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Home , Asenapine, Iloperidone, Lurasidone

Prior Authorization Protocol FANAPT (), LATUDA (), SAPHRIS (), SEROQUEL XR ( extended-release), VRAYLAR  (), REXULTI ()

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Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.

I. FDA Approved Indications: • Fanapt: For treatment of in adults • Latuda: o For treatment of schizophrenia o Depressive episodes associated with (bipolar depression) as monotherapy and as adjunctive therapy with or • Rexulti: o For use as adjunctive therapy to for the treatment of major depressive disorder (MDD) o Treatment of schizophrenia • Saphris: o Schizophrenia o Acute treatment of manic or mixed episodes associated with Bipolar I Disorder as monotherapy or adjunctive treatment to lithium or valproate • Seroquel XR: o Schizophrenia o Bipolar I disorder, manic or mixed episodes o , depressive episodes o Major depressive disorder, adjunctive therapy with antidepressants • Vraylar: o Schizophrenia in adults o Acute treatment of manic or mixed episodes associated with bipolar 1 disorder

II. Health Net Approved Indications and Usage Guidelines: Seroquel XR: • Diagnosis of schizophrenia, schizoaffective disorder, bipolar depression, bipolar manic or mixed episodes, or major depressive disorder AND • Failure or clinically significant adverse effects to generic quetiapine AND one of the following atypical : , , , Fanapt, Latuda, Rexulti, Saphris, Vraylar: Schizophrenia, Schizoaffective Disorder, Bipolar Manic or Mixed Episodes: • Patient has a diagnosis of schizophrenia, schizoaffective disorder, or bipolar manic or mixed episodes AND • Failure or clinically significant adverse effects to TWO of the following atypical antipsychotics: aripiprazole, ziprasidone, quetiapine, olanzapine, risperidone Confidential and Proprietary Page - 1 Draft Prepared: 06.30.15 N Nguyen Approved by Health Net Pharmacy & Therapeutics Committee: 08.26.15, 11.18.15, 05.04.16 Revised: 09.28.15 N Nguyen, 10.14.15 A Myong, 12.10.15 N Nguyen, 05.17.16 N Nguyen, 06.03.16 N Nguyen, 10.19.16 N Nguyen

Prior Authorization Protocol FANAPT (iloperidone), LATUDA (lurasidone), SAPHRIS (asenapine), SEROQUEL XR (quetiapine extended-release), VRAYLAR  (cariprazine), REXULTI (brexpiprazole)

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Bipolar Depression: • Patient has a diagnosis of bipolar depression AND • Failure or clinically significant adverse effects to TWO of the following: aripiprazole, ziprasidone, quetiapine, risperidone or olanzapine OR • For Latuda only: Diagnosis of metabolic syndrome Major depressive disorder: • Diagnosis of major depressive disorder AND • Concomitant therapy with an medication AND • Failure or clinically significant adverse effects to TWO generic atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone or olanzapine) For all indications listed above: Requests for continuation of therapy will be approved.

III. Coverage is Not Authorized For: • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

IV. General Information: • Fanapt has a black box warning indicating increased mortality in elderly patients with -related . Prescribers should consider other agents first because Fanapt can prolong the QT interval. It should also be titrated slowly to avoid orthostatic . • According to the Texas Medication Algorithm Project (TMAP) and the American Psychiatric Association (APA), the choice of an should be guided by considering the clinical characteristics of the patient and the efficacy and profiles of the medication. At the time of publication Fanapt was not included. For a patient who experiences a first episode, the consensus is to use a single second generation antipsychotic agent (i.e. Abilify, Zyprexa, Seroquel, Risperdal, or Geodon). There is a lack of consensus to include first generation antipsychotics as an option for first episodes due to (EPS) such as acute dystonic reaction, tardive , and . • A ``failure`` to prior therapy is defined as inadequate or lack of symptom control on reasonable doses of an alternative antipsychotic for an adequate trial period. • For bipolar depression, TMAP recommends treatment with antimanics, , specific antipsychotics (i.e., quetiapine and olanzapine), and SSRIs as monotherapy or in Confidential and Proprietary Page - 2 Draft Prepared: 06.30.15 N Nguyen Approved by Health Net Pharmacy & Therapeutics Committee: 08.26.15, 11.18.15, 05.04.16 Revised: 09.28.15 N Nguyen, 10.14.15 A Myong, 12.10.15 N Nguyen, 05.17.16 N Nguyen, 06.03.16 N Nguyen, 10.19.16 N Nguyen

Prior Authorization Protocol FANAPT (iloperidone), LATUDA (lurasidone), SAPHRIS (asenapine), SEROQUEL XR (quetiapine extended-release), VRAYLAR  (cariprazine), REXULTI (brexpiprazole)

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combination prior to considering treatment with other atypical antipsychotics (e.g., aripiprazole, ziprasidone, risperidone).

