CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 3138-6

Step therapy for Caplyta (lumateperone)

Defines step therapy requirements for coverage of Caplyta (lumateperone) for adults with schizophrenia or depressive episodes associated with bipolar disorder for members of Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Caplyta (lumateperone)

Policy CodePolicy 2025 P 3138-6

Change TypeNo material change

Effective DateFeb 15, 2026

Next Review Date

Key ActionObtain and submit documentation of prior trials (drug name, date, and duration) of required atypical antipsychotics to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2bipolar trials

3schizophrenia trials

12 monthsauth duration

120 daysnew-to-plan window

Coverage Criteria for Caplyta (lumateperone)

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Bipolar depression initial approval - step trials: History of failure, contraindication, or intolerance to BOTH olanzapine (in combination with an SSRI, e.g., fluoxetine) AND quetiapine IR or ER (document drug, date and duration of each trial).both agents failed/contraindicated/intolerant

Please document date and duration of trial.

Bipolar depression initial approval - inpatient initiation: Caplyta was initiated during a recent behavioral inpatient admission with discharge within the past 3 months and the member is currently stable on therapy.discharge ≤ 3 months

Please document date of discharge from inpatient admission.

Bipolar depression initial approval - new to plan stabilization: Member is new to the plan and currently stabilized on Caplyta as evidenced by coverage effective date ≤ 120 days.≤ 120 days

Authorization will be issued for 12 months.

inv-02: Initial Authorization — Schizophrenia / Other

Covered when ANY of the following are met:

Schizophrenia initial approval - step trials: History of failure, contraindication, or intolerance to THREE of the following agents: aripiprazole; olanzapine; quetiapine IR or ER; risperidone; ziprasidone (document drug, date and duration of each trial).three agents failed/contraindicated/intolerant

Please document drug, date and duration of trial.

Schizophrenia initial approval - inpatient initiation: Caplyta was initiated during a recent behavioral inpatient admission with discharge within the past 3 months and the member is currently stable on therapy.discharge ≤ 3 months

Please document date of discharge from inpatient admission.

Schizophrenia initial approval - new to plan stabilization: Member is new to the plan and currently stabilized on Caplyta as evidenced by coverage effective date ≤ 120 days.≤ 120 days

Authorization will be issued for 12 months.

Coverage for Caplyta may be affected by multiple external requirements. State mandates and federal regulatory requirements can impose coverage obligations or restrictions that alter how these criteria are applied. In addition, coverage is subject to the member’s specific benefit plan provisions; eligibility, formulary status, and any plan-level exclusions or limits take precedence when determining coverage. Finally, other utilization management programs or related policies maintained by the plan may further modify authorization decisions.

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Caplyta (lumateperone). Requests must demonstrate that the member meets the step-therapy sequencing and documentation requirements below before authorization will be issued.

Affected indications: schizophrenia; depressive episodes associated with bipolar I or II disorder (monotherapy or adjunctive with lithium or valproate).
Authorization duration: 12 months when criteria met.

Step Therapy

Step Therapy Sequencing — Bipolar Depression

For bipolar depression, a trial history showing failure, contraindication, or intolerance must document both of the following trials (include drug name, dates, and duration):

Olanzapine (Zyprexa) in combination with an SSRI (e.g., fluoxetine).
Quetiapine IR or ER (Seroquel or Seroquel XR).

Step Therapy

Step Therapy Sequencing — Schizophrenia / Other Indications

For schizophrenia (and all other non-bipolar-depression indications), a trial history showing failure, contraindication, or intolerance must document trials of three different atypical antipsychotics (include drug name, dates, and duration). Acceptable agents include:

Aripiprazole (Abilify).
Olanzapine (Zyprexa).
Quetiapine IR or ER (Seroquel or Seroquel XR).
Risperidone (Risperdal).
Ziprasidone (Geodon).

Documentation Required

Required Documentation and Insufficient Trial Consequences

Provide complete documentation with the prior authorization request. If required trial documentation is missing or incomplete, the request may be delayed or denied.

Required documentation: drug name, dates of therapy, duration of each trial, and reason for failure/contraindication/intolerance.
If Caplyta was started during a recent behavioral health inpatient stay, include discharge date (must be within past 3 months).
If member is new to the plan and stabilized on Caplyta, include evidence of prior coverage effective date ≤ 120 days.
Consequences: missing or insufficient trial documentation may result in request denial or request for additional information, delaying approval.

