Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Depression. 
Treatment: Trintellix 10 MG OR Tabs. 

The insurer denied coverage for Trintellix 10 MG OR Tabs. 

The denial is overturned. 

This patient reportedly had continued depressive symptoms including irritable and sad mood, restlessness, and concentration problems.  He had a past psychiatric hospitalization due to suicidal and self-harm thoughts.  He reportedly had diagnoses of Major Depressive Disorder-Mild-recurrent, Bipolar Disorder-Depressed Type, Generalized Anxiety Disorder, and Post-traumatic Stress Disorder (PTSD).  He had medication trials of antidepressants including Bupropion, Citalopram, Sertraline, Venlafaxine, and Mirtazapine, mood stabilizers including Depakote, Olanzapine, Risperidone, and Quetiapine, and also took antianxiety medications including Buspirone and Clonazepam, and also took Tenex.  The treating mental health provider recommended Trintellix 10 mg per day to target depressive symptoms. 

This reviewer disagrees with the decision to deny coverage for Trintellix 10 mg per day as this patient tried 2 serotonin reuptake inhibitors, 1 serotonin norepinephrine reuptake inhibitor, a dopamine norepinephrine reuptake inhibitor, and Mirtazapine which had a unique mechanism of action in increasing serotonin and norepinephrine, and 5 mood stabilizers.   It did not appear in the best interests of the patient to deny coverage for Trintellix as it has a unique mechanism of action different than the serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitor, dopamine norepinephrine reuptake inhibitors, and Mirtazapine.  

The Food and Drug Administration (FDA) approval for Trintellix is for the treatment of Major Depressive Disorder and the maximum FDA approved dosage is 20 mg per day for adults.  This patient did have a reported diagnosis of Major Depressive Disorder-Mild recurrent in addition to other diagnoses so she was considered a candidate for this medication. Trintellix, which is also Vortioxetine, is a serotonin modulator as it is a serotonin reuptake inhibitor, norepinephrine transporter blocker, a 5HT1A and 5HTIB partial agonist, a 5HT1D, 5HT3A and 5HT7 receptor antagonist with a half-life of 66 hours.  According to FDA.gov it is FDA approved for adults with Major Depressive Disorder with a maximum FDA approved dosage of 20 mg per day.  The patient had reported failed trials of selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI), a dopamine norepinephrine reuptake inhibitor, and Mirtazepine so it was considered appropriate and within the guidelines of the criteria given for a trial of Trintellix 10 mg per day.  According to FDA.gov Trintellix is FDA approved for major depressive disorder and its efficacy was established in 6-8 week studies and one maintenance study.  Trintellix is available in 5 mg, 10 mg, or 20 mg immediate release tablets.  The American Psychiatric Association (APA) Practice Guidelines for the Treatment of Patients with Major Depressive Disorders reports that pharmacotherapy is considered standard treatment for major depressive episodes.  This patient continued with reports of depressive symptoms and had a past reported psychiatric hospitalization for suicidal and self-harm thoughts so he was considered at risk of suicide if his depressive symptoms did not subside so a trial of Trintellix which has a unique mechanism of action for the treatment of depression was considered appropriate and medically necessary treatment for this patient. 

The health care plan did not act reasonably or in the best interests of the patient. 

The insurer's denial of coverage for Trintellix 10 MG OR Tabs to Treat Depression is overturned.  Medical necessity is substantiated.