ModifiedConnectiCarePolicy C5016-A

Antipsychotics Coverage Criteria

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Coverage and prior authorization criteria for oral and transdermal atypical antipsychotic drugs, including FDA-approved and compendia-supported uses, under the pharmacy benefit.

Policy Summary

PayerConnectiCare

PolicyAntipsychotics Coverage Criteria

Policy CodePolicy C5016-A

Change TypeModified

Effective DateMarch 27, 2026

Next Review DateJanuary 1, 2027

Key ActionDocument at least three preferred generic matching-indication trials or a qualifying exception when requesting a non-preferred agent.

SourceLink

POLICY UPDATE CHANGES

Revisions address quantity limits, FDA-approved uses, available dosage forms, and policy references.

20Products affected

85%Continuation adherence threshold

12 monthsInitial authorization duration

12 monthsContinuation authorization duration

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ModifiedConnectiCarePolicy C5016-A

Antipsychotics Coverage Criteria

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Sign up for ConnectiCare Policy C5016-A alerts

Get alerted when Policy C5016-A changes without checking for updates manually.

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Coverage and prior authorization criteria for oral and transdermal atypical antipsychotic drugs, including FDA-approved and compendia-supported uses, under the pharmacy benefit.

Policy Summary

PayerConnectiCare

PolicyAntipsychotics Coverage Criteria

Policy CodePolicy C5016-A

Change TypeModified

Effective DateMarch 27, 2026

Next Review DateJanuary 1, 2027

Key ActionDocument at least three preferred generic matching-indication trials or a qualifying exception when requesting a non-preferred agent.

SourceLink

POLICY UPDATE CHANGES

Revisions address quantity limits, FDA-approved uses, available dosage forms, and policy references.

20Products affected

85%Continuation adherence threshold

12 monthsInitial authorization duration

12 monthsContinuation authorization duration

Oral and transdermal

Routes of administration

Not requiredNevada psychiatric step therapy

Coverage Criteria

Initial Therapy

Covered when the requested use is supported and at least ONE qualifying access pathway is met.

ALL of the following

Requested use is for an FDA-approved indication OR an indication supported in the compendia of current literature, such as AHFS, Micromedex, or current accepted guidelines.
ONE qualifying access pathway
- Formulary history or special Cobenfy pathway
  - Member's medication history, from claims or documentation, includes use of a minimum of three preferred generic formulary atypical antipsychotic agents with a matching indication.
  - Member has a documented FDA-labeled contraindication or serious side effects to all preferred generic formulary atypical antipsychotic agents with a matching indication.
  - Request is for Cobenfy (trospium/xanomeline) and the member is experiencing tardive dyskinesia on current antipsychotic therapy.
- Documentation shows that the member is using the requested agent and is at risk if therapy is changed OR has recently, within 48 hours, been discharged from an inpatient facility.
- Prescriber provides a treatment plan for utilization of a non-preferred oral agent to bridge to long-acting injectable therapy.
- Non-preferred aripiprazole dosage form for Tourette's Disorder
  - Request is for a non-preferred dosage form of aripiprazole for Tourette's Disorder.
  - Member has a documented treatment failure, serious side effects, or clinical contraindication to generic haloperidol and pimozide within the last 90 days.
  - Member has had a trial and failure of a preferred aripiprazole dosage form.

Continuation Therapy

Continuation therapy is covered when ALL of the following requirements are met:

ALL of the following

Adherence to therapy is at least 85% of the time, as verified by the prescriber or member medication fill history, OR adherence is less than 85% of the time with documented medical rationale from the prescriber.
Prescriber attests to, or clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity.
Documentation demonstrates a positive clinical response, as shown by low disease activity and/or improvement in the condition's signs and symptoms.

Age Restrictions

The following minimum ages apply; review the product labeling or compendia for age restrictions specific to the individual indication.

ALL of the following

LATUDA (lurasidone), SAPHRIS (asenapine), and VRAYLAR (cariprazine): member is 10 years of age or older.
INVEGA (paliperidone) and EQUETRO (carbamazepine): member is 12 years of age or older.
ABILIFY (aripiprazole) and OPIPZA (aripiprazole): member is 6 years of age or older.
REXULTI (brexpiprazole): member is 13 years of age or older.
CAPLYTA (lumateperone), COBENFY (xanomeline/trospium), FANAPT (iloperidone), LYBALVI (olanzapine and samidorphan), and SECUADO (asenapine): member is 18 years of age or older.

