CurrentUnitedHealthcarePolicy 2025 P 1314-5

Pa Notification Caplyta

Defines UnitedHealthcare prior authorization/notification criteria for Caplyta (lumateperone) including initial and reauthorization criteria, authorization durations, and additional clinical rules applicable to members subject to state mandates and plan benefits.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Caplyta

Policy CodePolicy 2025 P 1314-5

Change TypeCovered with criteria; no material change in 4/2025

Effective DateJul 1, 2025

Next Review Date

Key ActionCaplyta requires prior authorization/notification; initial approvals issued for 12 months when member has diagnosis of schizophrenia or bipolar depression. Reauthorization requires documentation of positive clinical response and is issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Coverage for depressive episodes associated with bipolar disorder was added in 3/2022 due to new labeling.

Annual review with no changes noted in 4/2025.

2Covered Indications

12mAuthorization Duration (initial & reauth)

5/2020-4/2025P&T Approval History

Coverage Summary

Caplyta (lumateperone) is FDA approved for the treatment of schizophrenia and for depressive episodes associated with bipolar I or II disorder as monotherapy and as adjunctive therapy with lithium or valproate in adults. Coverage is contingent on meeting the plan's prior authorization/notification criteria and may be influenced by state mandates and member-specific benefits. Coverage stance: covered_with_criteria. Policy number: 2025 P 1314-5.

Initial Therapy Criteria

Initial Authorization

Caplyta will be approved based on one of the following criteria:

ANY of the following

Diagnosis of schizophrenia
Diagnosis of depressive episodes associated with bipolar I or II disorder (bipolar depression)

Authorization duration

Authorization will be issued for 12 months

Continuation / Reauthorization Criteria

Reauthorization / Continuation Therapy

Caplyta will be approved for continuation of therapy when ALL of the following are met:

ALL of the following

Documentation of a positive clinical response to therapy
Authorization will be issued for 12 months

Provider Actions & Administrative Rules

Prior Authorization

Prior authorization/notification required

Caplyta requires prior authorization/notification. Initial approvals are issued for 12 months when the member has a diagnosis of schizophrenia or depressive episodes associated with bipolar I or II disorder (bipolar depression).

Documentation Required

Documentation of clinical response for reauthorization

For reauthorization, the provider must document a positive clinical response to therapy; reauthorizations are issued for 12 months.

Billing Rule

Automated approvals and claim-based logic

UnitedHealthcare may approve initial and reauthorization based solely on previous claim or medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval and re-approval processes varies by program or therapeutic class.

Step Therapy

Step therapy / supply limits may apply

Step therapy requirements and supply limits may apply to Caplyta depending on the program or plan.

Clinical Evidence & References

Evidence and references: Caplyta [package insert], Intra-Cellular Therapies, Inc., June 2023.

Initial authorization criteria: approval when member has a diagnosis of schizophrenia or depressive episodes associated with bipolar I or II disorder (bipolar depression); authorization duration: 12 months.

Reauthorization criteria: approval for continuation of therapy requires documentation of a positive clinical response to therapy; reauthorization duration: 12 months.

Additional clinical rules: UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; step therapy and supply limits may apply.

Background

Caplyta is FDA approved for schizophrenia and for depressive episodes associated with bipolar I or II disorder as monotherapy and adjunctive therapy with lithium or valproate in adults. Coverage requires prior authorization/notification; initial approvals are issued for 12 months when the member has a qualifying diagnosis. Reauthorization requires documentation of a positive clinical response and is issued for 12 months. State mandates, federal requirements, member-specific benefit plans, and other utilization management programs may affect coverage.

Revision History

2022-03material_change

Coverage for depressive episodes associated with bipolar disorder was added due to new labeling.

2025-04annual_reviewLatest

Annual review with no changes noted.