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

Physician 1:  The patient is a 39-year-old man with long history of depressive disorder resistant to multiple antidepressant medications and some medication combinations. He has had multiple psychiatric hospitalizations for treatment of depression and associated suicidal ideation. ECT treatments have not been of consistent benefit, both bilateral and unilateral series with monthly maintenance.  A review of documents seems to indicate that mono-amine oxidase inhibitors (MAOI) are the only class of antidepressant medications that have not been utilized.  The patient has requested authorization for vagus nerve stimulation (VNS) therapy to treat his depression.  The Health Plan denied his request based upon a determination that the nature of the therapy is investigational.In view of the fact that MAOIs have not been used for this patient and there is no stated clinical rationale for their absence, a trial of such medications should be attempted prior to consideration of VNS therapy.  The patient has also derived some benefit from electro-convulsive therapy. If at some point ECT is no longer effective and the patient fails a trial of MAOIs or cannot take this type of medication for some clinical reason, then VNS therapy might be reconsidered.  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 39-year-old male with history of recurrent major depressive episodes who was ultimately diagnosed with Bipolar Disorder, Type II. He has had several bouts of severe depression and has reportedly failed courses of Prozac, Paxil, Cymbalta, Lexapro, Buspar, Abilify, lithium, Risperdal, and Wellbutrin. The patient was most recently treated with Lamictal, Effexor, and Abilify. He has also responded favorably to electro-convulsive therapy (ECT) but has been troubled by post-ECT headaches.  His depressions have been attendant with severe withdrawal, crying episodes, and suicidal ideation necessitating several hospitalizations.  A review of treatment notes indicates the patient had several courses of ECT, the first in September 2004.  The record indicates three inpatient courses of ECT treatments, but it is not clear what course of outpatient ECT was subsequently pursued.  However, the patient was viewed as having started to improve with his depression by the point of discharge from inpatient treatment.  In October 2005 the patients Effexor was replaced by Cymbalta, his Lamictal was maximized and he was treated with lithium very briefly. He then went on to another course of inpatient ECT with unilateral lead placement totaling two treatments.  Finally, he received another inpatient course of ECT in March 2006, with three unilateral lead placement treatments.  The patients clinician has requested authorization for VNS therapy to treat his depression. The Health Plan denied authorization citing the investigational nature of the therapy.The patient has clearly endured severe recurrent major depressive episodes as part of his Bipolar Disorder and warrants aggressive medicinal and biological treatment.  Given the morbidity of his illness, anything that can be done to maximize the benefit from ECT should be done.  Some relevant consideration are as follows.  (1) It has been determined that concurrent treatment with benzodiazepines can diminish the benefit of ECT, even with adequate seizure times.  (2) Induction with propofol, though not contraindicated, may lessen the efficacy of ECT more than induction with methohexital or etomidate.  (3) Some patients do not respond as well to unilateral lead placement as they do to bilateral lead placement.  (4) Seizure time alone does not determine the efficacy of ECT, therefore appropriate electrical dose titration is important in optimizing outcome.  And, (5) because the patient has had relatively few inpatient treatments there is a concern that he really has not received a sufficient course of ECT at any one interval.  Additionally, it does not appear there has been an adequate trial of lithium.  It is unusual to see significant side effects after only a one-day trial given the long half-life of the drug. A more complete trial of lithium, with or without Lamictal, may be beneficial.  All told, the severity of the patients illness is clear, but it is not clear that conventional treatments have not been maximized during the course of his care.  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.Physician 3:  The patient is a 39-year-old man with a diagnosis of bipolar disorder and history of recurrent depression.  He has received on-going treatment, but has not achieved a significant, long-term, period of remission. The record documents extensive therapeutic interventions including talk therapy, cognitive behavioral therapy, multiple and varied classes of antidepressant medications, acute inpatient hospitalization, and inpatient electro-convulsive therapy (ECT) and maintenance outpatient ECT.  The patient fears long-term cognitive deficiency with additional ECT and the benefit appears to be short-term. The record does not mention a trial of high-dose MAOIs.  He is currently treated with Abilify, Lamictal and Effexor.  The patient has submitted a request for VNS therapy to his Health Plan.  The Health Plan considers this an investigational therapy and has denied authorization.It is difficult to determine from a summary review of the patients treatment history whether or not he is truly refractory and resistant to all currently available treatments.  We do not know if there is potential for further benefit from a proper therapeutic alliance or how significant a role the axis II issues play in his poor long-term responses to treatment.  What is known is that VNS therapy was approved by the FDA in July 2005 over the unanimous objections of all psychiatric advisory committee members and that it was the first time that the FDA had approved a still unproven experimental treatment modality. VNS therapy will remain an experimental treatment until well-controlled, blinded, large sample size studies are required and the results of that research does in fact confirm the true efficacy of VNS therapy.  Within the psychiatric community, many prudent and experienced clinicians still view VNS therapy as investigational.  Because there is no substantiation of its efficacy, I have determined that VNS 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.