Illinois Medical-Exception Criteria

For an Illinois Marketplace member, an off-formulary medical-exception request shall not be denied when ANY of the following conditions is met:

ANY qualifying exception condition

The formulary prescription drug is contraindicated for the patient.
The patient has tried the formulary prescription drug under the patient's current or previous health insurance or health benefit plan, and the prescribing provider submits evidence of failure or intolerance.
The patient is stable on a prescription drug selected by the patient's health care provider for the medical condition under consideration while covered by a current or previous health insurance or health benefit plan.

Nevada Psychiatric Step-Therapy Exception

Nevada Marketplace coverage without step therapy applies when ALL of the following statutory conditions are met:

ALL of the following

The drug is FDA-approved with an indication for the insured's psychiatric condition OR use of the drug to treat that psychiatric condition is otherwise supported by medical or scientific evidence.
Prescribing practitioner is ONE of the following
- A psychiatrist.
- A physician assistant under the supervision of a psychiatrist.
- An advanced practice registered nurse with the psychiatric training and experience prescribed by the State Board of Nursing pursuant to NRS 632.120.

Rexulti (brexpiprazole) is not indicated as an as-needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease.

Rexulti is excluded from coverage under the dementia-related agitation indication when prescribed on an as-needed ("prn") basis.

All other uses of antipsychotics are considered experimental/investigational and follow the Off-Label policy.

Prior Authorization and Provider Requirements

Prior Authorization

Initial Prior Authorization

Obtain prior authorization by documenting that the requested use is FDA-approved or supported by current compendia, accepted guidelines, or other current medical/scientific evidence, and that at least one qualifying access pathway applies.

Document one of the following: required preferred-agent history or an applicable contraindication/serious side effect; current use with risk if changed or recent inpatient discharge within 48 hours; a bridge plan to long-acting injectable therapy; or qualifying Tourette’s Disorder aripiprazole treatment history.

Prior Authorization

Continuation Prior Authorization

For continuation authorization, document ongoing adherence, tolerability, and positive clinical response. Initial and continuation authorizations are each approved for 12 months when criteria are met.

Adherence must be at least 85%, unless the prescriber documents a medical rationale for lower adherence.
There must be no intolerable adverse effects or drug toxicity.
Document low disease activity and/or improvement in signs and symptoms.

Policy Background

This policy addresses atypical antipsychotic therapy for conditions including schizophrenia, bipolar disorder, major depressive disorder, autism-related irritability, and Tourette’s Disorder, as well as other FDA-approved or compendia-supported uses. Covered products include branded and generic oral or transdermal formulations. Coverage remains subject to benefit eligibility, formulary preferencing, medical necessity, and required documentation.

Key Definitions

Compendial approved off-labeled uses

DefinitionUses supported by recognized compendia or current literature even when they are not specifically listed in FDA-approved labeling.

ExamplesCompendial-supported uses include delusional disorder, Huntington disease-associated chorea, treatment-resistant obsessive-compulsive disorder, and borderline personality disorder for aripiprazole.

Additional examplesCompendial-supported uses include psychosis or agitation associated with dementia for Invega, Latuda, Rexulti, Saphris, and Vraylar.

Preferred generic formulary atypical antipsychotic agents

DefinitionAtypical antipsychotic products designated by the formulary as preferred generic options for the requested indication.

Use in coverage review

Initial Authorization Criteria

Initial authorization requires the indication requirement and at least one qualifying access pathway.

Initial authorization

Qualifying access pathway: At least one of the following is documented: use of at least three preferred generic formulary atypical antipsychotics with a matching indication; FDA-labeled contraindication or serious side effects to all matching preferred generic agents; Cobenfy use for tardive dyskinesia during current antipsychotic therapy; current use of the requested agent with risk if changed; inpatient discharge within 48 hours; a plan to bridge with a non-preferred oral agent to long-acting injectable therapy; or the specified non-preferred aripiprazole criteria for Tourette's Disorder.At least 3 agents; 48 hours; 90 days where applicable

Continuation of Therapy

Continuation of therapy requires all of the following criteria.

Continuation requirements: Adherence is at least 85% or lower adherence has documented medical rationale from the prescriber; there is no evidence of intolerable adverse effects or drug toxicity; and the member has a positive clinical response shown by low disease activity and/or improvement in the condition's signs and symptoms.At least 85% adherence unless medically justified

Step-Therapy Requirements and Exceptions

Coverage status	Applies to	Step-therapy requirement	Exceptions
Step therapy required	Non-preferred atypical antipsychotic agents	Document use of at least three preferred generic formulary atypical antipsychotic agents with a matching indication.	The requirement may be met by a documented FDA-labeled contraindication or serious side effects to all matching preferred generic agents, current use with risk if therapy changes, recent inpatient discharge within 48 hours, a bridge plan to long-acting injectable therapy, Cobenfy use for tardive dyskinesia during current antipsychotic therapy, or the specified Tourette’s Disorder aripiprazole pathway.

