CurrentMass General Brigham Health PlanPolicy N/A

Caplyta (lumateperone) capsules

Defines the antipsychotic step therapy program (first-, second-, third-line agents), coverage/authorization criteria for individual antipsychotic agents including Caplyta (lumateperone), quantity limits, approval duration, and prior authorization requirements for Mass General Brigham Health Plan (Commercial/Exchange).

Policy Summary

PayerMass General Brigham Health Plan

PolicyCaplyta (lumateperone) capsules

Policy CodePolicy N/A

Change TypeStep therapy program review / updates (no clinical changes 03/01/2026)

Effective DateMar 1, 2026

Next Review Date

Key ActionIf a prescription denies at point of sale for not meeting step therapy, submit a prior authorization request and document 'started and stabilized' only with documented prior use (samples are not acceptable).

SourceLink

POLICY UPDATE CHANGES

02/11/2026 - Reviewed at February P&T. No clinical changes. Effective 03/01/2026.

02/12/2025 - Updated policy to reflect step therapy agent line assignments and added Erzofri PA requirement effective 05/01/2025.

01/20/2021 - Added Caplyta as second line agent and added quantity limit for Caplyta.

3Step therapy lines

36 monthsDefault approval duration

90 daysNew member continuity window

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180 daysLookback window for fill history

Coverage Summary & Step Therapy Structure

Defines the antipsychotic step therapy program for Mass General Brigham Health Plan (Commercial/Exchange) including first-, second-, and third-line agents, agent-specific prior authorization criteria, quantity limits, and prior authorization requirements; Erzofri (paliperidone palmitate) injection requires PA and is excluded from the step therapy program. Approvals are granted with a default duration of 36 months and coverage is provided as covered_with_criteria.

Program-level Step Therapy Rules

Initial step-therapy determines automatic adjudication at point of sale; denials require PA.

Step therapy line rules: First-Line: Medications listed as first-line are covered without prior-authorization.
See policy first-line agent list for included products.
Second-line adjudication: Second-Line: Second-line medications will pay if the member has filled at least one first-line or one second-line medication within the past 180 days.180 days
Claims within 180-day lookback required for auto-adjudication at point of sale.
Third-line adjudication: Third-Line: Third-line medications will pay if the member has filled at least one second-line or one third-line medication in the past 180 days.180 days
Claims within 180-day lookback required for auto-adjudication at point of sale.
Erzofri exclusion and PA: Erzofri (paliperidone extended-release) injection requires prior authorization and is not part of the antipsychotic step therapy program.
Submit PA per policy for Erzofri; it will not auto-adjudicate via step therapy.

Initial Therapy Criteria

Authorization exceptions - new members

Authorization may be granted when one condition below is met:

New-member continuity (90 days): Member is new to the plan within the past 90 days and is currently receiving treatment with the requested medication (excludes samples or manufacturer's patient assistance program supply).90 days
Samples and PAP supply do not qualify for continuity authorization.
Agent-specific criteria: Member meets the specific agent criteria listed in the agent-specific sections below.
See individual agent criteria groups for details.

Agent-specific Prior Authorization Criteria

Paliperidone tablets - Agent-specific criteria

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

Started and stabilized: Member has been started and stabilized on the requested medication (samples not adequate justification).
Document prior use via claims or medical record; samples insufficient.
Inadequate response/intolerance to ONE of
- Aripiprazole (tablet, oral solution, ODT)
- Asenapine SL tablet
- Clozapine (tablet, ODT)

Continuation Therapy / Approval Duration

Continuation approvals will be granted for 36 months. The policy allows authorization when the member has been “started and stabilized” on the requested medication; the term means the member initiated the requested medication and achieved clinical stability on it with documentation of prior use via claims or medical record (samples are not considered adequate justification).

Provider Actions & Billing Rules

Prior Authorization

Prior Authorization for non-automatic fills

Prior authorization is required for any prescription that denies at point-of-sale because it does not meet the antipsychotic step-therapy requirements. Submit a PA request when a claim is denied at the POS; approvals for non-automatic fills will be issued only after receipt of an approved PA.

