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Table 24: Antipsychotics


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Drug Category: Central Nervous System (CNS)

Medication Class/Individual Agents: Antipsychotics

I. Prior-Authorization Requirements

 Antipsychotics – First-Generation (Typical)

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

amitriptyline / perphenazine PA   A90
chlorpromazine PA   - < 6 years A90
fluphenazine PA   - < 6 years A90
haloperidol Haldol PA   - < 6 years # , A90
loxapine capsule Loxitane PA   - < 6 years # , A90
molindone PA   - < 6 years A90
perphenazine PA   - < 6 years A90
pimozide Orap PA   - < 6 years # , A90
thioridazine PA   - < 6 years A90
thiothixene Navane PA   - < 6 years # , A90
trifluoperazine PA   - < 6 years A90

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • Limited scientific data supports the concomitant use of two or more 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 formulations. 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 generally more costly than other oral formulations, all dissolvable tablets will require PA except for olanzapine orally disintegrating tablet and risperidone 0.25 mg, 0.5 mg, 1 mg and 2 mg orally disintegrating tablet within established quantity limits. 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 members 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. https://www.mass.gov/lists/second-generation-antipsychotics-also-known-as-atypical-antipsychotics

 

 Antipsychotics – Second-Generation (Atypical)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

aripiprazole extended-release injection Abilify Asimtufii PA  
aripiprazole extended-release injection Abilify Maintena PA  
aripiprazole lauroxil 1,064 mg Aristada PD PA   - < 6 years and PA > 1 injection/56 days
aripiprazole lauroxil 441 mg, 662 mg, 882 mg Aristada PD PA   - < 6 years and PA > 1 injection/28 days
aripiprazole lauroxil 675 mg Aristada Initio PD PA   - < 6 years and PA > 1 injection/28 days
aripiprazole orally disintegrating tablet PA   A90
aripiprazole solution PA   - < 6 years or ≥ 18 years and PA > 25 mL/day A90
aripiprazole tablet Abilify PA   - < 6 years and PA > 2 units/day # , A90
aripiprazole tablet with sensor Abilify Mycite PA  
asenapine sublingual tablet Saphris PA   A90
asenapine transdermal Secuado PA  
brexpiprazole Rexulti PA  
cariprazine Vraylar PD PA  
clozapine orally disintegrating tablet PA   A90
clozapine suspension Versacloz PA   A90
clozapine tablet Clozaril PA   - < 6 years # , A90
iloperidone Fanapt PA  
lumateperone Caplyta PA  
lurasidone Latuda PA   A90
olanzapine 15 mg orally disintegrating tablet Zyprexa Zydis PA   - < 6 years and PA > 2 units/day # , A90
olanzapine 210 mg, 300 mg extended-release injection Zyprexa Relprevv PA   - < 6 years and PA > 2 injections/28 days
olanzapine 405 mg extended-release injection Zyprexa Relprevv PA   - < 6 years and PA > 1 injection/28 days
olanzapine 5 mg, 10 mg, 20 mg orally disintegrating tablet Zyprexa Zydis PA   - < 6 years and PA > 1 unit/day # , A90
olanzapine injection Zyprexa test   #
olanzapine tablet Zyprexa PA   - < 6 years and PA > 2 units/day # , A90
paliperidone extended-release 1-month injection Invega Sustenna PD PA   - < 6 years, PA > 2 injections/28 days within the first 28 days of therapy and PA > 1 injection/28 days after 28 days of therapy
paliperidone extended-release 3-month injection Invega Trinza PD PA   - < 6 years and PA > 1 injection/84 days
paliperidone extended-release 6-month injection Invega Hafyera PD PA   - < 6 years and PA > 1 injection/168 days
paliperidone tablet Invega PA   A90
pimavanserin Nuplazid PA  
quetiapine Seroquel PA   - < 6 years and PA > 3 units/day # , A90
quetiapine extended-release Seroquel XR PA   - < 6 years and PA > 2 units/day # , A90
risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg orally disintegrating tablet PA   - < 6 years and PA > 2 units/day A90
risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg tablets Risperdal PA   - < 6 years and PA > 2 units/day # , A90
risperidone 12.5 mg, 25 mg, 37.5 mg, 50 mg extended-release intramuscular injection-Risperdal Consta Risperdal Consta PA   - < 6 years and PA > 2 injections/28 days BP
risperidone 150 mg, 200 mg, 250 mg extended-release subcutaneous injection Uzedy PD PA   - < 6 years and PA > 1 injection/56 days
risperidone 25 mg, 37.5 mg, 50 mg extended-release intramuscular injection-Rykindo Rykindo PA  
risperidone 3 mg, 4 mg orally disintegrating tablet PA   A90
risperidone 4 mg tablet Risperdal PA   - < 6 years and PA > 4 units/day # , A90
risperidone 50 mg, 75 mg, 100 mg, 125 mg extended-release subcutaneous injection Uzedy PD PA   - < 6 years and PA > 1 injection/28 days
risperidone 90 mg, 120 mg extended-release subcutaneous injection Perseris PD PA   - < 6 years and > 1 injection/28 days
risperidone solution Risperdal PA   - < 6 years and PA > 16 mL/day # , A90
ziprasidone capsule Geodon PA   - < 6 years and PA > 2 units/day # , A90
ziprasidone injection Geodon test   #

