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

Physician 1:  The patient is a 34-year-old female with an extensive history of depression complicated by multiple sclerosis (MS). Based on the information provided, the patient first sought treatment of her depression in the mid-1990s. She initially responded to Paxil, but over time began to slip back into her depression, requiring higher doses, though eventually not even responding to 60mg per day.  The patient has since been in continuous psychiatric care, but with results less than optimal. At her most recent evaluation, she endorsed profoundly depressed mood, severe anhedonia, loss of libido, sleep disturbance, extreme fatigue, difficulty completing routine tasks, difficulty in concentrating and making decisions, excessive crying, worrying and guilty ruminations, and feelings of helplessness and hopelessness. During the last four years, she had received combinations of Lexapro, Wellbutrin SR, Topamax, Celexa, Lamictal, and Paxil. Her most recent medication regimen included Paxil, Lamictal, Abilify, and Xanax.  She also receives Copaxone for her MS.  Review of the treatment notes indicates that in December 2005, when she was receiving Lamictal, Remeron, Wellbutrin SR, and Paxil, she was felt to be better than (she) has in a long time.  Treatment notes since that time point to her not having fared nearly as well, though apparently she was taken off of the Remeron at some point, for reasons not documented. Based on the information provided, it does not appear the patient has been treated with just an MAOI of substantial dosage, Lithium, or both.  The patients provider states he is reluctant to prescribe electroconvulsive therapy (ECT) in light of the patients MS.The patient is seeking authorization for vagus nerve stimulation (VNS) therapy. The Health Plan has denied this request indicating there is insufficient evidence of the efficacy of VNS therapy for treatment of the patients condition.Review of the submitted clinical information indicates the patient suffers from rather recalcitrant Major Depressive episodes. However, she also suffers from at least one of the atypical depressive features, namely hypersomnolence, such that a trial of an MAOI would be appropriate. An EMSAM patch has been tried, but at a very low dosage, which cannot be equated to a full-fledged trial of a standard MAOI, such as Parnate or Nardil. The latter would necessitate a complete washout from the patients current medications, except for the Lamictal. In addition, Lithium, either alone or as a supplement, was never tried. Furthermore, MS does not preclude prescribing ECT. All told, the patient has not exhausted conventional approaches to treatment and the scientific evidence does not establish that VNS therapy surpasses these approaches. Therefore, 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 a 34-year-old female who has multiple sclerosis and has been diagnosed as having major depressive disorder, for which she has been in treatment for over 10 years. She has been tried on Zoloft, Effexor, Celexa, Serzone, Remeron, Provigil, Xanax, Ambien, Lexapro, Wellbutrin, Topamax, Paxil and Lamictal. The patient and her providers are hesitant to try ECT due to her diagnosis of multiple sclerosis. It has been recommended that the patient undergo VNS therapy for treatment of her depression. The Health Plan has determined VNS therapy is investigational and therefore, not a covered benefit. Upon review of the relevant scientific literature, there are no case reports of prior studies of VNS therapy in patients with depression and multiple sclerosis. In fact, in previous studies concurrent chronic neurological condition was an exclusion criterion. Moreover, the literature shows that VNS remains an investigational modality and double-blind studies demonstrating clear benefit over standard therapies have yet to be performed. Thus, VNS therapy is not widely accepted within the medical community and cannot be recommended in this case.For the reasons stated above, 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 3:  The patient is a 34-year-old female with diagnoses of treatment resistant depression and multiple sclerosis. She and her physician are requesting VNS therapy, which has been denied by the Health Plan as an investigational therapy.  At issue is whether VNS therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.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 therapy 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. It has not been accepted by the psychiatric community as routine treatment in the management of refractory 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. Therefore, the Health Plans denial should be upheld.