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Prior Authorization Protocol
FANAPTTM (iloperidone), LATUDA (lurasidone), SAPHRIS (asenapine), SEROQUEL XR (quetiapine extended-release)

NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Fanapt: For treatment of schizophrenia in adults
    • Latuda:
      • For treatment of schizophrenia
      • Depressive episodes associated with Bipolar I Disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate
    • Saphris:
      • Schizophrenia
      • Acute treatment of manic or mixed episodes associated with Bipolar I Disorder as monotherapy or adjunctive treatment to lithium or valproate
    • Seroquel XR:
      • Schizophrenia
      • Bipolar I disorder, manic or mixed episodes
      • Bipolar disorder, depressive episodes
      • Major depressive disorder, adjunctive therapy with antidepressants
  2. 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 antipsychotics: aripiprazole, ziprasidone, olanzapine, risperidone
    Fanapt, Latuda, Saphris:
    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
    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 antidepressant medication
    AND
    • Failure or clinically significant adverse effects to TWO of the following: aripiprazole, ziprasidone, quetiapine, risperidone or olanzapine
    Requests for continuation of therapy will be approved.
  3. 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.
  4. General Information:
    • Fanapt has a black box warning indicating increased mortality in elderly patients with dementia-related psychosis. Prescribers should consider other agents first because Fanapt can prolong the QT interval. It should also be titrated slowly to avoid orthostatic hypotension.
    • According to the Texas Medication Algorithm Project (TMAP) and the American Psychiatric Association (APA), the choice of an antipsychotic should be guided by considering the clinical characteristics of the patient and the efficacy and side effect 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 extrapyramidal symptoms (EPS) such as acute dystonic reaction, tardive dyskinesia, akathisia and Parkinsonism.
    • 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, lamotrigine, specific antipsychotics (i.e., quetiapine and olanzapine), and SSRIs as monotherapy or in combination prior to considering treatment with other atypical antipsychotics (e.g., aripiprazole, ziprasidone, risperidone).
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    aripiprazole (AbilifyR)

    10-30 mg PO QD

    30 mg/day

    ziprasidone (GeodonR)

    40-80 mg PO BID

    160 mg/day

    risperidone (RisperdalR)

    1-4 mg PO QD - BID

    16 mg/day

    quetiapine (SeroquelR)

    400-800 mg/day PO BID-TID in divided doses

    800 mg/day

    olanzapine (ZyprexaR)

    10-20 mg PO QD

    20 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Fanapt

    1 mg PO BID, titrate to 12-24 mg/day

    Length of Benefit

    Latuda

    Schizophrenia: 40-160 mg PO QD
    Bipolar Depression: 20-120 mg PO QD

    Length of Benefit

    Seroquel XR

    Schizophrenia, Bipolar I Disorder 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

    Length of Benefit

    Saphris

    5 - 10 mg SL BID

    Length of Benefit

  7. 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
    Seroquel XR: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg
    Saphris sublingual tablets: 2.5 mg, 5 mg, 10 mg
  8. 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. 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: Novartis 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. American Hospital Formulary Service Drug Information Accessed online June 17, 2014
    11. MicroMedex accessed at http://www.micromedexsolutions.com/micromedex2/librarian/ Accessed July 23, 2015.
    12. 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.
    13. 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.
    14. 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.
    15. Saphris [Prescribing Information]. St. Louis, MO: Forest Pharmaceuticals Inc.; March 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.