 Antipsychotics – Second-Generation (Atypical) Antipsychotic and Opioid Antagonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

olanzapine / samidorphan Lybalvi PA  

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

olanzapine / fluoxetine Symbyax PA   A90
Table Footnotes
# This designates 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.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
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.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Agitation associated with dementia due to Alzheimer’s Disease
  • Bipolar disorder
  • Hallucinations/delusions associated with Parkinson's Disease Psychosis
  • Irritability associated with autistic disorder
  • Major depressive disorder
  • Schizoaffective disorder
  • Schizophrenia
  • Tourette syndrome

non-FDA-approved, for example:

  • Autism spectrum disorders
  • Bipolar disorder
  • Schizoaffective disorder
  • Schizophrenia
  • Tourette syndrome

Note: The above lists may not include all FDA-approved and non-FDA approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

  

Abilify Asimtufii

  • Documentation of all of the following is required for all members:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to Aristada; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for Abilify Asimtufii will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 days out of the last 120 days.

     

Abilify Maintena

  • Documentation of all of the following is required for all members:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to Aristada; or
      • member refuses gluteal injections and requires a dose of Aristada that must be administered gluteally only (> 441 mg); and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for Abilify Maintena will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 days out of the last 120 days.

  

Abilify Mycite

  • Documentation of all of the following is required for all members:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: Abilify Maintena and Aristada; and
    • medical necessity for monitoring member’s ingestion of oral aripiprazole as noted by one of the following:
      • requirement of witnessed or recorded medication ingestion; or
      • alternative medication adherence methods were insufficient, including all of the following: medication alarms or reminders, pill boxes, pill counts, refill frequency assessment; and
    • member has been trained to use the Abilify Mycite (aripiprazole tablet with sensor) system; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • For recertification, documentation of continued medical necessity for use instead of alternatives is required.

   

aripiprazole ODT and solution

  • Documentation of all of the following is required for requests for aripiprazole ODT for members < 18 years of age: 
    • appropriate diagnosis; and
    • medical necessity for the orally disintegrating formulation as noted by one of the following:
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • need for witnessed administration; or
      • intolerance to other aripiprazole formulations; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for members ≥ 18 years of age with a diagnosis of autism spectrum disorder:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to risperidone; and
    • medical necessity for the orally disintegrating formulation as noted by one of the following:
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • need for witnessed administration; or
      • intolerance to other aripiprazole formulations; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for members ≥ 18 years of age with a diagnosis of major depressive disorder or treatment-resistant depression:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all antidepressants (either alone or in combination); and
    • requested agent will be used as adjunctive antidepressant therapy; and
    • medical necessity for the orally disintegrating formulation as noted by one of the following:
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • need for witnessed administration; or
      • intolerance to other aripiprazole formulations; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for members ≥ 18 years of age with a psychiatric diagnosis not listed above:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all second-generation (atypical) antipsychotics; and
    • medical necessity for the orally disintegrating formulation as noted by one of the following:
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • need for witnessed administration; or
      • intolerance to other aripiprazole formulations; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

     

asenapine sublingual tablet and paliperidone tablet

  • Documentation of all of the following is required for all members: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all second-generation (atypical) antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for asenapine sublingual tablet or paliperidone tablet will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for two second-generation (atypical) antipsychotics or of the requested agent for 90 days out of the last 120 days.

