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Drug Category: Central Nervous System (CNS)

Medication Class/Individual Agents: Second-Generation (Atypical) Antipsychotics

I. Prior-Authorization Requirements

 Second-Generation (Atypical) Antipsychotic and Selective Serotonin Reuptake Inhibitor

Clinical Notes

Drug Generic Name

Drug Brand Name

PA
Status

olanzapine / fluoxetine Symbyax PA  

Please note: In the case where the prior authorization (PA) status column indicates PA for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  PA requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

  • Limited scientific data supports the concomitant use of two or more second-generation (atypical) antipsychotics. It is recommended that monotherapy trials be attempted before polypharmacy is used.
  • Dissolvable tablets do not have a faster onset of action compared to their conventional oral dosage forms. They possess the same side effects and have similar pharmacokinetic profiles as the oral tablet. Since dissolvable tablets offer no therapeutic advantage, and they are more costly than other oral formulations, all dissolvable tablets will require PA. Asenapine has minimal to no absorption if swallowed and must be dissolved in the mouth to be absorbed via buccal/sublingual sites.
  • All second-generation (atypical) antipsychotics have a black box warning for increased mortality in elderly patients with dementia related psychosis.
  • Second-generation (atypical) antipsychotics have been associated with substantial weight gain. This risk is statistically greater with some products compared to others.
  • In November 2003, the FDA mandated that the following information be added to the WARNINGS section of all second-generation (atypical) antipsychotic drug labeling. Hyperglycemia in extreme progressing to ketoacidosis, hyperosmolar coma and/or death has been reported for this class of drugs. Fasting glucose should be obtained at the beginning of treatment and periodically. Patients with established diagnosis of diabetes mellitus should be monitored for worsening of glycemic control (for complete details see package insert).
  • A consensus statement issued by the APA, ADA and others suggested a scheduled monitoring of the following patients on these drugs: weight/BMI, waist circumference, blood pressure, fasting glucose, and fasting lipid profile.1
  • Antipsychotic induced metabolic complications such as weight increases, glucose increases and triglyceride increases are more pronounced in children and adolescents compared to the adult population.

1American 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 Psych 2004;65(2):267-72.

Please see the following link to find out more information regarding Second-Generation (Atypical) Antipsychotics (e.g., Letters to Prescribers as well as cost and utilization data): http://www.mass.gov/eohhs/provider/insurance/masshealth/pharmacy/atypical-antipsychotics.html

 

 Second-Generation (Atypical) Antipsychotics

Drug Generic Name

Drug Brand Name

PA
Status

aripiprazole extended-release injection Abilify Maintena PA   - < 6 years and PA > 1 injection/month
aripiprazole lauroxil Aristada PA   - < 6 years and PA > 1 injection/month
aripiprazole orally disintegrating tablet Abilify Discmelt PA  
aripiprazole solution Abilify # PA   - < 6 years or ≥ 18 years and PA > 750 mL/month
aripiprazole tablet Abilify # PA   - < 6 years or ≥ 18 years and PA > 30 units/month
asenapine Saphris PA  
brexpiprazole Rexulti PA  
clozapine orally disintegrating tablet Fazaclo PA  
clozapine suspension Versacloz PA  
clozapine tablet Clozaril # PA   - < 6 years
iloperidone Fanapt PA  
lurasidone Latuda PA  
olanzapine 15 mg tablet Zyprexa # PA   - < 6 years and PA > 60 units/month
olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg, 20 mg tablets Zyprexa # PA   - < 6 years and PA > 30 units/month
olanzapine 210 mg, 300 mg extended-release injection Zyprexa Relprevv PA   - < 6 years and PA > 2 injections/month
olanzapine 405 mg extended-release injection Zyprexa Relprevv PA   - < 6 years and PA > 1 injection/month
olanzapine injection Zyprexa  
olanzapine orally disintegrating tablet Zyprexa Zydis PA  
paliperidone extended-release 1-month injection Invega Sustenna PA   - < 6 years, PA > 2 units/month within the first 30 days of therapy and PA > 1 unit/month after 30 days of therapy
paliperidone extended-release 3-month injection Invega Trinza PA   - < 6 years and PA > 1 unit/3 months
paliperidone tablet Invega PA  
quetiapine Seroquel # PA   - < 6 years and PA > 90 units/month
quetiapine extended-release 50 mg, 300 mg and 400 mg Seroquel XR PA   - < 6 years or ≥ 18 years and PA > 60 units/month
quetiapine extended-release 150 mg, 200 mg Seroquel XR PA   - < 6 years or ≥ 18 years old and PA > 30 units/month
risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg tablets Risperdal # PA   - < 6 years and PA > 60 units/month
risperidone 4 mg tablet Risperdal # PA   - < 6 years and PA > 120 units/month
risperidone extended-release injection Risperdal Consta PA   - < 6 years and PA > 2 units (2 syringes)/month
risperidone orally disintegrating tablet Risperdal M-Tab PA  
risperidone solution Risperdal # PA   - < 6 years and PA > 480 mL/month
ziprasidone capsule Geodon # PA   - < 6 years and PA > 60 units/month
ziprasidone injection Geodon  
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Bipolar disorder
  • Irritability associated with autistic disorder
  • Major depressive disorder
  • Schizoaffective disorder
  • Schizophrenia

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the PA status column indicates PA for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  PA requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below).

