Appeal type: Medical necessity
Decision: Overturned

Mental Health
Pharmacy/Prescription Drug

Diagnosis: Bipolar I Disorder
Treatment: Vraylar 1.5 mg capsule
The insurer denied Vraylar 1.5 mg capsule.
The determination is overturned.

The patient is diagnosed with bipolar I disorder with a history of severe and recurrent episodes of depression. She is also diagnosed with a comorbid condition, posttraumatic stress disorder (PTSD). The patient has been prescribed Vraylar (cariprazine) 1.5 milligrams (mg) daily to address the symptoms of depression and to achieve improvement with mood and mood stabilization. The patient has tried and failed treatment with olanzapine, quetiapine and risperidone due to a lack of clinical response and/or tolerability issues. The health plan has denied coverage of Vraylar indicating that the patient should be managed with one of the other formulary alternatives.
The patient's prescribing clinician indicates that formulary alternatives are not as likely to provide a therapeutic response, as Vraylar is considered the best choice of medication in this case scenario. Moreover, the patient has tried and failed several antidepressant medications including Prozac, Zoloft, Lexapro, Wellbutrin and Effexor extended release (XR) and augmentation with buspirone. She has been treated for sleep disturbance associated with the comorbid psychiatric disorders including trazodone, clonidine and prazosin. The patient has received psychotherapy with a skilled and certified therapist without sustained benefit.
Health plan documents and correspondence, appeal documents, and case summary and recent progress notes were reviewed, as well as the correspondence from the patient's prescribing clinician. 
The issue under review is the medical necessity of Vraylar (cariprazine) 1.5 mg capsule.
Vraylar 1.5mg capsule is medically necessary for this patient. In this case scenario, the Vraylar is clinically indicated and appropriate in keeping with prevailing standards of medical practice. The patient has reportedly failed several trials of alternative medications without benefit or with adverse effects resulting in discontinuation of treatment. Vraylar has a unique mechanism of action and is the best choice in this case scenario in providing reasonable clinical benefit. Other formulary alternatives are not as likely to be of benefit to this patient, as the mechanisms of action are similar to those already tried and failed (olanzapine, quetiapine and risperidone). The formulary medication, Aripiprazole, is primarily indicated for bipolar mixed or manic phase or in combination with a mood stabilizer for maintenance therapy of bipolar disorder, or for use as an adjunct to an antidepressant medication in unipolar depression. Aripiprazole is not primarily indicated for the treatment of bipolar depression and would not be as likely to address the patient's bipolar depression as would Vraylar (cariprazine). The use of Vraylar for the treatment of bipolar disorder is consistent with product labeling and prevailing standards of medical practice and it is preferred according to the guidelines, published below based upon consensus among experts in the field-Yatham, et al. The patient has reportedly failed several trials of alternative medications without benefit or with adverse effects resulting in discontinuation of treatment. Vraylar has a unique mechanism of action and is the best choice in this case scenario in providing reasonable clinical benefit. Vraylar is likely to be superior to aripiprazole (Abilify) in this case scenario.