   

Caplyta

  • Documentation of all of the following is required for all members with a diagnosis of bipolar depression:
    • appropriate diagnosis; and
    • one of the following: 
      • inadequate response, adverse reaction, or contraindication to both of the following: olanzapine monotherapy or in combination with fluoxetine, quetiapine immediate-release or extended-release; or
      • inadequate response or adverse reaction to two different or contraindication to all second-generation (atypical) antipsychotics; and
    • one of the following:
      • request is for Caplyta 42 mg capsule; or
      • for Caplyta 10.5 mg capsule, member is being treated with a strong CYP3A4 inhibitor; or
      • for Caplyta 21 mg capsule, member is being treated with a moderate CYP3A4 inhibitor or has moderate or severe hepatic impairment (Child-Pugh Class B or C); and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for members < 18 years of age with a psychiatric diagnosis not listed above:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone; and
    • inadequate response or adverse reaction to two different or contraindication to all atypical and typical antipsychotics; and
    • one of the following:
      • request is for Caplyta 42 mg capsule; or
      • for Caplyta 10.5 mg capsule, member is being treated with a strong CYP3A4 inhibitor; or
      • for Caplyta 21 mg capsule, member is being treated with a moderate CYP3A4 inhibitor or has moderate or severe hepatic impairment (Child-Pugh Class B or C); and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for members ≥ 18 years of age with a psychiatric diagnosis not listed above: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all second-generation (atypical) antipsychotics; and
    • one of the following:
      • request is for the 42 mg capsule; or
      • for the 10.5 mg capsule, member is being treated with a strong CYP3A4 inhibitor; or
      • for the 21 mg capsule, member is being treated with a moderate CYP3A4 inhibitor or has moderate or severe hepatic impairment (Child-Pugh Class B or C); and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

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

   

clozapine ODT, risperidone ODT 3 mg and ODT 4 mg

  • Documentation of all of the following is required for all members:
    • appropriate diagnosis; and
    • medical necessity for the orally disintegrating formulation as noted by one of the following:
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • need for witnessed administration; or
      • intolerance to other formulations of the requested agent; and
    • for risperidone ODT 3 mg or ODT 4 mg, requested quantity does not exceed established quantity limits (please refer to reference table below).

   

Fanapt

  • Documentation of all of the following is required for members < 18 years of age:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone; and
    • inadequate response or adverse reaction to two different or contraindication to all atypical and typical antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for members ≥ 18 years of age: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all second-generation (atypical) antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

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

   

lurasidone

  • Documentation of all of the following is required for members < 18 years of age with a diagnosis of bipolar depression: 
    • appropriate diagnosis; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for members ≥ 18 years of age with a diagnosis of bipolar depression: 
    • appropriate diagnosis; and
    • one of the following: 
      • inadequate response, adverse reaction, or contraindication to both of the following: olanzapine monotherapy or in combination with fluoxetine, quetiapine immediate-release or extended-release; or
      • inadequate response or adverse reaction to two different or contraindication to all second-generation (atypical) antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for all members with a psychiatric diagnosis not listed above: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all second-generation (atypical) antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for lurasidone will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for two second-generation (atypical) antipsychotics or of the requested agent for 90 days out of the last 120 days.

    

Lybalvi

  • Documentation of all of the following is required for all members: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to two or contraindication to all second-generation (atypical) antipsychotics; and
    • both of the following:
      • member is not being treated with an opioid; and
      • member is not being treated for acute opioid withdrawal; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

SmartPA: Claims within specified quantity limits and polypharmacy requirements will usually process and pay at the pharmacy without PA if the member has a history of paid claims for the reference agent for at least 90 out of the last 120 days.

 

Nuplazid

  • Documentation of all the following is required for all members:
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurologist are provided; and
    • for Nuplazid 10 mg tablet, requested medication will be used in combination with a strong CYP3A4 inhibitor; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

   

perphenazine/amitriptyline and olanzapine/fluoxetine

  • Documentation of all of the following is required for all members:
    • appropriate diagnosis; and
    • medical necessity for use of the combination product instead of the commercially available separate agents.

SmartPA: Claims for perphenazine/amitriptyline will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 days of therapy out of the last 120 days.

   

Rexulti

  • Documentation of all of the following is required for all members with a diagnosis of major depressive disorder (MDD) or treatment-resistant depression:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all antidepressants (either alone or in combination); and
    • Rexulti will be used as adjunctive antidepressant therapy; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for all members with a psychiatric diagnosis not listed above: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all second-generation (atypical) antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to the 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 paid MassHealth pharmacy claims for any two antidepressants, and a history of paid MassHealth pharmacy claims for an antidepressant in the last 30 days. Claims within quantity limits and polypharmacy requirements for Rexulti will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for two second-generation (atypical) antipsychotics or of the requested agent for at least 90 days out of the last 120 days.†  

   

Rykindo

  • Documentation of all of the following is required for all members: 
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to all of the following: risperidone extended-release intramuscular injection (generic Risperdal Consta), Perseris, Uzedy; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

SmartPA: Claims within specified quantity limits will usually process and pay at the pharmacy without PA if the member has a history of paid claims for the reference agent for at least 90 days out of the last 120 days.