Submit PA when claim denies at POS indicating prior authorization required
Erzofri (paliperidone palmitate) injection requires its own PA and is excluded from step therapy — see separate PA for injectables

Documentation Required

Stabilization documentation

If requesting approval based on the member having been started and stabilized on the requested medication, submit clinical documentation showing ongoing treatment and clinical stability. Samples and medications obtained through manufacturer patient assistance programs (PAP) are NOT acceptable evidence of ‘‘started and stabilized.’’

Samples and PAP-provided product are excluded as documentation for started & stabilized

Quantity Limits / Code Mapping

Quantity limit list (drug-name to limit mapping)NDC|mixed

Caplyta 42mg	30 capsules per 30 days
Abilify Maintena	1 syringe per 28 days
Aripiprazole solution 1mg/ml	150 ml per 30 days
Aripiprazole tablets 15mg/20mg/30mg	30 tablets per 30 days
Aripiprazole tablets 2mg/5mg/10mg	60 tablets per 30 days
Aripiprazole tablets ODT	30 tablets per 30 days
Asenapine SL tablet	60 tablets per 30 days
Clozapine 100mg	270 tablets per 30 days
Clozapine 25mg	90 tablets per 30 days
Clozapine 50mg	135 tablets per 30 days

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Clinical Evidence & References

References cite multiple manufacturer prescribing information documents as supporting evidence, including the Caplyta (lumateperone) prescribing information dated November 2025.

Background & Definitions

Background: This policy governs the antipsychotic medication step therapy program, establishing first-, second-, and third-line agent assignments, agent-specific prior authorization criteria, and quantity limits for covered atypical antipsychotics; Erzofri (paliperidone palmitate) injection requires prior authorization and is excluded from the step therapy program.

Started and stabilized: Member initiated the requested medication and achieved clinical stability on it; documented prior use via claims or medical record (samples are not adequate).

Revision History

02/11/2026clarified

Reviewed at February P&T. No clinical changes. Effective 03/01/2026.

02/12/2025revised

Updated policy to reflect step therapy agent line assignments and added Erzofri PA requirement effective 05/01/2025.

01/20/2021added

Added Caplyta as second line agent and added quantity limit for Caplyta. Effective 02/01/21.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCaplyta (lumateperone) capsules

Policy CodePolicy N/A

Change TypeStep therapy program review / updates (no clinical changes 03/01/2026)

Effective DateMar 1, 2026

Next Review Date

SourceLink

On This Page

Olanzapine (tablet, ODT)

Quetiapine (IR or ER tablet)

Risperidone (tablet, oral solution, ODT)

Rexulti (brexpiprazole) tablet

Vraylar (cariprazine) capsule

Schizoaffective disorder: Member has a diagnosis of schizoaffective disorder.

Pediatric schizophrenia exception: Member has a diagnosis of schizophrenia and is 12 years of age or younger.12 years

Rexulti (brexpiprazole) tablet - Agent-specific criteria

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

Started and stabilized: Member has been started and stabilized on the requested medication (samples not adequate justification).
Inadequate response/intolerance to ONE of
- Aripiprazole (tablet, oral solution, ODT)
- Asenapine SL tablet
- Clozapine: Cloapine (tablet, ODT)
- Lurasidone tablet
- Olanzapine (tablet, ODT)
- Paliperidone ER: Paliperidone extended-release tablet
- Quetiapine (IR or ER tablet)
- Risperidone (tablet, oral solution, ODT)
- Ziprasidone capsule
- Vraylar (cariprazine) capsule
Dementia agitation indication: Member has a diagnosis of agitation in association with dementia due to Alzheimer's disease.

