CurrentCentenePolicy CP PMN.232

Lumateperone (Caplyta)

Defines medical necessity criteria, approval durations, dosing limits, exclusions, step-therapy and state-specific redirection/step therapy bypass rules for lumateperone (Caplyta) for commercial, HIM and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyLumateperone (Caplyta)

Policy CodePolicy CP PMN.232

Change TypeStep therapy revisions; state-specific bypass additions; exclusions updated

Effective Date03.01.20

Next Review Date

Key ActionProvider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

3Q 2024 annual review: for Schizophrenia, changed to failure of one of the following generic atypical antipsychotics (previously was failure of two) to align with other atypical antipsychotics.

3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395.

Added redirection bypass for members in States with limitations on step therapy in certain mental health settings and Appendix D (states listed include AR, NV, TX, IL provisions noted).

1Q 2022: revised Commercial auth limit from Length of Benefit to 12 months or duration of request whichever is less; RT4: added criteria for recently FDA-approved indication of bipolar depression.

1Q 2023: added dementia-related psychosis to section III (Diagnoses/Indications not authorized).

2Covered Indications (FDA)

1Excluded Indication

42 mg

≥4 wksRequired trial length

Coverage Summary

Policy CP PMN.232: Lumateperone (Caplyta) coverage policy — covered with criteria. Defines medical necessity criteria, approval durations, dosing limits, exclusions, step-therapy and state-specific redirection/step therapy bypass rules for lumateperone. FDA-covered indications: schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults. Excluded indication: dementia-related psychosis. Status: CURRENT (last review 08.25).

Key thresholds and approval durations

Trial duration≥ 4 weeks for prior antipsychotic agents at up to maximally indicated doses unless clinically significant adverse effects or contraindication

Age≥ 18 years

Maximum daily dose42 mg/day and 1 capsule/day

Approval duration (Medicaid/HIM)12 months

Approval duration (Commercial)12 months or duration of request, whichever is less

Initial Therapy Criteria (Medical Necessity)

Initial Approval Criteria

Caplyta is medically necessary when ALL of the following are met for the indicated diagnosis:

Indication

A. Schizophrenia (must meet all)
- Diagnosis of schizophrenia
- Age ≥ 18 years
- One of
  - Request is for the treatment of a member in a State with limitations on therapy in certain mental health settings (see Appendix D) (redirection bypass)

Continuation / Renewal Criteria

Continuation/Renewal Criteria

Approval for continuation when ALL of the following are met:

ALL of the following

Member currently receiving Caplyta via Centene benefit or documentation supports current receipt of Caplyta for schizophrenia or bipolar disorder and has received medication for at least 30 days
Member is responding positively to therapy
Dose limit for continuation
- Dose does not exceed 42 mg per day
- Dose does not exceed 1 capsule per day

Exclusions / Not Authorized

Denial Risk

Coverage denial for excluded indications

Requests for dementia-related psychosis are not authorized. Non‑FDA approved indications not addressed in this policy may be denied if sufficient documentation per off‑label use policies or evidence of coverage documents is not provided.

Provider Actions & Requirements

Prior Authorization

Prior authorization required with step therapy

Prior authorization is required. Failure of the specified step‑therapy agents must be documented unless the member qualifies for a state‑specific redirection bypass (see Appendix D) or has contraindication/clinically significant adverse effects.

Documentation Required

Submit supporting documentation

Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Applicable Codes / Product Availability

Product availability (HCPCS/NDC not specified in policy)mixed

Capsule strengths

42 mg, 21 mg, 10.5 mg (product availability; no NDCs listed)

Clinical Evidence & Background

Background: Lumateperone (Caplyta) is an atypical antipsychotic approved by the FDA for schizophrenia and for bipolar depression (depressive episodes associated with bipolar I or II disorder) in adults. Prescribing Information referenced: Caplyta Prescribing Information, Intra-Cellular Therapies, Inc.; June 2023. Guideline references: APA practice guidelines for schizophrenia and bipolar disorder are cited in the policy.

