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 acute agitation associated with Schizophrenia and bipolar I mania (adults) In combination with fluoxetine (as Symbyax®) for the C treatment of depressive episodes of bipolar I disorder (adults) In combination with fluoxetine (as Symbyax®) for the treatment of treatment resistant depression [as defined in the package insert as major depressive disorder in patents who do not respond to TWO separate trials of different antidepressants of adequate dose and duration in the current episode] (adults)
Reference Table:‡ Drugs That Require PA No PA Abilify® * (aripiprazole solution) ≥18 years old and Abilify® # (aripiprazole solution) <18 years old and QL >750 mL/month QL ≤750 mL/month Abilify® * (aripiprazole tablet) QL >30 units/month Abilify® # (aripiprazole tablet) QL ≤30 units/month Abilify® Discmelt * (aripiprazole orally disintegrating tablet) and QL >30 units/month Abilify® Maintena® (aripiprazole extended-release injection) Aristada® (aripiprazole lauroxil 441 mg, 662 mg Aristada® (aripiprazole lauroxil 441 mg, 662 mg and 882 mg) QL >1 injection/monthPD and 882 mg) QL ≤1 injection/month Aristada® (aripiprazole lauroxil 1,064 mg) QL >1 Aristada® (aripiprazole lauroxil 1,064 mg) QL ≤1 injection/2 monthsPD injection/2 months Clozaril® # (clozapine tablet) Fazaclo® † (clozapine orally disintegrating tablet) 12.5 mg, 150 mg, 200 mg Fazaclo® * (clozapine orally disintegrating tablet) 25 mg, 100 mg Versacloz® (clozapine suspension) ® Fanapt (iloperidone) and QL >60 units/month 4 Administered for the MassHealth Pharmacy Program
Drugs That Require PA No PA Geodon® * (ziprasidone capsule) QL >60 Geodon® # (ziprasidone capsule) QL ≤60 units/month units/month Geodon® (ziprasidone injection) Invega® * (paliperidone tablet) 1.5 mg, 3 mg, 9 mg and QL >30 units/month Invega® * (paliperidone tablet) 6 mg and QL >60 units/month Invega Sustenna® (paliperidone extended-release 1- Invega Sustenna® (paliperidone extended-release 1- month injection) QL >2 syringes month 1, >1 month injection) QL ≤2 syringes month 1, ≤1 syringe/month thereafter syringe/month thereafter Invega Trinza® (paliperidone extended-release 3- Invega Trinza® (paliperidone extended-release 3- month injection) QL >1 syringe/3 months month injection) QL ≤1 syringe/3 months Latuda® (lurasidone) 20 mg, 40 mg, 60 mg, 120 mg and QL >30 units/month Latuda® (lurasidone) 80 mg and QL >60 units/month Rexulti® (brexpiprazole) and QL >30 units/month Risperdal® * (risperidone 0.25 mg, 0.5 mg, 1 mg, 2 Risperdal® # (risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg tablets) QL >60 units/month mg, 3 mg tablets) QL ≤60 units/month Risperdal® * (risperidone 4 mg tablet) QL >120 Risperdal® # (risperidone 4 mg tablet) QL ≤120 units/month units/month Risperdal® * (risperidone solution) QL >480 Risperdal® # (risperidone solution) QL ≤480 mL/month mL/month risperidone 1 mg/mL, 2 mg/2 mL and 3 mg/3 mL risperidone 1 mg/mL, 2 mg/2 mL and 3 mg/3 mL oral syringes QL>480 mL/month **non-rebate** oral syringes QL ≤480 mL/month **non-rebate** Risperdal® Consta® (risperidone extended-release Risperdal® Consta® (risperidone extended-release injection) QL >2 syringes/month injection) QL ≤2 syringes/month Risperdal® M-Tab * (risperidone orally disintegrating tablet) 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and QL >60 units/month Risperdal® M-Tab * (risperidone orally disintegrating tablet) 4 mg and QL >120 units/month Saphris® (asenapine) and QL >60 units/month Seroquel® * (quetiapine) QL >90 units/month Seroquel® # (quetiapine) QL ≤90 units/month Seroquel® XR (quetiapine extended-release 150 Seroquel® XR (quetiapine extended-release 150 mg†, 200 mg†) ≥18 years old and QL >30 mg, 200 mg) <18 years old and QL ≤30 units/month§ units/month Seroquel® XR (quetiapine extended-release 50 Seroquel® XR # (quetiapine extended-release 50 mg†, 300 mg†, 400 mg*) ≥18 years old and QL mg, 300 mg, 400 mg) <18 years old and QL ≤60 >60 units/month§ units/month Vraylar®(cariprazine) and QL >30 units/month Zyprexa® * (olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 Zyprexa® # (olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg, 20 mg tablets) QL >30 units/month mg, 20 mg tablets) QL ≤30 units/month Zyprexa® * (olanzapine 15 mg tablet) QL >60 Zyprexa® # (olanzapine 15 mg tablet) QL ≤60 units/month units/month Zyprexa® Relprevv® (olanzapine 210 mg, 300 mg Zyprexa® Relprevv® (olanzapine 210 mg, 300 mg extended-release injection) QL >2 vials/month extended-release injection) QL ≤2 vials/month
5 Administered for the MassHealth Pharmacy Program
Drugs That Require PA No PA Zyprexa® Relprevv® (olanzapine 405 mg extended- Zyprexa® Relprevv® (olanzapine 405 mg extended- release injection) QL >1 vial/month release injection) QL ≤1 vial/month Zyprexa® Zydis * (olanzapine orally disintegrating tablet) 2.5 mg, 5 mg, 10 mg, 20 mg and QL >30 units/month Zyprexa® Zydis * (olanzapine orally disintegrating tablet) 15 mg and QL >60 units/month Zyprexa® # (olanzapine injection) # This is a brand-name drug with FDA "A"-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA "A"-rated generic equivalent. * A-rated generic available, both brand and A-rated generic require PA. † Authorized generic available, both brand and authorized generic require PA. ‡ Use of antipsychotics in members <18 years of age is discussed in the MassHealth Pediatric Behavioral Health Medication Initiative guideline. § Available in a starter pack. Seroquel XR 50 mg-200 mg-300 mg starter packs are sample kits. Prior authorization should not be entered for these products. PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
NOTE: MassHealth will allow for a lower strength of the same tablet to be filled for “breakthrough psychosis” as necessary. See the Appendix for more information.
Procedure:1-88 The MassHealth Pediatric Behavioral Health Medication Initiative may apply to MassHealth members <18 years of age due to polypharmacy, age, and/or drug restrictions. As indicated within this guideline, please refer to the Pediatric Behavioral Health Initiative guideline to assess appropriateness of therapy.
Approval Diagnosis: Please refer to Table 1 above for FDA-approved indications.
Notes: Other indications will be reviewed on a case by case basis. See appendix for details. Approval Criteria: Members ≥ 18 years old: Prescriber provides documentation of ALL of the following: Polypharmacy 1. Psychiatric diagnosis including treatment-resistant conditions 2. Documentation of treatment plan including names of current (overlap of 60 days or antipsychotics and corresponding diagnoses more of ≥2 3. Prescriber is a psychiatrist or psychiatry consult was provided antipsychotics within a 4. Documentation of ONE of the following: 90 day period, including a. Cross-titration/taper of antipsychotic therapy first-generation b. Inadequate response or adverse reaction to two monotherapy antipsychotics and trials as clinically appropriate (include trial duration with second generation dates of use as documented on request or POPS claims, if antipsychotics. available) Clozapine and injectable c. Member had recent psychiatric hospitalization and was formulations are discharged on the current regimen excluded.) Notes: Psychiatry consults dated within the last year are acceptable
6 Administered for the MassHealth Pharmacy Program
Please refer to the MassHealth Pediatric Behavioral Health Medication Initiative guideline regarding the review of requests for members <18 years of age Approval Criteria: All Members: Prescriber provides documentation of ONE of the following: Exceeding Quantity 1. Rationale why the dose cannot be consolidated Limits 2. Rationale why the member requires dosing at intervals exceeding what is recommended by the FDA (for example twice daily when FDA approved dosing is only once daily)
Notes: Please refer to the MassHealth Pediatric Behavioral Health Medication Initiative guideline regarding the review of requests for members <18 years of age Please see the appendix for examples of approvable requests Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Clinical rationale for use of the requested agent instead of Aristada® Abilify® Maintena® (aripiprazole lauroxil) (aripiprazole extended- release injection) Notes: A diagnosis of bipolar I disorder is not a sufficient rationale to bypass a trial with Aristada® (aripiprazole lauroxil) Outgoing denial messaging for Abilify Maintena® requires addition of the following statement: “Please note, Aristada® (aripiprazole lauroxil) is available without prior authorization within established limits.” Approval Criteria: Members <18 years of age: Prescriber provides documentation of ALL of the following: Fanapt® (iloperidone) 1. Appropriate diagnosis Invega® (paliperidone 2. Inadequate response or adverse reaction to ONE of the following tablet)* generic second-generation (atypical) antipsychotics: aripiprazole, Latuda® (lurasidone) clozapine, olanzapine, quetiapine, risperidone or ziprasidone (POPS Saphris® (asenapine) claims or documentation of drug name on the PA form is sufficient) Vraylar® (cariprazine) o Unless a contraindication to all second-generation (atypical) antipsychotics exist, one of them must be tried *A-rated generic 3. ONE of the following: available, both brand and a. Inadequate response or adverse reaction to TWO other A-rated generic require different atypical or typical antipsychotics (generic or brand) PA (POPS claims or documentation of drug name on the PA form is sufficient) b. Contraindication to all other antipsychotics 4. Requested quantity does not exceed established quantity limits (please refer to reference table above) 5. If the request is for brand name Invega® tablet, prescriber must meet the above criteria and provide medical records documenting an inadequate response or adverse reaction to generic paliperidone (as per the Brand Name guideline)
Notes: Please refer to the MassHealth Pediatric Behavioral Health Medication Initiative guideline regarding the review of requests for 7 Administered for the MassHealth Pharmacy Program
members <18 years of age
Members ≥18 years of age: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis 2. Inadequate response or adverse reaction to TWO second-generation (atypical) antipsychotics (generic or brand) (POPS claims or documentation of drug name on the PA form is sufficient) o Unless a contraindication to all second-generation (atypical) antipsychotics exist, TWO of them must be tried 3. Requested quantity does not exceed established quantity limits (please refer to reference table above) 4. If the request is for brand name Invega® tablet, prescriber must meet the above criteria and provide medical records documenting an inadequate response or adverse reaction to generic paliperidone (as per the Brand Name guideline)
Notes: If the request is for Latuda® and the PA notes that the member is pregnant and Latuda® is preferred, then the request can be approved without additional trials Please see the appendix for requests citing need to stabilize on oral paliperidone prior to IM therapy. Please see the appendix under Duration of Approval/Denial scenarios for requests to initiate Fanapt® therapy that meet the approval criteria Please see the appendix section for requests citing hepatic impairment Approval Criteria: Members <18 years of age: Aripiprazole solution, and quetiapine extended-release do not require Abilify® (aripiprazole PA. Quantity limits, polypharmacy rules, and PBHMI restrictions solution)* still apply. If the request is for brand name Abilify® tablets or Abilify® Discmelt solution, or brand name Seroquel XR®, prescriber must provide (aripiprazole orally medical records documenting an inadequate response or adverse disintegrating tablet)* reaction to the generic equivalent (as per the Brand Name guideline). Seroquel® XR (quetiapine extended- Abilify Discmelt (aripiprazole orally disintegrating tablets) release)*§ Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis 2. Medical necessity for an orally disintegrating dosage form (i.e. *A-rated generic swallowing disorder, need for witnessed administration) available, both brand and 3. Requested quantity does not exceed established quantity limits of 30 A-rated generic require units/month PA. 4. If the request is for brand name Abilify® Discmelt, prescriber must meet the above criteria and provide medical records documenting an inadequate response or adverse reaction to generic aripiprazole orally §Available in a starter disintegrating tablets (as per the Brand Name guideline) pack. Seroquel XR 50 mg-200 mg-300 mg Notes: starter packs are sample Please refer to the MassHealth Pediatric Behavioral Health 8 Administered for the MassHealth Pharmacy Program
kits. Prior authorization Medication Initiative guideline regarding the review of requests for should not be entered for members <18 years of age these products. Members ≥18 years of age: If the request is for brand name Abilify® solution, or brand name Seroquel XR®, prescriber must provide medical records documenting an inadequate response or adverse reaction to the generic equivalent (as per the Brand Name guideline). Prescriber provides documentation of ALL of the following: 1. ONE of the following: a. ALL of the following: i. Requested agent is solution, or orally disintegrating tablets ii. Diagnosis of autism spectrum disorder iii. Inadequate response, adverse reaction or contraindication to risperidone (History of claims in POPS is sufficient) b. ALL of the following: i. Requested agent is solution, or orally disintegrating tablets or quetiapine extended- release ii. Diagnosis of major depressive disorder or treatment resistant depression iii. Inadequate response or adverse reaction to TWO antidepressants (either alone or in combination) (POPS claims or documentation of drug name on the PA form is sufficient) o Unless a contraindication to all antidepressants exist, TWO of them must be tried iv. Documentation that aripiprazole solution or orally disintegrating tablets or quetiapine extended- release will be used as adjunctive antidepressant therapy (POPS claims for an antidepressant in the past 30 days are acceptable) c. ALL of the following: i. Requested agent is aripiprazole solution, or orally disintegrating tablets or quetiapine extended- release ii. Diagnosis of ANY psychiatric nature (EXCEPT autism spectrum disorder when requesting Abilify, major depressive disorder/treatment resistant depression: see above a. or b.) iii. Inadequate response or adverse reaction to TWO second-generation (atypical) antipsychotics (generic or brand) (POPS claims or documentation of drug name on the PA form is sufficient) o Unless a contraindication to all second- generation (atypical) antipsychotics exist, TWO of them must be tried
9 Administered for the MassHealth Pharmacy Program
2. If the request is for quetiapine extended-release, inadequate response or adverse reaction to immediate-release quetiapine (History of claims in POPS is sufficient) 3. If the request is for aripiprazole solution or orally disintegrating tablets, then the prescriber provides medical necessity for dosage form (i.e. swallowing disorder, need for witnessed administration) 4. Requested quantity does not exceed established quantity limits (please refer to reference table above) 5. If the request is for brand name Abilify® solution, or Discmelt or Seroquel XR®, prescriber must meet the above criteria and provide medical records documenting an inadequate response or adverse reaction to the generic equivalent (as per the Brand Name guideline)
Notes: For brand name requests, if medical records are not included with the request, please choose the appropriate Enterprise denial message and add “medical records documenting inadequate response or adverse reaction to the generic equivalent” to any of the other missing information Approval Criteria: Members <18 years of age with appropriate diagnosis (except treatment- resistant depression): Rexulti® (brexpiprazole) Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis (except treatment-resistant depression) 2. Inadequate response or adverse reaction to ONE of the following generic second-generation (atypical) antipsychotics: aripiprazole, clozapine, olanzapine, quetiapine, risperidone or ziprasidone (POPS claims or documentation of drug name on the PA form is sufficient) o Unless a contraindication to all second-generation (atypical) antipsychotics exist, one of them must be tried 3. ONE of the following: a. Inadequate response or adverse reaction to TWO other different atypical or typical antipsychotics (generic or brand) (POPS claims or documentation of drug name on the PA form is sufficient) b. Contraindication to all other antipsychotics 4. Requested quantity does not exceed established quantity limits of 30 tablets/30 days
Members ≥18 years of age with appropriate diagnosis (except treatment- resistant depression): Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis (except treatment-resistant depression) 2. Inadequate response or adverse reaction to TWO second-generation (atypical) antipsychotics (generic or brand) (POPS claims or documentation of drug name on the PA form is sufficient) o Unless a contraindication to all second-generation (atypical) antipsychotics exist, TWO of them must be tried 3. Requested quantity does not exceed established quantity limits of 30 tablets/30 days
10 Administered for the MassHealth Pharmacy Program
Adjunctive treatment for MDD (treatment-resistant depression): Prescriber provides documentation of ALL of the following: 1. Diagnosis of major depressive disorder or treatment-resistant depression 2. Inadequate response or adverse reaction to TWO antidepressants (either alone or in combination) (POPS claims or documentation of drug name on the PA form is sufficient) o Unless a contraindication to all antidepressants exist, TWO of them must be tried 3. Documentation that Rexulti® (brexpiprazole) will be used as adjunctive antidepressant therapy (POPS claims for an antidepressant in the past 30 days are acceptable) 4. Requested quantity does not exceed established quantity limits of 30 tablets/30 days
Notes: Please refer to the MassHealth Pediatric Behavioral Health Medication Initiative guideline regarding the review of requests for members <18 years of age Approval Criteria: All Members: Prescriber provides documentation of ALL of the following: Fazaclo® (clozapine 1. Appropriate diagnosis orally disintegrating 2. Medical necessity for an orally disintegrating dosage form (i.e. tablet) 12.5 mg † swallowing disorder, need for witnessed administration) Fazaclo® (clozapine 3. Requested quantity does not exceed established quantity limits orally disintegrating (please refer to reference table above) tablet) 25 mg, 100 mg, 4. If the request is for brand name FazaClo® 25 mg, 100 mg, 150 mg, or 150 mg, 200 mg * 200 mg tablet, Risperdal® M-Tab or Zyprexa® Zydis, member must Risperdal® M-Tab meet the above criteria and prescriber must also provide medical (risperidone orally records documenting an inadequate response or adverse reaction to disintegrating tablet)* the generic equivalent (as per the Brand Name guideline) Zyprexa® Zydis 5. If the request for brand name FazaClo® 12.5 mg, member must meet (olanzapine orally the above criteria and the prescriber must provide medical records disintegrating tablet)* documenting an inadequate response or adverse reaction to the therapeutically equivalent generic †Authorized generic available, both brand and Notes: authorized generic Please refer to the MassHealth Pediatric Behavioral Health require PA Medication Initiative guideline regarding the review of requests for members <18 years of age *A-rated generic Please see the appendix for more information regarding medical available, both brand and necessity for an ODT formulation A-rated generic require PA Approval Criteria: All Members: Prescriber provides documentation of ALL of the following: Versacloz® (clozapine 1. Appropriate diagnosis suspension) 2. Medical necessity for an oral suspension dosage form (i.e., swallowing disorder, need for witnessed administration, intolerance to other clozapine formulations)
11 Administered for the MassHealth Pharmacy Program
Notes: Please refer to the MassHealth Pediatric Behavioral Health Medication Initiative guideline regarding the review of requests for members <18 years of age Please see the appendix for more information regarding medical necessity for an oral suspension formulation Denial Criteria: Cases that do not meet the approval criteria will be denied. If a request is denied and the prescriber has additional clinical documentation, a new prior authorization request must be submitted. Appeal Information: Appeals are only accepted when initiated by the member. Information about the appeal process is sent to the member with the denial letter. Request Submission: Documentation should be submitted to DUR as a detailed letter on the prescriber’s letterhead, or on a “Drug Prior Authorization Request” form. Duration/Quantity of Prior authorization may be issued for 1 month to 1 year (please see Authorization: appendix for details) If the member is <18 years of age, review using the criteria and approval duration in the MassHealth Pediatric Behavioral Health Medication Initiative guideline, if applicable. Provisional prior authorization may be issued for 1 month for members who do not meet the Pediatric Behavioral Health Medication Initiative guideline approval criteria to avoid risk of destabilization only if the member was stabilized on the medication [e.g., medication was covered by a previous insurer or third party liability (TPL) claims]. Provisional approvals do not apply to new starts for medications that require prior authorization (e.g., drug, quantity limits, brand name). Prescriber outreach via telephone will be attempted on all provisional approvals. Recertification Prescriber provides documentation of the following: Criteria: Continued stability on the specifically requested regimen (evidence of regularly paid claims in POPS or notification on the PA form is sufficient documentation) Recertification may be issued for 1 year
Handling recertification with criteria and PA status change: If the member was approved for a second-generation (atypical) antipsychotic (drug, polypharmacy, dosage form, quantity limits, etc) prior to changes implemented on May 13, 2013, the member must meet the new criteria for recertification unless stability rules apply. If a member <18 years of age was approved for an antipsychotic, prior to the changes implemented on 11/24/2014, the request should meet the criteria in the MassHealth Pediatric Behavioral Health Medication Initiative guideline for recertification. If a member ≥18 year of age was approved for quetiapine extended- release prior to changes implemented on 05/31/2016 the request can be recertified without the additional trial (i.e., immediate-release quetiapine trial). If a member was approved for polypharmacy prior to changes implemented on 05/31/2016, the request can be request can be recertified without the additional trial requirements.