Vraylar (cariprazine) capsule - Agent-specific criteria

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

Started and stabilized: Member has been started and stabilized on the requested medication (samples not adequate justification).
Inadequate response/intolerance to ONE of
- Aripiprazole (tablet, oral solution, ODT)
- Asenapine SL tablet
- Clozapine: Cloapine (tablet, ODT)
- Lurasidone tablet
- Olanzapine (tablet, ODT)
- Paliperidone ER: Paliperidone extended-release tablet
- Quetiapine (IR or ER tablet)
- Risperidone (tablet, oral solution, ODT)
- Ziprasidone capsule
- Rexulti (brexpiprazole) tablet

Caplyta (lumateperone) capsule - Agent-specific criteria

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

Started and stabilized: Member has been started and stabilized on the requested medication (samples not adequate justification).
Inadequate response/intolerance to ONE of
- Rexulti (brexipiprazole) tablet
- Vraylar (cariprazine) capsule
- Paliperidone ER: Paliperidone extended-release tablet
- Fanapt (iloperidone) tablet
- Secuado (asenapine) transdermal patch
- Lybalvi (olanzapine/samidorphan) tablet
Bipolar II depression criteria
- Quetiapine prior inadequate response: Member has had an inadequate response or intolerance to quetiapine.
- Adjunct to lithium/valproate: Member is using Caplyta as an adjunct to lithium or valproate.

Fanapt (iloperidone) tablet - Agent-specific criteria

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

Started and stabilized: Member has been started and stabilized on the requested medication (samples not adequate justification).
Inadequate response/intolerance to ONE of
- Rexulti (brexipiprazole) tablet
- Vraylar (cariprazine) capsule
- Paliperidone ER: Paliperidone extended-release tablet
- Caplyta (lumateperone) capsule
- Secuado (asenapine) transdermal patch
- Lybalvi (olanzapine/samidorphan) tablet

Secuado (asenapine) transdermal patch - Agent-specific criteria

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

Started and stabilized: Member has been started and stabilized on the requested medication (samples not adequate justification).
Inadequate response/intolerance to ONE of
- Rexulti (brexipiprazole) tablet
- Vraylar (cariprazine) capsule
- Paliperidone ER: Paliperidone extended-release tablet
- Caplyta (lumateperone) capsule
- Fanapt (iloperidone) tablet
- Lybalvi (olanzapine/samidorphan) tablet

Lybalvi (olanzapine/samidorphan) tablet - Agent-specific criteria

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

Started and stabilized: Member has been started and stabilized on the requested medication (samples not adequate justification).
Inadequate response/intolerance to ONE of
- Rexulti (brexipiprazole) tablet
- Vraylar (cariprazine) capsule
- Paliperidone ER: Paliperidone extended-release tablet
- Caplyta (lumateperone) capsule
- Fanapt (iloperidone) tablet
- Secuado (asenapine) transdermal patch
Bipolar I maintenance criteria
- Asenapine SL prior fail: Member has had an inadequate response or intolerance to Asenapine sublingual tablet.
- Olanzapine ODT prior fail: Member has had an inadequate response or intolerance to Olanzapine tablet, orally disintegrating tablet.

Include clinical notes, medication start date, dose history, and documentation of stabilization (efficacy/tolerability)

Prior Authorization

Erzofri prior authorization

Erzofri (paliperidone extended-release injection) requires prior authorization and is explicitly excluded from the oral antipsychotic step-therapy program. Submit a separate PA for Erzofri per long-acting injectable PA requirements.

Erzofri is not part of antipsychotic step therapy
Erzofri requires its own PA even if member has met oral step-therapy criteria

Billing Rule

Point-of-sale adjudication windows

Point-of-sale adjudication follows the 180-day lookback windows: second-line agents will adjudicate if the member filled at least one first- or second-line antipsychotic in the prior 180 days; third-line agents will adjudicate if the member filled at least one second- or third-line agent in the prior 180 days. If the 180-day lookback is not met, the prescription will deny and a PA must be submitted.

Second-line: requires ≥1 fill of a first- or second-line agent within 180 days
Third-line: requires ≥1 fill of a second- or third-line agent within 180 days
If lookback window not met, claim will deny at POS and requires PA submission

Documentation Required

New member continuity

For members new to the plan, continuity of therapy may be authorized for up to 90 days if the member is currently receiving the requested medication. Continuity approvals do not accept samples or medications obtained via manufacturer's patient assistance programs as proof of prior therapy.

New member continuity window = 90 days from plan enrollment
Samples and PAP-provided product are not acceptable for continuity approvals

Billing Rule

Approval duration

Approvals for antipsychotic PA requests are granted for a duration of 36 months unless otherwise specified in the limitations section.

Standard approval duration = 36 months