Definitions

Step Therapy — definition

DefinitionStep Therapy: a utilization management program that encourages trials of lower-cost alternative medications before authorizing coverage of a requested medication.

PurposePromotes use of lower-cost alternatives within a therapeutic class prior to coverage of Caplyta (lumateperone).

Program requirement for bipolar depressionMember must trial two atypical antipsychotics prior to Caplyta (e.g., olanzapine + SSRI and quetiapine IR/ER are specified elsewhere in the policy).

Program requirement for schizophreniaMember must trial three atypical antipsychotics prior to Caplyta for schizophrenia or other indications.

Exception contextsExceptions to step therapy may apply for recent behavioral inpatient initiation, members new to the plan and stabilized on Caplyta, or other qualifying stabilization scenarios described in the policy.

Initial Therapy Requirements by Indication

inv-11: Initial therapy requirements

Initial authorization requirements by indication

Bipolar depression initial: Require failure, contraindication, or intolerance to BOTH olanzapine (in combination with an SSRI, e.g., fluoxetine) AND quetiapine IR or ER, OR Caplyta initiated during recent behavioral inpatient admission (discharge ≤ 3 months) with current stability, OR member new to plan and stabilized on Caplyta (coverage effective date ≤ 120 days).see criteria

Authorization for 12 months; document drug, date and duration of trials or discharge date as applicable.

Schizophrenia initial: Require failure, contraindication, or intolerance to THREE of the following agents: aripiprazole; olanzapine; quetiapine IR or ER; risperidone; ziprasidone, OR Caplyta initiated during recent behavioral inpatient admission (discharge ≤ 3 months) with current stability, OR member new to plan and stabilized on Caplyta (coverage effective date ≤ 120 days).three agents or stabilization exceptions

Authorization for 12 months; document drug, date and duration of trials or discharge date as applicable.

Step Therapy Sequencing and Required Trials

Indication	Required trials (agents and count)	Inpatient-initiation / new-to-plan exception
Bipolar depression (depressive episodes associated with bipolar I or II disorder)	Failure, contraindication, or intolerance to BOTH: 1) olanzapine in combination with an SSRI (e.g., fluoxetine) AND 2) quetiapine IR or ER (document date and duration).	Caplyta initiated during behavioral inpatient admission with discharge ≤ 3 months OR member new to plan stabilized on Caplyta with coverage effective date ≤ 120 days (document discharge date or coverage effective date).
Schizophrenia (and all other indications)	Failure, contraindication, or intolerance to THREE of the following: aripiprazole; olanzapine; quetiapine IR or ER; risperidone; ziprasidone (document drug, date and duration).	Caplyta initiated during behavioral inpatient admission with discharge ≤ 3 months OR member new to plan stabilized on Caplyta with coverage effective date ≤ 120 days (document discharge date or coverage effective date).

Background

Caplyta (lumateperone) is FDA-approved for schizophrenia and for depressive episodes associated with bipolar I or II disorder as monotherapy and as adjunctive therapy with lithium or valproate in adults. This policy uses that regulatory context to define step-therapy and prior-authorization requirements for adults enrolled with Colorado Rocky Mountain Health Plans.

For depressive episodes associated with bipolar disorder, initial authorization is granted when one of the following is met: documented failure, contraindication, or intolerance to both olanzapine (given with an SSRI such as fluoxetine) and quetiapine IR or ER; or Caplyta was initiated during a behavioral inpatient admission with discharge within the past 3 months; or the member is new to the plan and stabilized on Caplyta with the coverage effective date ≤ 120 days. For schizophrenia and other indications, initial authorization requires documented failure, contraindication, or intolerance to three listed atypical antipsychotics (aripiprazole; olanzapine; quetiapine IR/ER; risperidone; ziprasidone), or the same inpatient-initiation or new-to-plan stabilization exceptions.

Prior authorization is required for Caplyta. The program promotes use of lower-cost alternatives by requiring trials of specified atypical antipsychotics prior to authorization unless an exception applies (recent inpatient initiation or new-to-plan stabilization). Required documentation must include drug name, dates, and duration of trials; for inpatient-initiated therapy provide the discharge date; for members new to the plan provide evidence the coverage effective date is ≤ 120 days.

When reauthorization is requested, coverage is contingent on documentation of a positive clinical response to therapy. Reauthorization will be issued for 12 months when criteria are met. Note that state mandates, federal requirements, the member’s benefit plan, and other utilization management policies may also affect coverage determinations.