Diagnosis: Anxiety, Depression.
Treatment: Trintellix 5 mg.

The insurer denied Trintellix 5 mg.

The denial was upheld.

This is a male patient who has a history of anxiety, depression and cerebrovascular accident (CVA). He presented to his provider for evaluation of anxiety and depressive symptoms related to stressors. The patient reported depressed and irritable mood, anxiety including excessive worrying and nervousness. The patient's symptoms were not adequately controlled with maximal doses of Lexapro at 20 mg per day. The patient has tried Duloxetine in the past but could not continue treatment due to side-effects. The patient was currently taking Wellbutrin samples and was doing well. It was reported that due to his history of cerebrovascular accident (CVA), it was not advisable to take selective serotonin reuptake inhibitors (SSRI) such as paroxetine or citalopram. It was reported that the patient was given samples of Trintellix 5 mg per day and was doing well with that medication.

Based on the review of the medical record, this patient did not have a diagnosis of Major Depressive Disorder but rather Adjustment Disorder with Mixed Anxiety and Depressed Mood and not Major Depressive Disorder. While Trintellix is FDA-approved for major depressive disorder, it is not FDA-approved for Adjustment Disorder. According to literature review, Trintellix, which is also known as Vortioxetine, is a serotonin modulator as it is a serotonin reuptake inhibitor, norepinephrine transporter blocker, and a 5HT1A and 5HTIB partial agonist, and 5HT1D, 5HT3A and 5HT7 receptor antagonist with a half-life of 66 hours. It is FDA-approved for adults with Major Depressive Disorder with a maximum FDA-approved dosage of 20 mg per day. As per the medical record submitted for review, the patient had reported failed trials of SSRI's including Lexapro at 20 mg per day and also had side effects to Duloxetine. It also was reported that the patient could not take Paroxetine or Citalopram due to his CVA. Based on the patient's diagnosis of Adjustment Disorder with Mixed Anxiety and Depressed Mood, this requested medication, Trintellix is not supported by FDA and literature to be medically necessary for this patient. The literature supports that the standard of treatment for Adjustment Disorder is psychotherapy since this patient's anxiety and depressive symptoms are thought to be in response to a stressor. Psychiatrists sometimes prescribe antidepressant and anti-anxiety medication to target depressive and anxiety symptoms but this patient has not tried and failed other anti-anxiety and antidepressant medications that are generic medications prior to requesting a non-formulary medication, such as Trintellix. Thus, Trintellix is not considered medically necessary for this patient.

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for Trintellix 5 mg OR Tablets is not substantiated. The insurer's denial should be upheld.