A   B   C   D   E   F   G   H   I   J   K   L   M   N   O   P   Q   R   S   T   U   V   W   X   Y   Z


Drug Category: Central Nervous System (CNS)

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

I. Prior-Authorization Requirements

 Second-Generation (Atypical) Antipsychotics

Clinical Notes

Drug Generic Name

Drug Brand Name

PA
Status

aripiprazole extended-release injectable suspension Abilify Maintena PA   - > 1 vial/month
aripiprazole IM Abilify  
aripiprazole solution Abilify PA   - ≥ 18 years old and PA > 750 ml/month
aripiprazole tablet Abilify PA   - ≥ 18 years old and PA > 30 units/month
aripiprazole, orally disintegrating tablet Abilify Discmelt PA  
asenapine Saphris PA  
clozapine Clozaril #  
clozapine, orally disintegrating tablet Fazaclo PA  
iloperidone Fanapt PA  
lurasidone Latuda PA  
olanzapine 15 mg tablet Zyprexa # PA   - > 60 units/month
olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg, 20 mg tablets Zyprexa # PA   - > 30 units/month
olanzapine pamoate 210 mg, 300 mg long-acting im Zyprexa Relprevv PA   - > 2 injections/month
olanzapine pamoate 405 mg long-acting im Zyprexa Relprevv PA   - > 1 injection/month
olanzapine short acting im Zyprexa  
olanzapine, orally disintegrating tablet Zyprexa Zydis PA  
paliperidone IM Invega Sustenna PA   - > 2 units/month within the first 30 days of therapy; PA > 1 unit/month after 30 days of therapy
paliperidone tablet Invega PA  
quetiapine Seroquel # PA   - > 90 units/month
quetiapine extended-release 50 mg, 300 mg and 400 mg Seroquel XR PA   - ≥ 18 years old and PA > 60 units/month
quetiapine extended-release 150 mg, 200 mg Seroquel XR PA   - ≥ 18 years old and PA > 30 units/month
risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg tablets Risperdal # PA   - > 60 units/month
risperidone 4 mg tablet Risperdal # PA   - > 120 units/month
risperidone IM Risperdal Consta PA   - > 2 units (2 syringes)/month
risperidone solution Risperdal # PA   - > 480 ml/month
risperidone, orally disintegrating tablet Risperdal M-Tab PA  
risperidone, orally disintegrating tablet PA  
ziprasidone capsule Geodon # PA   - > 60 units/month
ziprasidone injection Geodon IM  

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.  Prior authorization 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 prior authorization. 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

 

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

Drug Generic Name

Drug Brand Name

PA
Status

olanzapine / fluoxetine Symbyax PA  
# 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 - manic or mixed episodes, depressive episodes
  • irritability associated with autistic disorder
  • schizophrenia

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

Back to top


III.  Evaluation Criteria for Approval

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

Monotherapy

Fanapt (iloperidone), Invega (paliperidone), Latuda (lurasidone), Saphris (asenapine) for members <18 years of age

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to ONE generic second-generation (atypical) antipsychotic (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 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 for Invega, Fanapt, Saphris or Latuda, for members <18 years of age will usually process at the pharmacy without a prior authorization request if the member has a MassHealth history of pharmacy claims of one generic second-generation (atypical) antipsychotic and any two other antipsychotics or of the requested agent for 90 days in the past 120 days. 

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

  • Documentation 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 for Invega, Fanapt, Saphris or Latuda, for members ≥18 years of age will usually process at the pharmacy without a prior authorization 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

clozapine ODT, risperidone ODT and olanzapine ODT  for all members

  • Documentation 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).

Abilify DiscMelt for members < 18 years

  • Documentation 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.

Abilify tablets, Abilify solution and Abilify DiscMelt for members ≥ 18 years with the diagnosis of autism spectrum disorder

  • Documentation of the following is required:
    • inadequate response, adverse reaction or contraindication to risperidone; and
    • if the request is for Abilify solution or DiscMelt, then the prescriber provides 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 for Abilify tablets, for members ≥18 years of age will usually process at the pharmacy without a prior authorization request if the member has a diagnosis of autism spectrum disorder and claims for risperidone.

Claims within quantity limits for Abilify tablets for members ≥18 years of age will usually process at the pharmacy without a prior authorization request if the member has a history of MassHealth pharmacy claims of the requested agent for 90 days in the past 120 days

Abilify tablets, Abilify solution, Abilify DiscMelt and Seroquel XR for members ≥ 18 years with the diagnosis of major depressive disorder or treatment resistant depression

  • Documentation of the following is required:
    • 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
    • if the request is for Abilify solution or DiscMelt, then the prescriber provides medical necessity for dosage form; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits for Abilify tablets and Seroquel XR, for members ≥18 years of age will usually process at the pharmacy without a prior authorization request if the member has a diagnosis of major depressive disorder and a history of MassHealth pharmacy claims for any two antidepressants. 

Claims within quantity limits for Abilify tablets and Seroquel XR, for members ≥18 years of age will usually process at the pharmacy without a prior authorization request if the member has a history of MassHealth pharmacy claims of the requested agent for 90 days in the past 120 days

Abilify tablets, Abilify solution, Abilify DiscMelt and Seroquel XR for members ≥ 18 years with a psychiatric diagnosis not listed above

  • Documentation of the following is required:
    • 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 Abilify solution or DiscMelt, then the prescriber provides medical necessity for dosage form; and
    • requested quantity does not exceed established quantity limits (please refer to reference table below).

SmartPA: Claims within quantity limits for Abilify tablets and Seroquel XR, for members ≥18 years of age will usually process at the pharmacy without a prior authorization request if the member has a history of MassHealth pharmacy claims for two second-generation (atypical) antipsychotics.

Claims within quantity limits for Abilify tablets and Seroquel XR, for members ≥18 years of age will usually process at the pharmacy without a prior authorization request if the member has a history of MassHealth pharmacy claims of the requested agent for 90 days in the past 120 days

Polypharmacy (Overlap of 60 days or more in prescriptions of two or more second-generation (atypical) antipsychotics except clozapine and injectable formulations) for all members

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • ONE of the following:
      • inadequate response on maximum dose of monotherapy and a second requested second-generation (atypical) antipsychotic is required for full response; or
      • recent discharge from an inpatient setting on the requested combination and needs another 90 days to allow for taper of one medication; or
      • transitioning from one antipsychotic medication to the other.

 

Exceeding quantity limits for all members

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

Symbyax

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • compelling 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.

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 vial/month

Fanapt (iloperidone)

60 units/month

Geodon # (ziprasidone)

60 units/month

Invega Sustenna (paliperidone IM)

2 syringes month 1, 1 syringe/month thereafter

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

30 units/month

Invega (paliperidone) 6 mg

60 units/month

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

30 units/month                           

Latuda (lurasidone) 80 mg

60 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) 2.5 mg, 5 mg, 7.5 mg, 10 mg, 20 mg

30 units/month

Zyprexa # (olanzapine) 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: 01/2014


Clinical Criteria Main Page | Back to topPrevious  |  Next

Last updated 03/10/14