Coverage status	Requested therapy	Required prior treatment	Time frame
Step therapy required	Non-preferred aripiprazole dosage form for Tourette’s Disorder	Document treatment failure, serious side effects, or clinical contraindication to generic haloperidol and pimozide, plus a trial and failure of a preferred aripiprazole dosage form.	Haloperidol and pimozide: within the prior 90 days; preferred aripiprazole dosage form: trial and failure required.

Coverage status	Nevada condition	Prescriber requirement	Drug evidence	Alternative drugs
No psychiatric step therapy required	The requested drug is for a psychiatric condition and all statutory conditions are met.	Prescribed by a psychiatrist; a physician assistant supervised by a psychiatrist; an appropriately trained psychiatric advanced practice registered nurse; or a primary-care provider consulting with an eligible psychiatric practitioner when the closest participating practitioner is at least 60 miles from the insured’s residence.	The drug is FDA-approved for the insured’s psychiatric condition or its use is supported by medical or scientific evidence.	The prescribing practitioner knows from the insured’s medical history, or reasonably expects, that each alternative required earlier in the step-therapy protocol would be ineffective.

Quantity and Dose Limits

Quantity limits

Applies toAll products covered under this policy.

Maximum quantityThe prescribed quantity must not exceed FDA-labeled or compendia-supported dosing maximums.

Additional limitsConsult the formulary or prescription drug list (PDL) for specific quantity limits.

Site of Care and Administration

Billing Rule

Use the pharmacy benefit for oral and transdermal therapy

Oral and transdermal medications under this policy are recommended for pharmacy benefit coverage and patient self-administration.

Use the pharmacy benefit and home self-administration setting when applicable.

Policy Summary

PayerConnectiCare

PolicyAntipsychotics Coverage Criteria

Policy CodePolicy C5016-A

Change TypeModified

Effective DateMarch 27, 2026

Next Review DateJanuary 1, 2027

Key ActionDocument at least three preferred generic matching-indication trials or a qualifying exception when requesting a non-preferred agent.

SourceLink

On This Page

A primary care provider caring for the insured in consultation with a qualifying psychiatrist, physician assistant, or advanced practice registered nurse, when the closest participating network practitioner in one of those categories is located 60 miles or more from the insured's residence.

The prescribing practitioner knows, based on the insured's medical history, or reasonably expects, that each alternative drug required earlier in the step-therapy protocol will be ineffective in treating the psychiatric condition.

A step-therapy protocol is a requirement to use a prescription drug or sequence of prescription drugs other than the drug recommended by the practitioner before coverage is provided for the recommended drug.

Unsupported block type: prior_auth

Prior Authorization

Nevada Psychiatric-Drug Exception

For Nevada psychiatric-drug requests, review without requiring the otherwise applicable medication trials when the statutory conditions are met.

The FDA-approved drug is indicated for the psychiatric condition or its use is supported by medical or scientific evidence.
The prescriber is a psychiatrist; a physician assistant supervised by a psychiatrist; a qualifying psychiatric APRN; or, in the specified access circumstance, a primary care provider consulting with one of those practitioners.
The prescriber knows from the member’s history or reasonably expects that each required alternative would be ineffective.

Step Therapy

Preferred Generic Trials

Before requesting a non-preferred antipsychotic, document the member’s medication history showing trials of at least three preferred generic formulary atypical antipsychotics with the matching indication, unless an applicable exception applies.

Alternatively, document an FDA-labeled contraindication or serious side effects to all preferred generic agents with the matching indication.
For Cobenfy, document tardive dyskinesia on current antipsychotic therapy when relying on the specific exception.

Step Therapy

Tourette’s Disorder Aripiprazole Step Therapy

For a non-preferred aripiprazole dosage form requested for Tourette’s Disorder, document treatment failure, serious side effects, or a clinical contraindication to generic haloperidol and pimozide within the preceding 90 days, plus trial and failure of a preferred aripiprazole dosage form.

