CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Coverage and prior authorization criteria for Invega Sustenna, Invega Trinza, and Invega Hafyera

Coverage and prior authorization criteria for Invega Sustenna, Invega Trinza, and Invega Hafyera for members in the Medicaid scope of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCoverage and prior authorization criteria for Invega Sustenna, Invega Trinza, and Invega Hafyera

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date6/2017

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months when the drug-specific clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period when criteria met

Sustenna ≥4 mostabilization prerequisite before Trinza or Hafyera

1 syringe/180dquantity limit for Hafyera

1 syringe/90dquantity limit for Trinza

Coverage and Medical Necessity Criteria

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Invega Hafyera 6 Initial Coverage Criteria

Covered when ALL of the following are met for Invega Hafyera (authorization up to 12 months):

Hafyera criteria: A. The requested drug is being prescribed for the treatment of schizophrenia

Hafyera prior treatment: B. The member has been adequately treated with Invega Sustenna for at least four months or Invega Trinza for at least one three-month cycle

Invega Sustenna 6 Initial Coverage Criteria

Covered when ALL of the following are met for Invega Sustenna (authorization up to 12 months):

Sustenna tolerability: A. Tolerability with oral paliperidone or oral risperidone has been established

Sustenna indication: B. The requested drug is being prescribed for the treatment of schizophrenia in adults or schizoaffective disorder in adults as monotherapy or adjunct to mood stabilizers/antidepressants

Invega Trinza 6 Initial Coverage Criteria

Covered when ALL of the following are met for Invega Trinza (authorization up to 12 months):

Trinza indication: A. The requested drug is being prescribed for the treatment of schizophrenia

Trinza prior treatment: B. The member has been adequately treated with Invega Sustenna for at least four months

All other indications for paliperidone long‑acting injectable formulations are considered experimental/investigational and are not a covered benefit.

Authorization, Documentation, and Step-Therapy Requirements

Prior Authorization

12‑month prior authorization when criteria met

When the drug-specific clinical criteria are met for Invega Hafyera, Invega Sustenna, or Invega Trinza, prior authorization may be granted for a 12-month period. See each product's criteria for the required indication and prior-treatment/stabilization conditions that must be satisfied to authorize 12 months.

Step Therapy

Step therapy / stabilization prerequisites

Members must be stabilized on the shorter-interval paliperidone formulation before receiving longer-interval products: specifically, Invega Trinza requires prior stabilization on Invega Sustenna for at least four months; Hafyera requires prior treatment with Sustenna ≥4 months or Trinza for one three‑month cycle.

Trinza: member must have been adequately treated with Invega Sustenna for at least four months [[citation provided above]].
Hafyera: member must have been adequately treated with Invega Sustenna for at least four months or Invega Trinza for at least one three‑month cycle.

Documentation Required

Prior treatment documentation

Documentation submitted with requests must demonstrate the required prior treatment or stabilization on the specified antecedent paliperidone product per the drug-specific criteria (e.g., tolerability established on oral paliperidone/risperidone before Sustenna; ≥4 months Sustenna before Trinza; Sustenna ≥4 months or Trinza one 3‑month cycle before Hafyera).

For Sustenna: record showing tolerability with oral paliperidone or oral risperidone prior to initiating Sustenna.
For Trinza: documentation that the member was adequately treated with Sustenna for ≥4 months.
For Hafyera: documentation that the member was adequately treated with Sustenna ≥4 months or Trinza for one 3‑month cycle.

Denial Risk

Non‑approved indications — denial risk

Requests for indications other than the specified/approved uses are considered experimental/investigational and are not a covered benefit; such requests risk denial.

Coverage is limited to the indicated uses (e.g., treatment of schizophrenia; Sustenna also for schizoaffective disorder as specified).
All other indications are considered experimental/investigational and will not be covered.

Key Definitions and Clinical Terms

inv-10: Adequately treated / stabilized

DefinitionAdequately treated / stabilized means the member has completed the specified prior paliperidone long-acting injectable regimen: at least 4 months of once-monthly Invega Sustenna or at least one 3-month cycle of Invega Trinza before initiating Invega Hafyera.

Required prior regimen for TrinzaInvega Trinza requires prior stabilization on Invega Sustenna (1-month formulation) for at least 4 months before Trinza may be used.

Required prior regimen for HafyeraInvega Hafyera requires prior stabilization with either Invega Sustenna for ≥4 months or Invega Trinza for at least one 3-month cycle.

PurposeThese stabilization requirements apply to transitions to longer-interval paliperidone injectable formulations to ensure treatment continuity and appropriateness of therapy.

inv-11: Tolerability established

DefinitionTolerability established requires documented tolerability with oral paliperidone or oral risperidone prior to initiating Invega Sustenna.

TimingTolerability must be confirmed before the first dose of the long-acting injectable (Invega Sustenna) is administered.

Acceptable agentsOral paliperidone or oral risperidone are the specified agents for establishing tolerability per policy criteria.

ScopeThis requirement is part of the initial coverage criteria for Invega Sustenna and must be met for authorization (up to 12 months when criteria are satisfied).