12 Administered for the MassHealth Pharmacy Program
Appendix:
Stability/Court Orders
In the majority of cases where criteria for stability is met, the request can be approved. Requests for Abilify® Maintena® (aripiprazole extended-release injection) are discussed further below. For requests for other agents, use the criteria below and please see the Duration of Approval section for further information regarding whether the request should be approved for 1 month, 3 months or 1 year.
Requests for the majority of antipsychotic agents (excluding Abilify® Maintena® [aripiprazole extended- release injection])
Definition of stability for second-generation (atypical) antipsychotics: Member was initiated on the requested medication(s) while inpatient (regardless of diagnosis) Member is currently taking the requested medication(s) from a previous insurer Member has a history of paid claims for the medication(s) via MassHealth (regardless of diagnosis) Stability on samples is not a rationale for approval in all cases, however, due to the severity of most psychiatric diagnoses, requests for members with a documented history of hospitalization (at any point), risk of harm to self or others, suicidal/homicidal ideation (at any point), homelessness, or any other type of behavior or medical history that is compelling to the individual consultant reviewing the case, the request may be approved Any submitted court order (Roger’s Order) that cites a specific drug, dose, dosage form and regimen that would require PA should be given authorization for a full year
All other compelling cases of stability should be reviewed with a supervisor or clinical reviewer of the day. If clinical review/supervisor is not available and compliance is an issue, please approve or deny based on your professional clinical judgment and forward to clinical review for follow-up. If necessary, attempt to contact the pharmacy for a 3 day emergency override.
All drugs that require a PA will continue to process at the pharmacy without recertification for the drug itself as long as there are paid claims in history for 90 days of therapy out of the last 120. However, quantity limits and polypharmacy rules continue to apply. If there is a lapse in therapy, members will require prior authorization following above stated criteria unless other stability criteria are met. For members <18 years of age, all requests will be reviewed using the MassHealth Pediatric Behavioral Health Medication Initiative guideline, regardless of stability.
Requests for Abilify® Maintena® (aripiprazole extended-release injection)
A point of sale rule for Abilify® Maintena® (aripiprazole extended-release injection) will allow a claim to pay without a submitted prior authorization if the member has 90 days of therapy out of the last 120 days. If there are no claims in history, documentation of stability on Abilify® Maintena® will be accepted if the member has been stable for at least three months and the provider documents the start date of therapy. Members with breaks in therapy will be required to transition to Aristada® (aripiprazole lauroxil) unless there is documentation of a hospitalization or other compelling situation. In addition, any submitted court order (Roger’s Order) that cites a specific drug, dose, dosage form and regimen should be approved.
All other compelling cases of stability should be reviewed with a supervisor or clinical reviewer of the day. If clinical review/supervisor is not available and compliance is an issue, please approve or deny based on your professional clinical judgment and forward to clinical review for follow-up. If necessary, attempt to contact the pharmacy for an emergency override. For members <18 years of age, all requests 13 Administered for the MassHealth Pharmacy Program
will be reviewed using the MassHealth Pediatric Behavioral Health Medication Initiative guideline, regardless of stability.
Outgoing denial messaging for Abilify Maintena® requires addition of the following statement: “Please note, Aristada® (aripiprazole lauroxil) is available without prior authorization within established limits.”
Grandfathering
Prior to 2/12/18, Abilify® Maintena® (aripiprazole extended-release injection) was available without PA for members ≥ 6 years of age within the quantity limit of 1 vial or syringe/month. Prescriptions written prior to 02/12/18 will be grandfathered for the life of the prescription. A point of sale rule exists to allow members who continue to fill the agent (90 days out of the 120 days of therapy) to continue treatment without a prior authorization. New prescriptions written on or after 02/12/18 will require prior authorization if the point of sale rule criteria are not met.
Historical: Prior to 3/1/10, Invega® (paliperidone) tablets were available without PA. Prescriptions written on or before 3/1/10 were grandfathered and did not require PA (no longer applicable after 3/2/11). A POS rule was created at that time to allow members who maintain compliance (90/120 days of therapy) to continue on the medication without requiring a PA. However, if the member has a lapse in compliance, a written PA request will be required and should be reviewed as a new start.
Prior to 5/13/13, Abilify® (aripiprazole) and Seroquel XR® (quetiapine extended-release) were available without PA (within quantity limits and polypharmacy rules) for adult members 18 years of age and older. Prescriptions written on or before 5/13/13 were grandfathered for the life of the prescription. A POS rule was created to allow members who maintain compliance (90/120 days of therapy) to continue on the medication without requiring a PA. However, if the member has a lapse in compliance, a written PA request will be required and should be reviewed as a new start unless criteria for stability are met.
Prior to 05/31/2016, first-generation (typical) antipsychotics were available without PA (monotherapy and polypharmacy). First-generation (typical) antipsychotics monotherapy will continue to be available without PA. Prescriptions written prior to 05/31/2016 as part of a polypharmacy regimen will be grandfathered for the life of the prescription.
MassHealth Pediatric Behavioral Health Medication Initiative
The Pediatric Behavioral Health Medication Initiative requires prior authorization for members <18 years of age for behavioral health medication classes and/or specific medication combinations (i.e., polypharmacy) that have limited evidence for safety and efficacy in the pediatric population. The aspects of the MassHealth Pediatric Behavioral Health Medication Initiative that may apply to the Second- generation (Atypical) Antipsychotic guideline include the following:
1. Behavioral health medication polypharmacy (pharmacy claims for 4 or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, hypnotic agents, and mood stabilizers] filled within a 45 day period) 2. Antipsychotic polypharmacy (overlapping pharmacy claims for 2 or more antipsychotics for ≥60 days within a 90 day period) 3. Antipsychotic pharmacy claim for pediatric members less than 6 years old
14 Administered for the MassHealth Pharmacy Program
Please refer to the MassHealth Pediatric Behavioral Health Medication Initiative guideline to assess appropriateness of therapy when reviewing prior authorization requests for pediatric members <18 years of age.
Duration of Approval / Denial Scenarios
Please note: For members <18 years of age, all requests for antipsychotics will also be reviewed using additional criteria in the MassHealth Pediatric Behavioral Health Medication Initiative guideline.
Age – use for aripiprazole or quetiapine extended-release monotherapy
Age – Standard Approval (1 year) o Select this approval for quetiapine extended-release as it requires PA for adult members only
Age – Denial o Select appropriate denial based on diagnosis AND drug ( quetiapine extended-release) . Autism and Depression = LCA . General psych dx = LOI
Drug – use for Fanapt ® (iloperidone), Latuda® (lurasidone), paliperidone, Rexulti® (brexpiprazole), Saphris® (asenapine), or Vraylar® (cariprazine) monotherapy
Drug - Standard Approval (1 year) o The request is for monotherapy not above quantity limits and the appropriate approval criteria are met for Fanapt® (iloperidone), Latuda® (lurasidone), paliperidone, Rexulti® (brexpiprazole), Saphris® (asenapine), or Vraylar®(cariprazine) Drug – Fanapt Titration Pack Approval o If a PA is received specifically for Fanapt® (iloperidone) titration pack and it is approvable, then please enter two PA approvals; one approval for Fanapt® (iloperidone) titration pack (Drug – Fanapt Titration Pack) and another PA for all strengths of Fanapt® (iloperidone) (Drug – Standard). This will allow the member to titrate and become stabilized on a dose and then continue to receive the medication without having to resubmit a PA as long as it is within quantity limits o If a PA is received for Fanapt® (iloperidone) tablets (does not specify titration pack) and is approvable, then please enter one PA approval for all strengths of Fanapt® (iloperidone) (excluding the titration pack) (Drug – Standard)
Drug– LOI Denials o Select appropriate denial based on age of member; <18 or ≥18 years
Drug – paliperidone Tolerability: o Select this LCA denial if request indicates that the prescriber wishes to establish the member’s tolerability to paliperidone (using tablets) before start the member on Invega® Sustenna (paliperidone) intramuscular injection.
15 Administered for the MassHealth Pharmacy Program
Dosage Form – use for ODTs (all ages), aripiprazole solution for adult members or Versacloz® (clozapine suspension) (all ages)
Dosage Form - Standard Approval (1 year) in ANY of the following cases: o The request meets the approval criteria requirements stated in the procedure table above o The request states the member is acutely psychotic (recently discharged or even if no mention of hospitalization) and has been witnessed cheeking medications o The request states the member has a psychological aversion to other formulations o Roger’s Order is provided that specifically states the member must have the ODT or solution or suspension formulation
Dosage Form – LOI Denials o Select appropriate denial based on age of member; <18 or ≥18 years
Dosage Form – aripiprazole solution Denial o Select this LOI denial for aripiprazole solution for an adult member ONLY. As a reminder, aripiprazole solution is available without a PA for pediatric members
Dosage Form – Versacloz® (clozapine suspension) Denial o Select this LOI denial for Versacloz® (clozapine) for all members
Dosage Form - Roger’s Order Denial o Select this LOI denial if the request references a Roger’s Order, but a copy of the order is not included. A call to the office informing them of this should be attempted and documented in the internal comment
Polypharmacy (for members ≥ 18 years old) - use of antipsychotics being used as polypharmacy, which includes first-generation antipsychotics and second generation antipsychotics. Clozapine and injectable formulations are excluded from the polypharmacy restriction.
Polypharmacy - Provisional Approval (3 months) in the following case: o The request clearly states the goal is to taper/transition from one agent to the other and meets all other approval criteria.
Polypharmacy - Standard Approval (1 year) in ANY of the following case): o All approval criteria met. o The request documents member is a risk of harm to self/others and/or recent hospitalization in which the requested polypharmacy regimen was initiated and all approval criteria is NOT met.
Polypharmacy - LOI Denial in ANY of the following cases: o The request does not address dose and frequency of all antipsychotic medications the member is taking. A call to the office for clarification should be attempted and documented in the internal comment. o No other criteria for a provisional or standard approval is met
16 Administered for the MassHealth Pharmacy Program
Quantity Limits – use for all generic second-generation (atypical) antipsychotics above quantity limits
Quantity limits - Standard Approval (1 year) in ANY of the following cases: o The request states (or POPS claims show history) that the requested drug was ineffective at maximum FDA recommended dosing o The member is currently suicidal o The request is for two strengths of the same second-generation (atypical) antipsychotic which create a dose that is not commercially available. Requests should not be denied if the dose consolidation would require the splitting of tablets (see table titled “GSNs when Processed Together Adds to a Strength that is Not Commercially Available and the Copayment for the Second Agent Processed is Waived for the Member”) o Certain claims for two strengths of the same second-generation (atypical) antipsychotic will pay at the pharmacy if the member is not routinely filling both together (<45 days in the last 60 day period). These requests should be approved (see table in “Breakthrough Dosing”section)
Quantity Limits - LOI Denial in ANY of the following cases: o No other criteria for approval is met o The request is for two strengths of the same second-generation (atypical) antipsychotic which may be dose consolidated into a commercially available strength (and the prescriber has not documented rationale for not consolidating the dose; a call to the office to inform of denial and what is needed should be attempted and documented). Requests should not be denied if the dose consolidation would require the splitting of tablets o The request states the lower dose is for breakthrough, but the member has been filling both consistently (>45 days in the last 60 day period). Please discuss with clinical reviewer- this may require a phone call to the prescriber to discuss increasing the total daily maintenance dose for next fill. If it is unclear if the member has filled for < 45 days in a 60 day period or the claims history does not match with the prn dosing documented by the prescriber, please forward to clinical review. If clinical review/supervisor is not available and compliance is an issue, please approve or deny based on your professional clinical judgment and forward to clinical review for follow- up. If necessary, attempt to contact the pharmacy for a 3 day emergency override Phone overrides for quantity limits: o MassHealth will accommodate members who are exceeding quantity limits due to dose titration in the last 30 days with a telephone override. If the new dose exceeds quantity limits, then a written PA request must be submitted.
Age and Polypharmacy (for members ≥ 18 years old) – use for quetiapine extended-release along with polypharmacy
Age and Polypharmacy – Provisional Approval (3 months) o The request states the member is currently stable on the requested regimen including quetiapine extended-release and meets the definition of stability, but does NOT meet the polypharmacy approval criteria.
Age and Polypharmacy – Standard Approval (1 year)
17 Administered for the MassHealth Pharmacy Program
o The request demonstrates no intention to alter the regimen including quetiapine extended- release in the future (i.e. states the member needs to be on this regimen, the request is consistent with a previous request and the POPS claims confirm regimen) and meets the polypharmacy approval criteria.
Age and Polypharmacy – Denials o Select appropriate denial based on diagnosis AND drug . Autism and Depression = LCA . General psych dx = LOI
Age and Quantity Limits – use for quetiapine extended-release above quantity limits o Select appropriate denial based on diagnosis AND drug . Autism and Depression = LCA . General psych dx = LOI
Drug and Polypharmacy (for members ≥ 18 years old) – use for Fanapt ® (iloperidone), Latuda® (lurasidone), paliperidone, Rexulti® (brexpiprazole), Saphris® (asenapine) or Vraylar® (cariprazine) as part of regimen for polypharmacy
Drug and Polypharmacy – Provisional Approval (3 months) o The request states the member is currently stable on the requested regimen including Fanapt® (iloperidone), Latuda® (lurasidone), paliperidone, Rexulti® (brexpiprazole), Saphris® (asenapine), and/or Vraylar® (cariprazine) and meets the definition of stability, but does NOT meet the polypharmacy approval criteria.
Drug and Polypharmacy – Standard Approval (1 year) o The request demonstrates no intention to alter the regimen Fanapt® (iloperidone), Latuda® (lurasidone), paliperidone, Rexulti® (brexpiprazole), Saphris® (asenapine), and/or Vraylar® (cariprazine) in the future (i.e. states the member needs to be on this regimen, the request is consistent with a previous request or the POPS claims confirm regimen) and meets the polypharmacy approval criteria
Drug and Polypharmacy – LOI Denials o Select appropriate denial based on age of member; <18 or ≥18 years
Drug and Quantity Limits – use for Fanapt ® (iloperidone), Latuda® (lurasidone), paliperidone, Rexulti® (brexpiprazole), Saphris® (asenapine), Vraylar® (cariprazine) above quantity limits o Select appropriate LOI Denial based on age of member; <18 or ≥18 years
Polypharmacy (for members ≥ 18 years old) and Quantity Limits – use only for combination of generic second-generation (atypical) antipsychotics
Polypharmacy and Quantity Limits - Provisional Approval (3 months) o The request states the member is currently stable on the requested regimen and meets the definition of stability, but does NOT meet the polypharmacy approval criteria 18 Administered for the MassHealth Pharmacy Program
Polypharmacy and Quantity Limits - Standard Approval (1 year) if ALL of the following criteria is met: o The request states (or POPS claims show history) that the requested drug (that is over the QL) at maximum FDA recommended dosing was ineffective o The request demonstrates no intention to alter the regimen in the future (i.e. states the member needs to be on this regimen, the request is consistent with a previous request and the POPS claims confirm regimen) and meets the polypharmacy approval criteria
Multiple – use for two or more PA Reasons that do not already have specific messaging
Multiple – LOI Denials o Select appropriate denial based on age of member; <18 or ≥18 years and delete any of the pre-populated messaging that does not apply to why the request is being denied.
Quantity Limit Scenarios: Applies to All Second-Generation (Atypical) Antipsychotic Agents
Please note: For members <18 years of age, all requests for antipsychotics will also be reviewed using additional criteria in the MassHealth Pediatric Behavioral Health Medication Initiative guideline.
If you are approving a request for multiple strengths of the same medication that would cause it to be above quantity limits, i.e. aripiprazole 5 mg QD and aripiprazole 10 mg QD PRN, please enter one PA using the GL list with a max daily dose of 1, units and day amount of all 9999s with a DQ template. This will allow the member to get up to 1/day of more than one strength of the medication for titration purposes
If you are approving a request for over the quantity limit of a single medication, i.e. aripiprazole 5 mg BID, please enter one PA using the GL list with a max daily dose of 2, units and day amount of all 9999s with a DQ template. This will allow the member to get up to 2/day of any strength of the medication
The above two scenarios would apply for 3/day, etc…depending on the medication and its quantity limits
Renal and Hepatic Dosing2-18, 85-88
Many second-generation (atypical) antipsychotics do not require dose adjustment for renal or hepatic impairment. The prescribing information suggests avoiding the use of Fanapt® (not recommended in any level of hepatic impairment), paliperidone (in severe renal impairment) and Saphris® (in severe hepatic impairment). Please take all information (including other therapies that could be used) into consideration if request addresses renal or hepatic impairment. Requests for paliperidone that state “hepatic impairment” should generally not be approved as risperidone can be dose adjusted in all cases and many other second-generation (atypical) antipsychotics that do not require PA also do not require adjustment for hepatic impairment.
Drug Renal Dosing Hepatic Dosing Abilify®, Abilify® No change No change 19 Administered for the MassHealth Pharmacy Program
Drug Renal Dosing Hepatic Dosing Maintena®, Aristada® (aripiprazole) Clozaril®, FazaClo®, Not studied in renal dysfunction; Not studied in hepatic dysfunction; Versacloz® (clozapine) however, dose reduction may be however, dose reduction may be necessary with significant necessary with significant impairment impairment Fanapt® (iloperidone) No change Not recommended for use in hepatic impairment Geodon® (ziprasidone) Oral: no change Oral: no change (even though IM: administer with caution as hepatically metabolized) cyclodextrin excipient is excreted IM: has not been systematically renally evaluated Invega®, Invega® Mild impairment (CrCL >50 mL/min Mild-moderate impairment (Class Sustenna®, Invega® to <80 mL/min): 3 to 6 mg daily; for A/B): no dose adjustment Trinza® (paliperidone) Invega® Sustenna®: 156 mg on treatment day 1 and 117 mg one Severe impairment: not studied week later followed by monthly injections of 78 mg
Moderate/severe impairment (CrCL >10 mL/min to <50 mL/min): 1.5 to 3 mg daily; Invega® Sustenna® is not recommended for use in patients with CrCL <50 mL/min
CrCL <10 mL/min: not recommended for use Latuda® (lurasidone) Moderate/severe impairment (CrCL Moderate/severe impairment (Class >10 mL /min to <50 mL /min) B/C): maximum dose = 80 mg maximum dose: 80 mg daily (moderate) and 40 mg daily (severe) Rexulti® (brexpiprazole) Moderate, severe, or end-stage renal Moderate to severe hepatic impairment (CrCl <60 mL/minute): impairment (Child-Pugh score ≥7): maximum recommended dosage is 2 maximum recommended dosage is 2 mg once daily for MDD and 3 mg mg once daily for MDD and 3 mg once daily for schizophrenia for schizophrenia Risperdal®, Risperdal® Severe impairment: 0.5 mg twice Severe impairment: 0.5 mg twice Consta® (risperidone) daily initially and increase by no daily initially and increase by no more than 0.5 mg twice daily; for more than 0.5 mg twice daily; for Risperdal® Consta®: if oral Risperdal® Consta®: if oral risperidone of at least 2 mg is well risperidone of at least 2 mg is well tolerated, then an injection of 12.5 or tolerated, then an injection of 12.5 or 25 mg may be administered every 2 25 mg may be administered every 2 weeks weeks Saphris® (asenapine) No change Mild/moderate impairment (Class A and B): no change
Severe impairment (Class C): not recommended for use Seroquel® (quetiapine) No change Any level of impairment: initiate at 20 Administered for the MassHealth Pharmacy Program
Drug Renal Dosing Hepatic Dosing 25 mg daily and increase at 25 to 50 mg daily based on response to an effective dose Seroquel XR® (quetiapine No change Any level of impairment: initiate at extended-release) 50 mg daily and increase at 50 mg daily based on response to an effective dose Vraylar® (cariprazine) No dosage adjustment required in No dosage adjustment required in mild to moderate renal impairment mild to moderate hepatic (CrCl≥30 mL/min). Use of impairment. Use of cariprazine in cariprazine in severe renal severe hepatic impairment has not impairment (CrCl <30mL/min) has been evaluated. not been evaluated. Zyprexa® (olanzapine) No change No change
Olanzapine Oral or ODT for Chemotherapy-Induced/Radiation-Induced and Postoperative Nausea/Vomiting (CINV, RINV, PONV)41-44
The published literature using olanzapine as an antiemetic have suggested its therapeutic role as adjunctive therapy in the prevention of chemotherapy-induced nausea and vomiting (CINV). The ASCO (American Society of Clinical Oncology), MASCC (Multinational Association of Supportive Care in Cancer), and NCCN (National Comprehensive Cancer Network) guidelines have all recommended ® various combinations of 5-HT3 antagonists, dexamethasone, Emend (aprepitant), and/or lorazepam for prophylaxis against CINV when cancer chemotherapy regimens with moderate to high emesis risk are used. A recent update to the ASCO guidelines also noted that olanzapine can be considered for addition to the antiemetic regimen for emesis or nausea occurring despite optimal prophylaxis. However, they also note that additional trials are needed to define the role of olanzapine in this setting.42 The NCCN guideline recommends that olanzapine 10 mg daily for three days can be added to a current regimen when breakthrough antiemetic treatment for CINV is needed.44
Requests to approve olanzapine for CINV/RINV/PONV should meet ALL of the following criteria: 1. Inadequate response, adverse reaction, or contraindication to THREE antiemetics (conventional or non-5HT3 receptor antagonists) from two different classes. History of claims in POPS is sufficient. (Refer to Antiemetics guideline for more information) 2. Maximum daily dose does not exceed ≥2 tablets daily of either the 2.5 mg or 5 mg tablets
NOTE for POPS processing: For oral olanzapine, a standard DQ template would be used for 60/30 quantities; for olanzapine ODT both a DQ (for quantity) and DL (for ODT) template would be used.
