Centene paliperidone LAI Coverage & Prior Auth

Coverage Criteria

Initial therapy for schizophrenia

Covered for schizophrenia when ALL of the following are met:

Schizophrenia initial therapy criteria: 1) Diagnosis of schizophrenia; 2) Prescribed by or in consultation with a psychiatrist; 3) Age ≥ 18 years; 4) Member meets one of the following: (a) requested product was initiated in an inpatient setting within the last 60 days, OR (b) history of non-adherence to oral antipsychotic therapy and product-specific prior treatment/tolerability requirements (see notes); 5) Dose does not exceed product-specific maximums.

Product-specific prior treatment: If Invega Trinza is requested, adequate treatment established with Invega Sustenna or Erzofri for ≥4 months; if Invega Sustenna or Erzofri is requested, established tolerability with oral paliperidone or oral risperidone and no known hypersensitivity to paliperidone/risperidone; if Invega Hafyera is requested, adequate treatment with Invega Sustenna or Erzofri for ≥4 months or Invega Trinza for at least one 3-month cycle.

Initial therapy for schizoaffective disorder

Covered for schizoaffective disorder when ALL of the following are met:

Schizoaffective disorder criteria: 1) Diagnosis of schizoaffective disorder; 2) Request is for Invega Sustenna or Erzofri; 3) Prescribed by or in consultation with a psychiatrist; 4) Age ≥ 18 years; 5) Member meets one of the following: (a) history of non-adherence to oral antipsychotic therapy AND established tolerability to oral risperidone (preferred) or paliperidone, OR (b) therapy initiated in an inpatient setting within the last 60 days; 6) Dose does not exceed product-specific maximums for the requested product.

Preferred oral risperidone for tolerability when non-adherence is the reason.

Continuation therapy

Continuation/renewal criteria (All indications):

Continuation therapy: 1) Member is currently receiving the medication via the Centene benefit for at least 30 days, OR documentation supports inpatient initiation within the last 60 days; 2) Member is responding positively to therapy; 3) If the request is for a dose increase, the new dose does not exceed product-specific maximums.

Approval durations vary by line of business: Medicaid/HIM up to 12 months; Commercial 6 months or to member renewal date, whichever is longer.

Exclusions / Not authorized

Not covered (explicit exclusions):

Exclusions: Non–FDA approved indications that are not addressed in this policy without sufficient off‑label documentation per referenced off‑label policies; dementia‑related psychosis.

Refer to off‑label use policies CP.CPA.09 (Commercial), HIM.PA.154 (HIM), and CP.PMN.53 (Medicaid) for documentation requirements.

Initial and product-specific coverage

Covered when meeting labeled indication and product-specific initiation/continuation requirements

General requirements

Product-specific initiation: Invega Sustenna: initial 234 mg IM day 1 and 156 mg IM day 8 (deltoid), maintenance 39–234 mg monthly starting 5 weeks after first injection (maximum 234 mg/month).; Invega Trinza: use only after ≥4 months of Invega Sustenna or Erzofri; initiate Trinza at ~3.5× prior monthly Sustenna dose per conversion table and administer every 3 months (maximum 819 mg q3 months).; Invega Hafyera: use only after Invega Sustenna established ≥4 months or after Invega Trinza for at least one 3‑month cycle; initiate Hafyera based on prior Sustenna/Trinza dose per conversion table (examples: last Sustenna 156 mg → Hafyera 1,092 mg; last Sustenna 234 mg → Hafyera 1,560 mg) (maximum 1,560 mg q6 months).; Erzofri: initial 351 mg IM day 1 (deltoid), maintenance 39–234 mg monthly (recommended 117 mg monthly), administered 4 weeks after first injection (maximum 351 mg first dose then 234 mg/month).
Refer to dosing tables in policy for exact conversion amounts.

Coverage is not authorized for dementia-related psychosis and for non‑FDA approved indications unless the request includes sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (see referenced off‑label policies).