 

Secuado

  • Documentation of all of the following is required for all members: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to two second-generation (atypical) antipsychotics; and
    • one of the following:
      • inadequate response or adverse reaction to asenapine sublingual; or
      • medical necessity for the transdermal formulation; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

SmartPA: Claims within specified quantity limits and polypharmacy requirements will usually process and pay at the pharmacy without PA if the member has a history of paid claims for the reference agent for at least 90 days out of the last 120 days.

     

Versacloz

  • Documentation of all of the following is required for all members:
    • appropriate diagnosis; and
    • medical necessity for the oral suspension formulation as noted by one of the following: 
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • need for witnessed administration; or
      • intolerance to other clozapine formulations.

    

Vraylar

  • Documentation of all of the following is required for all members for adjunctive treatment for MDD or treatment-resistant depression:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all antidepressants (either alone or in combination); and
    • Vraylar will be used as adjunctive antidepressant therapy; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for all members with a diagnosis of bipolar depression:
    • appropriate diagnosis; and
    • one of the following: 
      • inadequate response or adverse reaction to one or contraindication to both of the following: olanzapine monotherapy or in combination with fluoxetine, quetiapine immediate-release or extended-release; or
      • inadequate response or adverse reaction to one different or contraindication to all second-generation (atypical) antipsychotics; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).
  • Documentation of all of the following is required for all members with a psychiatric diagnosis not listed above:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: aripiprazole, clozapine, olanzapine, quetiapine, risperidone,  ziprasidone; and
    • requested quantity does not exceed established quantity limits (please refer to the reference table below).

SmartPA: Claims within quantity limits and polypharmacy requirements for Vraylar will usually process at the pharmacy without a PA request if the member has a diagnosis of major depressive disorder, a history of paid MassHealth pharmacy claims for any one antidepressant, and a history of paid MassHealth pharmacy claims for an antidepressant in the last 30 days. Claims within quantity limits and polypharmacy requirements for Vraylar will usually process and pay at the pharmacy without prior authorization if the member has a history of a paid claim for the reference agent for at least 90 out of 120 days. Claims for Vraylar will usually also process and pay without prior authorization for members who have a history of paid claims for one of the following: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, or ziprasidone in all claims history.

    

Exceeding quantity limits

  • Documentation of all of the following is required for all members:
    • appropriate diagnosis; and
    • one of the following: 
      • 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, Nuplazid, and injectable formulations] for at least 60 days within a 90-day period) for members ≥ 18 years of age

  • 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 consult notes from a psychiatrist are 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, armodafinil, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, donepezil, hypnotic agents, memantine, modafinil, mood stabilizers (agents considered to be used only for seizure diagnoses are not included), naltrexone and viloxazine] within a 45-day period) for members < 18 years of age

  • For all requests, individual drug PA criteria must be met first where applicable.
  • For regimens including ≤ two 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 ≥ three 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, with or without seizure 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), with or without seizure diagnosis, and 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), with or without seizure diagnosis, and 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.  

Antipsychotic Polypharmacy (overlapping pharmacy claims for 2 or more antipsychotics [includes first-generation and/or second-generation antipsychotics, except short-acting injectable formulations] for at least 60 days within a 90-day period) for members < 18 years of age

  • 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:
      • treatment plan including name, dose, and frequency of all current behavioral health medications, associated target symptom(s), and behavioral health diagnoses; and
      • a comprehensive behavioral health plan (i.e., non-pharmacologic interventions) is in place; and
      • prescriber is a psychiatrist or consult is provided; and
      • stage of treatment is acute, maintenance, or discontinuation; and
      • one of the following:
        • for acute stage (initiation of antipsychotic treatment likely with subsequent dose adjustments to maximize response and minimize side effects), one of the following:
          • cross-titration/taper of antipsychotic therapy; or
          • inadequate response or adverse reaction to two monotherapy trials as clinically appropriate; or
        • for maintenance stage (response to antipsychotic treatment with goal of remission or recovery), all of the following:
          • regimen is effective, therapy benefits outweigh risks, and appropriate monitoring is in place; and
          • if member has been on the antipsychotic regimen for the last 12 months, clinical rationale for extended therapy including at least one of the following: previous efforts to reduce/simplify the antipsychotic regimen in the last 24 months resulted in symptom exacerbation; or family/caregiver does not support the antipsychotic regimen change at this time due to risk of exacerbation; or other significant barrier for antipsychotic therapy discontinuation; or
        • for discontinuation stage (clinically indicated that the antipsychotic regimen can likely be successfully tapered), cross-titration/taper of antipsychotic therapy.

