Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Major Depressive Disorder.
Treatment:  Formulary Exception for Vilazodone.
The insurer denied Formulary Exception for Vilazodone.  
The denial is overturned.

This adult patient had depressive symptoms including depressed mood and isolation, stressors at work and with the family, and a diagnosis of Major Depressive Disorder-moderate. The patient also had reported diagnoses of Attention-deficit hyperactivity disorder (ADHD) and increased alcohol use. The patient's provider increased Vilazodone from 20 milligrams (mg) to 30 mg per day to try to better target depressive symptoms. The patient had not attended counseling recently due to finances. The patient had previously tried Sertraline, Bupropion, and Gabapentin. 
  
The insurer denied the request for Vilazodone 30 mg per day, stating that there were other medications on formulary that the patient did not try yet, including Escitalopram, Fluoxetine, Paroxetine, and Trintellix. They stated that the patient did not have reports of lack of efficacy, adverse effects, or evidence that these medications were contraindicated.
  
The American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorders reports that pharmacotherapy with antidepressant medications is considered first line treatment for depression. 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". 

The Food and Drug Administration (FDA) approved Vilazodone for the treatment of major depressive disorder. The patient met diagnostic criteria, as the patient had a reported diagnosis of Major Depressive Disorder-moderate-recurrent. Vilazodone has a unique pharmacological profile, as it is a serotonin reuptake inhibitor (SSRI) and a 5HT2 (5-hydroxy-tryptamine) serotonin antagonist and 5HT1a agonist, and the patient had some efficacy with this FDA approved medication. Due to the patient's symptoms worsening, the provider recommended that the least restrictive treatment was to increase the dose of Vilazodone from 30 mg to 40 mg per day. The patient also tried a past formulary medication, Sertraline, with lack of sustained efficacy and also tried another antidepressant FDA approved for major Depressive Disorder, Bupropion. The FDA approved recommended dosing is from 10 mg to 40 mg per day of Vilazodone. 30 mg Vilazodone is considered within the standard dosing for Vilazodone. It was not considered in the patient's best interest to stop an FDA approved medication, Vilazodone, for which the patient did not take the maximum dosage. It is more likely the patient's current medication at a higher dosage within FDA approved and recommended range, would be more effective for the patient than trying another formulary medication in the same class (SSRI) as the patient's previous failed trial of Sertraline.

The formulary drugs are not expected to cause adverse effects. 
The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.
The formulary drug is not expected to be ineffective.
The non formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of Formulary Exception for Vilazodone is overturned.