CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Atypical antipsychotics — step therapy for brand oral/transdermal products

Step therapy criteria and post-prior authorization policy for select brand oral and transdermal atypical antipsychotics; applies to providers prescribing these branded products under the payer/CVS Caremark management.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAtypical antipsychotics — step therapy for brand oral/transdermal products

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must follow CVS Caremark step therapy and post-prior authorization procedures for the listed brand oral and transdermal atypical antipsychotics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~24brand products listed

9+list of generics named for step

30minimum trial duration (days)

CVS Caremarkdocument owner/manager

657-Dpolicy ref

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Coverage Criteria — Indications and Special Populations

Initial Authorization

Initial Authorization — Covered when ALL of the following are met:

ALL of the following

The requested agent is FDA-approved for the requested indication (e.g., risperidone for schizophrenia, bipolar mania, adjunctive therapy with lithium or valproate, irritability associated with autistic disorder; saphris for schizophrenia and bipolar disorder indications; secuado for adult schizophrenia; seroquel/seroquel XR for schizophrenia; vryalar for adult schizophrenia and acute bipolar mania).
Documentation of diagnosis consistent with the FDA-labeled indication is provided in the medical record (diagnostic evaluation, relevant history, symptom presentation).
Include age-specific documentation where applicable (pediatric age, Tanner stage if relevant, baseline metabolic measures).
For pediatric patients, prescriber documentation that a thorough diagnostic evaluation was performed and that medication is part of a comprehensive treatment plan including psychological, educational, or social interventions.
If the requested use is for adjunctive therapy (e.g., risperidone or olanzapine adjunctive to lithium or valproate), documentation must indicate combination therapy with lithium or valproate and rationale for adjunctive antipsychotic use.
For maintenance therapy requests, evidence of prior response to the agent during an acute treatment phase or trial of the agent is provided, unless the request is for an agent with established maintenance indication supported by clinical trials (e.g., certain agents have maintenance data).
Seroquel effectiveness for maintenance of schizophrenia has not been systematically evaluated in controlled trials; include this consideration when approving maintenance requests.
Prescriber attestation that risks and benefits (including metabolic risks, weight gain, dyslipidemia) have been reviewed with the patient/caregiver, and that monitoring plans are in place (weight, BMI, fasting glucose, lipids).
When prescribing to adolescents, clinicians should consider increased potential for weight gain and dyslipidemia and document consideration of alternative drugs if appropriate.

Pediatric Considerations

Pediatric Considerations — Additional requirements when the patient is <18 years of age:

ALL of the following

Diagnosis and treatment plan documented by a clinician experienced in pediatric psychiatry or with documented consultation with pediatric psychiatry when initiating antipsychotic therapy for schizophrenia or bipolar disorder in children/adolescents.
Documentation that a thorough diagnostic evaluation was completed and that medication is part of a total treatment program including psychological, educational, and social interventions.
Prescriber documentation of baseline and ongoing metabolic monitoring (weight/BMI, fasting glucose/HbA1c, fasting lipids) and plan for follow-up monitoring.
For adolescent patients, documentation that the prescriber considered the increased potential for weight gain and dyslipidemia compared with adults and rationale for agent selection documented in the record.

The effectiveness of Seroquel for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials; this should be considered when reviewing maintenance therapy requests and when documenting rationale for long-term use.

Zyprexa monotherapy is not indicated for the treatment of depressive episodes associated with bipolar disorder, nor is it indicated for treatment-resistant depression; Zyprexa in combination with fluoxetine (Symbyax) is indicated for those uses. This limitation should be applied when evaluating coverage for depressive episodes or treatment-resistant depression.

title

Initial Therapy — Step Therapy Requirements

Initial Therapy

Authorization may be granted when ONE of the following is met:

Initial step exception criteria: Any ONE of: 1) patient has intolerance or contraindication to a 30-day trial of ONE listed generic antipsychotic (aripiprazole, asenapine, lurasidone, olanzapine, paliperidone, quetiapine, quetiapine extended‑release, risperidone, ziprasidone); 2) patient experienced inadequate response after a trial of at least 30 days to ONE listed generic antipsychotic; 3) patient has a clinical condition for which there is no generic alternative or generic alternatives are not recommended based on published guidelines or clinical literature.at least one condition met

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Continuation Therapy — Renewal Requirements

Prior Authorization

Prior Authorization Required for Renewal

Prior authorization is required to renew therapy. Submit documentation showing the member is currently using the requested medication and demonstrating clinical improvement. If prior authorization is not obtained, claims may be rejected for lack of authorization — submit a PA to resolve rejected claims.

