Sunflower Health Plan ZYPREXA RELPREVV, Olanzapine Pamoate Form

Olanzapine (Zyprexa Relprevv®) is a long-acting atypical antipsychotic. FDA Approved Indication(s) Zyprexa Relprevv is indicated for the treatment of schizophrenia. 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 Zyprexa Relprevv is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Schizophrenia (must meet all): 1. Diagnosis of schizophrenia; 2. Prescribed by or in consultation with a psychiatrist; 3. Age ≥ 18 years; 4. Member meets one of the following (a or b): a. History of non-adherence to oral antipsychotic therapy (see Appendix D for examples) and has established tolerability to oral olanzapine; b. Therapy was initiated in an inpatient setting during a recent (within 60 days) hospital admission; 5. Dose does not exceed one of the following (a or b): a. 405 mg every 4 weeks; b. 300 mg every 2 weeks. Approval duration: 6 months 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 (health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace and CP.PMN.255 for Medicaid; or Page 1 of 6 CLINICAL POLICY Olanzapine Long-Acting Injection b. For drugs NOT on the formulary (health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: 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: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid. II. Continued Therapy A. Schizophrenia (must meet all): 1. Currently receiving medication via Centene benefit, or documentation supports one of the following (a or b): a. Member is currently receiving Zyprexa Relprevv for schizophrenia and has received this medication for at least 30 days; b. Therapy was initiated in an inpatient setting for schizophrenia during a recent (within 60 days) hospital admission; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. 405 mg every 4 weeks; b. 300 mg every 2 weeks. Approval duration: 12 months 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 (health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: 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: 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 – HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents; B. Dementia-related psychosis; Page 2 of 6 CLINICAL POLICY Olanzapine Long-Acting Injection C. Alzheimer’s disease. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Dose Limit/ Maximum Dose 20 mg/day 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 olanzapine (Zyprexa®) 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. Schizophrenia 5 to 10 mg PO QD Appendix C: Contraindications / Boxed warnings • Contraindication(s): none reported • Boxed warning(s): Patients are at risk for severe sedation (including coma) or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency response services; Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Atypical/Second Generation Antipsychotics Appendix D: Examples of Oral Antipsychotics – Generic (Brand) Typical/First Generation Antipsychotics† Chlorpromazine (Thorazine) Fluphenazine (Prolixin) Haloperidol (Haldol) Loxapine (Loxitane) Perphenazine (Trilafon) Pimozide (Orap) Thioridazine (Mellaril) Thiothixene (Navane) Trifluoperazine (Stelazine) Aripiprazole (Abilify)* Asenapine maleate (Saphris) Brexpiprazole (Rexulti) Cariprazine (Vraylar) Clozapine (Clozaril) Iloperidone (Fanapt) Lumateperone (Caplyta) Lurasidone (Latuda) Olanzapine (Zyprexa)* Olanzapine/Fluoxetine (Symbyax) Paliperidone (Invega)* Quetiapine (Seroquel) Risperidone (Risperdal)* Ziprasidone (Geodon) †Most typical/first generation antipsychotics are available only as generics in the U.S. *Long-acting injectable formulation available Page 3 of 6 CLINICAL POLICY Olanzapine Long-Acting Injection Appendix E: General Information Zyprexa Relprevv is available only through a restricted distribution program called Zyprexa Relprevv Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment. Adverse events with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of Zyprexa Relprevv. The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post- injection delirium/sedation syndrome. V. Dosage and Administration Indication Schizophrenia Dosing Regimen IM: 150 mg/2 weeks, 300 mg/4 weeks, 210 mg/2 weeks, 405 mg/4 weeks, or 300 mg/2 weeks Maximum Dose 405 mg every 4 weeks or 300 mg every 2 weeks Zyprexa Relprevv should be administered by a healthcare professional. VI. Product Availability Powder for suspension single-dose vials: 210 mg, 300 mg, and 405 mg VII.