Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Major Depressive Disorder.
Treatment:  Fluoxetine 60mg (milligrams).

The insurer is denied coverage of a formulary exception for Fluoxetine 60mg.  The denial is overturned. 

This female patient had has a diagnosis of Major Depressive Disorder. She was taking Fluoxetine one 60 mg tablet per day to target depressive symptoms and for approximately 5 years with efficacy and lack of adverse effects. She has stable mood, denies suicidal ideation, has no neuro-vegetative symptoms, less guilt, and good functioning. She tried past antidepressant trials of Prozac and had adverse effects of diaphoresis and euphoria. She tried Lexapro and Zoloft without success. She tried Ativan, Lamictal, Mydayis, and is currently taking Vyvanse, Neurontin, Seroquel and Clonidine as needed in addition to Fluoxetine 60 mg per day. 

This patient had efficacy and lack of adverse effects from taking Fluoxetine 60 mg tablets. The American Psychiatric Association (APA) Practice Guidelines for the Treatment of Patients with Major Depressive Disorders reports that many studies and meta-analyses have compared selective serotonin reuptake inhibitors (SSRIs) among themselves as well as with other classes of antidepressants and that serotonin reuptake inhibitors are Food and Drug Administration (FDA) approved for the treatment of major depressive disorders and it is considered first line pharmacotherapy treatment. According the National Institute of Mental Health (NIMH) trial, the Sequential Treatment and Algorithm in Treatment of Depression (STAR*D), the first response to a SSRI is the best response at 47% and subsequent change in treatment has a lower response. It was in this patient's best interest to continue with the SSRI that she responded best to, even though there were no contraindications to her taking a formulary antidepressant medication of Citalopram. It is considered standard treatment consistent with current peer reviewed literature.  

Many randomized trials have found that various antidepressants have similar effectiveness overall, but drugs might not be equally effective for an individual patient.  For a subset of patients there are indications that specific psychotropic medications could have a greater likelihood of response and tolerability based on clinical characteristics such as psychiatric comorbidities, medical comorbidities that could be exacerbated by psychotropic medication side effects, or family member history of response to a particular psychotropic agent.  While these clinical characteristics might guide a clinician to select a particular type of first-line drug treatment, for many patients the best treatment match is not clear, and treatment decision-making is a process of trial and error. There was specific evidence that the other forms of Fluoxetine including Prozac, the brand name, resulted in adverse effects of diaphoresis and euphoria, and she tried the brand name version of Escitalopram, Lexapro, with lack of efficacy, and also took another SSRI, Zoloft, which is the brand name for Sertraline.  Fluoxetine 60 mg per day was considered to be more effective than other formulary medications remaining, as she had a good response with efficacy and lack of adverse effects with it.  Also Fluoxetine is on formulary, but it states that the 60 mg tablet is not. The FDA maximum approved dosage for the treatment of Major Depressive Disorder is 80 mg per day so taking 60 mg per day is considered within standard treatment for her.  The tablet form of Fluoxetine at 60 mg per day resulted in treatment efficacy for major depressive symptoms and for a long duration, so it is in her best interest to continue with Fluoxetine 60 mg tablets for major depressive disorder.  

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The medical necessity is not substantiated. The carrier's denial of coverage for Fluoxetine 60mg is overturned.