CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Long-acting injectable paliperidone (Invega Sustenna, Trinza, Hafyera) — Coverage Criteria

Clinical coverage and authorization criteria for Medicaid members of Neighborhood Health Plan of Rhode Island for long-acting injectable paliperidone products (Invega Sustenna, Invega Trinza, Invega Hafyera).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLong-acting injectable paliperidone (Invega Sustenna, Trinza, Hafyera) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document FDA‑approved indication plus required prior-treatment history (e.g., Sustenna for ≥4 months before Trinza/Hafyera) to qualify for coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmaximum authorization period when criteria met

1 syringe / 180 daysquantity limit for Invega Hafyera (1092mg & 1560mg)

Medicaidscope / applicable program

3 formulationsproducts covered (Sustenna, Trinza, Hafyera)

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Product-specific medical necessity criteria

Covered when ALL of the following are met for each product:

Invega Hafyera - Coverage criteria: 1) Indication: the drug is prescribed for the treatment of schizophrenia in adults; 2) Prior treatment: the patient has been adequately treated with Invega Sustenna for at least four months OR Invega Trinza for at least one three-month cycle; 3) Authorization duration: an authorization of up to 12 months may be granted when criteria are met.

From chunks 2 and 5.

Invega Sustenna - Coverage criteria: 1) Indication: the drug is prescribed for the treatment of schizophrenia in adults OR schizoaffective disorder in adults (as monotherapy or adjunct to mood stabilizers or antidepressants); 2) Tolerability: established tolerability to oral paliperidone or oral risperidone; 3) Authorization duration: an authorization of up to 12 months may be granted when criteria are met.

From chunk 3 and 6.

Invega Trinza - Coverage criteria: 1) Indication: the drug is prescribed for the treatment of schizophrenia in adults; 2) Prior treatment: the patient has been adequately treated with Invega Sustenna for at least four months; 3) Authorization duration: an authorization of up to 12 months may be granted when criteria are met.

From chunks 4 and 7.

All indications beyond the products' listed FDA‑approved uses and accepted compendial uses are considered experimental/investigational and are not covered benefits. Coverage and prior authorization are limited to the specific indications and treatment pathways described for each paliperidone palmitate formulation in this policy.

Provider Requirements, Prior Authorization, and Restrictions

Prior Authorization

Prior Authorization Required

Authorization (up to 12 months) is required and will be granted only when documentation supports the FDA‑approved indication and the specific product criteria below.

Supports only FDA‑approved or compendial indications; non‑approved indications are considered experimental/investigational and are not covered.

Documentation Required

Invega Hafyera authorization — documentation and treatment history required

Invega Hafyera (6‑month paliperidone palmitate) requests require documentation that the medication is being used for the treatment of schizophrenia and that the patient has been adequately stabilized on a shorter‑interval paliperidone palmitate formulation prior to initiation. An authorization may be granted for up to 12 months when all criteria are met.

Patient diagnosed with schizophrenia (documentation required).
Evidence of adequate treatment with Invega Sustenna (1‑month paliperidone palmitate) for at least four months OR Invega Trinza (3‑month paliperidone palmitate) for at least one full 3‑month cycle.
Documented treatment history and dates of prior formulations (start/stop dates, tolerability).

Prior Authorization

Invega Sustenna / Trinza authorization — tolerability and formulation‑specific requirements

Invega Sustenna (monthly paliperidone palmitate) and Invega Trinza (every‑3‑month paliperidone palmitate) requests: authorizations (up to 12 months) require meeting product‑specific criteria including indication and tolerability.

Invega Sustenna: Tolerability to oral paliperidone or oral risperidone must be documented prior to long‑acting injectable (LAI) initiation.
Invega Sustenna: Indication must be schizoaffective disorder (as monotherapy or adjunct to mood stabilizers/antidepressants) or schizophrenia in adults.
Invega Trinza: Indication must be schizophrenia in adults and patient must have been adequately treated with Invega Sustenna for at least four months before Trinza initiation.

Step Therapy

Step therapy between formulations — prior adequate treatment required

Step‑therapy between long‑acting paliperidone formulations is enforced: members must demonstrate adequate treatment and tolerability on the required shorter‑interval formulation before moving to the longer‑interval product.

To start Invega Trinza: documentation of ≥4 months of Invega Sustenna treatment is required.
To start Invega Hafyera: documentation of either ≥4 months of Invega Sustenna OR ≥1 full 3‑month cycle of Invega Trinza is required.
Provide dates and clinical notes showing stability and tolerability on the prior formulation to satisfy step‑therapy requirements.

Formulations and Definitions

Formulations

Invega SustennaMonthly paliperidone palmitate (1-month paliperidone palmitate extended‑release injectable suspension); indicated for treatment of schizophrenia in adults and schizoaffective disorder in adults (monotherapy or adjunct).

Invega TrinzaThree‑month paliperidone palmitate (3‑month injection); indicated for treatment of schizophrenia in adults after adequate treatment with Invega Sustenna for at least four months.

Invega HafyeraSix‑month paliperidone palmitate (every‑six‑month injection); indicated for treatment of schizophrenia in adults after adequate prior treatment with Invega Sustenna for at least four months or Invega Trinza for at least one three‑month cycle.