proprietary efforts and company-supported studies, while interesting and worthy of further inquiry, do not critically evaluate VNS as to its safety and validity as an adjuvant to standard treatments. Although VNS is an interesting, optimistic approach to the treatment of depression, longer term, better controlled, multi-centered, academic studies of much larger cohorts of varied depressive patients are needed to advance VNS therapy from an investigational/experimental status to that of a viable treatment enhancement.  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 2: The patient is a 57-year-old male with a nine-year history of recurrent depression. He has been treated with multiple medications and combinations of medications without relief. ECT, performed about three years ago, was apparently unsuccessful as well. The patients psychiatrist would like to add VNS therapy to the patients treatment regimen in an attempt to overcome his intractable depression. The Health Plan has deemed the therapy experimental/investigational and authorization and coverage were denied.Although VNS treatment has recently been approved by the Food and Drug Administration for the treatment of refractory depression, the psychiatric community remains cautious concerning the use of this therapy. To date, insufficient well-controlled double blind studies have been performed. Accordingly, there is inadequate data from which to conclude VNS therapy is likely to be more efficacious for this patient than standard pharmacological and psychotherapeutic therapies. 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.Physician 3: The patient is a 57-year-old male with recurrent refractory depression. He requests coverage for vagus nerve stimulation (VNS) therapy as a way to treat his non-responsive depression. The patients provider indicates that the patient has failed treatment with ECT and various antidepressants alone, and in combination with other medications. The Health Plan has denied coverage for VNS therapy on the basis that it is considered investigational for the treatment of patients such as this patient.The current scholarly literature shows that VNS is no more effective at treating depression than standard treatment. The reports continue to state that double-blind, reproducible studies have yet to be done and need to be performed. The submitted articles show no definitive evidence of shortterm efficacy was found with adjunctive VNS in treatment-resistant depression. Until a more critical analysis of this therapy is accomplished, VNS will remain an experimental and unproven treatment for depression.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.