Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Schizophrenia
Treatment: Clozapine 150 milligrams (mg) oral (OR) tablet dispersible (TBDP)
The insurer denied coverage for clozapine 150 mg OR TBDP
The denial is overturned

This patient had multiple psychiatric hospitalizations including lengthy state psychiatric hospitalizations and started Clozapine 150 mg OR TBDP which is rapid disintegrating tablets while in the psychiatric state hospital stay. It was reported that he was on assisted outpatient treatment (AOT) also due to his noncompliance. The request was to continue Clozapine due to his past noncompliance in order to improve compliance.
  
The insurer denied coverage for Clozapine stating that there was not sufficient documentation that he could not take formulary immediate release Clozapine and stated that Clozapine 150 mg OR TBDP was not on the formulary list.
  
The medical records provided documented that he had a diagnosis of schizophrenia and had multiple past psychiatric hospitalizations and tried and failed at least 2 or more antipsychotic medications. The American Psychiatric Association (APA) Practice Guidelines for the Treatment of Patients with Schizophrenia reports that antipsychotic medication is indicated for psychosis and that determining the optimal dose of antipsychotic medication in the acute phase is complicated by the fact that there is usually a delay between initiation of treatment and full therapeutic response.  

According to the Food and Drug Administration (FDA), Clozapine is FDA approved for the treatment of treatment resistant schizophrenia which is described as failing two or more trials of other antipsychotic medications for the treatment of psychosis in schizophrenia. Clozapine is also indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for reexperiencing suicidal behavior, based on history and recent clinical state. Clozapine is a dibenzazepine compound with a distinct pharmacologic profile. It shows affinity in vitro not only for dopamine (D) type 1 and 2 receptors and has a high affinity for D4 receptors but also for histamine type 1, alpha-adrenergic type 1 and 2, serotonin type 2, and muscarinic receptors. Clozapine is the only drug with established efficacy in reducing symptoms and the risk of relapse for adults with treatment resistant schizophrenia. It is licensed only for use in persons whose schizophrenia has not responded to, or who are intolerant of, conventional antipsychotic drugs. 

The medical records provided did document at least 2 specific antipsychotic medications that were tried and failed with adequate dosages and durations and did document a diagnosis of Schizophrenia. The rapid disintegrating tablets requested Clozapine 150 mg was considered an immediate release form of Clozapine and it was considered medically necessary treatment of treatment resistant schizophrenia due to his history of noncompliance. The immediate release tablets were not considered to be the best available treatment due to his history of noncompliance which resulted in multiple psychiatric hospitalizations including a long stay in the state psychiatric hospital. It was reported that it was medically necessary for him to have the dissolving tablets and the request of continuing Clozapine rapid disintegrating tablets was considered appropriate, standard, medically necessary treatment, and the best available treatment for this patient. He started this in the hospital, and it was considered in his best interests to continue with this medication and also considered in his best interest due to his noncompliance history. 

The insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Clozapine 150 mg OR TBDP is substantiated.