FANAPT, Iloperidone Form

Iloperidone (Fanapt®) is an atypical antipsychotic.
FDA Approved Indication(s) Fanapt is indicated for the treatment of schizophrenia in adults.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Fanapt is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Schizophrenia (must meet all):

1. Diagnosis of schizophrenia;
2. Age ≥ 18 years;

3. Member meets one of the following (a or b): a. Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings (see Appendix D); b. Failure of two preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) at up to maximally indicated doses, each used for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated;

   4. Dose does not exceed both of the following (a and b):
      a. 24 mg per day; b. 2 tablets per day. Approval duration:
      Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
   5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 1 of 6

   CLINICAL POLICY Iloperidone CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Schizophrenia (must meet all):
   3. Currently receiving medication via Centene benefit or documentation supports that member is currently receiving Fanapt for schizophrenia and has received this medication for at least 30 days;
   4. Member is responding positively to therapy;

4. If request is for a dose increase, new dose does not exceed both of the following (a and b):
   a. 24 mg per day; b. 2 tablets per day.
   Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      Page 2 of 6

   CLINICAL POLICY Iloperidone III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents;
   B. Dementia-related psychosis. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose 30 mg/day 20 mg/day 800 mg/day 16 mg/day aripiprazole (Abilify®) olanzapine (Zyprexa®) quetiapine (Seroquel®) risperidone (Risperdal®) 10 to 15 mg PO QD Initial: 5 to 10 mg PO QD; target: 10 mg PO QD Initial: 25 mg PO BID; target: 400 to 800 mg/day
   Initial: 1 mg PO BID or 2 mg PO QD; target: 4 to 8 mg PO QD 20 mg PO BID
   ziprasidone (Geodon® ) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 160 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to Fanapt or to any components in the formulation • Boxed warning(s): elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Fanapt is not approved for use in patients with dementia-related psychosis.
   Appendix D: States with Limitations against Redirections in Certain Mental Health Settings State Step Therapy Notes Prohibited? No NV TX No Applies to Medicaid requests only Failure of ONE preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) at up to maximally indicated doses, used for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated. Applies to HIM requests only Page 3 of 6

   CLINICAL POLICY Iloperidone State Step Therapy Notes Prohibited? Failure of ONE preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) at up to maximally indicated doses, used for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated. V. Dosage and Administration
   Indication Schizophrenia Dosing Regimen Initial: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg PO BID on consecutive days from Day 1 to Day 7
   Maximum Dose 24 mg/day Maintenance: 12 to 24 mg/day PO BID VI. Product Availability
   Tablets: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg VII.