V. Therapeutic Alternatives: Drug Dosing Regimen Dose Limit/Maximum Dose aripiprazole (Abilify) 10-30 mg PO QD 30 mg/day ziprasidone 40-80 mg PO BID 160 mg/day (Geodon ® ) risperidone 1-4 mg PO QD - BID 16 mg/day (Risperdal ® ) quetiapine 400-800 mg/day PO BID - TID in 800 mg/day (Seroquel ®) divided doses olanzapine (Zyprexa ®) 10-20 mg PO QD 20 mg/day * Requires Prior Authorization

VI. Recommended Dosing Regimen and Authorization Limit: Drug Dosing Regimen Authorization Limit Fanapt 1 mg PO BID, titrate to 12-24 Length of Benefit mg/day Latuda Schizophrenia: 40-160 mg PO QD Length of Benefit Bipolar Depression: 20-120 mg PO QD Seroquel XR Schizophrenia, Bipolar I Disorder Length of Benefit manic or mixed-acute monotherapy or adjunct to lithium or divalproex: titrate to 400-800 mg/day

Bipolar I Disorder manic acute monotherapy in children and adolescents aged 10 to 17 years: titrate to 400-600 mg/day

Bipolar Disorder depressive episodes in adults: titrate to 300 mg/day

Major Depressive Disorder: titrate to 150-300 mg/day Saphris 5-10 mg SL BID Length of Benefit Vraylar Schizophrenia: Length of Benefit 1.5 mg – 6 mg PO QD Bipolar 1 (manic or mixed):

Confidential and Proprietary Page - 3 Draft Prepared: 06.30.15 N Nguyen Approved by Health Net Pharmacy & Therapeutics Committee: 08.26.15, 11.18.15, 05.04.16 Revised: 09.28.15 N Nguyen, 10.14.15 A Myong, 12.10.15 N Nguyen, 05.17.16 N Nguyen, 06.03.16 N Nguyen, 10.19.16 N Nguyen

Prior Authorization Protocol FANAPT (iloperidone), LATUDA (lurasidone), SAPHRIS (asenapine), SEROQUEL XR (quetiapine extended-release), VRAYLAR  (cariprazine), REXULTI (brexpiprazole)

NATL

Drug Dosing Regimen Authorization Limit 3 mg – 6 mg PO QD Rexulti MDD: 0.5 to 3 mg/day Length of Benefit Schizophrenia: 1 to 4 mg/day

VII. Product Availability: Fanapt tablets: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg Latuda tablets: 20 mg, 40 mg, 60 mg, 80 mg, 120 mg Rexulti Tablets: 0.25, 0.5, 1, 2, 3, and 4 mg Saphris sublingual tablets: 2.5 mg, 5 mg, 10 mg Seroquel XR: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg Vraylar capsules: 1.5 mg, 3 mg, 4.5 mg, 6 mg

VIII. References: 1. Argo TR, Crimson ML, Miller AL, etal . Texas Medication Algorithm Project Procedural Manual: Schizophrenia Algorithm. The Texas Department of State Health Services. 2007. 2. Lehman AF, Lieberman JA, Dixon LB, etal. Practice guideline for the treatment of patients with schizophrenia. Am J Psychiatry . 2004; 161 (Suppl 2):1-56. 3. Abilify [Prescribing Information]. Princeton, NJ: Bristol-Myers Squibb; February 2012. 4. Fanapt [Prescribing Information]. East Hanover, NJ: Pharmaceuticals; April 2014. 5. Geodon [Prescribing Information]. New York, NY: Pfizer; November 2009. 6. Risperdal [Prescribing Information]. Titusville, NJ: Janssen; March 2012. 7. Seroquel [Prescribing Information]. Wilmington, DE: Astra Zeneca; November 2011. 8. Zyprexa [Prescribing Information]. Indianapolis, IN: Eli Lilly; June 2011. 9. Seroquel XR [Prescribing Information]. Wilmington, DE: Astra Zeneca; October 2013. 10. Vraylar [Prescribing Information]. Actavis Pharma | Gedeon Richter Plc. September 2015. 11. American Hospital Formulary Service Drug Information Available at: http://www.medicinescomplete.com/mc/ahfs/current/ . Accessed online June 17, 2014. 12. MicroMedex accessed at http://www.micromedexsolutions.com/micromedex2/librarian/ Accessed July 23, 2015. 13. American Psychiatric Association Practice Guideline for the Treatment of Patients with Major Depressive Disorder: Third Edition (2010). Available at: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf . Accessed online July 23, 2015. 14. American Psychiatric Association Practice Guideline for the Treatment of Patients with Bipolar Disorder: Second Edition (2010). Available at: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/bipolar.pdf . Accessed online July 23, 2015. 15. Crismon ML, Argo TR, Bendele SD et al. Texas Medication Algorithm Project Procedural Manual: Bipolar Disorder Algorithms. July 2007. Available at: http://www.harding.edu/assets/druginfo/pdf/tmapalgorithmforbipolardisorder.pdf . Accessed online July 23, 2015. 16. Saphris [Prescribing Information]. St. Louis, MO: Forest Pharmaceuticals Inc.; March 2015. 17. Rexulti [Prescribing Information]. Rockville, MD: Otsuka Pharmaceutical Inc.; July 2015. Confidential and Proprietary Page - 4 Draft Prepared: 06.30.15 N Nguyen Approved by Health Net Pharmacy & Therapeutics Committee: 08.26.15, 11.18.15, 05.04.16 Revised: 09.28.15 N Nguyen, 10.14.15 A Myong, 12.10.15 N Nguyen, 05.17.16 N Nguyen, 06.03.16 N Nguyen, 10.19.16 N Nguyen

Prior Authorization Protocol FANAPT (iloperidone), LATUDA (lurasidone), SAPHRIS (asenapine), SEROQUEL XR (quetiapine extended-release), VRAYLAR  (cariprazine), REXULTI (brexpiprazole)

NATL

The materials provided to you are guidelines used by this health plan to authorize, modify, or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual needs and the benefits covered under your contract.

Confidential and Proprietary Page - 5 Draft Prepared: 06.30.15 N Nguyen Approved by Health Net Pharmacy & Therapeutics Committee: 08.26.15, 11.18.15, 05.04.16 Revised: 09.28.15 N Nguyen, 10.14.15 A Myong, 12.10.15 N Nguyen, 05.17.16 N Nguyen, 06.03.16 N Nguyen, 10.19.16 N Nguyen