Anthem Blue Cross California Commercial Clinical Policy

Anthem Blue Cross California Aristada Initio (aripiprazole lauroxil) Form

Effective Date

03/27/2023

Last Reviewed

02/24/2023

Original Document

  Reference



Overview

Clinical criteria

Overview

Coding

Document history

References

This document addresses the use of Aristada Initio. Long-acting injectable antipsychotic agents provide for the ability to dose less frequently and may improve adherence to therapy. Tolerability to the oral counterpart is a requirement for the use of the long-acting atypical injections.

Aristada Initio is unique in that it is an IM injection of aripiprazole lauroxil indicated for the initiation or re-initiation of Aristada IM therapy in the treatment of schizophrenia. Aristada Initio allows for transition to injectable Aristada without the need for oral supplementation. While Aristada requires oral aripiprazole supplementation for 21 days, Aristada Initio plus a single oral dose of aripiprazole 30 mg allows for immediate use of Aristada.

Long acting injectable antipsychotic agents have black box warnings regarding the use of these agents in the treatment of psychosis in the elderly. Elderly patients with dementia-related psychosis are at an increased risk of death. Antipsychotic agents are not approved for treatment of dementia related psychosis.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Aristada Initio (aripiprazole lauroxil) extended-release injectable suspension

Requests for Aristada Initio (aripiprazole lauroxil) extended-release injectable suspension may be approved if the following criteria are met:

  • Individual is 18 years of age or older; AND
  • Individual has a diagnosis of schizophrenia; AND
  • Individual has established tolerability with oral aripiprazole; AND
  • Individual is initiating or re-initiating therapy with Aristada; AND
  • Individual will use in conjunction with first Aristada (aripiprazole lauroxil) injection (Note: first Aristada injection may be administered on the same day as Aristada Initio or up to 10 days thereafter); AND
  • Individual will use in conjunction with one 30 mg dose of oral aripiprazole for the following regimens:
A.

Individual is initiating therapy with Aristada; OR

B.

Individual is re-initiating therapy with Aristada after greater than 7 weeks since last Aristada 441 mg injection or greater than 12 weeks after all other strengths of Aristada.

Requests for Aristada Initio (aripiprazole lauroxil) extended-release injectable suspension may not be approved for the following criteria:

  • Individual is using for repeat Aristada dosing; OR
  • Individual has not established tolerability to oral aripiprazole.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J1943

Injection, aripiprazole lauroxil1 mg [Aristada Initio]

ICD-10 Diagnosis

F20.0-F20.9

Schizophrenia

Document History

Revised: 02/24/2023