WHA
 

Atypical Antipsychotics

Indications for Prior Authorization

Fanapt (iloperidone)
  • For diagnosis of Schizophrenia
    Indicated for the treatment of adults with schizophrenia.

    When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that Fanapt is associated with prolongation of the QTc interval. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether Fanapt will cause torsade de pointes or increase the rate of sudden death is not yet known. Patients must be titrated to an effective dose of Fanapt. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia.

  • For diagnosis of Bipolar I Disorder
    Indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Invega Hafyera (paliperidone palmitate)
  • For diagnosis of Schizophrenia
    Indicated for the treatment of schizophrenia in adults after they have been adequately treated with either 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.

Criteria

Fanapt, Fanapt Pak

Step Therapy

Length of Approval: When approved; no reauthorization required

  • Both of the following:
    • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
      • AND
    • Trial and failure (of a minimum 30 day supply), contraindication, or intolerance to TWO of the following:
      • aripiprazole
      • asenapine
      • clozapine
      • olanzapine
      • paliperidone
      • quetiapine IR/ER
      • risperidone
      • ziprasidone
    OR
  • For continuation of prior therapy
Invega Hafyera

Step Therapy

Length of Approval: When approved; no reauthorization required

  • Both of the following:
    • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
      • AND
    • Trial of ONE of the following:
      • Invega Sustenna for at least 4 months
      • Invega Trinza for at least one 3-month cycle
    OR
  • For continuation of prior therapy

  • Guideline ID
    GL-489200

  • Formulary
    ehb

  • Effective date
    Mar 1, 2026

  • P&T approval date

P & T Revisions

2026-01-07, 2025-12-08, 2025-10-02, 2025-07-24, 2025-05-29, 2025-05-23, 2025-02-19, 2025-02-06, 2025-01-02, 2024-12-04, 2024-09-18, 2024-06-05, 2023-12-15, 2023-02-01, 2022-10-21, 2022-08-05, 2022-02-14, 2022-01-31, 2021-11-22, 2021-11-16, 2021-01-19, 2021-01-19, 2020-09-03, 2020-03-18, 2020-01-08

  1. Fanapt prescribing information. Vanda Pharmaceuticals, Inc. Washington, D.C. January 2016.
  2. Secuado prescribing information. Hisamitsu Pharmaceutical Co., Inc. Japan Saga Tosu. October 2019.
  3. Caplyta prescribing information. Intra-Cellular Therapies, Inc. Bedminster, NJ. November 2025.
  4. Saphris prescribing information. Allergan USA, Inc. Irvine, CA. January 2025.
  5. Invega Hafyera prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. September 2021.
  6. Lybalvi prescribing information. Alkermes, Inc. Waltham, MA. May 2021.
  7. Opipza prescribing information. Xiamen LP Pharmaceutical Co., Ltd. Fujian, China. July 2024.
  8. Abilify prescribing information. Otsuka America Pharmaceutical, Inc. Rockville, MD. November 2022.
  9. Saphris prescribing information. Schering Corporation. Kenilworth, NJ. July 2009.
  10. Geodon prescribing information. Pfizer Inc. New York, NY. January 2022.
  11. Risperdal prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2022.
  12. Seroquel XR prescribing information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. January 2022.
  13. Seroquel prescribing information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. January 2022.
  14. Zyprexa prescribing information. Lilly USA, LLC. Indianapolis, IN. October 2019
  15. Clozaril prescribing information. HLS Therapeutics (USA), Inc. Rosemont, PA. September 2024.
  16. Invega prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. December 2021.
  • 2026-01-07: New custom EHB standalone guideline.
  • 2025-12-08: Addition of criteria for Caplyta's new indication for MDD. Updated Caplyta criteria into separate indication buckets. Added IL statute operational note.
  • 2025-10-02: Caplyta trial and failure requirements updated from double to single step, with additional preferred options Vraylar & Rexulti.
  • 2025-07-24: Update Guideline
  • 2025-05-29: Removing reauthorization requirement as part of extended reauthorization program
  • 2025-05-23: Removed Nuplazid as a target from guideline
  • 2025-02-19: update guideline
  • 2025-02-06: GPI cleanup
  • 2025-01-02: update guideline
  • 2024-12-04: Addition of new Erzofri as target drug
  • 2024-09-18: Updated indication section, to include Fanapt's indication in bipolar I disorder. No change to criteria.
  • 2024-06-05: Annual Review - No criteria changes
  • 2023-12-15: Added Optum RX EHB formulary to guideline.
  • 2023-02-01: Annual Review - no criteria changes
  • 2022-10-21: update guideline
  • 2022-08-05: Update Guideline
  • 2022-02-14: Annual Review - Separation of Caplyta to address new indication of Bipolar Depression. Addition of diagnosis check within ST criteria.
  • 2022-01-31: Annual Review - Separation of Caplyta to address new indication of Bipolar Depression. Addition of diagnosis check within ST criteria.
  • 2021-11-22: Removal of Vraylar - ST retired
  • 2021-11-16: Addition of Invega Hafyera and Lybalvi
  • 2021-01-19: Program Update: Brand Saphris added as target to step therapy
  • 2021-01-19: Program Update: added generic Saphris (asenapine) to list of prerequisite drugs
  • 2020-09-03: Program Update: update prerequisite drug list to add clozapine, ziprasidone, paliperidone
  • 2020-03-18: Annual Review, also added Caplyta as target to guideline
  • 2020-01-08: Added Secuado as target to guideline