CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aripiprazole Injection: Abilify Maintena, Aristada, Aristada Initio

Defines Medicaid coverage criteria for Abilify Asimtufii, Abilify Maintena, Aristada, and Aristada Initio long-acting injectable aripiprazole products for treatment of schizophrenia and maintenance monotherapy of bipolar I disorder where indicated; excludes other indications as investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAripiprazole Injection: Abilify Maintena, Aristada, Aristada Initio

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProvider must document that tolerability with oral aripiprazole has been established prior to approval.

SourceLink

POLICY UPDATE CHANGES

No material changes

Schizophrenia & bipolar ICovered Indications

Other indicationsNot Covered

12mo / 1 doseCoverage Duration

Coverage Summary

This policy covers the long-acting injectable aripiprazole products Abilify Asimtufii, Abilify Maintena, Aristada, and Aristada Initio for the treatment of schizophrenia and for maintenance monotherapy treatment of bipolar I disorder where indicated (for Abilify Asimtufii and Abilify Maintena). Other indications are considered experimental/investigational and not covered. Coverage stance: covered_with_criteria. Status: CURRENT; Last review: 2024-11.

Policy key facts

Covered IndicationsSchizophrenia; Bipolar I maintenance (Abilify Asimtufii or Abilify Maintena)

Not CoveredAll other indications considered experimental/investigational (not a covered benefit)

Coverage Duration12 months for Abilify Asimtufii, Abilify Maintena, Aristada; Aristada Initio: one dose for up to 2 months (in addition to Aristada 12 months)

Policy Status / Last ReviewCURRENT; Last review: 11/2024

Medical Necessity Criteria

Criteria for approval

An authorization may be granted when the following criteria (A) and (B) are met:

ALL of the following

ANY of the following
- Tolerability with oral aripiprazole has been established
- AND
  - The requested drug is being prescribed for the treatment of schizophrenia
  - Abilify Asimtufii or Abilify Maintena is being prescribed for maintenance monotherapy treatment of bipolar I disorder

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Not Covered / Experimental Uses

Uses other than the listed FDA-approved indications and compendial uses for the included long-acting injectable aripiprazole products (Abilify Asimtufii, Abilify Maintena, Aristada, Aristada Initio) are considered experimental/investigational and are not covered.

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required

Authorization is required and may be granted only if the approval criteria are met (tolerability and indication).

Documentation Required

Oral aripiprazole tolerability documentation

Provider must document that tolerability with oral aripiprazole has been established prior to approval.

Billing Rule

Coverage duration rules

Abilify Asimtufii, Abilify Maintena, and Aristada approvals are for 12 months; Aristada Initio approval is for one dose for up to 2 months in addition to approval of Aristada for 12 months.

Abilify Asimtufii, Abilify Maintena, Aristada: 12 months
Aristada Initio: one dose for up to 2 months in addition to Aristada 12-month approval

Background & Evidence

This policy lists the FDA-approved indications and compendial uses for long-acting injectable aripiprazole products and limits coverage to those indications when the approval criteria are met. Included products are Abilify Asimtufii, Abilify Maintena, Aristada, and Aristada Initio. Approval is limited to the indicated uses (schizophrenia; for Abilify Asimtufii and Abilify Maintena, also maintenance monotherapy of bipolar I disorder) and other indications are considered investigational and not a covered benefit. Evidence references: Product package inserts (2025) for Abilify Asimtufii, Abilify Maintena, Aristada, and Aristada Initio; clinical resources Lexicomp and Micromedex; and the American Psychiatric Association guideline for treatment of schizophrenia.