Asenapine (Saphris, Secuado) Form

Asenapine (Saphris®, Secuado®) is an atypical antipsychotic. FDA Approved Indication(s) Saphris and Secuado are indicated for the treatment of schizophrenia in adults. Saphris is also indicated for bipolar I disorder: • Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults • Maintenance monotherapy treatment in adults ____ *For Health Insurance Marketplace (HIM), if request is through pharmacy benefit, Secuado is non-formulary and cannot be approved using these criteria; refer to the formulary exception policy, HIM.PA.103.
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 Saphris and Secuado are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Bipolar Disorder (must meet all):

1. Diagnosis of bipolar disorder;
2. Age ≥ 10 years;
3. Request is for Saphris;

4. 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 all are contraindicated or clinically significant adverse effects are experienced;

   5. For Saphris requests, member must use generic asenapine tablets, unless contraindicated or clinically significant adverse effects are experienced;
   6. Dose does not exceed both of the following (a and b):
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   CLINICAL POLICY Asenapine a. 20 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. Schizophrenia (must meet all):

5. Diagnosis of schizophrenia;
6. Age ≥ 18 years;

7. 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 all are contraindicated or clinically significant adverse effects are experienced;

   4. For Saphris requests, member must use generic asenapine tablets, unless contraindicated or clinically significant adverse effects are experienced;
   5. Dose does not exceed any of the following (a or b): a. Saphris (i and ii):
      i. 20 mg per day; ii. 2 tablets per day; b. Secuado (i and ii):
      i. 7.6 mg per day; ii. 1 patch per day. Approval duration:
      Medicaid – 12 months HIM – 12 months for Saphris (refer to HIM.PA.103 for Secuado) Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (must meet 1 or 2):
   6. 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
   7. 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 Page 2 of 8

   CLINICAL POLICY Asenapine of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All Indications in Section I (must meet all):

   1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Saphris or Secuado for bipolar disorder or schizophrenia and has received this medication for at least 30 days;
   2. Member is responding positively to therapy;

8. If request is for a dose increase, new dose does not exceed any of the following (a or b):
   a. Saphris (i and ii):
   i. 20 mg per day; ii. 2 tablets per day; b. Secuado (i and ii):
   i. 7.6 mg per day; ii. 1 patch per day.
   Approval duration:
   Medicaid – 12 months HIM – 12 months for Saphris (refer to HIM.PA.103 for Secuado) 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.
      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.
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   CLINICAL POLICY Asenapine 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 aripiprazole (Abilify®) olanzapine (Zyprexa®) Bipolar Disorder and Schizophrenia Adults: 10 to 15 mg PO QD Schizophrenia Initial: 5 to 10 mg PO QD; target: 10 mg PO QD Bipolar Disorder Monotherapy: 10 to 15 mg PO QD; adjunct to lithium or valproate: 10 mg PO QD
   Schizophrenia Initial: 25 mg PO BID; target: 400 to 800 mg/day 800 mg/day Bipolar Disorder Initial: 50 mg PO BID; target: 400 to 800 mg/day Schizophrenia Initial: 1 mg PO BID or 2 mg PO QD; target: 4 to 8 mg PO QD quetiapine (Seroquel®) risperidone (Risperdal®) Schizophrenia: 16 mg/day Bipolar Disorder: 6 mg/day 160 mg/day Bipolar Disorder 2 to 3 mg PO QD Schizophrenia 20 mg PO BID ziprasidone (Geodon®) Bipolar Disorder Initial: 40 mg PO BID; target: 40 to 80 mg PO BID 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. Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o Severe hepatic impairment (Child-Pugh C) o Known hypersensitivity to Saphris, Secuado, or to any components in the sublingual formulation or transdermal system • Boxed warning(s): Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Saphris and Secuado are not approved for the treatment of patients with dementia-related psychosis. Page 4 of 8

   CLINICAL POLICY Asenapine 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 all are contraindicated or clinically significant adverse effects are experienced. Applies to HIM 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 all are contraindicated or clinically significant adverse effects are experienced. V. Dosage and Administration
   Indication Schizophrenia Bipolar in adults Bipolar in pediatric members Schizophrenia Dosing Regimen 5 to 10 mg SL BID Maximum Dose 20 mg/day 2.5 to 10 mg SL BID 3.8 to 7.6 mg TD QD 7.6 mg/day Drug Name Asenapine sublingual tablets (Saphris) Asenapine transdermal system (Secuado) VI. Product Availability
   Drug Name Asenapine sublingual tablets (Saphris) Asenapine transdermal system (Secuado) Availability Sublingual tablets: 2.5 mg, 5 mg, 10 mg Transdermal systems: 3.8 mg/day, 5.7 mg/day, 7.6 mg/day VII.