The listing or omission of codes in this policy is for informational purposes only; inclusion or exclusion of codes does not guarantee coverage. Providers should verify current professional coding guidance before submitting claims for reimbursement.

Use of paliperidone long‑acting injections for dementia-related psychosis is contraindicated or considered not authorized per the policy’s explicit exclusions and boxed warning; such requests will not be approved under this policy.

Initial Therapy Prerequisites and Dosing

Initial therapy prerequisites and dosing

Initial dosing and product-specific prerequisites:

Invega Trinza prerequisite: Invega Trinza requests require adequate treatment with Invega Sustenna or Erzofri for at least the last 4 months before conversion to Trinza.

Conversion uses a 3.5-fold multiplier of the prior monthly Sustenna dose (see conversion table).

Invega Sustenna/Erzofri prerequisite: Requests for Invega Sustenna or Erzofri require established tolerability with oral paliperidone or oral risperidone and no known hypersensitivity to paliperidone or risperidone.

Erzofri recommended initial tolerability considerations align with Sustenna requirements for oral tolerability.

Invega Hafyera prerequisite: Invega Hafyera may be used only after adequate treatment established with Invega Sustenna for ≥4 months or Invega Trinza for at least one 3‑month cycle; the initial Hafyera dose is based on the last Sustenna or Trinza dose and is initiated when the next Sustenna/Trinza dose would have been scheduled.

Continuation Therapy

Continuation therapy

Continuation therapy requirements and durations vary by line of business

Continuation therapy nodes: Member must be currently receiving the medication via Centene benefit or have documentation of recent inpatient initiation; member must be responding positively to therapy; dose increases must not exceed product maximums.

Approval duration: Medicaid/HIM up to 12 months; Commercial 6 months or to member renewal date.

Continuation Therapy

Continuation/maintenance dosing must follow product labeling and documented prior tolerability/stabilization

Continuation criteria: Member was previously started on the product per labeled initiation and demonstrates clinical benefit or stability; maintenance dosing must remain within labeled ranges (Invega Sustenna monthly 39–234 mg; Invega Trinza q3 months up to 819 mg; Invega Hafyera q6 months up to 1,560 mg; Erzofri monthly 39–234 mg after initial 351 mg).

Documentation should demonstrate prior stabilization on required predecessor product when applicable (e.g., Sustenna before Trinza; Sustenna or Trinza before Hafyera).

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for paliperidone long-acting injectable (LAI) products billed to the plan. Provider must submit supporting documentation (such as office chart notes, lab results, or other clinical information) demonstrating that the member meets all approval criteria, including documentation of current therapy or recent inpatient initiation and positive response when applicable. Requests for dementia-related psychosis or other non‑FDA indications will not be authorized unless supported by the plan's off-label use policies.

PA required when billing HCPCS J2426, J2427, or J2428
Include clinical documentation of initiation (inpatient within 60 days) or evidence of current therapy
Document positive response to therapy for continuation requests

Documentation Required

Established Tolerability Required for Initiation

For initiation of Invega Sustenna or Erzofri, the provider must document established tolerability with oral paliperidone or oral risperidone and no known hypersensitivity to paliperidone or risperidone. For initiation of Invega Sustenna/Erzofri when started in the inpatient setting, provide documentation of the recent hospitalization (within 60 days).

Coding and HCPCS

Policy referencemixed

No codes listed

Covered HCPCS CodesHCPCSCovered

J2426

Injection, paliperidone palmitate extended release (Invega Sustenna), 1 mg.

Covered HCPCS CodesHCPCSCovered

J2427

Injection, paliperidone palmitate extended release (Invega Hafyera or Invega Trinza), 1 mg.

Covered HCPCS CodesHCPCSCovered

J2428

Injection, paliperidone palmitate extended release (Erzofri), 1 mg.

Maximum doses by product

Invega HafyeraMaximum 1,560 mg every 6 months.

Invega SustennaMaximum 234 mg per month.