Indication-based prior authorization is required for renewal.
Step therapy or prior authorization noncompliance may affect approval; if a member did not complete required step therapy, include rationale for continuing the requested agent.
There is no automatic authorization or denial trigger — renewal decisions are made after review of submitted documentation.
Claims submitted without an approved PA may be rejected; refile with an approved PA to avoid denial.
Step therapy requirements apply to the listed brand medications; confirm whether the member has met any brand-specific step requirements.
For adolescents, consider medically appropriate therapeutic alternatives and document why the requested agent is preferred.
An initial step-therapy trial is required when initiating therapy unless documentation supports exemption (e.g., intolerance, contraindication).

Step Therapy — Managed Brand Product Requirements

Requirement	Notes
Step therapy applies to listed brand oral and transdermal atypical antipsychotics (brand products only)
If patient does not meet initial step therapy criteria claim will reject and a prior authorization (PA) is required; managed per CVS Caremark Atypical Antipsychotics ST, Post PA Policy 657-D

Guidance	Implication for prescribers
Clinicians should consider the increased potential in adolescents for weight gain and dyslipidemia when choosing antipsychotic therapy
May consider prescribing other drugs first for adolescents due to metabolic risk; document evaluation and rationale if selecting higher-risk agents

Required trial	Listed generics
Trial of ONE listed generic antipsychotic for at least 30 days is required unless intolerance/contraindication or other exception applies
aripiprazole; asenapine; lurasidone; olanzapine; paliperidone; quetiapine; quetiapine extended-release; risperidone; ziprasidone

inv-07: Step trial duration — minimum required duration

Minimum step trial duration>= 30 days

Listed generic alternatives for trialaripiprazole; asenapine; lurasidone; olanzapine; paliperidone; quetiapine; quetiapine XR; risperidone; ziprasidone

Exception criteriaIntolerance/contraindication to a 30-day trial, inadequate response after >=30 days, or no appropriate generic alternative per guidelines

Provider Actions — Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Post‑Step Therapy prior authorization (Policy 657‑D)

Select brand atypical antipsychotics are managed under CVS Caremark Step Therapy/Post‑Prior Authorization per Policy 657‑D; prescribers must follow the post‑PA process when a prior authorization is required after step therapy evaluation.

Prior Authorization

Indication‑based prior authorization

Indication statements in the drug labeling (e.g., risperidone for schizophrenia, bipolar mania, and irritability in autism; quetiapine/Seroquel and Seroquel XR for schizophrenia and bipolar disorder; cariprazine/Vraylar for schizophrenia and bipolar depression; olanzapine/Zyprexa for schizophrenia and bipolar) may be used to support prior authorization requests for those indications.

Prior Authorization

PA required when step criteria not met — exceptions allowed

A prior authorization is required when the patient does not meet initial step therapy criteria; PA may be granted if one of the listed exceptions (intolerance/contraindication, inadequate response after ≥30 days to one listed generic, or clinical need with no appropriate generic) is documented.

Definitions and Background Information

Atypical antipsychotics are a heterogeneous class indicated for a range of psychiatric conditions including schizophrenia, bipolar disorder (acute manic/mixed episodes and, for certain agents, bipolar depression), adjunctive treatment of major depressive disorder, and behavioral symptoms such as irritability in autistic disorder. Individual agents have distinct, FDA‑approved indications and evidence bases: for example, quetiapine (Seroquel/Seroquel XR) and olanzapine (Zyprexa) have demonstrated efficacy in short-term trials for schizophrenia and bipolar presentations, while combinations (e.g., olanzapine + fluoxetine) are required for bipolar depression or treatment‑resistant depression. Clinicians should also be aware of agent‑specific safety considerations (for instance, QTc prolongation risk with ziprasidone and device/monitoring caveats with Abilify Mycite) and the need to weigh metabolic risks, particularly in adolescents, when selecting therapy.

inv-21: Abilify Mycite — device/drug combination note and limitations

Product descriptionAbilify Mycite is a drug–device combination: aripiprazole tablets embedded with an ingestible event marker (IEM) sensor to track ingestion

Indicated use citedTreatment of adults with schizophrenia (Abilify Mycite)

Limitations notedIEM tracking capabilities and real‑time adherence benefits are not established in the evidence; device does not replace clinical assessment

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAtypical antipsychotics — step therapy for brand oral/transdermal products

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must follow CVS Caremark step therapy and post-prior authorization procedures for the listed brand oral and transdermal atypical antipsychotics.

SourceLink

On This Page

Continuation Therapy — Renewal Requirements

Authorization may be granted when ALL of the following are met:

ALL of the following

The patient is currently taking the requested drug with documentation of ongoing use (e.g., recent medication lists, dispensing records, or clinic notes).
There is clinical evidence of improvement while on the requested drug, documented in the medical record (symptom reduction, lab/imaging improvement, functional gains).
If initial therapy required step therapy, documentation confirms the member completed the required step(s) or has a documented contraindication/intolerance to step agents.
For adolescents, prescriber has considered alternative therapies and documented the medical reason why alternatives are not appropriate or were ineffective.
Operational note: Authorization duration aligns with payer limits (e.g., DOA: 36 months where applicable); provide follow-up plans and monitoring documentation.