  

Monotherapy

aripiprazole ODT for members < 18 years

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • medical necessity for an orally disintegrating dosage form; and
    • requested quantity does not exceed established quantity limits of 30 units/month.

aripiprazole ODT, solution, and tablet for members ≥ 18 years with the diagnosis of autism spectrum disorder

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction or contraindication to risperidone; and
    • if the request is for aripiprazole ODT or solution, medical necessity for dosage form; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

Smart PA: Claims within quantity limits and polypharmacy requirements for aripiprazole tablets for members ≥ 18 years of age will usually process at the pharmacy without a PA request if the member has a diagnosis of autism spectrum disorder and a history of MassHealth pharmacy claims for risperidone. Claims within quantity limits and polypharmacy requirements for aripiprazole tablets for members ≥ 18 years of age will also usually process at the pharmacy without a PA request if the member has a history of MassHealth pharmacy claims of the requested agent for 90 days in the past 120 days.

aripiprazole ODT, solution, tablet, and Seroquel XR for members ≥ 18 years with the diagnosis of major depressive disorder or treatment resistant depression

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two antidepressants (either alone or in combination). Note: unless a contraindication to all antidepressants exist, two of them must be tried; and
    • requested agent will be used as adjunctive antidepressant therapy; and
    • if the request is for aripiprazole ODT or solution, medical necessity for dosage form; and
    • if the request is for Seroquel XR, inadequate response or adverse reaction to immediate-release quetiapine; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for aripiprazole tablets for members ≥ 18 years of age will usually process at the pharmacy without a PA request if the member has a diagnosis of major depressive disorder, a history of MassHealth pharmacy claims for any two antidepressants, and a history of MassHealth pharmacy claims for an antidepressant in the past 30 days. Claims within quantity limits and polypharmacy requirements for aripiprazole tablets for members ≥ 18 years of age will also usually process at the pharmacy without a PA request if the member has a history of MassHealth pharmacy claims of the requested agent for 90 days in the past 120 days.

SmartPA: Claims within quantity limits and polypharmacy requirements for Seroquel XR for members ≥ 18 years of age will usually process at the pharmacy without a PA request if the member has a diagnosis of major depressive disorder, a history of MassHealth pharmacy claims for immediate-release quetiapine, a history of MassHealth pharmacy claims for any two antidepressants, and a history of MassHealth pharmacy claims for an antidepressant in the past 30 days. Claims within quantity limits and polypharmacy requirements for Seroquel XR for members ≥ 18 years of age will also usually process at the pharmacy without a PA request if the member has a history of MassHealth pharmacy claims of the requested agent for 90 days in the past 120 days.

aripiprazole ODT, solution, tablet, and Seroquel XR for members ≥ 18 years with a psychiatric diagnosis not listed above

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two second-generation (atypical) antipsychotics (generic or brand). Note: unless a contraindication to all second-generation (atypical) antipsychotics exist, two of them must be tried; and
    • if the request is for aripiprazole ODT or solution, medical necessity for dosage form; and
    • if the request is for Seroquel XR, inadequate response or adverse reaction to immediate-release quetiapine; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for aripiprazole tablets for members ≥ 18 years of age will usually process at the pharmacy without a PA request if the member has a history of MassHealth pharmacy claims for two second-generation (atypical) antipsychotics. Claims within quantity limits and polypharmacy requirements for aripiprazole tablets for members ≥ 18 years of age will also usually process at the pharmacy without a PA request if the member has a history of MassHealth pharmacy claims of the requested agent for 90 days in the past 120 days.

