Pharmacy Prior Authorization Criteria

Atypical Antipsychotics - PA, ST

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.

Nuplazid (pimavanserin)

• For diagnosis of Parkinson's disease psychosis
  Indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

Secuado (asenapine)

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

Caplyta

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

• For diagnosis of Bipolar Depression
  Indicated for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate

Lybalvi

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

• For diagnosis of Bipolar I disorder
  Indicated for the acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate in adults with Bipolar I disorder. Indicated as maintenance monotherapy treatment in adults with Bipolar I disorder.

Saphris

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

• For diagnosis of Bipolar I Disorder
  Indicated for acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age, indicated for adjunctive treatment to lithium or valproate in adults, and indicated for maintenance monotherapy treatment 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.

Erzofri (paliperidone palmitate)

• For diagnosis of Schizophrenia
  Indicated for the treatment of 1) Schizophrenia in adults, and 2) Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.

Criteria

Nuplazid

Prior Authorization

Length of Approval: 12 Month(s)

• Both of the following:
• Diagnosis of Parkinson's disease
AND
• Patient has at least one of the following:
• Hallucinations
• Delusions
OR
• For continuation of prior therapy

Fanapt, Fanapt Pak, Secuado, Brand Saphris, Lybalvi

Step Therapy

Length of Approval: 12 Month(s)

• 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
• olanzapine
• quetiapine IR/ER
• risperidone
• clozapine
• ziprasidone
• paliperidone
• asenapine
OR
• For continuation of prior therapy

Invega Hafyera

Step Therapy

Length of Approval: 12 Month(s)

• 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

Caplyta

Step Therapy

Length of Approval: 12 Month(s)

• Both of the following:
• Diagnosis of Schizophrenia
AND
• Trial and failure (of a minimum 30 day supply), contraindication, or intolerance to two of the following:
• aripiprazole
• olanzapine
• quetiapine IR/ER
• risperidone
• clozapine
• ziprasidone
• paliperidone
• asenapine
OR
• BOTH of the following:
• Patient has a diagnosis of Bipolar Depression
• Trial and failure (of a minimum 30 day supply), contraindication, or intolerance to quetiapine IR/ER
OR
• For continuation of prior therapy

Erzofri

Step Therapy

Length of Approval: 12 Month(s)

• 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
• Invega Trinza
OR
• For continuation of prior therapy

P & T Revisions

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

References

1. Fanapt prescribing information. Vanda Pharmaceuticals, Inc. Washington, D.C. January 2016.
2. Nuplazid prescribing information. Acadia Pharmaceuticals Inc. San Diego, CA. May 2019.
3. Secuado prescribing information. Hisamitsu Pharmaceutical Co., Inc. Japan Saga Tosu. October 2019.
4. Caplyta prescribing information. Intra-Cellular Therapies, Inc. New York, NY. December 2021.
5. Saphris prescribing information. Allergan USA, Inc. Irvine, CA. February 2017.
6. Invega Hafyera prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. September 2021.
7. Lybalvi prescribing information. Alkermes, Inc. Waltham, MA. May 2021.
8. Erzofri prescribing information. Shandong Luye Pharmaceutical Co., Ltd. Yantai, Shandong Province, China. July 2024.

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Revision History

• 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

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