Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 23-year-old female with previously diagnosed bipolar disorder, onset seven years prior and having typically suffered from one episode of depression per year. She was referred for evaluation of implantation of vagus nerve stimulation. She has also had occasional episodes of hypomania with feelings of elation and lots of energy.  In the past, the patient was treated with a variety of medications, including Celexa, Lexapro, Zoloft, Wellbutrin, and later, Topamax, Neurontin, and then Lamictal.  By November of 2004, she was on Neurontin 600 mg twice daily, Wellbutrin XL 300 mg once a day, Lamictal starter pack and Zyprexa 2.5 mg. The final dosage of Lamictal reached is unknown. She was then begun on Lithium and found this effective but experienced nausea as well as slowed thinking and it was eventually discontinued.  Finally, Depakote and Cymbalta were tried but also felt to be ineffective. In December 2005 it was noted the patients most recent depressive episode was about three months prior and though the patient had partial recovery, she remained in a mild to moderately depressed phase. She has continued in school but has a difficult time focusing on her studies and is somewhat withdrawn. She was being currently treated with Wellbutrin XL 75.5 mg and Prozac 20 mg. Her provider noted she was not overtly anxious or hypomanic but remained depressed. A mental status exam revealed her to be very neatly dressed and groomed, making excellent eye and emotional contact, and to be of dysphoric mood and blunted affect.  There was no evidence of a thought disorder and she denied suicidal ideation.  The patients provider has recommended vagus nerve stimulation therapy. The Health Plan has denied this request on the basis that the therapy is considered investigational.Review of the submitted clinical documentation does not demonstrate the patient has exhausted all standard therapies for the treatment of depression. For example, there is no indication of a trial of electroconvulsive therapy. Given her relatively young age, it appears premature to declare the patient treatment refractory. Furthermore, the literature is not compelling as to the efficacy of vagus nerve stimulation therapy. All told, I have determined 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 23-year-old female apparently diagnosed with bipolar disorder for seven years. She has a strong family history of depression. She has tried multiple trials and seemingly adequate attempts using various psychotropic medications with little or no evidence of benefit. According to her physicians evaluation, her history is consistent with bipolar disorder II. It has been recommended the patient receive vagus nerve stimulation (VNS) therapy. The Health Plan has denied authorization for the therapy citing a lack of proven efficacy.Upon review of the submitted clinical evidence it is not entirely clear that the patient is treatment resistant since there is no documented use of MAOI medications or a trial of ECT. 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 3:  The patient is a 23-year-old female diagnosed with bipolar disorder at the age of 15.  She is currently treated with Wellbutrin 75mg per day and Prozac 20mg per day. Her provider indicates she was previously tried on Lexapro, Neurontin, Wellbutrin, Zoloft, Celexa, Zyprexa, Depakote, Cymbalta, Topamax, Lamictal, and lithium. The patients provider has recommended the patient proceed with vagus nerve stimulation (VNS) therapy. At issue is whether VNS therapy is likely to be more beneficial for the patient than any available standard therapies.The efficacy of vagus nerve stimulation for the treatment of refractory depression remains unproven at this time. It has not been established to be beneficial as a treatment for bipolar disorder. There is no indication for VNS or that VNS would be of greater benefit than any available standard therapy. 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.