Subject: Versacloz PA Policy 1099-A 10-2022

Drug

VERSACLOZ  (clozapine oral suspension)

Policy:

FDA-approved Indications          
Treatment-Resistant Schizophrenia
Versacloz is indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Versacloz should be used only in patients who have failed to respond adequately to standard antipsychotic treatment.

The effectiveness of clozapine in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics.

Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorders
Versacloz is 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 re-experiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that put him/herself at risk for death.

The effectiveness of clozapine in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the InterSePT trial.

COVERAGE CRITERIA

The requested drug will be covered with prior authorization when the following criteria are met:
      •    The requested drug is being prescribed for any of the following:
            A) Treatment of a severely ill patient with schizophrenia who
            failed to respond adequately to standard antipsychotic
            treatment (i.e., treatment-resistant schizophrenia), B) To
            reduce the risk of recurrent suicidal behavior in a patient with
            schizophrenia or schizoaffective disorder

Place of Service:

Outpatient

The above policy is based on the following references:

1. Versacloz [package insert]. Tampa, FL: TruPharma, LLC; August 2020.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed August 25, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/. Accessed August 25 , 2022.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

February 10, 2023