Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Schizoaffective Disorder.
Treatment: Lumateperone (caplyta), Pre-service.
The insurer denied the Lumateperone (caplyta), Pre-service.
The denial is upheld. 

The patient is a female. She is diagnosed with schizoaffective disorder. The patient has been prescribed Caplyta (lumateperone) at 42 mg (milligrams) daily with plan to titrate. In this case, approval is being requested for a 42 mg (milligrams) capsule per day to address symptoms related to the patient's severe mood and psychotic disorder. The patient has a history of severe psychosis with command auditory hallucinations and homicidal behavior leading to hospitalization. She has been incarcerated in the past, reportedly due to her homicidal behavior. She receives ACT (assertive community treatment) level care in the community with intensive case management and psychosocial interventions and medication management. There is no report of psychiatric co-morbidity, or current or past substance use disorder in this case.

The patient's pharmacy records indicate use of various psychotropic medications, including long-acting injectable antipsychotics (haloperidol and paliperidone), fluphenazine, bupropion and buspirone. She has general medical comorbidity with obesity and a BMI (body mass index) of 46.82, as well as treatment for metabolic syndrome with Lipitor and metformin. She also receives Flovent, Spiriva, albuterol inhaler, and omeprazole for other general medical conditions. She is tobacco dependent and has been treated with medications to achieve smoking cessation.

The patient's clinician is requesting coverage for Caplyta due to concern for the risk of weight gain with formulary medications that include aripiprazole, ziprasidone, risperidone, quetiapine, and olanzapine. The patient is prescribed Caplyta with reference to a favorable adverse effect profile with regard to risks of weight gain as had been experienced with the previous trials with the referenced antipsychotic medications.

The health plan has denied coverage of Caplyta indicating that the patient should be managed with one of the other available formulary alternatives in keeping with the plan coverage exception policy. Again, the health plan formulary includes alternative and same-class medications: quetiapine, aripiprazole, olanzapine, risperidone, or ziprasidone.

No, the treatment with Lumateperone (caplyta) is not medically necessary.

The patient's continued treatment could appropriately proceed with one of the formulary alternatives with titration as clinically appropriate, and with a formulary alternative in the class of atypical antipsychotics. In this case scenario, the patient could be treated with one of the FDA (United States Food and Drug Administration)-approved medications that is covered under the plan, which includes quetiapine, aripiprazole, olanzapine, risperidone, or ziprasidone.  The concern for weight gain in a patient who is obese is an appropriate concern; however, the risk to benefit analysis of the formulary drugs favors the use of formulary alternatives, and there is no evidence that these available alternatives will adversely contribute to the patient's obesity and body mass index.

This answer is consistent with the scientific literature and published guidelines, referenced below, as well as prevailing standards of care applicable to this case.

The health plan has appropriately denied coverage of Caplyta indicating that the patient should be managed with one of the available formulary alternatives. In this case the patient has tried and failed to benefit from haloperidol, paliperidone, and fluphenazine, but formulary alternatives that are covered include quetiapine, aripiprazole, olanzapine, risperidone, or ziprasidone, as noted in the clinical summary.

This answer is consistent with the scientific literature and published guidelines, referenced below, as well as prevailing standards of care and the NY (New York) State instruction, applicable to this case.