Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 50-year-old female with a history of Major Depression, recurrent, referred for placement of a vagus nerve stimulator (VNS) after she was felt to be treatment refractory to Effexor, Wellbutrin, Provigil, Zyprexa, and Seroquel. Review of her psychiatrists treatment notes indicate his first being consulted by the patient in 1999 at which time she was diagnosed as suffering from Major Depression, attendant with neurovegetative disturbances consistent with the diagnosis. At this point, she had begun a starter pack of Effexor. Her first follow-up appointment thereafter was a month later, at which time she was noted as getting some more energy. Not been crying as much anymore and feels more confident. Her Effexor XR was then changed to 75 mg twice a day. Over the ensuing years, she was either maintained at just this dose or actually had it lowered at one point, with the addition of Zyprexa and later Seroquel.  Effexor was then deemed ineffective and Wellbutrin was added at a dosage of 150 mg XL in August 2005. By January 2006, she was switched back to just Effexor XR 150 mg once daily again. As of this point, her psychiatrist felt that she was seriously depressed and that there were no other options for the patient other than VNS. This was felt preferable to continuing to add medications that do not work.  The clinical evidence does not demonstrate the patient has been non-responsive to available standard therapy. Effexor XR 150 mg is not the most therapeutically robust dosage for this, or any, patient who suffers from recurrent Major Depression. Moreover, the fact that the patient was treated with no higher dosage of Effexor for seven years either demonstrates her relative well-being or that other treatments were not provided. There are numerous other medications available to this patient that very well could be effective for her condition. There is no evidence the patient has exhausted available standard therapy. 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.Physician 2:  The patient is a 50-year-old female with a diagnosis of a major depressive disorder with psychotic features. The progress notes from the treating psychiatrist do not address psychotic features. The psychiatrist does provide a history of trials of stimulants, Zyprexa, Effexor, Wellbutrin, Sonata, Rozerem, Lamictal and Seroquel. The psychiatrist states in his progress note of June 2006, Pt has had poor response to different drugs .for a total of 16 months, plus psychotherapy.  She is a candidate for VNS therapy.   The clinical notes furnished by the physician do not clarify when the patient received psychotherapy, if she participated in cognitive therapy or if she had group therapy. There is no mention if she has had collateral therapy with significant others. It is not clear under Axis IV with work and family how these supports have been utilized.The progress note from January 2006 does not mention if the patient is suicidal or has vegetative signs of depression. The note does state that she has had no improvement and is functioning about the same. Her GAF is 64 and she is apparently working. The psychiatrist has recommended vagus nerve stimulation (VNS).The complete packet of information was read. All of the review articles were read. The patient has had trials of stimulants, mood stabilizers, antidepressants and antipsychotic medications. The patient continues to have symptoms of depression. It is not clear if or when she has been in intensive therapy with the utilization of cognitive therapy or psychodynamic psychotherapy. The recommendation for the use of VNS was made due to the refractive nature of the depression.The FDA, on their official website, lists the traditional and accepted modalities of therapy utilized for the treatment of a Major Depression. This list includes different types of psychotherapy and group therapy as well as combinations of medications that are now utilized. The possibility of ECT is also listed. The designation of refractive is more extensive than the use and partial response to several different medications. The medical documentation furnished by this physician does not meet the FDA description of the depression being refractive.The patient has not had a trial of ECT, she has not had intensive psychotherapy and she has not had a differential diagnosis (listed) to explore the impact of other conditions that impact her poor response to treatment.  Other areas to explore include information about her family, stresses at work, health issues and other environmental issues.  None of these were described.  The VNS clinical trials demonstrate that VNS is only effective as an adjunct to other treatment modalities. Current modalities of treatment, including ECT, have a greater chance of improvement in a patient with a refractive depression if the diagnosis is accurately made. There is no evidence that this patient has utilized all of the current modalities of treatment available to her. Combinations of different medications, psychotherapy and possibly ECT all have a greater likelihood of offering the patient improvement in her condition than VNS. Although VNS, post-marketing phase, has been approved by the FDA, the available evidence does not conclude VNS is effective for treatment of the patients condition.Based upon the information set forth above, I have determined the requested therapy is not likely to be more beneficial for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Physician 3:  The patient is a 50-year-old female with a history of severe depressive disorder allegedly resistant to multiple treatment modalities. She has been treated with antidepressants including Effexor and Wellbutrin; however, records do not demonstrate she has exhausted available standard treatment options. There is no evidence she has failed a trial of four or more antidepressants. Her provider is recommending vagus nerve stimulation (VNS). There is no evidence the patient has had adequate documented trials of four or more antidepressants or failure of ECT or other trials of standard therapy. Therefore, there is no evidence that VNS is indicated for this patient. Furthermore, there is no evidence that VNS would be more beneficial than the standard therapy she has not attempted. Accordingly, 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.