Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Schizoaffective Disorder
Treatment: Latuda, Pre-service
The insurer denied the Latuda, pre-service.
The denial is overturned.

The patient is an adult male diagnosed with schizoaffective disorder, bipolar type, depressed phase. Latuda at a dose of 40 mg (milligrams) has been prescribed with a reduction in symptoms of depression and fewer visits to an emergency department. The patient has longstanding and severe and persistent mental disorder, spending most of his sick time with severe symptoms of depression. There is a comorbid psychiatric condition in this case, PTSD (posttraumatic stress disorder), and no current substance use disorders other than tobacco dependence though the patient has had substance use disorder and is in remission-abstinent.

General medical co-morbidities are noted in the submitted documents and include mild and persistent asthma, hypertension, hyperlipidemia, insulin dependent and uncontrolled type II diabetes mellitus and history of a seizure disorder and stroke (cerebrovascular accident). Associated medications for the general medical conditions include albuterol inhaler, losartan, HCTZ (hydrochlorothiazide), atorvastatin, ALogliptin, and Semglee pen, as well as insulin and nicotine replacement lozenges. The psychotropic medication regiment includes prazosin 1 mg daily, bupropion 150 mg twice daily and Latuda 40 mg daily.

The health plan has denied coverage of Latuda, indicating that this medication is non-formulary and that step therapy and prior authorization criteria require failed treatments with formulary medication within the same class. The patient has failed two formulary alternatives including risperidone and quetiapine; other formulary medications include aripiprazole and ziprasidone, suggested by the health plan. The denial determination indicates that alternative medications are available, as noted, and indicated that the request for coverage of Latuda is denied accordingly.

The prescribing physician argues that Latuda is a better choice, because the patient has uncontrolled diabetes and other general medical conditions that pose a risk if the formulary medications result in weight gain or elevation of lipids or contribute to the diabetes, and Latuda is less likely to produce an adverse effect with respect to the risk for weight gain indicating that the patient has only gained one pound while on Latuda with a positive clinical response, as noted in the clinical summary and submitted information.

Yes, the requested Latuda is medically necessary for this patient.

The requested benefit of Latuda (lurasidone) is clinically indicated and appropriate in keeping with prevailing standards of medical practice. Moreover, there is no indication in the submitted documentation that the request for Latuda is considered to be non-medically necessary under the plan. In fact, Latuda is one of only five FDA (United States Food and Drug Administration) approved medications for bipolar depression including mixed features that include olanzapine/fluoxetine, quetiapine, cariprazine and ziprasidone, as well as Latuda (lurasidone), and Latuda is clearly indicated for bipolar mood disorder with depressed phase in the context of a primary diagnosis of schizoaffective disorder. The prescribing physician reasonably argues that the plan alternatives of aripiprazole and ziprasidone are at greater risk for adverse effect with weight gain in a patient with uncontrolled diabetes and metabolic syndrome including history of stroke. Moreover, the suggested alternative of aripiprazole is not known with medical certainty to benefit the depressed phase of a bipolar depression.

The continued benefit of Latuda is reasonable and in the patient's best interest, and reflects sound medical judgment in this case scenario. Thus, medical necessity is met in keeping with the FDA indicated use of Latuda and prevailing standards of medical practice, and the request for Latuda is consistent with the scientific literature and published guidelines indicating Latuda's relative superiority in this case scenario in comparison the plan alternatives.

The recommended length of approval is for 12 months or more including titration as clinically appropriate from the current dose of Latuda at 40 mg daily. The 12-month recommendation is warranted, as the patient will require maintenance therapy beyond the acute phase of treatment.

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

Latuda is clearly indicated for bipolar depression, as in this case, with a satisfactory response with tolerability. Indeed, the fact that the patient has shown a clinical response to Latuda and the fact that the patient has failed to benefit from treatment with two alternatives in the same class further supports the medical necessity for Latuda medication use in the treatment of this patient. Moreover, to discontinue a medication that has resulted in a clinical response is more likely than not to be detrimental to this patient, as other formulary alternatives have only a 50 percent probability of producing a clinical response or remission with tolerability. Thus, the requested benefit of Latuda is reasonable and in the patient's best interest, and reflects sound medical judgment in this case scenario. Medical necessity is met in keeping with the FDA indicated use of Latuda and prevailing standards of medical practice, and the request for Latuda is consistent with the New York State instructions for this case review.