Atypical Antipsychotics - NC Standard

Restriction is on branded products unless otherwise noted.

• Fanapt® (iIoperidone) 
• Quetiapine 150mg tablet
• Secuado® (asenapine) 

• Fanapt 
  • For the treatment of adults with schizophrenia 
  • For the acute treatment of manic or mixed episodes in bipolar I disorder in adults 
• Quetiapine 150mg tablet 
  • For the treatment of schizophrenia 
  • For the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex 
  • For the acute treatment of depressive episodes associated with bipolar disorder 
  • For maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex 
• Secuado 
  • For the treatment of adults with schizophrenia 

1. The patient is currently taking one of the restricted access atypical antipsychotics; AND 
   1. The prescribing provider must certify to BCBSNC that the patient cannot be safely transitioned to a non-restricted access agent from a restricted access agent; OR 
2. The patient has the Enhanced Formulary; AND 
   1. Before approval of a restricted access agent is given, ONE non-restricted access agent must be tried; OR 
3. The patient has the Essential Formulary; AND 
   1. Before approval of a restricted access agent is given, TWO non-restricted access agents must be tried; AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval: 365 days (1 year)

All information referenced is from FDA package insert unless otherwise noted below.

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

January 2025: Criteria change: Removed Caplyta, Rexulti, and Vraylar from restricted products. Added Latuda to QL chart.

December 2024: Criteria update: Added new to market Opipza to policy.

November 2024: Criteria update: Added Abilify MyCite to the Quantity Limitations section.October 2023: Criteria change: Rexulti added to restricted products for Net Results. Reduced number of step requirements for Rexulti from two step to one step. Policy name changed to NC Standard.

May 2023: Criteria update: Updated FDA approved section to include Rexulti’s new indication for agitation associated with dementia due to Alzheimer’s disease.

August 2022: Criteria update: Added Quetiapine 150 mg tablet and Caplyta 10.5 mg and 21 mg capsules to the policy.

May 2022: Criteria update: Updated Fazaclo (Clozapine ODT is now the brand name)

January 2022: Criteria update: Updated FDA approved section to include Bipolar II disorder.

October 2021: Criteria update: Latuda moved to its own separate policy.

July 2021: Criteria change: Created Enhanced/Essential only policy. Changed requirement on Vraylar to ONE t/f medication.

December 2020: Criteria update: Removed Saphris from restriction. Will continue to require QL. Duration of approval decreased to 365 days.

February 2020: Criteria update: Added new to market, Caplyta to the policy.

January 2020: Criteria update: Added new to market, Secuado patch to the policy.

Additional historical changes/updates available upon request from Corporate Pharmacy.