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Clinical Guideline Drug/Drug Class: Antipsychotics Prepared By MassHealth Drug Utilization Review Program Commonwealth Medicine University of Massachusetts Medical School P.O. Box 2586 Worcester MA, 01613-2586 Clinical Guideline Drug/Drug Class: Antipsychotics Prepared by: Drug Utilization Review Program Prepared for: MassHealth Pharmacy Program Purpose: The purpose of this guideline is to clarify the procedures for approving and denying prior authorization (PA) requests for: Polypharmacy with two or more antipsychotics for members ≥ 18 years old (including first- generation [typical] and second-generation [atypical]) for greater than 60 days (excluding clozapine and injectable formulations) Orally disintegrating dosage forms and Versacloz® (clozapine) oral suspension Medication exceeding defined quantity limits Fanapt® (iloperidone), Invega® (paliperidone), Latuda® (lurasidone), Rexulti® (brexpiprazole), Saphris® (asenapine), and Vraylar® (cariprazine) for members of all ages and all quantities Abilify® (aripiprazole) and Seroquel XR® (quetiapine extended-release) for members 18 years of age and older and all quantities Background: Since 2003, MassHealth has determined that oral second-generation (atypical) antipsychotics (with the exception of clozapine and injectables) would require prior authorization for polypharmacy, defined as two or more second-generation (atypical) antipsychotics for greater than 60 days. Clozapine is excluded from the polypharmacy requirement because the guidelines for the treatment of schizophrenia recognize that combinations including clozapine have been reported. 1 In 2016, the adult antipsychotic polypharmacy criteria was updated and the PA restriction was expanded to include first-generation (typical), and second-generation (atypical) antipsychotics, excluding clozapine and injectable formulations. Orally disintegrating tablets (ODT) of aripiprazole, clozapine, olanzapine and risperidone, as well as Versacloz® (clozapine) oral suspension also require PA since there are more cost-effective alternatives available. Because of limited data to support the dosing of second-generation (atypical) antipsychotics at intervals greater than those indicated by the Food and Drug Administration (FDA), requests for second- generation (atypical) antipsychotics exceeding quantity limits based on FDA-approved dosages will also require prior authorization (PA) and dosages should be consolidated where appropriate. In 2010, after consultation with the Massachusetts Department of Mental Health, the MassHealth Pharmacy Program has determined that all new behavioral health drugs that do not have head-to-head trials showing substantial evidence of superiority (evidence of safety and efficacy) over currently available medications will require PA. As a result, Fanapt® (iloperidone), Latuda® (lurasidone), Invega® (paliperidone), and Saphris® (asenapine) were placed on PA. In 2013, after consultation with the Massachusetts Department of Mental Health, the MassHealth Pharmacy Program has determined to place all branded second-generation (atypical) antipsychotics on PA for adults given the availability of multiple generic second-generation (atypical) antipsychotics (i.e., clozapine, olanzapine, quetiapine, risperidone, ziprasidone) with different characteristics pertaining to safety and efficacy. As a result, Abilify® (aripiprazole) and Seroquel XR® (quetiapine extended-release) were placed on PA for adult MassHealth members 18 years of age and older. Abilify® (aripiprazole) and Seroquel XR® (quetiapine extended-release) will continue to be available without a PA for the drug itself for children and adolescents under the age of 18 years (existing quantity limits and polypharmacy rules apply); however, PA restrictions may apply for certain behavioral health medication regimens with the implementation of the MassHealth Pediatric Behavioral Health Medication Initiative. For detailed information regarding the initiative, please refer to the MassHealth Pediatric Behavioral Health Medication Initiative guideline. In 2014, the MassHealth Pharmacy Program, in collaboration with the Department of Children and Families (DCF) and the Department of Mental Health (DMH), implemented the Pediatric Behavioral Health Medication Initiative. The MassHealth Pharmacy Program has identified combinations of specific behavioral health medications or medication classes prescribed to members <18 years of age and will be subject to prospective consultant pharmacist review. The Pediatric Behavioral Health Medication Initiative will require prior authorization for specific behavioral health medication combinations that may be unnecessary, redundant, or cause additional adverse reactions, i.e. polypharmacy; as well as for medication