paliperidone palmitate (Invega Hafyera, Invega Trinza, Invega Sustenna)

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.