Definitions and quick-reference

BMI definitionBMI = body mass index

Trial duration (quick ref)≥ 4 weeks for prior antipsychotic agents

Age (quick ref)≥ 18 years

Maximum daily dose (quick ref)42 mg/day and 1 capsule/day

State-specific Redirection / Step Therapy Bypass

State-specific protections and redirection bypass: the policy includes an Appendix D listing states with limitations on step therapy in certain mental health settings and associated redirection/bypass provisions (examples shown include AR, NV, TX, and IL). The policy was updated to add redirection bypass provisions and to add Illinois-specific step therapy bypass for Illinois HIM per IL HB 5395 (effective 1/1/2026 for HIM requests). Requests for members in these states may be redirected or have step therapy bypassed per the policy Appendix D and the IL HIM statutory change.

Prior Authorization

State-specific step therapy bypass

State‑specific step therapy bypasses in Appendix D must be applied when applicable and documentation of qualifying status should be provided (see Appendix D for states and notes).

Revision History

06.07.24approval/effective

3Q 2024 annual review: Schizophrenia step therapy revised — changed to failure of one generic atypical antipsychotic (previously two) to align with other atypical antipsychotics.

08.24P&T approval

P&T Approval for 3Q 2024 change to schizophrenia step therapy (failure of one generic atypical antipsychotic).

11.03.22addition

1Q 2023: Dementia-related psychosis added to section III (Diagnoses/Indications not authorized).

Policy Summary

PayerCentene

PolicyLumateperone (Caplyta)

Policy CodePolicy CP PMN.232

Change TypeStep therapy revisions; state-specific bypass additions; exclusions updated

Effective Date03.01.20

Next Review Date

Key ActionProvider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

On This Page

Member has diabetes mellitus or body mass index (BMI) > 30

Failure of one of the following generic atypical antipsychotics at up to maximally indicated doses, each used for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated: risperidone, quetiapine, olanzapine, ziprasidone

Failure of a ≥ 4-week trial of aripiprazole at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced

Dose limit

Dose does not exceed 42 mg per day
Dose does not exceed 1 capsule per day

B. Bipolar Disorder (must meet all)

Diagnosis of bipolar disorder
Age ≥ 18 years
Step therapy bypass or failure
- Request is for the treatment of a member in a State with limitations on therapy in certain mental health settings (see Appendix D) (redirection bypass)
- Failure of two preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, olanzapine) at up to maximally indicated doses, each used for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated
Dose limit
- Dose does not exceed 42 mg per day
- Dose does not exceed 1 capsule per day

C. Other diagnoses/indications

For drugs on formulary/PDL: follow no coverage criteria policy for the relevant line of business (CP.CPA.190 commercial, HIM.PA.33 marketplace, CP PMN.255 Medicaid) OR for drugs NOT on formulary/PDL: follow non-formulary policy for relevant line (CP.CPA.190 commercial, HIM.PA.103 marketplace, CP PMN.16 Medicaid)
If requested use (diagnosis, age, dosing) is not listed and criterion 1 above does not apply, refer to off-label use policy (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid)

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Billing Rule

Approval duration

Medicaid/HIM: 12 months. Commercial: 12 months or duration of request, whichever is less.

Step Therapy

Step therapy requirements

Schizophrenia: failure of one generic atypical antipsychotic (risperidone, quetiapine, olanzapine, or ziprasidone) at up to maximally indicated doses for ≥ 4 weeks plus a separate ≥ 4‑week trial of aripiprazole at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects. Bipolar disorder: failure of two preferred atypical antipsychotics (examples: aripiprazole, ziprasidone, quetiapine, risperidone, olanzapine) at up to maximally indicated doses, each used for ≥ 4 weeks, unless contraindicated or clinically significant adverse effects.

02.23P&T approval

P&T Approval for 1Q 2023 update adding dementia-related psychosis to exclusions.

06.27.25addition

3Q 2025 annual review: added step therapy bypass for Illinois HIM in accordance with IL HB 5395 (state-specific redirection bypass added).

08.25P&T approvalLatest

P&T Approval for 3Q 2025 change adding IL HIM step therapy bypass per IL HB 5395.

2023 (multiple dates: 07.05.23, 07.19.23, 08.31.23)addition

Added redirection/step therapy bypass entries and Appendix D additions in 2023 (Arkansas, Texas, Nevada) to reflect states with limitations on step therapy in certain mental health settings; affects application of step therapy.