classes that have limited evidence of safety and efficacy in the pediatric population. For more details for the specifics of this initiative, please refer to the MassHealth Pediatric Behavioral Health Medication Initiative guideline. Due to the high cost of long-acting antipsychotic agents and the similar place in therapy between the formulations of the same chemical entity when used in practice, MassHealth has selected Aristada® (aripiprazole lauroxil) as the preferred long-acting aripiprazole formulation. Table 1. FDA-Approved Indications and Pregnancy Category of Second-Generation (Atypical) Antipsychotics2-18, 85- 88 Pregnancy Drug FDA Approved Indication(s) Category Abilify®, Abilify Schizophrenia (adults and adolescents ages 13 to 17 years Discmelt®, [Abilify®]; adults ages 18 years and older [Abilify Abilify Maintena®]) Maintena® Acute treatment of manic or mixed episodes of bipolar I (aripiprazole), disorder - monotherapy or as an adjunct to lithium or Aristada® valproate (adults and children ages 10 to 17 years) C (aripiprazole Maintenance treatment of bipolar I disorder - monotherapy lauroxil) or as an adjunct to lithium or valproate (adults) Adjunctive treatment for major depressive disorder (adults) Treatment of irritability associated with autistic disorder (children ages 6 to 17 years) Acute treatment of agitation associated with schizophrenia or 2 Administered for the MassHealth Pharmacy Program Pregnancy Drug FDA Approved Indication(s) Category bipolar I disorder (adults) Clozaril®, Treatment resistant schizophrenia FazaClo® ODT, Reduction in the risk of suicidal behavior in schizophrenia or B Versacloz® schizoaffective disorder (clozapine) Fanapt® Schizophrenia (adults) C (iloperidone) Geodon® Schizophrenia (adults) (ziprasidone) Acute treatment of manic or mixed episodes of bipolar I disorder – monotherapy (adults) Maintenance treatment of bipolar I disorder - as an adjunct to C lithium or valproate (adults) Acute treatment of agitation in schizophrenic patients (adults) Invega®, Invega Schizophrenia (adults and adolescents ages 12 to 17 years for Sustenna® , oral tablets, adults for injectables) ® C Invega Trinza Schizoaffective disorder - monotherapy or as an adjunct to (paliperidone) mood stabilizers and/or antidepressants (adults) Latuda® Schizophrenia (adults) (lurasidone) Depressive episodes associated with bipolar I disorder B (bipolar depression) – monotherapy and as adjunctive therapy with lithium or valproate (adults) Rexulti® Schizophrenia (adults) Fetal risk (brexpiprazole) Adjunctive therapy to antidepressants for the treatment of cannot be major depressive disorder (adults) ruled out Risperdal®, Schizophrenia (adults and adolescents ages 13 to 17 years) Risperdal Acute manic or mixed episodes of bipolar I disorder - alone Consta®, or in combination with lithium or valproate (adults and Risperdal M- children ages 10 to 17 years) ® tab Maintenance treatment of bipolar I disorder – alone or as C (risperidone) adjunctive therapy to lithium or valproate (Risperdal® Consta®) (adults) Irritability associated with autistic disorder (children ages 5 to 16 years) Saphris® Schizophrenia (adults) (asenapine) Acute treatment of manic or mixed episode of bipolar I C disorder – monotherapy or adjunctive therapy (adults) and monotherapy (children ages 10 to17 years) Seroquel® Schizophrenia (adults and adolescents ages 13 to 17 years) (quetiapine) Acute treatment of manic episodes of bipolar I disorder - monotherapy or adjunct to lithium or divalproex (adults and children ages 10 to 17 years) C Acute treatment of depressive episodes associated with bipolar disorder (adults) Maintenance treatment of bipolar disorder - adjunct to lithium or divalproex (adults) Seroquel XR® Schizophrenia (adults) C 3 Administered for the MassHealth Pharmacy Program Pregnancy Drug FDA Approved Indication(s) Category (quetiapine Acute treatment of manic or mixed episodes associated with extended- bipolar I disorder – monotherapy and as an adjunct to lithium release) or divalproex (adults) Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex (adults) Acute treatment of depressive episodes associated with bipolar I or II disorder (adults) Adjunctive treatment of major depressive disorder (adults) Vraylar® Schizophrenia (adults) Fetal risk (cariprazine) Acute treatment of manic or mixed episodes associated with cannot be bipolar I disorder (adults) ruled out Zyprexa®, Schizophrenia (adults and adolescents ages 13 to 17 years) Zyprexa Zydis®, Acute treatment of manic or mixed episodes of bipolar I Zyprexa disorder and maintenance treatment of bipolar I disorder - Relprevv® monotherapy or adjunct to lithium or valproate (adults and (olanzapine) adolescents ages 13 to 17 years) As Zyprexa Relprevv® for the treatment of
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