Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 55-year-old female with a diagnosis of major depression. She is now seeking vagus nerve stimulation (VNS) therapy for treatment and management of her depression. Her provider reports the patients condition has been refractory to psychopharmacological treatment and electroconvulsive therapy (ECT). The Health Plan has denied authorization for VNS therapy on the basis that it is an experimental treatment and therefore a non-covered benefit. The patient is appealing the Health Plans denial.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 is any better than sham treatment. VNS is not a part of the established principles of health care practice as of this date for the management of refractory depression. VNS remains an experimental, controversial and unproven therapy. It has not been accepted by the psychiatric community as routine treatment in the management of refractory depression. For these reasons, 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.Physician 2:  The patient is 55-year-old woman with a history of severe depression since 1992. She has been hospitalized 30 times, reports chronic suicidal ideation and a total inability to sustain a lasting remission despite varied medications in varying combinations. Her provider indicates her depressive symptoms have not abated with four series of electroconvulsive therapy (ECT). The records submitted for review do not mention a trial of any monoamine oxidase inhibitors (MAOI). The patient was disabled from 1995 to 2002 due to her depression. She sees a therapist two times per week and a psychiatrist once a month. There is no mention of any major axis II issues, possibly relevant to the patients failure to sustain treatment. The patient wishes to undergo vagus nerve stimulation (VNS) therapy. The Health Plan has denied authorization for the therapy on the basis that it is experimental.The FDA approved VNS therapy in July of 2005. However, this approval is now regarded by experienced clinicians as hasty, premature and very controversial. VNS remains unproven to those in the psychiatric community who expect more rigorous, well controlled studies to be forthcoming from well respected peer-reviewed journals where the researchers are in no way connected to the pacemaker manufacturer. To date, such studies have not been produced, therefore VNS treatment must still be viewed as experimental despite the FDAs approval.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 55-year-old female first diagnosed with depression in 1992. Her course has been a difficult one with many psychiatric admissions between the years 1993-1998. Despite ongoing treatment her mood worsened and she was on disability from her work from 1995-2000. The patient has been tried on many antidepressants and has undergone four courses of electroconvulsive therapy (ECT). A number of medication combinations and augmentation strategies were also tried but typically discontinued secondary to poor results and/or side effects.In 2000 the patient was able to return to work after a combination of antidepressants and antipsychotics gave her relief. However, she gained 100 pounds while on this regimen, and eventually tapered off the medication and underwent gastric bypass surgery. She lost the weight but after 18 months without medication her depression recurred. The patient has had one psychiatric admission since 2004. She is again on medication and has regained some of her weight. Her mood is somewhat improved but she typically feels depressed  or anxious. The patient reports she misses a day or two of work each month secondary to her mood disorder and work-related stress. The patient is currently maintained on Seroquel, Effexor XR, and Wellbutrin. She and her treating psychiatrist feel that VNS is her only alternative at this point. The patient has requested authorization and coverage for VNS therapy. The Health Plan denied her request based upon the experimental/investigational nature of the treatment.The vagus nerve stimulation (VNS) treatment system for treatment-resistant depression was finally approved by the FDA in July 2005. This followed a rather chaotic decision-making process marked by two reversals of the decision. The FDA requires two randomized, double-blinded, placebo-controlled trials that prove a proposed treatment to be statistically superior to placebo. Very briefly the first study had significant design problems and failed to demonstrate the superiority of VNS over the sham (placebo) treatment. This was true for the primary outcome measure and two of the three secondary measures. Only the self-report questionnaire showed statistical superiority in the VNS group. The Second study was a one year observational study (an open trial) that could be submitted to the FDA only after data from a parallel cyberonics (VNS manufacturer) study was co-opted as a control group. Their data was positive but there is debate about what the data actually means. All further studies have been open label or care reports. The psychiatric community at large has not yet embraced VNS as part of the national standard of care for severe depression. The American Psychiatric Association (APA) has gone on record in stating, While VNS has been studied over the past five years, evidence is not yet sufficient to recommend its use in routine clinical care. VNS is not, at this time, included in the APA treatment guidelines for major depression. That said, it is very likely a future iteration of the guidelines will include a recommendation regarding the use of VNS therapy for carefully selected patient and provide a stringent protocol-driven selection process. Clinical and preclinical research with VNS is ongoing and when sufficient data is accumulated the role of VNS therapy in the treatment of depression will become clearer. Until that time recommendations for its use for patients such as this one are premature. 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.