Duration of approval: 3 months
For members <18 years of age, all requests for antipsychotics will also be reviewed using additional criteria in the MassHealth Pediatric Behavioral Health Medication Initiative guideline.
Requests for Oral Paliperidone Citing Need to Stabilize Prior to Invega® Sustenna® Initiation9,45
The prescribing information for Invega® Sustenna® (paliperidone) states the following:
21 Administered for the MassHealth Pharmacy Program
For members who have never taken oral Invega® (paliperidone) or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with Invega® Sustenna®.
The prescribing information also contains exact dosing equivalents: Invega® Sustenna® (paliperidone) 39 to 78 mg, 117 mg and 234 mg maintenance doses injected once monthly provide steady-state exposure similar to 3 mg, 6 mg and 12 mg daily doses of oral paliperidone, respectively. Also, limited evidence does suggest similar efficacy between paliperidone 6 to 12 mg and risperidone 4 to 6 mg.41
It is recommended that requests for paliperidone oral tablets that specifically cite the need to stabilize prior to initiation of Invega® Sustenna® (paliperidone) are denied and the Invega® Tolerability denial message is utilized:
Your prior authorization request for
For members <18 years of age, all requests for antipsychotics will also be reviewed using additional criteria in the MassHealth Pediatric Behavioral Health Medication Initiative guideline.
Availability and Dosage2-18, 85-88
Drug Recommended Dose/Dose Range* Availability GSN Abilify®, Schizophrenia: 2 mg tablet 060225 Abilify 10 to 30 mg daily 5 mg tablet 052898 Maintena® 10 mg tablet 051333 (aripiprazole)†, 400 mg monthly (Abilify Maintena®) 15 mg tablet 051334 ® Aristada 20 mg tablet 051335 ® (aripiprazole 441 mg to 882 mg monthly or every-six-weeks (Aristada ) 30 mg tablet 051336 lauroxil) 1 mg/mL 058594 Bipolar disorder: solution 15 to 30 mg daily 10 mg Discmelt 060319 Irritability associated with autistic disorder: 15 mg 060322 5 to 15 mg daily Discmelt 300 mg 070669 Adjunct treatment to antidepressants for the treatment of Maintena® major depressive disorder: vial 2 to 15 mg daily 300 mg 073298 Maintena® syringe 400 mg 070670 Maintena® vial 400 mg 073299 Maintena® syringe
22 Administered for the MassHealth Pharmacy Program
Drug Recommended Dose/Dose Range* Availability GSN 441 mg 074887 Aristada® syringe 662 mg 074888 Aristada® syringe 882 mg 074889 Aristada® syringe 1,064 077464 Aristada® syringe Fanapt® Schizophrenia: 1 mg tablet 065901 (iloperidone) 6 to 12 mg twice daily 2 mg tablet 065902 4 mg tablet 065903 6 mg tablet 065904 8 mg tablet 065905 10 mg tablet 065906 12 mg tablet 065907 Titration 065908 pack (21 mg, 22 mg, 24 mg, 26 mg – total of 8 tablets) Clozaril®, Treatment resistant schizophrenia and reducing the risk of 25 mg tablet 013648 FazaClo®, recurrent suicidal behavior in patients with schizophrenia or 50 mg tablet 027037 Versacloz® schizoaffective disorder: 100 mg 013649 (clozapine) Initially 12.5 mg once or twice daily with a target dose of 300 tablet to 450 mg daily by the end of 2 weeks with a maximum daily 200 mg 046416 dose of 900 mg daily in three divided doses tablet 12.5 mg 063031 ODT 25 mg ODT 053994 100 mg ODT 053995 150 mg ODT 066557 200 mg ODT 066558 50 mg/mL 064429 oral suspension Geodon® Schizophrenia: 20 mg 047563 (ziprasidone) ‡ 20 to 80 mg twice daily capsule 40 mg 047564 Bipolar disorder: capsule 40 to 80 mg twice daily 60 mg 047567 capsule Acute agitation in schizophrenia: 80 mg 047568
23 Administered for the MassHealth Pharmacy Program
Drug Recommended Dose/Dose Range* Availability GSN 10 mg IM every 2 hours or 20 mg IM every 4 hours up to capsule maximum of 40 mg daily 20 mg vial 050102 for injection Invega®, Schizophrenia/Schizoaffective disorder: 1.5 mg ER 065667 Invega® 3 to 12 mg daily tablet Sustenna®§, 3 mg ER 061985 Invega® 234 mg initial IM dose, 156 mg one week later and 117 mg tablet Trinza® monthly thereafter with range of 39 to 234 mg based on 6 mg ER 061986 (paliperidone) tolerability and/or efficacy (Invega® Sustenna®) tablet 9 mg ER 061987 273 mg to 819 mg IM every three months (Invega® Trinza®) tablet ® administered after at least four months of stability Invega 39 mg 065448 ® Sustenna Sustenna injection ® ® The initial Invega Trinza dose should be determined as 78 mg 065449 follows: Sustenna ® Invega Sustenna Invega Trinza injection ® (paliperidone palmitate) (paliperidone palmitate) 117 mg 065450 Dose Dose Sustenna 78 mg 273 mg injection 117 mg 410 mg 156 mg 065451 156 mg 546 mg Sustenna 234 mg 819 mg injection 234 mg 065452 Sustenna injection 273 mg 074140 Trinza injection 410 mg 074141 Trinza injection 546 mg 074142 Trinza injection 819 mg 074143 Trinza injection Latuda® Schizophrenia: 20 mg tablet 068448 (lurasidone) 40 to 160 mg once daily 40 mg tablet 066932 60 mg tablet 071415 Bipolar depression: 80 mg tablet 066933 20 to 120 mg once daily 120 mg 069894 This medication should be taken with food (at least 350 tablet calories) Rexulti® Adjunctive Treatment of Major Depressive Disorder: 0.25 mg 074442 (brexpiprazole) Initial dose of 0.5 mg or 1 mg orally once daily. Titrate to 1 tablet mg once daily, then up to the target dosage of 2 mg once 0.5 mg tablet 074444 24 Administered for the MassHealth Pharmacy Program
Drug Recommended Dose/Dose Range* Availability GSN daily. Dose increases should occur at weekly intervals. 1 mg tablet 074445 Maximum daily dose is 3 mg. 2 mg tablet 074446 3 mg tablet 074447 Schizophrenia: 4 mg tablet 074448 Initial dose of 1 mg orally once daily on days one to four. Target dosage is 2 mg to 4 mg once daily. Titrate to 2 mg once daily on day five through day seven, then to 4 mg on day eight. Maximum daily dose is 4 mg. Risperdal®, Schizophrenia: 0.25 mg 042922 Risperdal® 1 mg twice daily up to 4 to 16 mg once daily or twice daily tablet Consta® 0.5 mg tablet 042923 (risperidone) 25 to 50 mg IM every 2 weeks (Risperdal® Consta®) 1 mg tablet 021154 2 mg tablet 021155 Bipolar mania: 3 mg tablet 021156 2 to 6 mg once daily 4 mg tablet 021157 1 mg/mL 026177 ® ® 25 to 50 mg IM every 2 weeks (Risperdal Consta ) solution (30 mL) Irritability associated with autistic disorder: 12.5 mg 062640 0.25 to 3 mg daily Consta injection 25 mg 052934 Consta injection 37.5 mg 052935 Consta injection 50 mg 052936 Consta injection 0.25 mg 065235 ODT 0.5 mg ODT 052049 1 mg ODT 051799 2 mg ODT 051800 3 mg ODT 059402 4 mg ODT 059403 1 mg/mL 071304 syringe¶ 2 mg/2 mL 071305 syringe¶ 3 mg/3 mL 071306 syringe¶ Saphris® Schizophrenia: 2.5 mg 073981 (asenapine) 5 to 10 mg twice daily sublingual tablet Bipolar disorder: 5 mg 065537 2.5 to 10 mg twice daily sublingual tablet 25 Administered for the MassHealth Pharmacy Program
Drug Recommended Dose/Dose Range* Availability GSN 10 mg 065538 sublingual tablet Seroquel® Schizophrenia: 25 mg tablet 034187 (quetiapine) 150 to 800 mg/day twice daily or three times daily 50 mg tablet 060292 100 mg 034188 Bipolar depression: tablet 300 mg daily 200 mg 034189 tablet Bipolar mania/Bipolar I disorder maintenance: 300 mg 047198 400 to 800 mg/day twice daily tablet 400 mg 060293 tablet Seroquel XR® Schizophrenia: 50 mg XR 063240 (quetiapine 400 to 800 mg once daily in the evening tablet extended- 150 mg XR 064725 release) Bipolar I disorder: tablet 400 to 800 mg once daily 200 mg XR 062748 tablet Bipolar depression: 300 mg XR 062749 300 mg once daily tablet 400 mg XR 062750 Adjunct treatment to antidepressants for the treatment of tablet major depressive disorder: 50 mg-200 074076 150 to 300 mg once daily mg-300 mg XR tablet ¥ starter pack
Vraylar® Schizophrenia: 1.5 mg 074807 (cariprazine) 1.5 mg to 6 mg daily capsule
Manic of mixed episodes associated with bipolar I disorder: 3 mg 074808 1.5 mg to 6 mg daily capsule 4.5 mg 074809 capsule 6 mg 074810 capsule Dose pack 075566 (1.5 mg/3 mg capsules) Zyprexa®, Schizophrenia: 2.5 mg tablet 029077 Zyprexa® 5 to 20 mg daily 5 mg tablet 027961 Relprevv® 7.5 mg tablet 027959 (olanzapine) Bipolar disorder: 10 mg tablet 027960 10 to 20 mg daily 15 mg tablet 041026 20 mg tablet 041027 26 Administered for the MassHealth Pharmacy Program
Drug Recommended Dose/Dose Range* Availability GSN Agitation associated with schizophrenia: 5 mg Zydis 045190 2.5 to 10 mg IM (max of 3 doses every 2 to 4 hours) tablet 10 mg Zydis 045191 Depressive episodes associated with bipolar I disorder: tablet 5 mg/20 mg once daily (as Symbyax®) 15 mg Zydis 047285 tablet Treatment resistant depression: 20 mg Zydis 047286 5 mg/20 mg once daily (as Symbyax®) tablet 10 mg vial 050386 ® ® Recommended dosing of Zyprexa Relprevv based on for injection corresponding oral olanzapine doses: 210 mg 065795 Relprevv Target oral Dosing of Maintenance injection olanzapine Zyprexa dose after 8 dose Relprevv weeks of 300 mg 065794 during the Zyprexa Relprevv first 8 weeks Relprevv injection treatment 405 mg 065793 10 mg/day 210 mg/2 150 mg/2 weeks or weeks or 300 Relprevv 405 mg/4 mg/4 weeks injection weeks 15 mg/day 300 mg/2 210 mg/2 weeks weeks or 405 mg/4 weeks 20 mg/day 300 mg/2 300 mg/2 weeks weeks
* Recommended dose/dose range is for adults (unless indication is specifically for use in pediatric population i.e. autistic disorder); please refer to appropriate package inserts for pediatric doses. † Members may be converted to aripiprazole solution from tablets on a mg per mg basis. However, those receiving 30 mg of aripiprazole should receive 25 mg of the solution due to enhanced absorption of the solution at higher dosages.2 ‡ Ziprasidone hydrochloride for capsules and ziprasidone mesylate for IM injection.6 § The first dose of Invega® Sustenna® should be administered in the deltoid muscle and starting second dose, it can be administered either in the deltoid or gluteal muscle.7 ¶ Risperidone 1 mg/mL, 2 mg/2 mL and 3 mg/3mL oral syringes currently do not participate in federal rebate program. ¥ Available in a starter pack. Seroquel XR 50 mg-200 mg-300 mg starter packs are sample kits. Prior authorization should not be entered for these products.
Enterprise Messaging*
Message Type ENTERPRISE APPROVAL MESSAGES PA Reason: Age Approvals Standard Your prior authorization request for
Seroquel XR – LOI Your prior authorization request for
use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. LOI, Your prior authorization request for
29 Administered for the MassHealth Pharmacy Program
≥6 and <18 years of generic risperidone tablets to determine tolerability. Since the member is <18 age, years of age, additional documentation (e.g., diagnosis/target symptoms, Pedi Initiative: previous drug trials, treatment plan for each medication and indication, specialist Antipsychotic consult, comprehensive behavioral health plan with non-pharmacologic polypharmacy interventions, treatment stage, medical rationale for antipsychotic polypharmacy) is also required. In addition, use of 4 or more behavioral health medications in members <18 years of age requires prior authorization. If applicable, please provide medical rationale for the use of multiple behavioral health medications in this pediatric member. For additional information about antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. Invega Tolerability, Your prior authorization request for
Standard Your prior authorization request for
Health Medications prior authorization. Please provide medical rationale for the use of multiple behavioral health medications in this pediatric member along with other documentation (e.g., diagnoses, treatment plan for each medication and indication, specialist consult). For additional information about antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. LOI ≥18 years of Your prior authorization request for
antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. Abilify solution, Your prior authorization request for
Versacloz Your prior authorization request for
Versacloz Your prior authorization request for
Versacloz Your prior authorization request for
Versacloz Your prior authorization request for
Versacloz Your prior authorization request for
Antipsychotic member is <18 years of age, additional documentation (e.g., diagnosis/target polypharmacy AND symptoms, previous drug trials, treatment plan for each medication and Age <6 indication, specialist consult, comprehensive behavioral health plan with non- pharmacologic interventions, treatment stage, medical rationale for antipsychotic polypharmacy) is needed. In addition, use of 4 or more behavioral health medications in members <18 years of age requires prior authorization. If applicable, please provide medical rationale for the use of multiple behavioral health medications in this pediatric member. For additional information about antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist.