SmartPA: Claims within quantity limits and polypharmacy requirements for Seroquel XR for members ≥ 18 years of age will usually process at the pharmacy without a PA request if the member has a history of MassHealth pharmacy claims for immediate-release quetiapine and a history of MassHealth pharmacy claims for two second-generation (atypical) antipsychotics. Claims within quantity limits and polypharmacy requirements for Seroquel XR for members ≥ 18 years of age will also usually process at the pharmacy without a PA request if the member has a history of MassHealth pharmacy claims of the requested agent for 90 days in the past 120 days.

clozapine ODT, olanzapine ODT and risperidone ODT for all members

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • medical necessity for an orally disintegrating dosage form; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

Fanapt, Latuda, paliperidone tablet, and Saphris for members < 18 years of age

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one of the following generic second-generation (atypical) antipsychotics: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, or ziprasidone. Note: unless a contraindication to all second-generation (atypical) antipsychotics exist, one of them must be tried; and
    • one of the following:
      • inadequate response or adverse reaction to two other different atypical or typical antipsychotics; or
      • contraindication to all other antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for Fanapt, Latuda, paliperidone tablet, or Saphris for members < 18 years of age will usually process at the pharmacy without a PA request if the member has a MassHealth history of pharmacy claims of one of the following generic second-generation (atypical) antipsychotics: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, or ziprasidone, and any two other atypical or typical antipsychotics, or of the requested agent for 90 days in the past 120 days.

Fanapt, Latuda, paliperidone tablet, and Saphris for members ≥ 18 years of age

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two second-generation (atypical) antipsychotics (generic or brand). Note: unless a contraindication to all second-generation (atypical) antipsychotics exist, two of them must be tried; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for Fanapt, Latuda, paliperidone tablet, or Saphris for members ≥ 18 years of age will usually process at the pharmacy without a PA request if the member has a MassHealth history of pharmacy claims for two second-generation (atypical) antipsychotics or of the requested agent for 90 days in the past 120 days.

olanzapine/fluoxetine for all members

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale as to why the doses available in the combination product would provide a therapeutic advantage over the doses in the commercially available separate agents.

Rexulti for members with the diagnosis of major depressive disorder or treatment resistant depression

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two antidepressants (either alone or in combination). Note: unless a contraindication to all antidepressants exist, two of them must be tried; and
    • Rexulti will be used as adjunctive antidepressant therapy; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for Rexulti will usually process at the pharmacy without a PA request if the member has a diagnosis of major depressive disorder, a history of MassHealth pharmacy claims for any two antidepressants, and a history of MassHealth pharmacy claims for an antidepressant in the past 30 days.†  

Rexulti for members < 18 years of age with an appropriate psychiatric diagnosis (excluding major depressive disorder or treatment-resistant depression)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one of the following generic second-generation (atypical) antipsychotics: aripiprazole, clozapine, olanzapine, quetiapine, risperidone or ziprasidone. Note: unless a contraindication to all second-generation (atypical) antipsychotics exist, one of them must be tried; and
    • one of the following:
      • inadequate response or adverse reaction to two other different atypical or typical antipsychotics; or
      • contraindication to all other antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for Rexulti for members < 18 years of age will usually process at the pharmacy without a PA request if the member has a MassHealth history of pharmacy claims of one of the following generic second-generation (atypical) antipsychotics: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, or ziprasidone, and any two other antipsychotics or of the requested agent for 90 days in the past 120 days.

Rexulti for members ≥ 18 years of age with an appropriate psychiatric diagnosis (excluding major depressive disorder or treatment-resistant depression)

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two second-generation (atypical) antipsychotics (generic or brand). Note: unless a contraindication to all second-generation (atypical) antipsychotics exist, two of them must be tried; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for Rexulti for members ≥ 18 years of age will usually process at the pharmacy without a PA request if the member has a MassHealth history of pharmacy claims for two second-generation (atypical) antipsychotics or of the requested agent for 90 days in the past 120 days.

Versacloz for all members

  • Documentation of all of the following is required:  
    • appropriate diagnosis; and
    • medical necessity for an oral suspension dosage form. 

  

Exceeding quantity limits for all members

  • Documentation of one of the following is required:
    • clinical rationale why the dose cannot be consolidated; or
    • clinical rationale why the member requires dosing at intervals exceeding what is recommended by the FDA. 

   

Polypharmacy (overlapping pharmacy claims for two or more antipsychotics [includes first-generation and/or second-generation antipsychotics, except clozapine and short-acting injectable formulations] for at least 60 days within a 90 day period) for members ≥ 18 years old

  • Documentation of all of the following is required:
    • psychiatric diagnosis including treatment-resistant conditions; and
    • treatment plan including names of current antipsychotics and corresponding diagnoses; and
    • prescriber is a psychiatrist or a psychiatry consult is provided; and
    • one of the following:
      • inadequate response or adverse reaction to two monotherapy trials as clinically appropriate; or
      • member had a recent psychiatric hospitalization and was discharged on the current regimen; or
      • cross-titration/taper of antipsychotic therapy.

  

In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions.

