Aripiprazole Orally Disintegrating Tablet Form

Aripiprazole orally disintegrating tablet (ODT) is an atypical antipsychotic. FDA Approved Indication(s) Aripiprazole ODT is indicated: • For the treatment of schizophrenia • For the acute treatment of manic and mixed episodes associated with bipolar I disorder • For the adjunctive treatment of major depressive disorder • For the treatment of irritability associated with autistic disorder • For the treatment of Tourette’s disorder 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 aripiprazole ODT is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. All FDA Approved Indications (must meet all):

1. Diagnosis of one of the following (a, b, c, d, or e):
   a. Schizophrenia; b. Bipolar disorder; c. Major depressive disorder; d. Autistic disorder; e. Tourette’s disorder;
2. Member meets one of the following (a, b, c, d, or e): a. Schizophrenia: Age ≥ 13 years; b. Bipolar disorder: Age ≥ 10 years; c. Major depressive disorder: Age ≥ 18 years;
   d. Autistic disorder: Age between 6 and 17 years; e. Tourette’s disorder: Age between 6 and 18 years;
3. Member must use generic aripiprazole tablet and oral solution, unless clinically significant adverse effects are experienced or both are contraindicated;

4. For major depressive disorder, aripiprazole ODT is prescribed concurrently with an antidepressant; Page 1 of 7

   CLINICAL POLICY Aripiprazole Orally Disintegrating Tablet

5. Dose does not exceed any of the following (a, b, or c): a. Schizophrenia, bipolar disorder: both of the following (i and ii):
   i. 30 mg per day; ii. 2 tablets per day; b. Major depressive disorder, autistic disorder: 15 mg (1 tablet) per day; c. Tourette’s syndrome, one of the following (i or ii): i. Weight < 50 kg: 10 mg (1 tablet) per day; ii. Weight ≥ 50 kg: 20 mg (2 tablets) per day.
   Approval duration:
   HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. 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), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; 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 of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. All Indications in Section I (must meet all):
8. Documentation supports that member is currently receiving aripiprazole ODT for bipolar disorder or schizophrenia and has received this medication for at least 30 days;

9. Member is responding positively to therapy;

   3. If request is for a dose increase, new dose does not exceed any of the following (a, b, or c): a. Schizophrenia, bipolar disorder: both of the following (i and ii):
      i. 30 mg per day; ii. 2 tablets per day; b. Major depressive disorder, autistic disorder: 15 mg (1 tablet) per day; c. Tourette’s syndrome (i or ii): i. Weight < 50 kg: 10 mg (1 tablet) per day; ii. Weight ≥ 50 kg: 20 mg (2 tablets) per day.
      Approval duration:
      HIM – 12 months Commercial – 12 months or duration of request, whichever is less Page 2 of 7

   CLINICAL POLICY Aripiprazole Orally Disintegrating Tablet B. Other diagnoses/indications (must meet 1 or 2):

10. 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), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or

11. 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 and HIM.PA.154 for health insurance marketplace.
    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 and HIM.PA.154 for health insurance marketplace, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration ODT: orally disintegrating tablet
    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 Bipolar Disorder and Schizophrenia: 30 mg/day aripiprazole (Abilify) tablet or oral solution Bipolar Disorder and Schizophrenia Adults: 10 to 15 mg PO QD Major Depressive Disorder, Autistic Disorder, and Tourette’s Disorder 5 to 10 mg PO QD Major Depressive Disorder, Autistic Disorder: 15 mg/day Tourette’s Disorder: 20 mg/day 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. Page 3 of 7

    CLINICAL POLICY Aripiprazole Orally Disintegrating Tablet Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to aripiprazole • Boxed warning(s): elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. V. Dosage and Administration
    Indication Schizophrenia Dosing Regimen Adults: 10 to 15 mg PO QD Maximum Dose 30 mg/day Bipolar mania Adolescents: initial: 2 mg PO QD; target: 10 mg PO QD Adults, as monotherapy: 15 mg PO QD 30 mg/day Adults, as adjunct to lithium or valproate: 10 to 15 mg PO QD Pediatric, as monotherapy or as an adjunct to lithium or valproate: initial: 2 mg PO QD; target: 10 mg PO QD Adults, as adjunct to antidepressants: initial: 2 to 5 mg PO QD; target: 5 to 10 mg PO QD Pediatric: initial: 2 mg PO QD; target: 5 to 10 mg PO QD 15 mg/day 15 mg/day Weight < 50 kg: initial: 2 mg PO QD; target: 5 mg PO QD Weight < 50 kg: 10 mg/day Major depressive disorder
    Irritability associated with autistic disorder Tourette’s disorder Weight ≥ 50 kg: initial: 2 mg PO QD; target: 10 mg PO QD Known CYP2D6 poor metabolizers: half of the usual dose Weight ≥ 50 kg: 20 mg/day VI. Product Availability
    Orally disintegrating tablets: 10 mg, 15 mg
    VII.