Versacloz Your prior authorization request for
Drug List at www.mass.gov/druglist. Roger’s Order, Your prior authorization request for
Denials LOI Your prior authorization request for
Health Medications Prescriber may submit a new prior authorization request with additional clinical documentation of dose and frequency of all antipsychotics the member is taking and complete treatment plan. In addition, use of 4 or more behavioral health medications in members <18 years of age requires prior authorization. Please provide medical rationale for the use of multiple behavioral health medications in this pediatric member along with other documentation (e.g., diagnoses, treatment plan for each medication and indication, specialist consult). For additional information about antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. PA Reason: Quantity Limits Approvals Standard Your prior authorization request for
pediatric member. For additional information about antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. LOI, Your prior authorization request for
the antipsychotic medications if clinically appropriate. Additional information regarding the MassHealth Drug List can be found at www.mass.gov/druglist. Seroquel XR – LOI Your prior authorization request for
consult, medical rationale for polypharmacy within the same medication class). Provisional – Your prior authorization request for
Pedi Initiative: not contain sufficient information to determine medical necessity. MassHealth Multiple Behavioral pharmacy claims also indicate that this member already fills another Health Medications antipsychotic agent. Prescriber may submit a new prior authorization request with additional clinical documentation INCLUDING: 1) previous antipsychotic drug trials AND 2) dose and frequency of all antipsychotics the member is taking. In addition, use of 4 or more behavioral health medications in members <18 years of age requires prior authorization. Please provide medical rationale for the use of multiple behavioral health medications in this pediatric member along with other documentation (e.g., diagnoses, treatment plan for each medication and indication, specialist consult). For additional information about antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. LOI ≥18 years of Your prior authorization request for
<18 years of age requires prior authorization. If applicable, please provide medical rationale for the use of multiple behavioral health medications in this pediatric member. For additional information about antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. LOI, Your prior authorization request for
age not contain sufficient information to determine medical necessity for requested drug AND for quantities greater than those normally prescribed. Many oral second-generation (atypical) antipsychotics do not require prior authorization within established limits (clozapine, olanzapine, immediate-release quetiapine, risperidone, ziprasidone). Prescriber may submit a new prior authorization request with additional clinical documentation (e.g., trials with < > at FDA- approved doses or dosing interval, treatment plan including names of current antipsychotics and corresponding diagnoses, previous antipsychotic monotherapy trials, specialist consult, medical rationale for polypharmacy within the same medication class). Additional information regarding the MassHealth Drug List can be found at www.mass.gov/druglist. PA Reason: Polypharmacy and Quantity Limits Approvals Provisional Your prior authorization request for
(Consultants: Please provide specific quantity limits for requested medication above quantity limits). Standard Your prior authorization request for
indication, specialist consult, medical rationale for antipsychotic polypharmacy) is also required. In addition, use of 4 or more behavioral health medications in members <18 years of age requires prior authorization. If applicable, please provide medical rationale for the use of multiple behavioral health medications in this pediatric member. For additional information about antipsychotic agent use and the Pediatric Behavioral Health Medication Initiative, please refer to the MassHealth Drug List at www.mass.gov/druglist. LOI, Your prior authorization request for quantity limit of < #/month>.> Please ensure that all necessary documentation has been submitted including < previous trials with all medications that do not require PA, medical records documenting outcome of trial with the FDA approved generic agent, medical necessity for a disintegrating tablet dosage form, dose and frequency of all antipsychotics the member is taking AND complete treatment plan, rationale for dosing outside of FDA approved package labeling >. Additional information regarding the MassHealth Drug List can be found at www.mass.gov/druglist. (Consultants: Please select the appropriate message and delete the rest). LOI ≥18 years of Your request for Processing Requests POPS* Is there a POS rule that allows "X" drug to Yes pay at the pharmacy without a paper PA? Template ID DL and/or DQ (for Quantity Limit) and/or SS (for Polypharmacy) and/or D1 (for brand name) Max Qty/Day 9999s unless approval is above quantity limit, then as requested/as approved (if more than 1/day of a single medication then max daily = 1; if more than 1/day of single strength then max daily = 2, etc…) GL list Yes (excluding solutions and titration pack) Units Fanapt titration pack: 8 All others: 9999s Day Amount Fanapt titration pack: 30 Provisional: 9999s All others: 9999s Duration of PA Up to 1 year based on Day Amount ENTERPRISE* 45 Administered for the MassHealth Pharmacy Program Category Antipsychotics PA Reason Age Age and Polypharmacy Drug Age and Quantity Limits Dosage Form Drug and Polypharmacy Polypharmacy Drug and Quantity Limits Quantity Limits Polypharmacy and Quantity Limits Multiple Status Reason Approvals Denials Age Standard Seroquel XR – LCA Depression (all Seroquel XR – LOI General psych dx possible Abilify- Brand Name ≥18 scenarios) Drug Standard LOI ≥6 and <18 years of age (all LOI ≥6 and <18 years of age, and polypharm possible LOI in Age <6 scenarios) LOI, polypharm AND Age <6 LOI, Multiple PBHM Fanapt LOI ≥18 years of age, Invega Tolerability Titration Invega Tolerability ≥6 and <18 years of age and polypharm pack Invega Tolerability in Age <6 Invega Tolerability, polypharm AND Age <6 Invega Tolerability, Multiple PBHM Rexulti - Depression Dosage Form Standard LOI ≥6 and <18 years of age LOI ≥6 and <18 years of age and polypharm (all LOI in Age <6 possible LOI, polypharm AND Age <6 scenarios) LOI, Multiple PBHM LOI ≥18 years of age Abilify solution ≥18 years of age Abilify solution, ≥6 and <18 years of age and polypharm Abilify solution in Age <6 Abilify solution, polypharm AND Age <6 Abilify solution, Multiple PBHM Versacloz ≥18 years of age Versacloz ≥6 and <18 years of age Versacloz ≥6 and <18 years of age and polypharm Versacloz in Age <6 Versacloz polypharm AND Age <6 Versacloz, Multiple PBHM Roger’s Order Roger’s Order ≥6 and <18 years of age polypharm Roger’s Order in Age <6 Roger’s Order, polypharm AND Age <6 Roger’s Order, Multiple PBHM Polypharmacy 46 Administered for the MassHealth Pharmacy Program Provisional LOI LOI ≥6 and <18 years of age and polypharm Standard LOI in Age <6 (all LOI, polypharm AND Age <6 possible LOI, Multiple PBHM scenarios) Quantity Limits Standard LOI (all LOI ≥6 and <18 years of age and polypharm possible LOI in Age <6 scenarios) LOI, polypharm AND Age <6 LOI, Multiple PBHM Age and Polypharmacy Provisional Seroquel XR – LCA Depression Seroquel XR – LOI General psych dx Standard Age and Quantity Limits Standard Seroquel XR – LCA Depression Seroquel XR – LOI General psych dx Drug and Polypharmacy Provisional LOI ≥6 and <18 years of age and polypharm LOI, polypharmacy AND Age <6 Standard LOI, Multiple PBHM (all possible LOI ≥18 years of age scenarios) Drug and Quantity Limits Standard LOI ≥6 and <18 years of age (all possible LOI ≥6 and <18 years of age and polypharm scenarios) LOI in Age <6 LOI, polypharmacy AND Age <6 LOI Multiple PBHM LOI ≥18 years of age Polypharmacy and Quantity Limits Provisional LOI LOI ≥6 and <18 years of age and polypharm Standard LOI in Age <6 (all possible LOI, polypharm AND Age <6 scenarios) LOI, Pedi Initiative: Multiple Behavioral Health Medications Multiple Provisional LOI ≥6 and <18 years of age LOI ≥18 years of age Standard (all possible scenarios) NEW MMIS J code Abilify Maintena: J0401 Aristada: J1942 47 Administered for the MassHealth Pharmacy Program Invega Sustenna: J2426 Invega Trinza: J2426 Risperdal Consta: J2794 Zyprexa Relprevv: J2358 Units Abilify Maintena: 1 mg = 1 unit Aristada: 1 mg = 1 unit Invega Sustenna: 1 mg = 1 unit Invega Trinza: 1 mg = 1 unit Risperdal Consta: 50 mg = 100 units Zyprexa Relprevv: 1 vial = 1 unit *Processing information for members <18 years of age consistent with the MassHealth Pediatric Behavioral Health Medication Initiative are detailed within that specific internal guideline. SmartPA Flowcharts Drugs that follow this rule: aripiprazole ODT (060319, 060322) aripiprazole solution (058594) clozapine ODT (053994, 053995, 063031, 066557, 066558) Fanapt® (065901, 065902, 065903, 065904, 065905, 065906, 065907, 065908) Latuda® (066932, 066933, 068448, 069894, 071415) olanzapine ODT (045190, 045191, 047285, 047286) paliperidone tablet (061985, 061986, 061987, 065667) quetiapine extended-release (062748, 062749, 062750, 063240, 064725, 074076) Rexulti® (074442, 074444, 074445, 074446, 074447, 074448) risperidone ODT (051799, 051800, 052049, 059402, 059403, 065235) Saphris® (065537, 065538, 073981) Versacloz® suspension (064429) Vraylar® (074807, 074808, 074809, 074810, 075566) Short-acting IM injectables Geodon® injection (050102) olanzapine injection (050386) First-generation (typical) and Second-Generation (atypical) Long-acting IM injectables Abilify® Maintena® (070669, 070670, 073298, 073299) Aristada® (074887, 074888, 074889, 077464) fluphenazine decanoate (003818) haloperidol decanoate (003966, 003967, 0011876, 013076 ) Invega Sustenna® (065448, 065449, 065450, 065451, 065452) Invega Trinza® (074140, 074141, 074142, 074143) Risperdal® Consta® (052934, 052935, 052936, 062640) Zyprexa® Relprevv® (065793, 065794, 065795) Generic second-generation (atypical) antipsychotics that do not require PA for the drug itself (except for non-rebate) aripiprazole tablet (051333, 051334, 051335, 051336, 052898, 060225) clozapine tablet (013648, 013649, 027037, 046416) olanzapine tablets (027959, 027960, 027961, 029077, 041026, 041027) quetiapine (034187, 034188, 034189, 047198, 060292, 060293) risperidone tablets (021154, 021155, 021156, 021157, 042922, 042923) 48 Administered for the MassHealth Pharmacy Program risperidone solution (026177) risperidone oral syringes (071304, 071305, 071306) **non-rebate** ziprasidone capsule (047563, 047564, 047567, 047568) First Generation (typical antipsychotics) chlorpromazine (003796, 003797, 003798, 003799, 003800) fluphenazine (003821, 003822, 003823, 003824, 003825, 003826) haloperidol (003972, 003973, 003974, 003975, 003976, 003977) loxapine (003981, 003982, 003983, 003984) molindone (003987, 003989, 003990) perphenazine (003830, 003831, 003832, 003833) perphenazine/amitriptyline (046184, 046185, 046186, 046187, 046188) pimozide (003892, 019448) thioridazine (003859, 003860, 003864, 003865) thiothixene (003995, 003996, 003997, 003999) trifluoperazine (003851, 003852, 003853, 003854) Criteria: 1. Claims for clozapine tablets will usually process and pay at the pharmacy without prior authorization. 2. Claims for Risperdal Consta® and Zyprexa Relprevv® 120 mg, 300 mg at a quantity ≤ 2 syringes within the last 30 days (28 days for Risperdal Consta®) will usually process and pay at the pharmacy without prior authorization. 3. Claims for Aristada® (441 mg, 662 mg and 882 mg) and Zyprexa Relprevv® 405 mg at a quantity ≤ 1 syringe within the last 30 days will usually process and pay at the pharmacy without prior authorization. 4. Claims for Aristada® (1,064 mg) at a quantity ≤ 1 syringe within the last 2 months will usually process and pay at the pharmacy without prior authorization. 5. Claims for Invega Sustenna® will usually process and pay at the pharmacy without prior authorization at a quantity ≤2 syringes within the last 30 days during the first month of treatment and ≤1 syringe within the last 30 days thereafter. 6. Claims for Invega Trinza® at a quantity ≤ 1 syringe within the last 90 days will usually process and pay at the pharmacy without prior authorization. 7. Claims for aripiprazole ODT, clozapine ODT, olanzapine ODT, risperidone ODT and Versacloz® suspension will usually deny at the pharmacy requiring prior authorization. 8. Claims for Abilify Maintena® at a quantity ≤ 1 syringe within the last 30 days will usually process and pay at the pharmacy if the member has a history of paid claims for the reference agent for at least 90 out of 120 days. 9. Claims for Fanapt®, Latuda®, paliperidone tablets, Rexulti®, Saphris®, or Vraylar® within specified quantity limits and polypharmacy requirements will usually process and pay at the pharmacy if the member has a history of a paid claim for the reference agent for at least 90 out of 120 days. Claims for these agents will usually also process and pay for members ≥18 years of age who have a history of paid claims for 2 second-generation (atypical) antipsychotics (excluding reference agent and emergency claims) in all claims history and for members <18 years of age who have a history of one of the following generic second-generation (atypical) antipsychotic: aripiprazole, clozapine, olanzapine, quetiapine, risperidone or ziprasidone; and any two other atypical or typical antipsychotics (brand or generic) in all claims history. 10. Claims for aripiprazole solution, and quetiapine extended-release tablets for members <18 years of age within specified quantity limits and polypharmacy requirements will usually process and pay at the pharmacy without prior authorization. 49 Administered for the MassHealth Pharmacy Program 11. Claims for aripiprazole solution for members ≥18 years of age will usually deny at the pharmacy requiring prior authorization 12. Claims for aripiprazole tablets within specified quantity limits and polypharmacy requirements will usually process and pay at the pharmacy 13. Claims for Rexulti® within specified quantity limits and polypharmacy requirements will usually process and pay at the pharmacy if the member has a diagnosis of major depressive disorder, claims for any two antidepressants in all claims history, and a claim for an antidepressant in the past 30 days. 14. Claims for quetiapine extended-release tablets for members ≥18 years of age within specified quantity limits and polypharmacy requirements will usually process and pay at the pharmacy if the member has a claim for immediate-release quetiapine in all claims history and ONE of the following: a. Diagnosis of major depressive disorder, claims for any two antidepressants in all claims history, and a claim for an antidepressant in the past 30 days, OR b. Claims for any two second-generation (atypical) antipsychotics in all claims history. 15. Claims for quetiapine extended-release within specified quantity limits and polypharmacy requirements will usually process and pay at the pharmacy if the member has a history of a paid claim for the reference agent for 90 out of 120 days. 16. Claims for all antipsychotics for members <18 years of age may be subject to additional PA requirements as outlined in the MassHealth Pediatric Behavioral Health Medication Initiative guideline. 17. Claims for Seroquel XR Sample Kit® (GSN: 074076)* will usually deny. *Available in a starter pack. Seroquel XR Sample Kit® is a sample kit. Prior authorization should not be entered for this product. Polypharmacy for members ≥ 18 years old: MassHealth requires prior authorization for polypharmacy with ≥2 antipsychotics for members ≥ 18 years old. The Smart PA system accomplishes this by evaluating whether the member has claims for ≥2 antipsychotics for at least 60 days of concurrent therapy out of the last 90 days (including first-generation [typical] and second-generation [atypical]) starting yesterday. Clozapine and injectable formulations are excluded. If polypharmacy is detected, the claim will usually deny at the pharmacy requiring prior authorization. Quantity Limits: Stated quantity limits apply to all second-generation (atypical) antipsychotics. If the current claim is above the stated quantity limit, it will usually deny at the pharmacy requiring prior authorization. If the current claim is within the stated quantity limit, but there are claims for the same chemical entity within the last 30 days, and the combination of the quantity of the current claim and the quantity in the historical claim is above the quantity limit, the claim will usually deny at the pharmacy requiring prior authorization. However, these quantity limits denials may be overridden in the following scenarios: Copay Waiver: Select combinations of second-generation (atypical) antipsychotics are allowed to process and pay at the pharmacy. These combinations are allowed to pay because they can be used to reach doses of products 50 Administered for the MassHealth Pharmacy Program that are not commercially available and are outlined in the table immediately following this section. This process occurs in the following steps: 1) If the Smart PA system identifies a claim that due to claims in history is above stated quantity limits, the system will first evaluate whether the current claim is an agent that can be used as part of a treatment regimen to reach a therapeutic dose that is not commercially available. 2) The Smart PA system will then identify whether there is a claim within the last 30 days that can be used with the current claim to reach a therapeutic dose that is not commercially available. 3) If the above criteria are met, the current claim will process and pay at the pharmacy without prior authorization above stated quantity limits. GSNs when Processed Together Adds to a Strength that is Not Commercially Available and the Copayment for the Second Agent Processed is Waived for the Member Drug Strengths GSNs 2 mg and 10 mg 060225 and 051333 ® Abilify (aripiprazole) 2 mg and 5 mg 060225 and 052898 2 mg and 15 mg 060225 and 051334 2 mg and 20 mg 060225 and 051335 5 mg and 20 mg 052898 and 051335 10 mg and 15 mg 051333 and 051334 Fanapt® (iloperidone) 1 mg and 2 mg 065901 and 065902 1 mg and 4 mg 065901 and 065903 1 mg and 6 mg 065901 and 065903 1 mg and 8 mg 065901 and 065905 1 mg and 10 mg 065901 and 065906 1 mg and 12 mg 065901 and 065907 2 mg and 12 mg 065902 and 065907 4 mg and 10 mg 065903 and 065906 4 mg and 12 mg 065903 and 065907 10 mg and 12 mg 065906 and 065907 6 mg and 8 mg 065904 and 065905 6 mg and 12 mg 065904 and 065907 8 mg and 10 mg 065905 and 065906 Geodon® (ziprasidone) 20 mg and 80 mg 047563 and 047568 40 mg and 60 mg 047564 and 047567 Invega® (paliperidone) 1.5 mg and 3 mg 065667 and 061985 1.5 mg and 6 mg 065667 and 061986 1.5 mg and 9 mg 065667 and 061987 6 mg and 9 mg 061986 and 061987 Latuda® (lurasidone) 20 mg and 80 mg 068448 and 066933 20 mg and 120 mg 068448 and 069894 40 mg and 60 mg 066932 and 071415 51 Administered for the MassHealth Pharmacy Program Drug Strengths GSNs Rexulti® (brexpiprazole) 0.25 mg and 0.5 mg 074442 and 074444 0.25 mg and 1 mg 074442 and 074445 0.25 mg and 2 mg 074442 and 074446 0.25 mg and 3 mg 074442 and 074447 0.5 mg and 1 mg 074444 and 074445 0.5 mg and 2 mg 074444 and 074446 0.5mg and 3 mg 074444 and 074447 Risperdal® (risperidone) 0.25 mg and 0.5 mg 042922 and 042923 0.25 mg and 1 mg 042922 and 021154 0.25 mg and 2 mg 042922 and 021155 0.25 mg and 3 mg 042922 and 021156 0.25 mg and 4 mg 042922 and 021157 0.5 mg and 1 mg 042923 and 021154 0.5 mg and 2 mg 042923 and 021155 0.5 mg and 3 mg 042923 and 021156 0.5 mg and 4 mg 042923 and 021157 1 mg and 4 mg 021154 and 021157 2 mg and 3 mg 021155 and 021156 3 mg and 4 mg 021156and 021157 Saphris® (asenapine) 2.5 mg and 5 mg 073981 and 065537 2.5 mg and10 mg 073981 and 065538 5 mg and 10 mg 065537 and 065538 Seroquel® (quetiapine) 50 mg and 200 mg 060292 and 034189 50 mg and 300 mg 060292 and 047198 50 mg and 400 mg 060292 and 060293 100 mg and 400 mg 034188 and 060293 200 mg and 300 mg 034189 and 047198 200 mg and 400 mg 034189 and 060293 Seroquel® XR (quetiapine 50 mg and 200 mg 063240 and 062748 extended-release) 50 mg and 300 mg 063240 and 062749 50 mg and 400 mg 063240 and 062750 150 mg and 200 mg 064725 and 062748 150 mg and 300 mg 064725 and 062749 150 mg and 400 mg 064725 and 062750 200 mg and 300 mg 062748 and 062749 300 mg and 400 mg 062749 and 062750 Zyprexa® (olanzapine) 2.5 mg and 10 mg 029077 and 027960 2.5 mg and 15 mg 029077 and 041026 2.5 mg and 20 mg 029077 and 041027 5 mg and 7.5 mg 027961 and 027959 5 mg and 20 mg 027961 and 041027 7.5 mg and 10 mg 027959 and 027960 52 Administered for the MassHealth Pharmacy Program Drug Strengths GSNs 7.5 mg and 15 mg 027959 and 041026 7.5 mg and 20 mg 027959 and 041027 10 mg and 15 mg 027960 and 041026 10 mg and 20 mg 027960 and 041027 15 mg and 20 mg 041026 and 041027 Breakthrough Dosing: Select combinations of second-generation (atypical) antipsychotics are allowed to process and pay at the pharmacy without prior authorization. These combinations are stated in the table immediately following this section. Breakthrough dosing works in the following manner: 1) If the Smart PA system identifies a claim that due to claims in history is above stated quantity limits, the system will first evaluate whether the current claim is an agent that can be used as part of a treatment regimen involving breakthrough dosing. 