Invega TrinzaMaximum 819 mg every 3 months.

Erzofri351 mg for the first dose, then maximum 234 mg per month thereafter.

Quantity Limits and Product Strengths

Invega Hafyera — quantity limit

Quantity limit (mg)1,560 mg every 6 months (maximum).

Clinical contextHafyera initiation requires prior adequate treatment with Invega Sustenna ≥4 months or Invega Trinza for at least one 3‑month cycle.

Strengths availableSee product availability for 1,092 mg and 1,560 mg kits.

Invega Sustenna — quantity limit

Quantity limit (mg)234 mg per month (maximum).

Initial dosingInitial: 234 mg IM day 1 and 156 mg IM day 8 (deltoid); maintenance 39–234 mg monthly.

Indications

Step Therapy Requirements

Step	Requirement
1
For initiation of Invega Sustenna or Erzofri: established tolerability with oral paliperidone or oral risperidone is required before approval.
1
Invega Trinza requests require adequate treatment established with Invega Sustenna or Erzofri for at least the last 4 months prior to initiation.

Product	Prior treatment requirement
Invega Trinza
May be used only after Invega Sustenna has been established as adequate treatment for at least 4 months; initiate Trinza at the 3.5x equivalent of the prior monthly Sustenna dose per conversion table (maximum 819 mg every 3 months).
Invega Hafyera
May be used only after adequate treatment with Invega Sustenna established for ≥4 months or after Invega Trinza established for at least one 3‑month cycle; initial Hafyera dose is based on prior Sustenna or Trinza dose (maximum 1,560 mg every 6 months).

Site of Care and Administration

Note

No site-of-care restriction specified

No site‑of‑care restrictions are specified in this portion of the policy for administration of paliperidone LAIs.

Policy does not impose office vs. clinic site restrictions in this section.

Note

IM injection site — deltoid for initiation; deltoid or gluteal for maintenance per label

Per product labeling, initial IM injections are given in the deltoid muscle (e.g., Sustenna day 1 and day 8; Erzofri initial 351 mg on day 1 in the deltoid). Maintenance injections may be administered in either the deltoid or gluteal muscle depending on product and dosing schedule.

Sustenna initiation: 234 mg day 1 and 156 mg day 8, both deltoid.
Erzofri initial: 351 mg day 1 in the deltoid; maintenance deltoid or gluteal per label.
Maintenance for Sustenna may be deltoid or gluteal as labeled; Trinza/Hafyera maintenance sites per labeling.

Definitions

Paliperidone

DefinitionPaliperidone is an atypical antipsychotic available as long-acting injectable formulations (Invega Hafyera, Invega Sustenna, Invega Trinza, Erzofri).

Drug classAtypical (second‑generation) antipsychotic.

Products coveredInvega Hafyera, Invega Sustenna, Invega Trinza, Erzofri.

Conversion / initiation guidance

Trinza prerequisiteInvega Trinza may be used only after Invega Sustenna (or Erzofri) has been established as adequate treatment for at least 4 months.

Hafyera prerequisiteInvega Hafyera may be used only after Invega Sustenna has been established as adequate treatment for ≥4 months or after Invega Trinza for at least one 3‑month cycle.

Background

Paliperidone is an atypical (second‑generation) antipsychotic available in multiple long‑acting injectable formulations (commercially: Invega Hafyera, Invega Sustenna, Invega Trinza, Erzofri). These products are indicated for treatment of schizophrenia in adults, with select formulations also indicated for schizoaffective disorder as specified in this policy.

OpenPayer

Paliperidone Long-Acting Injections (Invega Hafyera, Invega Sustenna, Invega Trinza, Erzofri) coverage criteria

Coverage Criteria

Initial Therapy Prerequisites and Dosing

Continuation Therapy

Provider Actions and Documentation

Coding and HCPCS

Quantity Limits and Product Strengths

Step Therapy Requirements

Site of Care and Administration

Definitions

Background