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.

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 Maintena for all members

• Documentation of all of the following is required:
  • 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 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 past 120 days.^†

Abilify Mycite for all members

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to one or contraindication to both Abilify Maintena and Aristada; and
  • medical necessity for monitoring member’s ingestion of oral aripiprazole; 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 for members < 18 years

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

aripiprazole ODT and solution 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
  • medical necessity for the requested formulation; and
  • requested quantity does not exceed established quantity limits (please refer to the reference table below).

aripiprazole ODT and solution 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 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 requested formulation; and
  • requested quantity does not exceed established quantity limits (please refer to the reference table below).

aripiprazole ODT and solution 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 or contraindication to all second-generation (atypical) antipsychotics; and
  • medical necessity for the requested formulation; and
  • requested quantity does not exceed established quantity limits (please refer to the reference table below).

asenapine sublingual tablet, Latuda, and paliperidone tablet for all members

• Documentation of all of the following is required: 
  • 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, Latuda, 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 and Fanapt for members < 18 years of age

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to one or contraindication to all of the following second-generation (atypical) antipsychotics available without PA: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, or ziprasidone; and
  • inadequate response or adverse reaction to two different or contraindication to all atypical or typical antipsychotics; and
  • for Caplyta, one of the following:
    • 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 or 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.^†

Caplyta and Fanapt for members ≥ 18 years of age

• Documentation of all of the following is required: 
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to two or contraindication to all second-generation (atypical) antipsychotics; and
  • for Caplyta, one of the following:
    • 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 or 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.^†

clozapine ODT, risperidone ODT 3 mg and ODT 4 mg for all members

• Documentation of all of the following is required: 
  • appropriate diagnosis; and
  • medical necessity for the orally disintegrating formulation; and
  • for risperidone ODT 3 mg or ODT 4mg, requested quantity does not exceed established quantity limits (please refer to the reference table below).

Lybalvi for all members

• Documentation of all of the following is required: 
  • 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 for all members

• Documentation of all the following is required:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurologist are provided; and
  • for the 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 for all members

• Documentation of all of the following is required:
  • 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.^†

Perseris for all members

• Documentation of all of the following is required:
  • one of the following:
    • inadequate response or adverse reaction to one of the following: Invega Hafyera, Invega Sustenna, Invega Trinza, Risperdal Consta; or
    • contraindication to Invega Sustenna and Risperdal Consta; 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 Perseris 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.^†

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 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).

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 past 30 days.^†  

Rexulti for members 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 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 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.^†

Secuado for all members

• Documentation of all of the following is required: 
  • 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 sublingual asenapine; 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 last120 days.^†

Versacloz for all members

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

Vraylar

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, or 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 for members < 18 years of age 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 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 injectable formulations] for at least 60 days within a 90-day period) for members ≥ 18 years 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 old

• 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 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:
    • 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 past 12 months, clinical rationale for extended therapy including at least one of the following: previous efforts to reduce/simplify the antipsychotic regimen in the past 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 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:
    • 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 past 12 months, clinical rationale for extended therapy including at least one of the following: previous efforts to reduce/simplify the antipsychotic regimen in the past 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:

^† 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.