2) The Smart PA system will then evaluate whether there is a claim within the last 30 days that can be used in combination with the current claim as part of a regimen involving break through dosing. 3) The Smart PA system will then evaluate stability on the higher agent by looking for claims of the higher strength encompassing 60 days of therapy out of the last 90 days (starting yesterday). 4) The Smart PA system will then rule out that both strengths are used concurrently (as defined by use of two second-generation (atypical) antipsychotics ≥75% of the time). This will be accomplished by ensuring that claims of the lower strength product do not exceed 45 days of therapy out of the last 60 days. 5) If the above criteria are met, the current claim will process and pay at the pharmacy without prior authorization above stated quantity limits. In the last 60 days, starting yesterday are there >/= 45 days of Is there a claim in the last In the last 90 days therapy of the lower Is the current claim for 30 days that could be used starting yesterday, are strength? (If yes, then an agent that can be used in combination with the there 60 days of therapy claim denies with an as part of regimen for reference agent starting with the higher strength exception code 4682. If breakthrough dosing? today? within the last 90 days? no, then claims pays with an exception code AAAA) Aripiprazole 10 mg, 15 mg, Aripiprazole 2 mg or 5 mg Aripiprazole 10 mg, 15 mg, Aripiprazole 2 mg or 5 20 mg or 30 mg 20 mg or 30 mg mg Aripiprazole 2 mg or 5 mg Aripiprazole 10 mg, 15 mg, Aripiprazole 10 mg, 15 mg, Aripiprazole 2 mg or 5 20 mg or 30 mg 20 mg or 30 mg mg Fanapt 10 mg or 12 mg Fanapt 1 mg, 2 mg, 4 mg, 6 Fanapt 10 mg or 12 mg Fanapt 1 mg, 2 mg, 4 mg or 8 mg mg, 6 mg or 8 mg Fanapt 1 mg, 2 mg, 4 mg, 6 Fanapt 10 mg or 12 mg Fanapt 10 mg or 12 mg Fanapt 1 mg, 2 mg, 4 mg or 8 mg mg, 6 mg or 8 mg Paliperidone 9 mg Paliperidone 1.5 mg, 3 mg Paliperidone 9 mg Paliperidone 1.5 mg, 3 or 6 mg mg or 6 mg Paliperidone 1.5 mg, 3 mg Paliperidone 9 mg Paliperidone 9 mg Paliperidone 1.5 mg, 3 53 Administered for the MassHealth Pharmacy Program In the last 60 days, starting yesterday are there >/= 45 days of Is there a claim in the last In the last 90 days therapy of the lower Is the current claim for 30 days that could be used starting yesterday, are strength? (If yes, then an agent that can be used in combination with the there 60 days of therapy claim denies with an as part of regimen for reference agent starting with the higher strength exception code 4682. If breakthrough dosing? today? within the last 90 days? no, then claims pays with an exception code AAAA) or 6 mg mg or 6 mg Latuda 40 mg, 60 mg, 80 Latuda 20 mg Latuda 40 mg, 60 mg, 80 Latuda 20 mg mg or 120 mg mg or 120 mg Latuda 20 mg Latuda 40 mg, 60 mg, 80 Latuda 40 mg, 60 mg, 80 Latuda 20 mg mg or 120 mg mg or 120 mg Olanzapine 15 mg or 20 mg Olanzapine 2.5 mg, 5 mg, Olanzapine 15 mg or 20 mg Olanzapine 2.5 mg, 5 7.5 mg or 10 mg mg, 7.5 mg or 10 mg Olanzapine 2.5 mg, 5 mg, Olanzapine 15 mg or 20 mg Olanzapine 15 mg or 20 mg Olanzapine 2.5 mg, 5 7.5 mg or 10 mg mg, 7.5 mg or 10 mg Quetiapine IR 300 mg or Quetiapine IR 25 mg, 50 Quetiapine IR300 mg or Quetiapine IR 25 mg, 50 400 mg mg, 100 mg or 200 mg 400 mg mg, 100 mg or 200 mg Quetiapine IR 25 mg, 50 Quetiapine IR 300 mg or Quetiapine IR 300 mg or Quetiapine IR 25 mg, 50 mg, 100 mg or 200 mg 400 mg 400 mg mg, 100 mg or 200 mg quetiapine extended-release quetiapine extended-release quetiapine extended-release quetiapine extended- 150 mg, 50 mg 400 mg, 300 mg, 200 mg 400 mg, 300 mg, 200 mg release 150 mg, 50 mg quetiapine extended-release quetiapine extended-release quetiapine extended-release quetiapine extended- 400 mg, 300 mg, 200 mg 150 mg, 50 mg 400 mg, 300 mg, 200 mg release 150 mg, 50 mg Rexulti 1 mg, 2 mg, 3 mg, Rexulti 0.25 mg, 0.5 mg Rexulti 1 mg, 2 mg, 3 mg, Rexulti 0.25 mg, 0.5 mg 4 mg 4 mg Rexulti 0.25 mg, 0.5 mg Rexulti 1 mg, 2 mg, 3 mg, Rexulti 1 mg, 2 mg, 3 mg, Rexulti 0.25 mg, 0.5 mg 4 mg 4 mg Risperidone 2 mg, 3 mg or Risperidone 0.25 mg, 0.5 Risperidone 2 mg, 3 mg or Risperidone 0.25 mg, 4 mg mg or 1 mg 4 mg 0.5 mg or 1 mg Risperidone 0.25 mg, 0.5 Risperidone 2 mg, 3 mg or Risperidone 2 mg, 3 mg or Risperidone 0.25 mg, mg or 1 mg 4 mg 4 mg 0.5 mg or 1 mg Saphris 10 mg Saphris 2.5 mg, 5 mg Saphris 10 mg Saphris 2.5 mg, 5 mg Saphris 2.5 mg, 5 mg Saphris 10 mg Saphris 10 mg Saphris 2.5 mg, 5 mg Vraylar 1.5 mg Vraylar 3 mg, 4.5 mg Vraylar 3 mg, 4.5 mg Vraylar 1.5 mg Vraylar 3 mg, 4.5 mg Vraylar 1.5 mg Vraylar 3 mg, 4.5 mg Vraylar 1.5 mg Ziprasidone 60 mg or 80 Ziprasidone 20 mg or 40 Ziprasidone 60 mg or 80 Ziprasidone 20 mg or 40 mg mg mg mg Ziprasidone 20 mg or 40 Ziprasidone 60 mg or 80 Ziprasidone 60 mg or 80 Ziprasidone 20 mg or 40 mg mg mg mg 54 Administered for the MassHealth Pharmacy Program Go to Page 8: Antipsychotics Is the current claim for a Yes polypharmacy first-generation (typical) criteria POS Flowchart Continue to antipsychotic (Appendix III, Pediatric Page 1 Group D)? Behavioral Health No PA Antipsychotic No required Polypharm POS Deny Is the Continue to Is the current claim for flowchart 4504 member <18 Pediatric Geodon IM (GSN: years old? Behavioral Health Yes No Yes 050102) or olanzapine Antipsychotic Is the member IM (GSN: 050386)? Yes No Polypharm POS <18 years old? No flowchart No Deny Yes No Is the current claim 4507 STOP plus history Yes Is the current claim for ≤2 units (2 syringes clozapine (GSNs: 013648, Yes or vials) per 30 days Is the current claim 027037, 013649, 046416)? for the reference Is the ≤2 units (2 syringes group* (28 days for Yes member <18 No STOP or vials) per 30 days No Risperdal Consta)? years old? Yes (28 days for Is the current claim for Risperdal Consta)? Continue to Risperdal Consta (GSNs: Yes Pediatric 052934, 052935, 052936, Is the current claim plus Yes Behavioral Health 062640) or Zyprexa Relprevv history Is the current Is there a claim Antipsychotic 210 mg or 300 mg (GSNs: ≤1 unit (1 vial) per 30 claim for Zyprexa Polypharm POS 065794, 065795)? No days for the reference ≤1 unit (1 vial) Yes Reprev 210 mg group*? flowchart No per 30 days? or 300 mg in the Yes last 30 days? No Yes Deny No No 4504 Is the current claim Is the for Zyprexa Deny member <18 Relprevv 405 mg 4507 years old? (GSN: 065793)? No Go to Page 2 *Quantity Limit Reference Groups Abilify Maintena Aristada Invega Sustenna Invega Trinza Riperdal Consta Zyprexa Relprevv 55 Administered for the MassHealth Pharmacy Program Antipsychotics No POS Flowchart Page 2 From Deny Page 1 4507 Is the current claim Is the STOP ≤1 unit (1 vial) member <18 Deny years old? per 90 days? Yes No No Is the current claim 4504 Yes plus history Yes ≤1 unit (1 vial) in the Is the current claim for Continue to past 90 days? Invega Trinza Pediatric (GSNs:074140, Yes Behavioral Health Yes 074141,074142, Antipsychotic 074143)? No PA Is the member <18 Polypharm POS No Required years old? flowchart No Is the current claim plus Yes Is the current history for ≤1 Is the current claim for Has the member Is the No PA claim for ≤1 Yes dose within 30 No Invega Sustenna not had a claim for Yes member <18 Required No dose within 30 days for the (GSNs: 065448, Yes Invega Sustenna years old? days? reference 065449, 065450, within the past 60 group*? 065451, 065452)? days? Yes No Deny Is the current No Deny Deny 4504 claim for ≤2 No 4507 4507 No doses within 30 Continue to days? Pediatric Behavioral Health Yes Yes Antipsychotic Is the PolypharmPOS member <18 Is the current claim flowchart Yes years old? No Is the current claim for Abilify plus history for ≤2 STOP Maintena (GSNs: 070669, doses within 30 Yes 070670, 073298, 073299)? days for the Yes reference group*? No Deny Does the member 4504 have paid claims for No 90 out of the last 120 days (any strength)? No Yes Deny 4405 Deny No Approve Deny 4504 No 4636 4507 Is the current claim Is the current claim plus history ≤1 unit (1 vial or for ≤1 unit (1 vial or syringe) Is the current claim for Yes Yes Aristada 441 mg, 662 mg, or syringe) per 30 within 30 days for the reference 882 mg (GSNs: 074887, days? group*? 074888, 074889)? Is the current claim plus history Yes No for ≤1 unit (1 vial or syringe) 2 Yes months for the reference Continue to group*? Is the current claim for Is the current claim Pediatric Aristada 1,064 mg (GSNs: ≤1 unit (1 vial or Behavioral Health Yes 077464)? syringe) per 2 Antipsychotic months? Yes Deny PolypharmPOS No 4504 flowchart Is the Yes Deny No member <18 Is the current claim for aripiprazole ODT (GSNs: 060319, 4507 No 060322), clozapine ODT (GSNs: 053994, 053995, 063031, years old? STOP 066557, 066558), olanzapine ODT (GSNs: 045190, 045191, 047285, 047286), risperidone ODT (GSNs: 051799, 051800, 052049, 059402, 059403, 065235), or Yes *Quantity Limit Reference Groups Versacloz (GSN: 064429)? Abilify Maintena Aristada No Invega Sustenna Deny Go to page 5 (except clozapine Invega Trinza 4405 ODT and Versacloz): Riperdal Consta Quantity Limits Go to page 3 Zyprexa Relprevv 56 Administered for the MassHealth Pharmacy Program Is the current claim for Fanapt (GSNs: 065901, 065902, 065903, Antipsychotics 065904, 065905, 065906, Go to page 4 POS Flowchart 065907), Latuda (GSNs: 066932, No 066933, 069894), paliperidone Page 3 (GSNs: 061985, 061986, 061987, Does the member have paid claims for a generic second- 065667), Rexulti (GSNs 074442, Does the member have paid claims for any two generation antipsychotic 074444, 074445, 074446, additional antipsychotics (generic or brand) (Appendix III, Group A) in all Approve 074447, 074448), Saphris (GSNs: (Appendix III, Group C, does not count the trial claims history (excluding Yes Yes 4636 065537, 065538, 073981) or already counted towards generic second-generation reference agent and Vraylar (GSNs:074807, 074808, (atypical) antipsychotic lookback in Group A) in all emergency claims)? 074809, 074810, 075566)? claims history (excluding reference agent and emergency claims)? Deny Yes No 4405 No No No Does the member have paid Does the Does the member Is the member member have Does the have paid claims for claims for two (generic or brand) member have No ≥18 years of Is the a diagnosis of 90 out of the last 120 Yes second-generation antipsychotics paid claims for age? current major days (any strength)? (Appendix III, Group B, No any two claim for Yes depressive (excluding reference agent and antidepressants Rexulti? disorder Yes emergency claims)? (Appendix I)in No (Appendix II, all claims history Yes Group B) in Yes all claims (excluding Deny history? emergency 4405 claims)? No Yes Is the current claim for paliperidone 1.5 Approve No Does the member have paid claims for 4636 mg, 3 mg or 9 mg (GSNs: 065667, 061985, 061987) or Latuda 20 mg, 40 an antidepressant (Appendix I) in the mg, 60 mg or 120 mg (GSNs: 068448, past 30 days (excluding emergency Approve claims)? 066932, 071415, 069894)? 4636 Yes Yes Is the current claim Is the current claim No for Rexulti or No Yes Go to Page 5 ≤30 units/month? Vraylar? No Is the current claim Yes No for paliperidone? Deny No Yes 4507 Is the current claim ≤60 units/month? Is there a claim for Is there a claim for Yes Latuda 80 mg paliperidone 6 mg (GSN: 066933) in (GSN: 061986) in Is the current claim plus history ≤60 Go to Page 9: the last 30 days? the last 30 days? Yes units/month for the polypharmacy criteria No reference group*? Yes No Yes No Is the current claim Is the current claim Deny plus history ≤60 plus history ≤30 4504 units/month for the units/month for the reference group*? reference group*? *Quantity Limit Reference Groups Aripiprazole tablet Aripiprazole ODT Yes Aripiprazole solution Fanapt tablet Yes No Latuda tablet No Olanzapine tablet Olanzapine ODT Paliperidone tablet Quetiapine IR tablet Go to Page 9: Deny Go to Page 7: Rexulti tablet polypharmacy criteria 4504 Copay Waiver Risperidone tablet Risperidone ODT Risperidone solution or oral syringes Saphris tablet quetiapine extended-release tablet Vraylar capsule Ziprasidone tablet 57 Administered for the MassHealth Pharmacy Program Antipsychotics POS Flowchart Page 4 Does the member have paid claims for any two Is the current claim for antidepressants Is the member ≥18 aripiprazole solution No (Appendix I) in all years of age? (GSN: 058594)? claims history Yes Does the member have (excluding emergency a diagnosis of major claims)? No depressive disorder Yes No (Appendix II, Group B) in all claims history? Does the member have paid claims for an antidepressant (Appendix I) in the past 30 No days (excluding emergency claims)? Yes Yes Does the member Is the current claim for quetiapine Approve have paid claims for exended-release (GSNs: 062748, No 90 out of the last Yes 062749, 062750, 063240, 064725)? 4636 120 days (any Yes strength)? Yes Does the member have paid claims for immediate-release Go to quetiapine (GSN: 034187, Page Yes 034188, 034189, 047198, 5 060292, 060293) in all No claims history (excluding Is the current claim emergency claims)? for aripiprazole solution (GSNs: 058594) or Does the member have No quetiapine extended- claims for two (generic or release (GSNs: Deny brand) second generation No 062748, 062749, Deny 4405 antipsychotics (Appendix 062750, 063240, 4405 III, Group B) in all claims 064725)? history (excluding reference agent and emergency claims)? No Yes No Yes Does the member have paid claims for immediate-release quetiapine (GSN: 034187, 034188, 034189, 047198, 060292, 060293) in all claims history (excluding emergency claims)? Approve Yes 4636 No Go to Page 5 58 Administered for the MassHealth Pharmacy Program Antipsychotics POS Flowchart Page 5 Is the current claim plus history for: ≤30 units/month: Is the current claim for aripiprazole ODT and tablet, Rexulti ≤30 units/month: tablet, Vraylar capsule aripiprazole tablet or ODT, Is the current claim for olanzapine ODT and tablet (≤60 aripiprazole (tablet, ≤60 units/month: olanzapine ODT and units/month for the 15 mg strength), solution, or ODT), tablets, quetiapine extended-release (50 Rexulti tablets, quetiapine extended- olanzapine 15 mg ODT mg, 300 mg, or 400 mg), ziprasidone release (150 mg or 200 mg) and tablet, quetiapine, Go to Page 9: Yes ≤60 units/month: Rexulti tablets, ≤90 units/month: polypharmacy criteria risperidone (≤120 units/month for the Yes risperidone solution or Yes quetiapine, 4 mg strength), quetiapine extended- oral syringes, risperidone release (50 mg, 300 mg, or 400 mg), 4 mg, quetiapine <120 units/month: Go to Page 7: ziprasidone extended-release (50 mg, risperidone No ≤90 units/month: 300 mg, or 400 mg), Copay waiver criteria quetiapine Vraylar capsule or ≤480 ml/month: ≤480 ml/month: ziprasidone? risperidone solution or oral syringes risperidone solution, oral syringes ≤750 ml/month: ≤750 ml/month: aripiprazole solution No aripiprazole solution No for the reference group*? Is the current claim for quetiapine extended- release 150 mg or 200 Go to Page 9: mg? Yes Deny Is the current claim polypharmacy criteria 4507 plus history for ≤30 units/month for the reference group*? Go to Page 7: No No No Copay waiver criteria Yes Go to Page 6: Is there a claim for Copay waiver quetiapine criteria extended-release Go to Page 9: 50 mg, 300 mg or Yes 400 mg in the last polypharmacy criteria 30 days? Yes Is the current claim plus history for ≤60 units/month for the Go to Page 7: reference group*? No Go to Page 6 Copay waiver criteria *Quantity Limit Reference Groups Aripiprazole tablet Aripiprazole ODT Aripiprazole solution Fanapt tablet Latuda tablet Olanzapine tablet Olanzapine ODT Paliperidone tablet Quetiapine IR tablet Rexulti tablet Risperidone tablet Risperidone ODT Risperidone solution or oral syringes Saphris tablet quetiapine extended-release tablet Vraylar capsule Ziprasidone tablet 59 Administered for the MassHealth Pharmacy Program Antipsychotics POS Flowchart Page 6 Go to Page 9: polypharmacy criteria Yes From Page 5 Is the current claim plus history for ≤60 units/ month for the reference No Go to Page 7: group*? Copay waiver criteria No Go to Page 9: polypharmacy criteria Is the current claim for Is there a claim for risperidone 4 mg tablet risperidone tablets or Yes ODT (0.25 mg, 0.5 mg, or ODT in the last 30 Yes 1 mg, 2 mg 3 mg)? days? Yes Is the current claim plus history for ≤120 units/ Go to Page 7: month for the reference No group*? Copay waiver criteria No Go to Page 9: polypharmacy criteria Yes Is the current claim plus Go to Page 7: No history for ≤30 units/ Copay waiver criteria month for the reference No group*? Is the current claim Is there a claim for for olanzapine 2.5 olanzapine 15 mg tablet mg, 5 mg, 7.5 mg, 10 Yes Go to Page 9: or ODT in the last 30 mg and 20 mg tablet polypharmacy criteria days? or ODT? Yes Yes Is the current claim plus history for ≤60 units/ Go to Page 7: month for the reference No group*? Copay waiver criteria *Quantity Limit Reference Groups Aripiprazole tablet Aripiprazole ODT Aripiprazole solution Fanapt tablet Latuda tablet Olanzapine tablet Olanzapine ODT Paliperidone tablet Quetiapine IR tablet Rexulti tablet Risperidone tablet Risperidone ODT Risperidone solution or oral syringes Saphris tablet quetiapine extended-release tablet Vraylar capsule Ziprasidone tablet 60 Administered for the MassHealth Pharmacy Program 61 Administered for the MassHealth Pharmacy Program Antipsychotics POS Flowchart Page 7 Is there a claim for a Is the current claim a strength of the same product that can be product that can be used From Page 3,5 and 6: used to reach a in combination with the in- Approve Yes Yes Copay waiver criteria dose that is not process claim to reach the 4679 commercially dose that is not available? commercially available within the last 30 days? No No Go to Page 9: polypharmacy criteria Go to Page 8: breakthrough dosing criteria PHARMACY MESSAGING Exception code 4679: Co-pay relieved b/c of dose consolidation initiative Short description: Copay reduced-dose consolidation Long description: Copay reduced for second claim dose consolidation Additional message: Co-pay relieved b/c of MassHealth dose consolidation initiative 62 Administered for the MassHealth Pharmacy Program Antipsychotics POS Flowchart Page 8 Is there a claim in the last 30 days In the current claim (starting today) In the last 60 days Is the current claim plus history (starting that could be used (starting for an agent that yesterday) are there From Page 7: can be used as in combination yesterday), are Yes Yes 60 days of therapy of Yes Breakthrough dosing criteria with the reference there ≥45 days of part of regimen the higher strength agent as part of therapy of the with breakthrough within the last 90 regimen with lower strength? dosing? days? breakthrough No dosing? Approve No 4636 Yes No No Deny 4683 Go to Page 9: Polypharmacy criteria 63 Administered for the MassHealth Pharmacy Program Antipsychotics POS Flowchart Page 9 Continue to Pediatric Behavioral Health Antipsychotic Polypharm POS flowchart Does claims history show paid claims for ≥2 Yes antipsychotics (Appendix III, Group E, by No reference group) From Pages 1,2,3,5,6,7 Is the member <18 for 60 days of and 8: Polypharmacy years old? concurrent therapy out the last 90 Yes days (starting yesterday)? No Deny STOP 4689 PHARMACY MESSAGING Exception code 4689: Adult Antipsychotic overlap restrict Short description: Adult Antipsych Concrnt Tx Restr Long description: Adult Antipsychotic Concurrent Therapy Restriction. Prior authorization is required to dispense a second antipsychotic when there is a history of 60 days of concurrent two or more antipsychotics. Emergency Override available via Level of Service code 03. Additional message: Adult Antipsychotic 60 day concurrent therapy drug restriction. Prescriber must obtain prior authorization per MassHealth Drug List. Emergency Override available via Level of Service code 03. 