Step Therapy

Nevada Prohibition on Psychiatric Step Therapy

Do not require psychiatric step therapy in Nevada when the statutory exception conditions are satisfied. This protection applies to formulary drugs requiring prior authorization and to non-formulary drugs, and is not limited to drugs designated as step therapy.

The protection applies when the psychiatric indication and supporting authority are documented, the prescriber meets the qualifying practitioner requirements, and required alternatives are known or reasonably expected to be ineffective.
A brand-name request may still be reviewed for the specific medical reason the formulary generic cannot be used.

Unsupported block type: documentation

Denial Risk

Unsupported Indication

Coverage may be denied when the requested use lacks FDA approval, accepted compendia support, or current guideline or other qualifying medical/scientific support.

Submit diagnosis and clinical documentation establishing a covered, non-investigational indication.

Denial Risk

Preferred-Agent Requirements Not Met

A non-preferred agent may be denied when the required history of preferred generic atypical-antipsychotic trials is absent and no documented contraindication, serious side effect, or other qualifying exception applies.

For the matching indication, document at least three preferred generic formulary atypical-antipsychotic trials or the applicable exception.

Denial Risk

Continuation Criteria Not Met

Continuation authorization may be denied when adherence, tolerability, or positive clinical response criteria are not established.

Document adherence of at least 85%, or a prescriber-supported medical rationale for lower adherence.
Document no intolerable adverse effects or drug toxicity and a positive clinical response.

Billing Rule

Quantity Exceeds Allowed Dosing

The requested quantity must remain within FDA-labeled or compendia-supported dosing maximums and applicable formulary or preferred drug list limits.

Submit weight, body-surface-area, or other member-specific dosing data when applicable.

Denial Risk

Insufficient Supporting Documentation

Additional documentation may be required to establish medical necessity, non-investigational status, benefit eligibility, or appropriate billing. Inadequate documentation may result in denial or other appropriate action.

Records may include patient history, test results, treatment history, medication fills, and ordering or performing provider credentials.
Documentation may also be reviewed for inappropriate or excessive billing patterns.

Denial Risk

Rexulti PRN Dementia-Related Agitation

Rexulti is not indicated as an as-needed treatment for agitation associated with dementia due to Alzheimer’s disease. Requests for PRN use may be denied or limited.

Rexulti’s covered dementia-related indication is treatment of agitation associated with Alzheimer’s disease, but not PRN administration.

Denial Risk

Experimental Uses and Contraindications

Uses outside covered FDA-approved or qualifying supported indications are experimental or investigational and may be denied under the applicable off-label policy. Requests involving listed contraindications may also be denied or limited.

Contraindications include drug-specific hypersensitivity and other listed conditions, such as opioid use or acute opioid withdrawal for Lybalvi, and urinary retention, moderate or severe hepatic impairment, gastric retention, or untreated narrow-angle glaucoma for Cobenfy.
Review the applicable product contraindications before requesting coverage.

Medication history may be used to document treatment with preferred generic formulary atypical antipsychotic agents that have a matching indication.

Typical requirementFor a non-preferred agent, documentation generally must show use of a minimum of three preferred generic formulary atypical antipsychotic agents with a matching indication.

Step therapy protocol

DefinitionA procedure that requires an insured to use a prescription drug or sequence of prescription drugs other than the drug recommended by the practitioner before coverage is provided for the recommended drug.

Nevada psychiatric-drug ruleNevada prohibits requiring a step therapy protocol before covering an FDA-approved psychiatric drug, or a drug supported by medical or scientific evidence for the psychiatric condition, when statutory conditions are met.

Alternative-drug considerationThe prescribing practitioner must know from the insured's medical history, or reasonably expect, that each alternative drug required earlier in the protocol would be ineffective.

Pharmacogenomics

DefinitionThe study of the relationship between genetic variation and how the body responds to medication.

Clinical relevanceGenetic information may help inform medication selection and dosing, particularly after an inadequate response or adverse reaction to a previous antidepressant or antipsychotic trial.

Current evidenceEvidence does not support widespread use of pharmacogenomic testing to make therapeutic treatment decisions; testing may help guide dosing and toxicity concerns for specific agents.

Pharmacogenetic testing

DefinitionTesting intended to support thoughtful clinical care, including medication selection and dosing, rather than serve as a standalone determinant of treatment.

Specific recommendationHLA-A and HLA-B testing is recommended before use of carbamazepine and oxcarbazepine, consistent with regulatory agencies and expert groups.

Use of available resultsWhen pharmacogenetic testing results are already available, providers are encouraged to integrate them into medication selection and dosing decisions.