Step Therapy

Step Therapy applies to listed brand products

Step Therapy applies to the listed brand oral and transdermal atypical antipsychotics (brand products only) managed by CVS Caremark under the Atypical Antipsychotics ST, Post PA Policy 657‑D.

Note

Consider alternative agents in adolescents due to metabolic risk

When treating adolescents, clinicians should consider the increased potential for weight gain and dyslipidemia and may consider prescribing other drugs first prior to certain antipsychotics.

Step Therapy

Initial step therapy: trial of one listed generic for ≥30 days

Initial step therapy requires a trial of ONE listed generic atypical antipsychotic (aripiprazole, asenapine, lurasidone, olanzapine, paliperidone, quetiapine, quetiapine XR, risperidone, or ziprasidone) for at least 30 days unless intolerance/contraindication or another listed exception is documented.

Minimum trial duration: ≥ 30 days
Listed generics: aripiprazole, asenapine, lurasidone, olanzapine, paliperidone, quetiapine, quetiapine extended‑release, risperidone, ziprasidone

Documentation Required

Follow CVS Caremark step‑therapy / post‑PA process

Prescribers must follow the CVS Caremark step therapy and post‑prior authorization procedures when requesting coverage for the listed brand oral and transdermal atypical antipsychotics.

Documentation Required

Pediatric evaluation and documentation prior to initiating therapy

Before initiating medication therapy in pediatric patients with schizophrenia or bipolar disorder, perform a thorough diagnostic evaluation and ensure medication is part of a comprehensive treatment program (including psychological, educational, and social interventions).

Denial Risk

Denial risk for noncompliance with step‑therapy/Post‑PA process

Failure to follow the CVS Caremark step therapy or post‑PA process for the listed branded atypical antipsychotics may result in denial of the claim per the step therapy policy.

Note

Provider action note — indications and pediatric considerations (no extra triggers)

The available chunks emphasize drug indications and pediatric treatment considerations but do not provide additional explicit authorization or denial triggers beyond the step therapy and PA rules described elsewhere in the policy.

Billing Rule

Claims will reject if initial step criteria are not met — PA required

If the patient does not meet the initial step therapy criteria, the claim will reject with a message that a prior authorization is required; submit a PA for evaluation per the PA criteria.

inv-22: QTc prolongation risk (ziprasidone)

AgentZiprasidone (Geodon)

Safety concernGreater capacity to prolong the QTc interval compared to several other antipsychotics

Clinical implicationProlonged QTc associated with risk of torsade de pointes; prescribers should consider trying other drugs first when appropriate

inv-23: Schizophrenia — definition and agents referenced

Condition definitionSchizophrenia — psychiatric disorder treated with antipsychotic agents; efficacy for risperidone established in multiple short‑term and maintenance trials

Agents referencedRisperdal (risperidone) — efficacy in adults and adolescents (13–17); other agents referenced in schizophrenia section include Seroquel, Seroquel XR, Zyprexa, Saphris, Secuado, Vraylar

Evidence noteRisperdal efficacy established in 4 short‑term adult trials, 2 adolescent trials, and one long‑term maintenance trial

inv-24: Autism-related irritability — definition and risperidone reference

DefinitionIrritability associated with autistic disorder includes aggression, deliberate self‑injurious behavior, temper tantrums, and rapidly changing moods

FDA‑approved agent for this indicationRisperdal (risperidone) — efficacy established in children and adolescents ages 5–17

Evidence noteEfficacy for risperidone demonstrated in 3 short‑term trials in children and adolescents

inv-25: Adjunctive therapy (Zyprexa + lithium/valproate)

Combination describedOral olanzapine (Zyprexa) used as adjunctive therapy with lithium or valproate for manic or mixed episodes of bipolar disorder

Evidence durationEfficacy established in two 6‑week clinical trials in adults

LimitationsEffectiveness of adjunctive therapy for longer‑term use has not been systematically evaluated in controlled trials

inv-26: Zyprexa + fluoxetine (Symbyax) — combination indication note

Combination productOlanzapine + fluoxetine (Symbyax) — olanzapine combined with fluoxetine

IndicationsIndicated for depressive episodes associated with bipolar disorder and for treatment‑resistant depression in adults (after failure of 2 adequate antidepressant trials)

Zyprexa monotherapy noteZyprexa monotherapy is not indicated for bipolar depressive episodes or treatment‑resistant depression; the combination (Symbyax) is required for these indications