64 Administered for the MassHealth Pharmacy Program Antipsychotics POS Flowchart Page 10 Is the current claim *Sample packs are for Seroquel XR Deny not covered by the Sample Kit Yes 4114 MassHealth (quetiapine) (GSN: Pharmacy Progam. 074076)*? Exception code: 4114: Product/ Service Not Covered, Plan/Benefit Exclusion 65 Administered for the MassHealth Pharmacy Program Is the request for a first- Continue to generation (typical) Antipsychotics Pediatric antipsychotic (Appendix Go to Page 5: Smart Fusion Flowchart Yes Behavioral Health III, Group D? Polypharmacy Antipsychotic Page 1 Yes No Polypharm Is the member SmartPA flowchart Deny Yes Is the request for <18 years old? 219 clozapine tablets? No No Does the member have paid claims for No Does the member have any two additional antipsychotics No Is the request No PA claims for a generic (generic or brand) (Appendix III, Group No for Rexulti? Is the request for aripiprazole required second generation C, does not count the trial already Yes ODT, solution, or tablets, antipsychotic (Appendix Yes counted towards generic second- Does the member have a clozapine ODT, Fanapt, Latuda, III, Group A) in all generation (atypical) antipsychotic diagnosis of major depressive olanzapine, paliperidone, Go to claims history lookback in Group A) in all claims disorder (Appendix II, Group B) quetiapine, Rexulti, risperidone, No Page 6 (excluding reference history (excluding reference agent and agent and emergency in all claims history? risperidone ODT, Saphris, emergency claims)? No quetiapine extended-release, claims)? Yes Yes Versacloz, Vraylar, ziprasidone, No Does the member have or Zyprexa Zydis? paid claims for any two Is there a history of Deny No antidepressants paid claims for 90 Is the member ≥18 219 No (Appendix I) in all claims Yes out of 120 days of years of age? Yes history (excluding the reference agent Yes emergency claims)? Is the request for (any strength) in Fanapt, Latuda, claims history? Yes Does the member have paliperidone, Rexulti, Does the member have paid claims Deny claims for two (generic or Yes Saphris, or Vraylar? No for an antidepressants (Appendix I) 219 brand) second generation in the past 30 days (excluding antipsychotic (Appendix Yes No Is the request for Yes emergency claims)? No III, Group B) in all claims Rexulti? No history (excluding Does the prescriber Go to Page 2 reference agent and Is the request for Latuda 20 mg, document that Yes emergency claims)? 40 mg, 60 mg or 120 mg (GSNs: Rexulti with be used Does the member 068448, 066932, 071415, Yes as adjunctive therapy Yes have paid claims for 069894), paliperidone 1.5 mg, 3 with an antidepressants mg or 9 mg (GSNs: 065667, antidepressants? Does the member have Yes (Appendix I) in the Does the prescriber 061985, 061987) ? a diagnosis of major Deny No past 30 days No document that depressive disorder 219 (excluding Rexulti with be used (Appendix II, Group B) No emergency claims)? as adjunctive therapy in all claims history? No Is the request for Go to with Deny Yes antidepressants? Rexulti or Vraylar? Page 3 Yes 219 Yes No Does the member Is the current claim No Yes No have paid claims for ≤60 units/month? any two antidepressants Is the current Did the prescriber Yes Yes (Appendix I) in all claim ≤30 units/ Is the current claim provide rationale Go to Page 5: claims history month? Is the current claim for paliperidone ? why the dose Polypharmacy (excluding emergency plus history ≤60 No cannot be criteria claims)? Yes Yes consolidated? units/month for the No No reference group*? Deny Is there a claim for Is there a claim for No 219 Latuda 80 mg No paliperidone 6 mg Did the prescriber Yes (GSN: 066933) in (GSN: 061986) in provide rationale why Did the prescriber *Quantity Limit Reference the last 30 days? the last 30 days? the member requires provide rationale why Groups Yes dosing intervals the dose cannot be Aripiprazole tablet Yes No greater than consolidated? Aripiprazole ODT recommended by the No Aripiprazole solution No FDA? Yes Fanapt tablet Did the prescriber Latuda tablet Is the current claim No provide rationale why the Olanzapine tablet plus history ≤60 Is the current claim member requires dosing Olanzapine ODT units/month for the plus history ≤30 intervals greater than Paliperidone tablet reference group*? units/month for the recommended by the Deny Quetiapine IR reference group*? FDA? Rexulti tablet No 219 Yes No Risperidone tablet Go to Page No Risperidone ODT Yes No 4: Copay Go to Page 5: Risperidone solution or oral Did the prescriber Did the prescriber provide Waiver Polypharmacy syringes provide rationale rationale why the member criteria Saphris tablet Go to Page 5: No why the dose cannot requires dosing intervals greater quetiapine extended-release Polypharmacy Yes Yes be consolidated? than recommended by the FDA? Vraylar capsule criteria Ziprasidone tablet 66 Administered for the MassHealth Pharmacy Program Antipsychotics Smart Fusion Flowchart From page 1 Page 2 Yes Go to Page 3 Is the request for aripiprazole Has medical No ODT, generic clozapine necessity for an orally disintegrating Is the request for generic ODT, brand name Fazaclo, Yes Is the request for brand name risperidone ODT, Versacloz, tablet or oral clozapine ODT (053994, No Fazaclo (063031, 066557, suspension been Yes Is the request 053995, 063031, 066557, or Zyprexa Zydis? No 066558)? provided? for aripiprazole 066558) or Versacloz? No ODT? No Yes Is the member ≥18 Yes years of age? No Go to Page 3 Did the prescriber provide No Yes Yes medical records documenting an inadequate response or Is the request for Deny Is the member adverse reaction with a aripiprazole solution or Yes Deny 219 <18 years of therapeutically equivalent or quetiapine Is the member age? formulation? extended-release? Samples not ≥18 years of age? No Yes covered. Please Yes No consult supervisor. Is the request for Yes Seroquel XR Deny Sample Kit 219 Continue to (quetiapine) (GSN: Approval 074076)*? Pediatric Behavioral Health 224 1 year No No Antipsych Polypharm Did the SmartPA flowchart Does the prescriber member have provide paid claims for 90 documentation of out of the last Yes medical 120 days (any necessity for the strength)? Is the request for No aripiprazole solution solution? formulation? Yes No Yes No Does the member have a diagnosis of major Yes Go to Page 3 depressive disorder Yes (Appendix II, Group B) Go to Page 3 Does the member in all claims history? Does the member have paid claims Does the Yes have paid claims for for an prescriber any two No antidepressants provide antidepressants Yes Yes (Appendix I) in documentation (Appendix I) in all the past 30 days No that aripiprazole claims history Is the request (excluding or Seroquel XR (excluding for aripiprazole emergency will be used a No emergency claims)? Yes ODT or claims)? adjunctive Is the request for solution? antidepressant aripiprazole ODT therapy? Yes No or solution? Does the member have Yes No claims for two (generic No or brand) second Does the member generation have a diagnosis antipsychotics Deny Does the prescriber document an of autism spectrum No (Appendix III, Group B) 229 inadequate response or adverse disorder (Appendix in all claims history reaction to immediate-release II, Group A) in all (excluding reference quetiapine or does the member have claims history? agent and emergency paid claims (GSN: 034187, 034188, claims)? 034189, 047198, 060292, 060293) in all claims history (excluding emergency Yes No claims)? Does the member have Is the request for paid claims for risperidone Yes aripiprazole ODT No in all claims history Deny or solution? Yes (excluding emergency 229 claims)? No Yes 67 Administered for the MassHealth Pharmacy Program Antipsychotics Smart Fusion Flowchart Page 3 From Page 2 Did the prescriber provide rationale why Yes the dose cannot be Is the current claim plus consolidated? history for: No ≤30 units/month: aripiprazole ODT or tablets, Did the prescriber Rexulti tablets, Vraylar provide rationale why Yes capsules member requires Deny No dosing intervals No ≤60 units/month: olanzapine, 219 exceeding what is Go to Page 5: quetiapine extended-release recommended by the Polypharmacy (50 mg, 300 mg, or 400 mg), FDA ? criteria ziprasidone Yes ≤90 units/month: Is the current claim for quetiapine ≤30 units/month: Go to Page 4: aripiprazole ODT or No <120 units/month: Copay Waiver tablets, olanzapine risperidone (≤60 units/month for the 15 mg strength), Yes ≤480 ml/month: Go to Page 5: Rexulti tablet, Is the current claim for risperidone solution or oral Polypharmacy quetiapine extended- aripiprazole ODT, syringes criteria release (150 mg or 200 solution, or tablets, Yes mg), Vraylar olanzapine 15 mg, ≤750 ml/month: Go to Page 4: ≤60 units/month: quetiapine, Rexulti, aripiprazole solution quetiapine extended- risperidone solution or Is the current No Copay Waiver claim plus history release (50 mg, 300 oral syringes, for the reference group*? mg, or 400 mg), risperidone 4 mg, for ≤30 units/ month for the risperidone (≤120 units/ quetiapine extended- Go to Page 5: month for the 4 mg release (50 mg, 300 reference group*? Polypharmacy strength), ziprasidone mg, or 400 mg), criteria ≤90 units/month: Vraylar, or No Yes quetiapine ziprasidone? Is the current ≤480 ml/month: claim plus history No Go to Page 4: risperidone solution or Is there a claim for ≤60 units/ No month for the Copay Waiver oral syringes Yes Is the current claim for for quetiapine Yes ≤750 ml/month: quetiapine extended- extended-release reference Yes aripiprazole solution release150 mg or 200 50 mg, 300 mg or group*? Go to Page 5: mg? 400 mg in the last Yes Polypharmacy No 30 days? criteria Is the current claim Is the current claim plus history for ≤60 Go to Page 4: for risperidone (0.25 No No Is there a claim for units/month for the Copay Waiver mg, 0.5 mg, 1 mg, 2 Yes risperidone 4 mg in reference group*? mg 3 mg)? the last 30 days? Yes Go to Page 5: No Is the current claim Yes Polypharmacy plus history for ≤120 criteria Is the current claim units/month for the for olanzapine 2.5 Is there a claim for reference group*? Go to Page 4: mg, 5 mg, 7.5 mg, Yes olanzapine 15 mg in No Copay Waiver 10 mg and 20 mg? the last 30 days? No Go to Page 5: *Quantity Limit Reference Groups Yes Polypharmacy Aripiprazole tablet Is the current claim criteria Aripiprazole ODT plus history for ≤30 Aripiprazole solution units/month for the Fanapt tablet reference group*? Go to Page 4: Latuda tablet No Copay Waiver Olanzapine tablet Olanzapine ODT Paliperidone tablet Quetiapine IR tablet Yes Go to Page 5: Rexulti tablet Is the current claim Polypharmacy plus history for ≤60 criteria Risperidone tablet Yes Risperidone ODT units/month for the Risperidone solution or oral syringes reference group*? Go to Page 4: Saphris tablet No quetiapine extended-release tablet Copay Waiver Vraylar capsule Ziprasidone tablet 68 Administered for the MassHealth Pharmacy Program Antipsychotics Smart Fusion Flowchart Page 4 Is there a claim for a Is the current claim strength of the same a product that can product that can be used From Pages 1 and 3: be used to reach a in combination with the in- Go to Page 5: Yes Yes Copay Waiver criteria dose that is not process claim to reach the Polypharmacy criteria commercially dose that is not available? commercially available No within the last 30 days? No No In the current Is there a claim in claim plus history Is the current claim In the last 60 days the last 30 days (starting for an agent that (starting (starting today) yesterday) are can be used as yesterday), are Yes that could be used Yes there 60 days of Yes part of regimen there ≥45 days of in combination therapy of the with breakthrough therapy of the with the reference higher strength dosing? lower strength? agent? within the last 90 days? No No No Did the prescriber provide documentation Yes Yes why the dose cannot be consolidated? Go to Page 5: polypharmacy criteria No Did the prescriber provide rationale why the member requires dosing Deny Yes intervals greater 219 than recommended by the FDA? *Quantity Limit Reference Groups Aripiprazole tablet Aripiprazole ODT Aripiprazole solution Fanapt tablet Latuda tablet Olanzapine tablet Olanzapine ODT Paliperidone tablet Quetiapine IR tablet Rexulti tablet Risperidone tablet Risperidone ODT Risperidone solution or oral syringes Saphris tablet quetiapine extended-release tablet Vraylar capsule Ziprasidone tablet 69 Administered for the MassHealth Pharmacy Program From Page 1 and 3: Polypharmacy Antipsychotics Smart Fusion Flowchart Page 5 Is the member Yes <18 years old? Continue to Pediatric Is the prescriber a Behavioral Health Deny psychiatrist or was No No Antipsychotic Yes 219 a psychiatry Polypharm consult provided? SmartPA flowchart Does claims Did prescriber Yes history show paid Approval document claims for ≥2 Did prescriber document 224 antipsychotics treatment plan psychiatric diagnosis Did the 3 months (Appendix III, (including names including treatment- Yes prescriber Group E, by Yes of antipsychotic resistant conditions? document cross- reference group) medications and Yes titration taper of for 60 days of corresponding antipsychotic concurrent therapy diagnosis? No polypharmacy? out the last 90 No days (starting yesterday)? No PA Deny No required 219 No Approval Did prescriber 224 document inadequate Is the request for a first- I year response or generation (typical) Yes Yes adverse reaction antipsychotic (Appendix to two III, Group D)? No Yes monotherapy trials as clinically appropriate Did the prescriber document recent (include trial psychiatric hospitalization and that duration with dates member was discharged on current of use as regimen? No documented on request or claims history, if available)? No Is the request for ODT, solution, quetiapine extended-release, Rexulti tablet, Fanapt, Yes paliperidone, Latuda, Saphris, Vraylar, risperidone ODT or *Quantity Limit Reference Groups olanzapine ODT? Aripiprazole tablet Aripiprazole ODT No Approval Aripiprazole solution 224 Fanapt tablet Is the current claim plus history for ≤30 1 year Latuda tablet units/month: Olanzapine tablet aripiprazole tablet, olanzapine tablet Olanzapine ODT (≤60 units/month for the 15 mg Paliperidone tablet strength), Quetiapine IR tablet ≤60 units/month: Rexulti tablet risperidone tablet (≤120 units/month for Risperidone tablet No the 4 mg strength), ziprasidone Risperidone ODT No PA ≤90 units/month: Yes Risperidone solution or oral syringes quetiapine required Saphris tablet ≤480 ml/month: quetiapine extended-release tablet risperidone solution Vraylar capsule Ziprasidone tablet for the reference group*? 70 Administered for the MassHealth Pharmacy Program Antipsychotics Smart Fusion Flowchart From page 1 Page 6 Is the current claim Is the current claim Continue to Yes Is the current claim plus Is the request for history for 1 dose within Invega Sustenna? Yes 30 days for the quantity (GSNs: No Go to page 7 limit reference group? 065448;065449;06545 Is the current claim for 1 0;065451;065452) No dose within 30 days? Yes No Did the member have Did the prescriber No Did the member have a Yes ≤2 doses within the last provide rationale why paid claim for Invega 60 days? the dose cannot be Sustenna within the No consolidated? past 60 days? Yes Did the Is the current claim for 1 prescriber Continue to dose within 30 days? provide Pediatric Yes Deny rationale why Behavioral Health No the member Deny Antipsychotic No 219 No requires dosing 219 Polypharm No intervals greater SmartPA flowchart Did the prescriber Did the prescriber provide than provide rationale why rationale why the member recommended Yes the dose cannot be No requires dosing intervals Yes by the FDA? consolidated? greater than recommended by the FDA? Yes Approve Is the member Yes No 224 x 1 <18 years old? Did the prescriber year Is the current claim for provide rationale why ≤2 doses within 30 No Yes the dose cannot be days? consolidated? Continue to Did the prescriber provide Yes Pediatric rationale why the member Behavioral Health No requires dosing intervals *Quantity Limit Reference Groups Is the member Yes <18 years old? Antipsychotic greater than recommended Abilify Maintena Invega Sustenna Polypharm by the FDA? No SmartPA flowchart Invega Trinza No PA Riperdal Consta No Required Deny Zyprexa Relprevv 219 71 Administered for the MassHealth Pharmacy Program 72 Administered for the MassHealth Pharmacy Program Antipsychotics Did the prescriber provide Smart FusionFlowchart From page 6 rationale why the member Deny No requires dosing intervals Page 7 219 greater than recommended by the FDA? No Is the request for Did the prescriber Zyprexa Relprevv 210 Is the current claim provide rationale Approve mg or 300 mg? Yes No Yes Is the Yes member <18 Is the current claim No plus history Deny Is the current claim Yes 219 Go to page No Is the member <18 Did the prescriber years old? provide rationale why the dose cannot be Yes consolidated? Continue to Pediatric Behavioral Health No Antipsychotic Continue to Polypharm Pediatric SmartPA flowchart Behavioral Health Antipsychotic No PA Polypharm Required *Quantity Limit Reference Groups SmartPA flowchart Abilify Maintena Aristada Invega Sustenna Invega Trinza Riperdal Consta Zyprexa Relprevv 73 Administered for the MassHealth Pharmacy Program Antipsychotics Smart Fusion Flowchart From page 7 Page 8 No Did the prescriber Is the request for Abilify Does the member document a clinical Maintena (GSNs: 070669, have paid claims for Yes No rationale for the 070670, 073298, 073299)? 