Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Major Depressive Disorder.
Treatment:  Formulary exception for Vilazodone.

The insurer denied the Formulary exception for Vilazodone.  The denial is overturned.

The case involves a young adult male diagnosed with severe major depressive disorder. The patient's physician has prescribed Viibryd (vilazodone) carefully selected in concert with the patient's neurologist. The patient has a "very serious form or epilepsy" that warrants the collaboration with neurology in selecting psychotropic or CNS (central nervous system) medications. The patient has shown a satisfactory clinical response to Viibryd with tolerability and a positive therapeutic effect. The patient has failed previous trials with escitalopram, fluoxetine, and sertraline. There are no reported symptoms of mania, formal thought disorder, psychosis, or severe cognitive impairment in this case. The patient has no other significant general medical conditions and no diagnosed substance use disorder or psychiatric comorbidity. 

The prescribing physician is requesting coverage for continued use of Viibryd in view of a satisfactory clinical response and tolerability, especially in view of the need for a medication that is not contraindicated with respect to the patient's comorbid diagnosis of epilepsy. Moreover, the prescribing clinician, a psychiatrist, argues that it is medically necessary that this patient continue Viibryd that has resulted in stability of the severe mood disorder. 

The health plan has denied coverage for the requested Viibryd indicating that plan policy/guidelines for a coverage exception requires a trial and treatment failure with at least three formulary alternatives, indicating that formulary alternatives include fluoxetine, sertraline, paroxetine, escitalopram, citalopram, and Trintellix. The health plan indicates that three formulary alternatives are required before a coverage exception for Viibryd would be considered. 

The treatment with Viibryd under review has been denied coverage by the health plan on the basis of coverage exclusion and plan-approved criteria, as alternative antidepressant medications are available under the plan guidelines and medical necessity criteria and prior authorization criteria that requires step therapy; again, the plan requires treatment failure with at least three alternative formulary medications prior to authorizing a coverage exception for Viibryd (step therapy).

The health plan should cover the proposed treatment, continued use of Vilazodone (Viibryd) to treat major depressive disorder. 

In this case, the remaining formulary drug options would be or has been ineffective for this patient in the case of three formulary alternatives, as noted in the clinical summary. The remaining formulary alternatives would not be as likely to be effective as the requested non-formulary drug, which is well tolerated and provides a positive therapeutic effect. Switching to another formulary alternative would pose risk for adverse effects for this patient, especially in view of any negative impact due to comorbid epilepsy. Moreover, switching form a medication that is effective and well tolerated would be detrimental to the patient and pose risk for a patient with contraindications for any medication that would alter seizure threshold. Indeed, switching to another antidepressant would have a 50 to 70 percent probability of a response and would most certainly pose a risk for side effects or adverse effects, as opposed to the continued treatment with Viibryd that is known to be effective and well-tolerated. Thus, the health plan's denial of coverage of Viibryd is not reasonable or in the best interest of this patient, and the continued use of Viibryd is medically appropriate in this case scenario and the health plan should cover the proposed treatment with vilazodone (Viibryd).