 

Antipsychotic for members < six years of age

  • 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:
      • complete medication treatment plan including name, dose, and frequency of all current behavioral health medications, associated target symptom(s), and behavioral health diagnoses; and
      • a comprehensive behavioral health treatment plan (i.e., non-pharmacological interventions) is in place; and
      • prescriber is a specialist (e.g., child psychiatry, pediatric neurology, or developmental/behavioral pediatrics) or consult is provided; and
      • one of the following:
        • member is in acute stage of treatment (initiation of antipsychotic treatment likely with subsequent dose adjustments to maximize response and minimize side effects); or
        • all of the following:
          • member is in maintenance stage of treatment (response to antipsychotic treatment with goal of remission or recovery); and
          • regimen is effective, therapy benefits outweigh risks, and appropriate monitoring is in place; and
          • if member has been on the antipsychotic regimen for the last 12 months, clinical rationale for extended therapy including at least one of the following: previous efforts to reduce/simplify the antipsychotic regimen in the last 12 months resulted in symptom exacerbation; or family/caregiver does not support the antipsychotic regimen change at this time due to risk of exacerbation; or other significant barrier for antipsychotic therapy discontinuation; or
        • all of the following:
          • member is in discontinuation stage of treatment (clinically indicated that the antipsychotic regimen can likely be successfully tapered); and
          • cross-titration/taper of antipsychotic therapy.

 

    

Reference Table:

Drug

Quantity Limits

Abilify (aripiprazole tablet)

2 units/day

Abilify Asimtufii (aripiprazole extended-release injection)

1 injection/56 days

Abilify Maintena (aripiprazole extended-release injection)

1 injection/28 days

Abilify Mycite (aripiprazole tablet with sensor)

1 unit/day

aripiprazole orally disintegrating tablet

1 unit/day

aripiprazole solution

25 mL/day (750 mL/30 days)

Aristada (aripiprazole lauroxil 441 mg, 662 mg, 882 mg)

1 injection/28 days

Aristada (aripiprazole lauroxil 1,064 mg)

1 injection/56 days

Aristada Initio (aripiprazole lauroxil 675 mg)

1 injection/28 days

Caplyta (lumateperone)

1 unit/day

Fanapt (iloperidone)

2 units/day

Geodon (ziprasidone)

2 units/day

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

1 unit/day

Invega (paliperidone tablet) 6 mg

2 units/day

Invega Hafyera (paliperidone IM)

1 injection/168 days

Invega Sustenna (paliperidone IM)

2 injections within first 28 days, 1 injection/28 days thereafter

Invega Trinza (paliperidone IM)

1 injection/84 days

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

1 unit/day

Latuda (lurasidone) 80 mg

2 units/day

Lybalvi (olanzapine/samidorphan)

1 unit/day

Nuplazid (pimavanserin)

1 unit/day

Perseris (risperidone 90 mg, 120 mg extended-release subcutaneous injection)

1 injection/28 days

Rexulti (brexpiprazole)

1 unit/day

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

2 units/day

Risperdal (risperidone tablet) 4 mg

4 units/day

Risperdal (risperidone solution)

16 mL/day (480 mL/30 days)

Risperdal Consta (risperidone intramuscular injection)

2 injections/28 days

risperidone orally disintegrating tablet 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

2 units/day

Rykindo (risperidone intramusuclar injection)

2 injections/28 days

Saphris (asenapine sublingual tablet)

2 units/day

Secuado (asenapine transdermal)

1 unit/day

Seroquel (quetiapine)

3 units/day

Seroquel XR (quetiapine extended-release) 50 mg,150 mg, 200 mg, 300 mg, 400 mg

2 units/day

Uzedy (risperidone 50 mg, 75 mg, 100 mg, 125 mg extended-release subcutaneous injection)

1 injection/28 days

Uzedy (risperidone 150 mg, 200 mg, 250 mg extended-release subcutaneous injection)

1 injection/56 days

Vraylar (cariprazine)

1 unit/day

Zyprexa (olanzapine tablet) 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg

2 units/day

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

2 injections/28 days

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

1 injection/28 days

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

1 unit/day

Zyprexa Zydis (olanzapine orally disintegrating tablet) 15 mg

2 units/day

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: https://www.mass.gov/lists/second-generation-antipsychotics-also-known-as-atypical-antipsychotics.


Original Effective Date: 03/2010

Last Revised Date: 03/2024


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Last updated 04/01/24

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