90 out of the last 120 requested agent days (any strength)? instead of Aristada? No Approve No Yes 224 x 1 Yes year Is the request for Aristada Is the current claim 441 mg, 662 mg, or 882 mg Yes Deny Approve 219 224 x 1 Is the current claim year plus history Continue to No No PA Yes Pediatric No Required Behavioral Health Antipsychotic Did the prescriber Polypharm Is the provide rationale SmartPA flowchart Yes member <18 No why the dose years old? cannot be Yes Is the current claim consolidated? ≤1 unit (1 vial or syringe) per 2 No months? Continue to Yes Pediatric Behavioral Health Is the current claim plus history Yes Antipsychotic for ≤1 unit (1 vial or syringe) per Polypharm 2 months for the reference SmartPA flowchart group*? Is the current claim for Yes Aristada 1,064 mg (GSNs: 077464)? Is the member <18 No PA No years old? Required Yes *Quantity Limit Reference Groups Continue to Abilify Maintena Pediatric Aristada STOP Behavioral Health Invega Sustenna Antipsychotic Invega Trinza Polypharm Riperdal Consta SmartPA flowchart Zyprexa Relprevv 74 Administered for the MassHealth Pharmacy Program Appendix I: Antidepressant GSN Lookback SSRIs (Selective serotonin reuptake inhibitors) Citalopram (046206, 046205, 046204, 046203) Fluoxetine (046217, 046214, 046213, 046215, 046219, 068117) Fluvoxamine (046208, 046209, 046210) Paroxetine (046222, 046223, 046224, 046225, 046226) Sertraline (046230, 046229, 046228, 046227) Lexapro (051698, 051642, 050760, 050712) Prozac Weekly (047571) Sarafem (065296, 046219, 046216) Symbyax (053400, 053401, 053402, 053403, 062878) Pexeva (053387, 053388, 053390) Paxil CR (050136, 050137, 050138) LuvoxCR (063767) SNRIs (serotonin/norepinephrine reuptake inhibitors) Venlafaxine (046398, 046399, 046400, 046401, 046402, 046403, 046404, 046405, 064444, 064445, 064446, 064447) Cymbalta (057891, 057892, 057893) Pristiq (063736, 063737) NDRIs (norepinephrine/dopamine reuptake inhibitors) Aplenzin (065345, 064899, 064896) Bupropion (IR/SR) (050496, 046239, 046238, 046237, 046236) Wellbutrin XL (053007, 053006) SARIs (serotonin antagonists/reuptake inhibitors) Trazodone >150 mg/day (046241, 064242, 046243, 046244) Nefazodone (046257, 046256, 046255, 046254, 046253) Oleptro (066436, 066440) MAOIs (Monoamine oxidase inhibitors) Phenelzine (046263) Tranylcypromine (046264) EMSAM (060453, 060454, 060455) NaSSA Mirtazapine (046450, 046451, 046452, 054009) Remeron SolTab (047453, 047454, 047636) TCAs Amitriptyline (046048, 046047, 046046, 046045, 046044, 046043) Amoxapine (046084, 046083, 046082, 046081) Clomipramine (046120, 046121, 046122) Desipramine (046108, 046107, 046106, 046105, 046104, 046103) Doxepin (046092, 046091, 046089, 046088, 046087, 046086) Imipramine (046068, 046069, 046070, 046075, 046076, 046077, 046078) 75 Administered for the MassHealth Pharmacy Program Maprotiline (046132, 046133, 046134) Nortriptyline (046063, 046062, 046061, 046060, 046059) Protriptyline (046079, 046080) Surmontil (046111, 046112, 046113) Appendix II: Second Generation (Atypical) Antipsychotics Diagnosis Codes Lookback Group Diagnosis ICD-9 ICD-10 A Autism Spectrum Disorder (includes 299.00 F84.0 pervasive developmental disorder) 299.01 F84.0 299.10 F84.3 299.11 F84.3 299.80 F84.5 F84.8 299.81 F84.5 F84.8 299.90 F84.9 299.91 F84.9 B Dysthymic Disorder 300.4 F34.1 Depressive Disorder, not elsewhere 311.00 F32.9 classified Major Depressive Disorder, single 296.20 F32.9 episode 296.21 F32.0 296.22 F32.1 296.23 F32.2 296.25 F32.4 296.26 F32.5 Major Depressive Disorder, recurrent 296.30 F33.40 episode F33.9 296.31 F33.0 296.32 F33.1 296.33 F33.2 296.35 F33.41 296.36 F33.42 Appendix III: Antipsychotic Lookbacks Group Medication GSNs A: Generic second- aripiprazole 051333, 051334, 051335, 051336, 052898, 060225 generation (atypical) clozapine 013648, 027037, 013649, 046416 antipsychotics quetiapine 034187, 060292, 034188, 034189, 047198, 060293 olanzapine 029077, 027961, 027959, 027960, 041026, 041027 risperidone 042922, 042923, 021154, 021155, 021156, 021157, 026177, 071304, 071305, 071306 76 Administered for the MassHealth Pharmacy Program ziprasidone 047563, 047564, 047567, 047568 B: All second aripiprazole aripiprazole ODT: 060319, 060322 generation (atypical) reference group Abilify Maintena: 070669, 070670, 073298, 073299 antipsychotic (brand Aristada: 074887, 074888, 074889, 077464 and generic) aripiprazole solution: 058594 aripiprazole tablets: 051333, 051334, 051335, 051336, 052898, 060225 clozapine clozapine: 013648, 027037, 013649, 046416 reference group clozapine ODT: 053994, 053995, 063031, 066557, 066558 Versacloz: 064429 Fanapt reference Fanapt: 065901, 065902, 065903, 065904, 065905, 065906, group 065907, 065908 Latuda reference Latuda: 068448, 066932, 071415, 066933, 069894 group olanzapine olanzapine: 029077, 027961, 027959, 027960, 041026, reference group 041027 olanzapine ODT: 045190, 045191, 047285, 047286 Zyprexa Relprevv: 065795, 065794, 065793 paliperidone paliperidone: 065667, 061985, 061986, 061987 reference group Invega Sustenna: 065448, 065449, 065450, 065451, 065452 Invega Trinza: 074140, 074141,074142, 074143 quetiapine quetiapine: 034187, 060292, 034188, 034189, 047198, reference group 060293 quetiapine extended-release: 063240, 064725, 062748, 062749, 062750 Rexulti reference Rexulti: 074442, 074444, 074445, 074446, 074447, 074448 group risperidone risperidone: 042922, 042923, 021154, 021155, 021156, reference group 021157, 026177, 071304, 071305, 071306 risperidone M-tabs: 065235, 052049, 051799, 051800, 059402, 059403 Risperdal Consta: 062640, 052934, 052935, 052936 Saphris reference Saphris: 073981, 065537, 065538 group Vraylar Vraylar: 074807, 074808, 074809, 074810, 075566 reference group ziprasidone ziprasidone: 047563, 047564, 047567, 047568 reference group C: All first- aripiprazole aripiprazole ODT: 060319, 060322 generation (typical) reference group Abilify Maintena: 070669, 070670, 073298, 073299 and second- Aristada: 074887, 074888, 074889, 077646 generation (atypical) aripiprazole solution: 058594 antipsychotics aripiprazole tablets: 051333, 051334, 051335, 051336, 052898, 060225 clozapine clozapine: 013648, 027037, 013649, 046416 reference group clozapine ODT: 053994, 053995, 063031, 066557, 066558 Versacloz: 064429 Fanapt reference Fanapt: 065901, 065902, 065903, 065904, 065905, 065906, group 065907, 065908 Latuda reference Latuda: 068448, 066932, 071415, 066933, 069894 77 Administered for the MassHealth Pharmacy Program group molindone molindone: 003987, 003989, 003990 reference group olanzapine olanzapine: 029077, 027961, 027959, 027960, 041026, reference group 041027 olanzapine ODT: 045190, 045191, 047285, 047286 Zyprexa Relprevv: 065795, 065794, 065793 paliperidone paliperidone: 065667, 061985, 061986, 061987 reference group Invega Sustenna: 065448, 065449, 065450, 065451, 065452 Invega Trinza: 074140, 074141,074142, 074143 quetiapine quetiapine: 034187, 060292, 034188, 034189, 047198, reference group 060293 quetiapine extended-release: 063240, 064725, 062748, 062749, 062750 Rexulti reference Rexulti: 074442, 074444, 074445, 074446, 074447, 074448 group risperidone risperidone: 042922, 042923, 021154, 021155, 021156, reference group 021157, 026177, 071304, 071305, 071306 risperidone M-tabs: 065235, 052049, 051799, 051800, 059402, 059403 Risperdal Consta: 062640, 052934, 052935, 052936 Saphris reference Saphris: 073981, 065537, 065538 group Vraylar Vraylar: 074807, 074808, 074809, 074810, 075566 reference group ziprasidone ziprasidone: 047563, 047564, 047567, 047568 reference group chlorpromazine chlorpromazine: 003796, 003797, 003798, 003799, 003800 reference group fluphenazine fluphenazine elixir/solution: 003821, 003822 reference group fluphenazine tablets: 003823, 003824, 003825, 003826 fluphenazine decanoate injection: 003818 haloperidol haloperidol tablets: 003972, 003973, 003974, 003975, reference group 003976, 003977 haloperidol lactate concentrate: 003971 haloperidol decanoate injection: 003966, 003967, 0011876, 013076 loxapine loxapine: 003981, 003982, 003983, 003984 reference group pimozide pimozide: 003892, 019448 reference group perphenazine perphenazine: 003830, 003831, 003832, 003833, 046184, reference group 046185, 046186, 046187, 046188 thioridazine thioridazine: 003859, 003860, 003864, 003865 reference group thiothixene thiothixene: 003995, 003996, 003997, 003999 reference group trifluoperazine trifluoperazine: 003851, 003852, 003853, 003854 78 Administered for the MassHealth Pharmacy Program reference group D: All first- chlorpromazine chlorpromazine: 003796, 003797, 003798, 003799, 003800 generation (typical) reference group antipsychotics fluphenazine fluphenazine elixir/solution: 003821, 003822 reference group fluphenazine tablets: 003823, 003824, 003825, 003826 haloperidol haloperidol tablets: 003972, 003973, 003974, 003975, reference group 003976, 003977 haloperidol lactate concentrate: 003971 loxapine loxapine: 003981, 003982, 003983, 003984 reference group molindone molindone: 003987, 003989, 003990 reference group pimozide pimozide: 003892, 019448 reference group perphenazine perphenazine: 003830, 003831, 003832, 003833, 046184, reference group 046185, 046186, 046187, 046188 thioridazine thioridazine: 003859, 003860, 003864, 003865 reference group thiothixene thiothixene: 003995, 003996, 003997, 003999 reference group trifluoperazine trifluoperazine: 003851, 003852, 003853, 003854 reference group E: Polypharmacy: aripiprazole aripiprazole ODT: 060319, 060322 First-generation reference group aripiprazole solution: 058594 (typical) and second- aripiprazole tablets: 051333, 051334, 051335, 051336, generation (atypical) 052898, 060225 antipsychotics Fanapt reference Fanapt: 065901, 065902, 065903, 065904, 065905, 065906, (excluding clozapine group 065907, 065908 and injectable Latuda reference Latuda: 068448, 066932, 071415, 066933, 069894 agents) group molindone molindone: 003987, 003989, 003990 reference group olanzapine olanzapine: 029077, 027961, 027959, 027960, 041026, reference group 041027 olanzapine ODT: 045190, 045191, 047285, 047286 paliperidone paliperidone: 065667, 061985, 061986, 061987 reference group quetiapine quetiapine: 034187, 060292, 034188, 034189, 047198, reference group 060293 quetiapine extended-release: 063240, 064725, 062748, 062749, 062750 Rexulti reference Rexulti: 074442, 074444, 074445, 074446, 074447, 074448 group risperidone risperidone: 042922, 042923, 021154, 021155, 021156, reference group 021157, 026177, 071304, 071305, 071306 risperidone M-tabs: 065235, 052049, 051799, 051800, 059402, 059403 Saphris reference Saphris: 073981, 065537, 065538 group 79 Administered for the MassHealth Pharmacy Program Vraylar Vraylar: 074807, 074808, 074809, 074810, 075566 reference group ziprasidone ziprasidone: 047563, 047564, 047567, 047568 reference group chlorpromazine chlorpromazine: 003796, 003797, 003798, 003799, 003800 reference group fluphenazine fluphenazine elixir/solution: 003821, 003822 reference group fluphenazine tablets: 003823, 003824, 003825, 003826 haloperidol haloperidol tablets: 003972, 003973, 003974, 003975, reference group 003976, 003977 haloperidol lactate concentrate: 003971 loxapine loxapine: 003981, 003982, 003983, 003984 reference group pimozide pimozide: 003892, 019448 reference group perphenazine perphenazine: 003830, 003831, 003832, 003833, 046184, reference group 046185, 046186, 046187, 046188 thioridazine thioridazine: 003859, 003860, 003864, 003865 reference group thiothixene thiothixene: 003995, 003996, 003997, 003999 reference group trifluoperazine trifluoperazine: 003851, 003852, 003853, 003854 reference group Appendix IV: Injectable Antipsychotic Units Drug Units Abilify Maintena ER 300 mg/vial 1 vial Abilify Maintena ER 400 mg/vial 1 vial Abilify Maintena ER 300 mg/syringe 1 syringe Abilify Maintena ER 400 mg/syringe 1 syringe Aristada ER 441 mg/syringe 1.6 mL Aristada ER 662 mg/syringe 2.4 mL Aristada ER 882 mg/syringe 3.2 mL Aristada 1,064 mg/syringe 3.9 mL Invega Sustenna 39 mg/syringe 0.25 mL Invega Sustenna 78 mg/syringe 0.5 mL Invega Sustenna 117 mg/syringe 0.75 mL Invega Sustenna 156 mg/syringe 1 mL Invega Sustenna 234 mg/syringe 1.5 mL Invega Trinza 273 mg/syringe 0.875 mL Invega Trinza 410 mg/syringe 1.315 mL Invega Trinza 546 mg/syringe 1.75 mL Invega Trinza 819 mg/syringe 2.625 mL Risperdal Consta 12.5 mg/syringe 1 box Risperdal Consta 25 mg/syringe 1 box Risperdal Consta 37.5 mg/syringe 1 box 80 Administered for the MassHealth Pharmacy Program Risperdal Consta 50 mg/syringe 1 box Zyprexa Relprevv 210 mg Kit 1 vial Zyprexa Relprevv 300 mg Kit 1 vial Zyprexa Relprevv 405 mg Kit 1 vial REFERENCES 1. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Schizophrenia: Second Edition [guideline on the internet]. American Psychiatric Association, 2004 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/schizophrenia.pdf 2. Abilify® [package insert]. Princeton (NJ): Bristol-Myers Squibb Company; 2014 Dec. 3. Abilify Maintena® [package insert]. Rockville (MD): Otsuka America Pharmaceutical, Inc.; 2015 Jul. 4. Clozaril® [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corporation; 2015 Sept. 5. FazaClo® [package insert]. Philadelphia (PA): Azur Pharma, Inc.; 2015 Sep. 6. Fanapt® [package insert]. East Hanover (NJ): Novartis Pharmaceuticals; 2014 Apr. 7. Geodon® [package insert] New York (NY): Roerig (division of Pfizer Inc.); 2015 Aug. 8. Invega® [package insert]. Titusville (NJ): Janssen Pharmaceuticals, Inc.; 2014 Apr. 9. Invega® Sustenna® [package insert]. Titusville (NJ): Janssen Pharmaceuticals, Inc.; 2015 Jun. 10. Latuda® [package insert]. Marlborough (MA): Sunovion Pharmaceuticals, Inc.; 2013 Jul. 11. Risperdal® [package insert]. Titusville (NJ): Janssen Pharmaceuticals, Inc.; 2014 Apr. 12. Risperdal® Consta® [package insert]. Titusville (NJ): Janssen Pharmaceuticals, Inc.; 2014 Jun. 13. Saphris® [package insert]. Whitehouse Station (NJ): Merck and Co. Inc.; 2015 Mar. 14. Seroquel® [package insert]. Wilmington (DE): AstraZeneca Pharmaceuticals LP; 2013 Oct. 15. Seroquel XR® [package insert]. Wilmington (DE): AstraZeneca Pharmaceuticals LP; 2013 Apr. 16. Versacloz® [package insert]. Palo Alto (CA): Jazz Pharmaceuticals, Inc; 2015 Sep. 17. Zyprexa® [package insert]. Indianapolis (IN): Lilly USA, LLC; 2015 Jul. 18. Zyprexa® Relprevv® [package insert]. Indianapolis (IN): Lilly USA, LLC; 2015 Sep. 19. American Psychiatric Association. Guideline Watch (September 2009): Practice Guideline for the Treatment of Patients with Schizophrenia [guideline on the internet]. American Psychiatric Association, 2009 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/schizophrenia-watch.pdf 20. Moore TA, Buchanan RW, Buckley PF, Chiles JA, Conley RR, Crismon ML, et al. The Texas Medication Algorithm Project antipsychotic algorithm for schizophrenia: 2006 Update. J Clin Psychiatry. 2007 Nov:68(11):1751-62. 21. Kreyenbuhl J, Buchanan RW, Dickerson FB, Dixon LB; Schizophrenia Patient Outcomes Research Team (PORT). The Schizophrenia Patient Outcomes Research Team (PORT): Updated Treatment Recommendations 2009. Schizophr Bull. 2010 Jan;36(1):94-103. 22. National Institute for Health and Clinical Excellence. Psychosis and schizophrenia in adults: treatment and management. Guideline number 178. 2014 [guideline on the Internet]. [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg178/evidence/full-guideline-490503565 23. National Institute for Health and Clinical Excellence. Psychosis and schizophrenia in children and young people: recognition and management. Guideline Number 155.2013[guideline on the Internet]. [cited 2016 Feb 25]. Available from: https://www.nice.org.uk/guidance/cg155/resources/psychosis-and-schizophrenia- in-children-and-young-people-recognition-and-management-35109632980933 24. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Bipolar Disorder: Second Edition [guideline on the internet]. American Psychiatric Association, 2002 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/bipolar.pdf 25. American Psychiatric Association. Guideline Watch: Practice Guideline for the Treatment of Patients with Bipolar Disorder, 2nd Edition [guideline on the internet]. American Psychiatric Association, 2005 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/bipolar-watch.pdf 26. Suppes T, Dennehy EB, Hirschfeld RM, Altshuler LL, Bowden CL, Calabrese JR, et al. The Texas Implementation of medication algorithms: update to the algorithm for treatment of bipolar I disorder. J Clin Psychiatry. 2005 Jul;66(7):870-86. 81 Administered for the MassHealth Pharmacy Program 27. Goodwin GM, Consensus Group of the British Association for Psychopharmacology. Evidence-based guidelines for treating bipolar-disorder: revised second edition-recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2009 Jun:23(4):346-88. 28. National Institute for Health and Clinical Excellence. Bipolar disorder: assessment and management. Guideline Number 185. 2014.[guideline on the Internet]. [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg185/resources/bipolar-disorder-assessment-and-management- 35109814379461 29. American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. J Clin Psychiatry. 2004 Feb;65(2):267-72. 30. Rush AJ, Fava M, Wisniewski SR, Lavori PW, Trivedi MH, Sackeim HA, et al. Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Control Clin Trials. 2004 Feb;25(1):119-142. 31. Shelton RC, Osuntokun O, Heinloth AN, Corya SA. Therapeutic options for treatment-resistant depression. CNS Drugs. 2010 Feb;24(2):131-61. 32. Shelton RC, Tollefson GD, Tohen M, Stahl S, Gannon KS, Jacobs TG, et al. A novel augmentation strategy for treating resistant major depression. Am J Psychiatry. 2001 Jan;158(1):131-4. 33. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Major Depressive Disorder: Third Edition [guideline on the internet]. American Psychiatric Association, 2010 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf 34. National Institute for Health and Clinical Excellence. Depression in children and young people: Identification and management. Guideline Number 28. 2005. [guideline on the Internet]. [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg28/resources/depression-in-children-and-young- people-identification-and-management-975332810437 35. National Institute for Health and Clinical Excellence. Depression in adults: recognition and management. Guideline Number 90. 2009[guideline on the Internet]. [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg90/resources/depression-in-adults-recognition-and-management- 975742636741 36. McCracken JT, McGough J, Shah B, Cronin P, Hong D, Aman MG, et al. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002 Aug;347(5):314-21. 37. Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, et al. A placebo-controlled, fixed- dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-9. 38. Owen R, Sikich L, Marcus RN, Corey-Lisle P, Manos G, McQuade RD, et al. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics. Dec 2009;124(6):1533-40. 39. National Institute for Health and Clinical Excellence. Aripiprazole for treating modereate to severe manic episodes in adolescents with bipolar disorder. Technology Appraisal Guideline Number 292.2013.[guideline on the Internet]. [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/ta292/resources/aripiprazole-for-treating-moderate-to-severe-manic- episodes-in-adolescents-with-bipolar-i-disorder-82600730031301 40. Nelson JC, Papakostas GI. Atypical antipsychotic augmentation in major depressive disorder: a meta- analysis of placebo-controlled randomized trials. Am J Psychiatry. 2009 Sept;166(9):980-91. 41. Hesketh PJ. Prevention and treatment of chemotherapy-induced nausea and vomiting. In: Basow DS (Ed). UpToDate [database on the internet]. Waltham (MA): UpToDate; 2016 [cited 2016 Feb 25]. Available from: http://www.utdol.com/utd/index.do. 42. American Society of Clinical Oncology. Antiemetics: American Society of Clinical Oncology Focused Guidelien Update [guideline on the Internet]. American Society of Clinical Oncology, 2015 [cited 2016 Feb 25]. Available from: http://jco.ascopubs.org/content/early/2015/10/26/JCO.2015.64.3635.full.pdf+html 43. Roila F, Herrstedt J, Aapro M, Gralla RJ, Einhorn LH, Ballatori E, et al. Guideline update for MASCC (Multinational Association of Supportive Care in Cancer) and ESMO (European Society for Medical Oncology) in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol. 2010 May;21 Suppl 5:v232-43. 44. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Antiemesis, Version 2.2015 [guideline on the internet]. NCCN, 2015 [cited 2015 Oct 23]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. 82 Administered for the MassHealth Pharmacy Program 45. Marino J, Caballero J. Paliperidone extended-release for the treatment of schizophrenia. Pharmacotherapy. 2008 Oct;28(10):1283-98. 46. Potkin SG, Ogasa M, Cucchiaro J, Loebel A. Double-blind comparison of the safety and efficacy of lurasidone and ziprasidone in clinically stable outpatients with schizophrenia or schizoaffective disorder. Schizophr Res. 2011 Nov;132(2-3):101-7. 47. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Acute Stress Disorder and Posttraumatic Stress Disorder [guideline on the Internet]. American Psychiatric Association, 2004 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/acutestressdisorderptsd.pd f 48. American Psychiatric Association. Guideline Watch (March 2009): Practice Guideline for the Treatment of Patients with Acute Stress Disorder and Posttraumatic Stress Disorder [guideline on the Internet]. American Psychiatric Association, 2009 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/acutestressdisorderptsd- watch.pdf 49. Berg AO, Breslau N, Goodman SN, Lezak MD, Matchar DB, Mellman TA, et al. Treatment of PTSD: An Assessment of the Evidence. Washington DC: Institute of Medicine of the National Academies: 2007 Oct [2016 Feb 25]. Available from: https://iom.nationalacademies.org/~/media/Files/Report%20Files/2007/Treatment-of-PTSD-An- Assessment-of-The-Evidence/PTSDReportBriefFINAL2.pdf 50. National Institute for Health and Clinical Excellence. Post-traumatic stress disorder (PTSD): management. Guideline Number 26. 2005[guideline on the Internet]. [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg26/resources/posttraumatic-stress-disorder-management-975329451205 51. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Borderline Personality Disorder [guideline on the Internet]. American Psychiatric Association, 2001 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/bpd.pdf 52. National Institute for Health and Clinical Excellence. Borderline personality disorder: recognition and management. Guideline Number 78.2009[guideline on the Internet]. [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg78/resources/borderline-personality-disorder-recognition-and- management-975635141317 53. American Psychiatric Association. Guideline Watch: Practice Guideline for the Treatment of Patients with Borderline Personality Disorder [guideline on the Internet]. American Psychiatric Association, 2005 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/bpd-watch.pdf 54. Silk KR. Personality disorders. In: Basow DS (Ed). UpToDate [database on the internet]. Waltham (MA): UpToDate; 2016 [cited 2016 Feb 25]. Available from: http://www.utdol.com/utd/index.do. 55. Simpson B. Pharmacotherapy for obsessive-compulsive disorder in adults. In: Basow DS (Ed). UpToDate [database on the internet]. Waltham (MA): UpToDate; 2016 [cited 2016 Feb 25]. Available from: http://www.utdol.com/utd/index.do. 56. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Obsessive- Compulsive Disorder [guideline on the Internet]. American Psychiatric Association, 2007 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/ocd.pdf 57. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Panic Disorder [guideline on the Internet]. American Psychiatric Association, 2009 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/panicdisorder.pdf 58. National Institute for Health and Clinical Excellence. Generalised anxiety disorder and panic disorder in adults: management . Guideline Number 113. 2011[guideline on the Internet]. [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg113/resources/generalised-anxiety-disorder-and-panic- disorder-in-adults-management-35109387756997 59. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Eating Disorders: Third Edition [guideline on the Internet]. American Psychiatric Association, 2006 [cited 2016 Feb 25]. Available from: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/eatingdisorders.pdf 83 Administered for the MassHealth Pharmacy Program 60. Seida JC, Schouten JR, Boylan K, Newton AS, Mousavi SS, Beaith A, et al. Antipsychotics for children and young adults: a comparative effectiveness review. Pediatrics. 2012 Mar;129(3):e771-84. Epub 2012 Feb 20. 61. National Institute for Health and Clinical Excellence. Autism in adults: diagnosis and management Guidelien Number 142. 2012 [guideline on the Internet] [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg142/resources/autism-in-adults-diagnosis-and-management- 35109567475909 62. National Institute for Health and Clinical Excellence. Autism in under 19s: recognition, referral and diagnosis. Guideline Number 128. 2011[guideline on the Internet] [cited 2016 Feb 25]. Available from: http://www.nice.org.uk/guidance/cg128/resources/autism-in-under-19s-recognition-referral-and-diagnosis- 35109456621253 63. Lieberman JA, Stroup TS, McElvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. 64. Stroup TS, Lieberman JA, McEvoy JP, Swartz MS, Davis SM, Rosenheck RA, Perkins DO, Keefe RS, Davis CE, Severe J, Hsiao JK; CATIE Investigators. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry. 2006 Apr;163(4):611-22. 65. Stroup TS, Lieberman JA, McEvoy JP, Davis SM, Swartz MS, Keefe RS, Miller AL, Rosenheck RA, Hsiao JK; CATIE Investigators. Results of phase 3 of the CATIE schizophrenia trial. Schizophr Res. 2009 Jan;107(1):1-12. 66. Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Second-generation versus first-generation drugs for schizophrenia: a meta-analysis.Lancet.2009; 373:31-41. 67. Komossa K, Rummel-Kluge, Schmid F, et al. Aripiprazole versus other atypical antipsychotics for schizophrenia. Cochrane Database of Systematic Reviews.2009, Issue 4. Art.No.:CD006569. 68. Komossa K, Rummel-Kluge C, Hunger H, et al. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD006654. 69. Komossa K, Rummel-Kluge C, Schmid F, et al. Quetiapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD006625. 70. Komossa K, Rummel-Kluge C, Schmid F, et al. Risperidone versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD006626. 71. Komossa K, Rummel-Kluge C, Hunger H, et al. Ziprasidone versus other atypical antipsychotics for schizophrenia. Cochrane Database of Systematic Reviews.2009, Issue 4. Art. No.: CD006627. 72. Leucht S, Komossa K, Rummel-Kluge C, Corves C, Hunger H, Schmid F, Asenjo Lobos C, Schwarz S, Davis JM. A meta-analysis of head-to-head comparisons of second-generation antipsychotics in the treatment of schizophrenia. Am J Psychiatry. 2009;166:152-63. 73. Asenjo Lobos C, Komossa K, Rummel-Kluge C, et al. Clozapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD006633. 74. Riedel M, Schennach-Wolff R, Dehning MS, et al. Neurocognition and its influencing factors in the treatment of schizophrenia-effects of aripiprazole, olanzapine, quetiapine and risperidone. Hum Psychopharmacol Clin Exp.2010; 25:116-25. 75. Cipriani A, Barbui C, Salanti G, et al. Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis. Lancet. 2011 Oct 8;378(9799):1306-15. 76. Perlis RH, Welge JA, Vornik LA, Hirschfeld RMA, Keck PE Jr. Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry. 2006;76:509-16. 77. Yildiz A, Vieta E, Leucht S, et al. Efficacy of antimanic treatments: meta-analysis of randomized, controlled trials. Neuropsychopharmacology.2011; 36:375-389. 78. Vieta E, Locklear J, Gunther O, et al. Treatment options for bipolar depression: a systematic review of randomized, controlled trials. J Clin Psychopharmacol.2010; 30:579-90. 79. Papakostas GI, Petersen TJ, Kinrys G, Burns AM, Worthington JJ, Alpert JE, Fava M, Nierenberg AA. Aripiprazole augmentation of selective serotonin-reuptake inhibitors for treatment-resistant major depressive disorder. J Clin Psychiatry. 2005 Oct; 66(10):1326-30. 80. Papakostas GI, Petersen TJ, Nierenberg AA, Murakami JL, Alpert JE, Rosenbaum JF, Fava M. Ziprasidone augmentation of selective serotonin-reuptake inhibitors (SSRIs) for SSRI-resistant major depressive disorder. J Clin Psychiatry. 2004 Feb; 65(2):217-21. 84 Administered for the MassHealth Pharmacy Program 81. Komossa K, Depping AM, Gaudchau A, et al. Second-generation antipsychotics for major depressive disorder and dysthymia. Cochrane Database of Systematic Reviews.2010, Issue 12.Art.No.:CD008121. 82. Maher AR, Maglione M, Bagley S, et al. Efficacy and comparative effectiveness of atypical antipsychotic medications for off-label uses in adults: a systematic review and meta-analysis. JAMA.2011; 306(12):1359-69. 83. Seida JC, Schouten JR, Boylan K, et al. Antipsychotics for children and young adults: a comparative effectiveness review. Pediatrics.2012; 129:e771-e784. 84. Seida JC, Schouten JR, Mousavi SS, Hamm M, et al. First- and second-generation antipsychotics for children and young adults. Comparative Effectiveness Review No. 39. (Prepared by the University of Alberta Evidence-based Practice Center under Contract No. 290-2007-10021). [Monograph on the internet]. Rockville (MD): Agency for Healthcare Research and Quality; 2012 Feb [cited 2016 Feb 25]. Available from: http://www.effectivehealthcare.ahrq.gov/ehc/products/147/918/CER39_First-and-Second- Generation-Antipsychotics_execsumm_20120104.pdf 85. Rexulti® [package insert]. Rockville (MD): Otsuka America Pharmaceutical; 2015 July. 86. Invega Trinza® [package insert]. Titusville (NJ): Janssen Pharmaceuticals; 2015 May. 87. Aristada® [package insert]. Waltham (MA): Alkermes; 2015 Oct. 88. Vraylar® [package insert]. Parsippany (NJ): Actavis Inc.; 2015 Sep. Historical Timeline Version Date Comments 0.0 6/26/2003- Original Guideline June 26, 2003, updated September 25, 2003, June 9, 2004, 05/03/2010 September 2, 2004, August 6, 2007, January 31, 2008 February 23, 2009 – Added Seroquel XR 50 mg & 150 mg (MDW) July 14, 2009 – Added QL for Risperdal Consta (MDW) March 1, 2010 – Added Fanapt, Saphris to MHDL w/PA; added Invega Sustenna to MHDL w/QL; changed Invega MHDL status to requiring PA; eliminated PA requirement for Zyprexa IM (MDW) May 3, 2010 – Full Clinical Update - literature and utilization review. Added Zyprexa Relprevv with associated QL restrictions (MDW) Added Abilify DiscMelt, Fazaclo, Risperdal M tab and Zyprexa Zydis as part of the process to disassemble the ODT guideline.The criteria for these agents has not changed and medical necessity for the ODT formulation is required as the regular tablet formulations are available with quantity limits only. The proposal to disassemble the guideline was approved at the MHPPM 5/20/10. A full EBM is scheduled for this guideline in this calendar year and was not performed at this time. 1.0 1/21/11 Guideline updated based on Quality Assurance analysis and Latuda® new drug review per full EBM review (both presented at MHPPM 1/13/2011). Latuda® placed on PA due to high cost and lack of head to head trials demonstrating improved efficacy over other agents. No changes made to criteria, additional clarification added for how to handle various scenarios utilizing the checkbox on the PA form (PA for updated as well). Appendix sections reorganized and clarified. POS rules updated to allow for 90/120 days stability as rationale for approval of Fanapt, Saphris and Latuda as well as Invega (update effective: 05/02/11) 1.1 5/10/11 Added quantity limit into SmartPA and POS flowcharts including verbal description (update effective: 05/10/11). 1.2 12/02/11 Availability of generic Zyprexa and Zyprexa Zydis was added to the guideline. A quality assurance analysis was conducted and presented at MHPPM on 10/06/11 and per recommendations, following changes were made to the guideline: added comparative metabolic benefit profile of Latuda versus Geodon to the appendix; added pregnancy category information for all agents and 85 Administered for the MassHealth Pharmacy Program Version Date Comments Antipsychotic PA form was updated to include the names of antipsychotics available without a PA to aid the prescribers in completing the form. In addition, the outgoing messages were updated to include olanzapine instead of Zyprexa and risperidone instead of Risperdal (update effective: 01/09/12). 2.0 6/19/12 Added Latuda 20 mg GSN 068448 to guideline and flowcharts. 2.1 08/08/12 Added olanzapine IM vials (for acute treatment) to the reference table under no PA required column to clarify that regular IM vials do not have any quantity limits (update effective: 08/08/12). 2.2 09/07/12 Added olanzapine, quetiapine and ziprasidone as appropriate generic trial (as they are available generically) within the approval criteria for atypical antipsychotics that require a PA (update effective: 09/07/12). 2.3 9/12/12 New strength of Latuda (120 mg) and non A-rated generic entered POPS system on 9/12/12. Latuda will follow same criteria as other strengths. Generic clozapine ODT will continue to require PA. Requests for brand name will also require a trial with generic clozapine ODT (update effective: 09/12/12). 2.4 9/20/12 Identified that long-acting injectable formulations and Fazaclo were included in polypharmacy lookback. These agents have been removed by POPS as they have historically not been included in the lookback. Also verified with POPS that Seroquel and Seroquel XR have the same HICL code and they will not hit out against each other for polypharmacy. Generic notation was incorrectly missing from Seroquel and Geodon and this was added back as a correction. (update effective: 09/25/12). 2.5 11/15/12 Biennial review completed per full EBM. QA analysis was completed and presented at MHPPM on 11/08/12; updated the FDA-approved indications, availability and dosing of all the agents per the most recent package inserts available (Update effective: 12/13/12). 3.1 2/21/13 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). 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 children and adolescents under the age of 18 (existing quantity limits and polypharmacy rules apply). Extended quantity limits for Invega® (paliperidone) 6 mg tablets from 30 units/month to 60 units/month and for Latuda® (lurasidone) 80 mg tablets from 30 units/month to 60 units/month to allow for maximum FDA-approved dosing per package labeling. Similarly, previously unpublished quantity limits for risperidone 4 mg of 120 units/month and olanzapine 15 mg of 60 units/month was added to the reference table, similar to Invega and Latuda to allow for dosing otherwise not available in commercial formulations. Added quantity limits for the orally disintegrating tablets (similar to regular oral tablets) of all second-generation (atypical) antipsychotics. Added Abilify Maintena® (aripiprazole) extended- release injection to the guideline with similar criteria as other branded second- generation (atypical) antipsychotic long-acting injectables. Updated breakthrough dosing table and copay waiver combinations and corresponding flowcharts. Updated enterprise messaging for the guideline based on new 86 Administered for the MassHealth Pharmacy Program Version Date Comments approval criteria. Added GL list combinations for this class. Per discussion at MHPPM on 3/14/13, upon review of the utilization data, pricing information on the long-acting injectable formulations and history of long-acting injectables available within quantity limits to MassHealth members, it was decided to place Abilify® Maintena® (aripiprazole) on the MHDL with quantity limits of 1 vial/month per FDA-approved dosing (Update effective: 5/13/13). 3.2 8/9/13 Added bipolar depression diagnosis for Latuda to the guideline without any changes to the approval criteria per email correspondences with MassHealth Pharmacy Director in July 2013. Also added 60 mg tablets for Latuda to the guideline per the most recent package insert; however, since it is not currently listed in POPS, the flowcharts do not need to be updated at this time. Updated SPA charts to include correct decision code for ODT antipsychotic formulations. (Update effective: 10/14/13). 3.3 10/9/13 Added Latuda 60 mg tablets to the guideline and flowcharts since it became available. Also added risperidone 1 mg/mL, 2 mg/2 mL and 3 mg/3 mL oral syringes with quantity limit of 480 mL/month similar to risperidone oral solution to the guideline and flowcharts. However, currently it does not participate in federal rebate program and will not be covered or listed on MHDL unless it gains federal rebate. (Update effective: 1/6/14). 4.0 4/22/14 Added Versacloz® oral suspension to the guideline and flowcharts. Prior authorization is required as lower cost clozapine formulations are available. Approval criteria presented and approved at MHPPM on 3/27/14. ICD-10 codes added. (Update effective: 8/4/14). 4.1 11/21/14 Guideline updated to reflect changes from the MassHealth Pediatric Behavioral Health Medication Initiative. Changes include updates to allow for the review of members <18 years of age using both the second-generation (atypical) antipsychotic guideline and the MassHealth Pediatric Behavioral Health Medication Initiative guideline. POS and SmartPA flowcharts were updated to reflect these changes (Update effective: 11/24/2014). 5.0 1/27/15 Guideline update to account for prefilled syringe formulations of Abilify Maintena® (aripiprazole), 300 mg and 400 mg, that entered POPS system on 1/21/2015. Decision made to add these products into existing coding. Updated POS written description for Abilify tablets and Seroquel XR to match POS flowchart. Update to account for authorized generic available for Fazaclo® (clozapine ODT). A request for the brand name version would be reviewed for failed trial of therapeutically equivalent generic. SmartPA and POS flowcharts were updated to reflect changes as described above. (Update effective: 3/25/15) 5.1 6/29/15 After consultation with MassHealth, the 60 day lookback period for the PBHMI PA restriction targeting regimens with four or more behavioral health medications was changed to 45 days. POS rule for PBHMI lookback updated to 45 days took effect on 6/1/2015. Guideline appendix updated to reflect this change. Guideline was also updated to include the new strength of Saphris 2.5 mg SL tablet. New A-rated generic for Abilify® tablets and authorized generics for Fazaclo® (clozapine ODT) 150 mg and 200 mg were added. Additionally, guideline updated to note the new Seroquel XR Sample Kit® formulation is a sample kit and is not covered. SmartPA and POS flowcharts were updated to reflect changes as described above (Update effective 7/2/15). 87 Administered for the MassHealth Pharmacy Program Version Date Comments 5.2 7/29/15 Guideline update following decision to remove emergency claims from duplicate therapy overlap for members ≥ 18 years old to match PBHMI coding. SmartPA and POS flowcharts updated to reflect the changes noted above. (Update effective 10/13/15) 5.3 10/14/15 Guideline update to reflect newly available A-rated generics for Invega® (paliperidone) tablets that entered POPS on 9/30/15. Guideline also updated to reflect newly available A-rated generics for Abilify® (aripiprazole) solution and ODT that entered POPS on 8/26/15 and 10/14/15 respectively. Decision was made to continue to require PA for both brand and generic paliperidone and aripiprazole ODT for all MassHealth members. Decision was made to continue to require PA for brand and generic aripiprazole solution when exceeding quantity limits and/or age limits. Generic aripiprazole solution is covered within age and quantity limits. SmartPA and POS flowcharts updated to reflect the changes noted above. (Update effective 10/23/15) 6.0 10/23/15 Guideline updated to include Rexulti® (GSNs 074442, 074444, 074445, 074446, 074447, 074448), and Invega Trinza® (GSNs 074140, 074141,074142, 074143) Decision was made to require prior authorization for Rexulti® and quantity limits for Invega Trinza®. SmartPA and POS flowcharts were updated to reflect changes as described above. Appendix for olanzapine for chemotherapy- induced/radiation-induced and postoperative nausea/vomiting updated to reflect current NCCN recommendations (Update effective 2/8/16). 6.1 2/18/16 Biennial review completed per full EBM. QA analysis was completed and presented at MHPPM on 1/28/16. Adult antipsychotic polypharmacy criteria were updated and first-generation antipsychotics and long-acting injectable formulations were included into the polypharmacy restriction. PA criteria for aripiprazole, Seroquel® XR, and Rexulti® indicated for depression was updated to reflect addition of documentation of adjunctive antidepressant therapy. Seroquel® XR criteria for all psychiatric diagnoses was updated to include a trial with immediate-release quetiapine. Guideline updated to include Aristada® (GSNs 074887, 074888, 074889), which was presented at MHPPM on 12/3/15, and molindone (GSNs 003987, 003989, 003990). Removed Abilify® 9.7mg/1.3mL injection as obsolete. SmartPA and POS flowcharts were updated to reflect changes as described above. (Update effective 05/31/16; Aristada covered within age and quantity limits as of 5/23/16). 6.2 5/27/16 Guideline title changed from Second Generation (Atypical) Antipsychotics to Antipsychotics as first generation antipsychotics were included in the antipsychotic polypharmacy restriction in the last update. Guideline also updated to include Vraylar® (GSNs 074807, 074808, 074809, 074810, 075566), which was presented at MHPPM on 4/7/2016. In addition, due to feedback from the Department of Mental Health, long-acting injectable formulations will be removed from the adult polypharmacy restriction. SmartPA and POS flowcharts were updated to reflect changes as described above. Updated Appendix IV, injectable antipsychotic units. (Update effective 08/29/16). 6.3 11/09/16 Guideline update following the availability of A-rated (400 mg) and authorized (50 mg, 150 mg, 200 mg, 300 mg strengths) generics for Seroquel XR (quetiapine extended-release) in POPS on 11/09/16. Both brand and generic versions will continue to require prior authorization for members ≥18 years old, and all members exceeding quantity limits. SmartPA and POS flowcharts updated to reflect the changes above (Update effective 11/28/16) 88 Administered for the MassHealth Pharmacy Program Version Date Comments 6.4 12/12/2016 Added specific Jcode for Aristada® (aripiprazole lauroxil) that will be added to the MassHealth Physician manual on 01/01/2017. No changes required to POS or SmartPA flowcharts for this update (Update effective: 01/03/17) 7.0 04/10/17 Guideline update following the availability of an A-rated generic for Fazaclo (clozapine ODT) 25 mg and 100 mg strengths, which entered POPS on 04/05/17 and 10/05/16, respectively. Both brand and generic will continue to require PA. Updates to Smart Fusion rule to reflect changes above. (Update effective 04/18/17). 7.1 09/27/17 Guideline update to account for inclusion of Aristada 1,064 mg strength which will require PA if exceeds a quantity limit of 1 syringe per 2 months. Given the decrease in cost of aripiprazole tablets, the PA restriction on aripiprazole tablets for members greater than or equal to 18 years old, within quantity limits and polypharmacy rules, was removed. SmartPa and POS flowcharts updated to reflect the changes above. (Update effective 11/06/17). 8.0 01/09/18 Guideline update to account for designation of Aristada as the preferred long- acting aripiprazole product. Abilify Maintena will require prior authorization. This will only be required for members who are new starts on the medication. SmartPA and POS rules updated to reflect the changes above. (Update effective 02/12/18). 89 Administered for the MassHealth Pharmacy Program