Pharmacy Prior Authorization Criteria

Antipsychotics, Long-Acting Injectable

Indications for Prior Authorization

Abilify Asimtufii, Abilify Maintena

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia in adults

• For diagnosis of Bipolar I Disorder
  Indicated for maintenance monotherapy treatment of bipolar I disorder in adults

Aristada

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia in adults

Aristada Initio

• For diagnosis of Schizophrenia
  Indicated in combination with oral aripiprazole for the initiation of Aristada when used for the treatment of schizophrenia in adults

Haldol Decanoate

• For diagnosis of Schizophrenia
  Indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy

Invega Hafyera

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia in adults after they have been adequately treated with a once-a-month paliperidone palmitate extended-release injectable suspension (e.g., Invega Sustenna) for at least four months, or an every-three-month paliperidone palmitate extended-release injectable suspension (e.g., Invega Trinza) for at least one three-month cycle

Invega Sustenna

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia in adults.

• For diagnosis of Schizoaffective Disorder
  Indicated for the treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants

Invega Trinza

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia in patients after they have been adequately treated with Invega Sustenna (1-month paliperidone palmitate extended-release injectable suspension) for at least four months

Perseris

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia in adults

Risperdal Consta

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia

• For diagnosis of Bipolar I Disorder
  Indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder

Rykindo

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia in adults

• For diagnosis of Bipolar I Disorder
  Indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults

Uzedy

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia in adults

Zyprexa Relprevv

• For diagnosis of Schizophrenia
  Indicated for the treatment of schizophrenia

Criteria

Abilify Asimtufii, Abilify Maintena, Aristada/Aristada Initio, Haldol Decanoate, Invega Trinza, Perseris, Risperdal Consta, Rykindo, Uzedy, or Zyprexa Relprevv

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Schizophrenia

• Diagnosis of Schizophrenia
AND
• Dose does not exceed FDA max as listed below
• Abilify Asimtufii: initial/maintenance: 960 mg every 2 months
OR
• Abilify Maintena: initial/maintenance: 400 mg monthly
OR
• Aristada/Aristada Initio:
• 2 ways to initiate treatment:
• Aristada Initio 675 mg with oral aripiprazole 30mg in conjunction with the first Aristada injection (the first Aristada injection may be administered on the same day as Aristada Initio or up to 10 days after),
OR
• Administer 21 consecutive days or oral aripiprazole in conjunction with the first Aristada injection.
OR
• Maintenance Aristada is up to 882 mg monthly or every 6 weeks OR 1064 mg every 2 months
OR
• Haldol Decanoate:
• Initial dose: 10 to 20x the previous daily dose in oral haloperidol equivalents
• Maintenance dose: 10 to 15x previous daily oral dose
OR
• Invega Trinza:
• If the Last Dose of Invega Sustenna is:
• 78 mg - Initiate Invega Trinza at the Following Dose: 273 mg
OR
• 117 mg – Initiate Invega Trinza at the Following Dose: 410 mg
OR
• 156 mg – Initiate Invega Trinza at the Following Dose: 546 mg
OR
• 234 mg – Initiate Invega Trinza at the Following Dose: 819 mg
AND
• Following the initial Invega Trinza dose, Invega Trinza should be administered every 3 months
AND
• Maintenance dose should not exceed 819 mg once every 3 months
OR
• Perseris: initial 90 mg or 120 mg once monthly
OR
• Risperdal Consta: initial 25 mg IM every 2 weeks (max 50 mg every 2 weeks)
OR
• Rykindo: Initial/maintenance: 25 mg every 2 weeks. Patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg
OR
• Uzedy: initial/maintenance: up to 125 mg monthly or up to 250 mg every 2 months.
OR
• Zyprexa Relprevv: initial/maintenance: up to 300 mg/2 weeks or 405 mg/4 weeks (depending on target oral Zyprexa dose)
AND
• Patient is 18 years of age or older
AND
• Prescribed by or in consultation with a psychiatrist
AND
• Documentation is provided confirming the product will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)

Invega Hafyera

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Schizophrenia

• Diagnosis of Schizophrenia
AND
• Dose does not exceed FDA max as listed below
• Invega Hafyera
• Last dose of PP1M (Once-a-month paliperidone palmitate extended-release injectable suspension):
• 156 mg - Initial Dose of Invega Hafyera: 1,092 mg
• 234 mg - Initial Dose of Invega Hafyera: 1,560 mg
OR
• Maintenance dose should not exceed 1,560 mg once every 6 months
AND
• Patient is 18 years of age or older
AND
• Prescribed by or in consultation with a psychiatrist
AND
• Documentation is provided confirming the product will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)
AND
• One of the following:
• Trial of Invega Sustenna for at least 4 months
• Trial of Invega Trinza for at least one 3-month cycle
• Continuation of prior therapy

Invega Sustenna

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Schizoaffective Disorder

• Diagnosis of schizoaffective disorder
AND
• Dose does not exceed FDA max as listed below
• Day 1: 234 mg
• Day 8: 156 mg
• Monthly maintenance: 78–234 mg
AND
• Patient is 18 years of age or older
AND
• Prescribed by or in consultation with a psychiatrist
AND
• Documentation is provided confirming the product will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)

Abilify Asimtufii, Abilify Maintena, Risperdal Consta, or Rykindo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Bipolar 1 Disorder:

• Dose does not exceed FDA max as listed below
• Abilify Asimtufii: initial/maintenance: 960 mg every 2 months
OR
• Abilify Maintena: initial/maintenance: 400 mg monthly
OR
• Risperdal Consta: initial 25 mg IM every 2 weeks (max 50 mg every 2 weeks)
OR
• Rykindo Initial/maintenance: 25 mg every 2 weeks. Patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg
AND
• Prescribed by or in consultation with a psychiatrist
AND
• Documentation is provided confirming the product will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)

Abilify Asimtufii, Abilify Maintena, Aristada/Aristada Initio, Haldol Decanoate, Invega Hafyera, Invega Sustenna, Invega Trinza, Perseris, Risperdal Consta, Rykindo, Uzedy, or Zyprexa Relprevv

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Dose does not exceed FDA max
AND
• Prescribed by or in consultation with a psychiatrist
AND
• Documentation is provided confirming the product will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)

P & T Revisions

1970-01-01, 2024-11-04

References

1. Ability Asimtufii prescribing information. Otsuka America Pharmaceutical Co., Ltd. Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, Japan. April 2023.
2. Ability Maintena prescribing information. Otsuka America Pharmaceutical, Inc. Rockville, MD. February 2024.
3. Aristada prescribing information. Alkermes, Inc. Wilmington, OH. December 2023.
4. Aristada Initio prescribing information. Alkermes, Inc. Wilmington, OH. December 2023.
5. Haloperidol Decanoate prescribing Information. Somerset Therapeutics Ltd. Karnataka, India. February 2023.
6. Invega Hafyera prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. August 2021.
7. Invega Sustenna prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. July 2022.
8. Invega Trinza prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. August 2021.
9. Perseris prescribing information. Indivior, Inc. North Chesterfield, VA. December 2022.
10. Risperdal Consta prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. February 2021.
11. Rykindo prescribing information.
12. Uzedy prescribing information. Teva Neuroscience, Inc. Parsippany, NJ. April 2024.
13. Zyprexa Relprevv prescribing information. Eli Lilly and Company. Indianapolis, IN. December 2023.

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Revision History

• 2024-11-04: 2025 New Client

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