 

Behavioral Health Medication Polypharmacy (pharmacy claims for any combination of four or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, hypnotic agents, and mood stabilizers] within a 45 day period) for members < 18 years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • For regimens including ≤ 2 mood stabilizers (also includes regimens that do not include a mood stabilizer), documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g.,  psychiatrist, neurologist) or consult is provided.

 

  • For regimens including ≥ 3 mood stabilizers, documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
      • one of the following:
        • member has a seizure diagnosis only; or
        • member has an appropriate psychiatric diagnosis and one of the following:
          • cross-titration/taper of mood stabilizer therapy; or
          • inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate; or
        • member has a diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain)  and documentation that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed ; or
        • member has  psychiatric and comorbid diagnosis in which mood stabilizers may be clinically appropriate  (e.g., migraine, neuropathic pain) and documentation that other clinically relevant  therapies have been tried and failed; therefore, multiple mood stabilizers are needed, and one of the following:
          • cross-titration/taper of mood stabilizer therapy; or
          • inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.

SmartPA: Claims will usually process at the pharmacy without a PA request if the member is < 18 years of age, has a history of MassHealth medical claims for seizure, and has a history of MassHealth pharmacy claims for four or less behavioral health medications within the past 45 days and one mood stabilizer agent is identified as being used for seizure only.

  

Antipsychotic Polypharmacy (overlapping pharmacy claims for 2 or more antipsychotics [includes first-generation and/or second-generation antipsychotics] for at least 60 days within a 90 day period) for members < 18 years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required:
    • one of the following:
      • member  had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate psychiatric diagnosis; and
      • treatment plan including names of current antipsychotics and corresponding diagnoses; and
      • prescriber is a  psychiatrist or consult is provided; and
      • one of the following:
        • cross-titration/taper of antipsychotic therapy; or
        • inadequate response or adverse reaction to two monotherapy trials as clinically appropriate.

    

Antipsychotic for members < six years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required:
    • one of the following:
      • member  had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnosis; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g. psychiatrist, neurologist) or consult is provided.

    

Reference Table:

Drug

Quantity Limits

Abilify (aripiprazole tablet)

30 units/month

Abilify (aripiprazole solution)

750 ml/month

Abilify Discmelt (aripiprazole orally disintegrating tablet)

30 units/month

Abilify Maintena (aripiprazole extended-release injectable suspension)

1 injection/month

Aristada (aripiprazole lauroxil)

1 injection/month

Fanapt (iloperidone)

60 units/month

Geodon (ziprasidone)

60 units/month

Invega (paliperidone tablet) 1.5 mg, 3 mg, 9 mg

30 units/month

Invega (paliperidone tablet) 6 mg

60 units/month

Invega Sustenna (paliperidone IM)

2 syringes month 1, 1 syringe/month thereafter

Invega Trinza (paliperidone IM)

1 syringe/3 months

Latuda (lurasidone) 20 mg, 40 mg, 60 mg, 120 mg

30 units/month              

Latuda (lurasidone) 80 mg

60 units/month

Rexulti (brexpiprazole)

30 units/month

Risperdal (risperidone tablet) 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg

60 units/month

Risperdal (risperidone tablet) 4 mg

120 units/month

Risperdal (risperidone solution)

480 ml/month

Risperdal Consta (risperidone injection)

2 syringes/month

Risperdal M-Tab (risperidone orally disintegrating tablet) 0.5 mg, 1 mg, 2 mg, 3 mg

60 units/month

Risperdal M-Tab (risperidone orally disintegrating tablet) 4 mg

120 units/month

Saphris (asenapine)

60 units/month

Seroquel (quetiapine)

90 units/month

Seroquel XR (quetiapine extended-release) 150 mg, 200 mg

30 units/month

Seroquel XR (quetiapine extended-release) 50 mg, 300 mg, 400 mg

60 units/month

Zyprexa (olanzapine tablet) 2.5 mg, 5 mg, 7.5 mg, 10 mg, 20 mg

30 units/month

Zyprexa (olanzapine tablet) 15 mg

60 units/month

Zyprexa Relprevv (olanzapine pamoate long-acting injection) 210 mg, 300 mg

2 vials/month

Zyprexa Relprevv (olanzapine pamoate long-acting injection) 405 mg

1 vial/month

Zyprexa Zydis (olanzapine orally disintegrating tablet) 5 mg, 10 mg, 20 mg

30 units/month                

Zyprexa Zydis (olanzapine orally disintegrating tablet) 15 mg

60 units/month

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.

Please see the following link to find out more information regarding Second-Generation (Atypical) Antipsychotics (e.g., Letters to Prescribers as well as cost and utilization data): http://www.mass.gov/eohhs/provider/insurance/masshealth/pharmacy/atypical-antipsychotics.html


Original Effective Date: 03/2010

Last Revised Date: 05/2016


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Last updated 05/31/16