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

Physician 1:  The patient is a 32-year-old female with a diagnosis of treatment resistant depression. She has had multiple hospitalizations for the treatment of depression and pseudotumor cerebri. The patient may also suffer from borderline personality disorder and episodes of self-destructive behavior and frequent suicidal ideation are noted. Several medications are mentioned, but only Cymbalta and Geodon are included in the current treatment regimen.  It is not clear from the record why Geodon was prescribed.   The patient has requested authorization and coverage for vagus nerve stimulation (VNS) therapy. The Health Plan has denied this request on the basis that there is insufficient evidence of its efficacy at this time.A review of the submitted clinical information does not indicate whether there has been a sufficient trial of medications, including MAOIs. The issue of pseudotumor also complicates the clinical picture.  If this condition is not resolved, it may represent an added risk when treatment with a new therapy such as VNS is considered. If on the other hand, the pseudotumor is resolved, a trial of electroconvulsive therapy (ECT) may be more appropriate at that time with the approval of the treating neurologist. However, neither ECT nor VNS therapy will alter the axis II personality disorder. Long-term consistent psychotherapy with periodic use of medications is the current standard of care for this type of patient and should be continued.  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.Physicain 2:  The patient is a 32-year-old female with a reported history of recurrent major depression and borderline traits. She has had frequent, short-term hospitalizations due to self-destructive urges such as overdosing or cutting on herself. She has been in treatment with her most recent psychiatrist since March 2005 and is treated with Cymbalta, Geodon, and Klonopin in varying dosages and has an unclear array of neurovegetative symptoms.  The patient has often expressed suicidal ideation, which has prompted inpatient admissions. She has been resistant to the idea of a medication change and until recently, ECT was thought to be proscribed due to her diagnosis of pseudotumor cerebri.  Symptoms of sleep continuity disturbance are noted but there is no consistent documentation of the neurovegetative symptoms experienced by the patient. The treatment records consistently note characteristics in line with a borderline personality disorder.  The patient was described as having a rather fractious relationship with her family, turbulence in romantic attachments, and no sustained employment.  A review of the progress notes reveals some struggles in the relationship between the patient and her psychiatrist.  The note of April 2005 indicates the patient has no interest in medication changes suggested by examiner. The possibility the patients birth control pills might be causing or at least exacerbating her pseudotumor cerebri was reviewed, but she was resistant to the idea of discontinuing them. In July 2005 the provider noted that the patient had some thoughts of cutting on herself and depressed feeling for the first time in about five months and attributes this to her Geodon cutback.  In August 2005 the patient stated she was having suicidal ideation and would like hospitalization.  The patient was offered the options of borderline coach and of seeking VNS.  She feels both are excessive measures and does not want them at this time.  A family therapy note of October 2005 notes general agreement that medication alone does not seem to be the answer.  In October 2005, the patient reported a weekend hospitalization.The patients provider has requested authorization for VNS therapy to treat her depression. The Health Plan denied the request citing the investigational nature of the therapy.Although it is not clear whether the patient has a unipolar or a bipolar spectrum of affective illness, there are strong indications of a borderline personality disorder. Past and present therapeutic relationships appear challenged. The patients suicidal gestures and ideation appear more self-destructive than a true reflection of an intent to end her life. She is resistant to any change in her medication regimen suggested by her provider.  The family therapy note is telling in that there is a consensus that medication alone does not seem to be the answer. Similar logic would apply to a biological therapy such as VNS. Ironically, the patient herself seems ambivalent about this treatment approach.  I would surmise that her depression is more a factor of her borderline personality disorder than a pure depressive illness.  Even within this context, there are untried medicinal approaches such as a course of MAOIs with or without lithium supplementation.  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.Physicain 3:  The patient is a 32-year-old female with a history of refractory depression that has not responded to medical management.  She has a history of pseudotumor cerebri and as such, electro-convulsive therapy is contraindicated.  The patient is currently treated with the antidepressant Cymbalta and several adjunctive medications including Ativan, Seroquel, and Geodon. Her psychiatrist indicates there has been no improvement with various trials of antidepressant medications and recommends VNS therapy.  The Health Plan denied the request for authorization based on a determination that VNS therapy is experimental/investigational for the treatment of the patients depression.Vagus nerve stimulation has been approved by the FDA for more than one year for the treatment of medication-resistant depression. The criteria for application of this therapy is simply the failure of four different antidepressant medications or antidepressant combinations. With a nine-year history of depression along with serious symptoms including suicidal ideation and at least one attempt, it is reasonable to assume that all of the standard medications have been tried. Her psychiatrist reports the patient is constantly depressed despite various drug and non-drug therapies.  In light of her diagnosis of pseudotumor cerebri, which precludes the treatment option of electro-convulsive therapy, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.