WHA

Atypical Antipsychotics, Long-Acting Injectable (Abilify Asimtufii, Abilify Maintena, Aristata, Aristada Initio, Perseris, Risperdal Consta, Uzedy, Zyprexa Relprevv)

Medical Administration - injectable (allowed under the pharmacy benefit if administered by a pharmacist at a pharmacy)

Indications for Prior Authorization:

Abilify Asimtufii

  • Indicated for the treatment of schizophrenia in adults
  • Indicated for maintenance monotherapy treatment of bipolar I disorder in adults

Abilify Maintena

  • Indicated for the treatment of schizophrenia in adults.
  • Indicated for maintenace monotherapy treatment of bipolar I disorder in adults.

Aristada

  • Indicated for the treatment of schizophrenia in adults.

Aristada Initio

  • Indicated in combination with oral aripiprzole for the initiation of Aristada® when used for the treatment of schizophrenia in adults.

Perseris

  • Indicated for the treatment of schizophrenia in adults.

Risperdal Consta

  • Indicated for the treatment of schizophrenia.
  • Indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenace treatment of Bipolar I Disorder.

Uzedy

  • Indicated for the treatment of schizophrenia in adults.

Zyprexa Relprevv

  • Indicated for the treatment of schizophrenia.
Coverage Criteria:

For Abilify Asimtufii, Abilify Maintena, Aristada/Aristad Initio, Perseris, Risperdal Consta, Uzedy, Zyprexa Relprevv

For diagnosis of schizophrenia:

  • Dose does not exceed FDA max as listed below; AND
    • Abilify Asimtufii: initial/maintenance: 960 mg every 2 months
    • Abilify Maintena: initial/maintenance: 400 mg monthly
    • Aristada/Aristada Initio:
      • 2 ways to initiate treatment:
        • Aristada Initio 675 mg with oral aripiprazole 30 mg in conjuction 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 aripiprzole in conjuction with the first Aristada injection.
      • Maintenace Aristada is up to 882 mg monthly or every 6 weeks OR 1064 mg every 2 months
    • Perseris: initial 90 mg or 120 mg once monthly
    • Risperdal Consta: initial 25 mg IM every 2 weeks (max 50 mg every 2 weeks)
    • Uzedy: initial/maintenance: up to 125 mg monthly or up to 250 mg every 2 months. 
    • Zyprexa Relprevv: initial/maintenance: up to 300 mg/2 weeks or 405 mg/4 weeks (depending on target oral Zyprexa dose)
  • 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)

For Abilify Asimtufii, Abilify Maintena or Rispderal Consta

For diagnosis of bipolar 1 disorder:

  • Dose does not exceed FDA max as listed below, AND
    • Abilify Asimtufii: initial/maintenance: 960 mg every 2 months
    • Abilify Maintena: initial/maintenance: 400 mg monthly
    • Risperdal Consta: initial 25 mg IM every 2 weeks (max 50 mg every 2 weeks)
  • 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)
Reauthorization Criteria:

For Abilify Asimtufii, Abilify Maintena, Aristada/Aristad Initio, Perseris, Risperdal Consta, Uzedy, Zyprexa Relprevv

For diagnosis of schizophrenia or bipolar 1 disorder:

  • Dose does not exceed FDA max as listed below; AND
    • Abilify Asimtufii: initial/maintenance: 960 mg every 2 months
    • Abilify Maintena: initial/maintenance: 400 mg monthly
    • Aristada/Aristada Initio:
      • 2 ways to initiate treatment:
        • Aristada Initio 675 mg with oral aripiprazole 30 mg in conjuction 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 aripiprzole in conjuction with the first Aristada injection.
      • Maintenace Aristada is up to 882 mg monthly or every 6 weeks OR 1064 mg every 2 months
    • Perseris: initial 90 mg or 120 mg once monthly
    • Risperdal Consta: initial 25 mg IM every 2 weeks (max 50 mg every 2 weeks)
    • Uzedy: initial/maintenance: up to 125 mg monthly or up to 250 mg every 2 months. 
    • Zyprexa Relprevv: initial/maintenance: up to 300 mg/2 weeks or 405 mg/4 weeks (depending on target oral Zyprexa® dose)
  • 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)
Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • Abilify Asimtufii and Abilify Maintena
    • Abilify Maintena and Asimtufii are only to be administered by intramuscular injection by a healthcare professional.
    • For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Abilify Maintena or Asimtufii.  Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.
  • Aristada:
    • Aristada is only to be administered by intramuscular injection by a healthcare professional.  For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Aristada.  Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.
  • Aristada Initio:
    • Aristada Initio is only to be used as a single dose to initiate Aristada treatment or as a single dose to reinitiate Aristada treatment following a missed dose of Aristada.  Aristada Initio is not for repeated dosing.
    • Aristada Initio is not interchangeable with Aristada due to differing pharmacokinetic profiles.
    • Aristada Initio is to be administered as an intramuscular injection by a healthcare professional.
    • For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Aristada Initio.  Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.
  • Perseris:
    • Each injection must be administered by a healthcare professional.
    • For patients who have never taken risperidone, establish tolerability with oral risperidone prior to starting Perseris.
  • Risperdal Consta:
    • For patients who have never taken oral Risperdal, it is recommended to establish tolerability with oral Resperdal prior to initiating treatment with Risperdal Consta.
    • Oral Risperdal (or another antipsychotic medication) should be given with the first injection of Risperdal Consta and continued for 3 weeks (and then discontinued) to ensure that adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection site.
  • Uzedy
    • Uzedy must be administered by a healthcare professional as an abdominal or upper arm subcutaneous injection. Do not administer Uzedy by any other route.
    • To start Uzedy, switch from oral daily risperidone. Initiate Uzedy, as either a once monthly injection or a once every 2 month injection, the day after the last dose of oral therapy.
    • Neither a loading dose nor supplemental oral risperidone doses are recommended when switching.
       
  • Zyprexa Relprevv:
    • Zyprexa Relprevv is available only through a restricted distribution program. Zyprexa Relprevv must not be dispensed directly to a patient.
    • Establish tolerability with oral olanzapine prior to initiating treatment.
    • Zyprexa Relprevv should be administered by a healthcare professional every 2 to 4 weeks by deep intramuscular gluteal injection.
Policy Updates:
  • 02/15/2022 – New policy approved by P&T.
  • 11/14/2023 – Added criteria for Ability Maintena and Uzedy
References:
  • Ability Asimtufii prescribing information. Otsuka America Pharmaceutical Co., Ltd. Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, Japan. April 2023.
  • Ability Maintena prescribing information. Otsuka America Pharmaceutical, Inc. Rockville, MD. September 2021.
  • Aristada prescribing information. Alkermes, Inc. Wilmington, OH. November 2021.
  • Aristada Initio prescribing information. Alkermes, Inc. Wilmington, OH. August 2021.
  • Perseris prescribing information. Indivior, Inc. North Chesterfield, VA. December 2019.
  • Risperdal Consta prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. February 2021.
  • Uzedy prescribing information. Teva Neuroscience, Inc. Parsippany, NJ. May 2023.
  • Zyprexa Relprevv prescribing information. Eli Lilly and Company. Indianapolis, IN. November 2021.

Last review date: December 1, 2023