Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bipolar disorder
Treatment: Latuda 20mg (milligram) Tablet, pre-service
The insurer denied the Latuda 20mg  (milligram)Tablet, pre-service
The denial is overturned.

The patient is a male who was reported to have been diagnosed with bipolar disorder, current episode depressed, severe (F31.4). The patient's provider is requesting the use of like to Latuda (lurasidone) 20 milligrams (mg) tablet, one tablet by mouth daily, #30 for 30 days for treatment of the patient's symptoms. The requested medication (Latuda) was noted to have been previously denied due to lack of clinical documentation indicating trials of previous medications.

An appeal letter provided by the treating provider indicates that the patient has been treated for bipolar disorder for the past several years. He was reported to have a significant history of behavioral health treatment in the past including inpatient psychiatric hospitalizations and emergency room visits for suicidal ideations and behaviors. The patient was reported to have marketed irritability, aggression and agitation during the manic phase. He was also reported to have significant depressed mood, suicidal thoughts, anhedonia, fatigue and hopelessness during the depressive phase. 

The provider indicates that the patient has failed trials of multiple psychotropic medications including atypical antipsychotic medications aripiprazole, quetiapine and risperidone. He was also reported to have been previously treated with sodium valproate and lithium. The medications were noted to have been prescribed at optimal doses for adequate durations. He was reported to have had lack of efficacy or adverse effects from previous trials of medications. He was noted to have been currently treated with lithium and risperidone. However, the patient was reported to have persistent symptoms of depression and suicidal ideations. The patient's provider is recommending adding Latuda (lurasidone) to the patient's medication regimen.

Most recently, the patient was noted to have been seen for a clinical encounter. He was noted to have worsening depression and suicidal thoughts despite optimal doses of lithium and risperidone. The provider was noted to have recommended adding lurasidone to the patient's medication regimen with a goal to titrate to an optimal dose. Previous clinical documentation indicates that the patient continued to have significant mood symptoms. Clinical documentation shows that the patient was previously treated with Latuda (lurasidone) 40 milligrams. The dosage of Latuda was noted to have been increased to 60 milligrams. 

Clinical documentation indicates that the patient was treated with psychotropic medications including lithium, lurasidone and fluoxetine. Other clinical documentation indicates trials of medications including bupropion and quetiapine. A paid claims report indicates trials of several atypical antipsychotic medications including quetiapine, risperidone, aripiprazole, olanzapine and lurasidone in addition to mood stabilizers including lithium, sodium valproate and lamotrigine and antidepressant medications including bupropion and fluoxetine.

Yes, the proposed treatment (Latuda 20 milligrams tablet) is found to be medically necessary.
Based on current peer-reviewed, evidence-based medical literature, the proposed medication (Latuda 20 milligrams tablet) was found to be medically necessary.

There is significant evidence in current peer-reviewed, evidence-based medical literature to indicate the safety and clinical benefit of Latuda (lurasidone) for treatment of bipolar disorder in children above the age of ten years (1-13). A double-blind, placebo-controlled, randomized controlled trial reported by DelBello et al. indicated that monotherapy with lurasidone at dosages between 20 milligrams and 18 milligrams per day significantly decreased depressive symptoms in children and adolescents with bipolar depression. Lurasidone was found to be well tolerated with minimal effects on weight and metabolic parameters (11). A subsequent study by DelBello et al. concluded that for youth with bipolar depression, up to two years of treatment with lurasidone was generally well tolerated, safe and effective with low rates of discontinuation due to adverse effects and continued improvement in depressive symptoms (12).

As the patient had previously failed trials of multiple atypical antipsychotic medications, a trial of Latuda (lurasidone) would be considered appropriate and medically necessary in this patient with persistent depressive symptoms associated with bipolar disorder.

Yes - The health plan was noted to have active reasonably, with sound medical judgment and in the best interest of the patient.
The health plan was noted to have active reasonably, with sound medical judgment and in the best interest of the patient while initially denying the request for Latuda (lurasidone) due to lack of clinical documentation confirming the diagnosis of bipolar disorder (bipolar depression) and trials of previous medications. However, the provider was noted to have subsequently submitted clinical documentation indicating trials of several medications and confirming the diagnosis of bipolar depression.