Paliperidone Palmitate (Invega Hafyera™, Invega Trinza®, Invega Sustenna®)

Medical Administration - injectable (allowed under the pharmacy benefit if administered by a pharmacist at a pharmacy)

Indications for Prior Authorization:

Invega Hafyera

  • Indicated for the treatment of schizophrenia in adults after they have been adequately treated with:
    • A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., Invega Sustenna®) for at least four months, or
    • An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., Invega Trinza®) for at least one three-month cycle.

Invega Trinza®

  • Indicated for the treatment of schizophrenia in patients after they have been adequately treated with Invega Sustenna® (1-month paliperidone palmitate extended-release injectable suspension) for at least four months

Invega Sustenna®

  • Indicated for the treatment of:
    • Schizophrenia in adults
    • Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants
Coverage Criteria:

Invega Hafyera

For diagnosis of schizophrenia:

  • Dose does not exceed 1,560 mg once every 6 months, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a psychiatrist, AND
  • The patient has tried one of the following:
    • Invega Sustenna® for at least 4 months
    • Invega Trinza® for at least one 3-month cycle, AND
  • Documentation is provided confirming Invega Hafyera™ will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)

Invega Trinza®

For diagnosis of schizophrenia:

  • Dose does not exceed 819 mg once every 3 months, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a psychiatrist, AND
  • The patient has tried Invega Sustenna® for at least 4 months, AND
  • Documentation is provided confirming Invega Trinza® will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)

Invega Sustenna®

For diagnosis of schizophrenia or schizoaffective disorder:

  • Dose does not exceed an initial dose of 234 mg on treatment day 1 and 156 mg one week later, followed by a monthly maintenance dose of up to 234 mg, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a psychiatrist, AND
  • Documentation is provided confirming Invega Sustenna® will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)
Reauthorization Criteria:

Invega Hafyera or Invega Trinza®

For diagnosis of schizophrenia:

  • Dose does not exceed
    • Invega Hafyera™: 1,560 mg once every 6 months
    • Invega Trinza®: 819 mg once every 3 months, AND
  • Prescribed by or in consultation with a psychiatrist, AND
  • Documentation is provided confirming the product will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)

Invega Sustenna®

For diagnosis of schizophrenia or schizoaffective disorder:

  • Dose does not exceed 234 mg once every month, AND
  • Prescribed by or in consultation with a psychiatrist, AND
  • Documentation is provided confirming the product will be administered at a specific pharmacy by a health care professional (pharmacy name and location are required)
Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • If Invega Hafyera™, Invega Trinza® or Invega Sustenna® will not be administered at a pharmacy by a healthcare professional then the request should be submitted to the member’s medical plan for coverage consideration.
  • Invega Hafyera™, Invega Trinza® or Invega Sustenna® is to be prepared and administered by a healthcare provider only.
  • Invega Sustenna®: It is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with Invega Sustenna®.
  • Invega Hafyera™: Dosing window: To avoid a missed dose, patients may be given the injection up to 2 weeks before or 3 weeks after the scheduled 6-month dose.
  • Invega Hafyera™, Invega Trinza® and Invega Sustenna® are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients.
  • Warnings and precautions include the following:
    • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
    • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
    • Neuroleptic Malignant Syndrome
    • QT Prolongation
    • Tardive Dyskinesia
    • Metabolic Changes
    • Orthostatic Hypotension and Syncope
    • Falls
    • Leukopenia, Neutropenia, and Agranulocytosis
    • Hyperprolactinemia
    • Potential for Cognitive and Motor Impairment
    • Seizures
    • Dysphagia
    • Priapism
    • Disruption of Body Temperature Regulation
Policy Updates:
  • 02/15/2022 – New policy approved by P&T.
References:
  • Invega Hafyera prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. October 2021.
  • Invega Sustenna prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. August 2021.
  • Invega Trinza prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. August 2021.

 

Last review date: February 15, 2022