Coverage Policy Manual
Policy #: 2016021
Category: Pharmacy
Initiated: August 2016
Last Review: August 2018
  Paliperidone Palmitate (Long-acting Injectables Invega Sustenna ┬« & Invega Trinza)

Description:
Paliperidone palmitate is the primary active metabolite of the older antipsychotic risperidone.  Paliperidone palmitate (trade name Invega), also known as 9-hydroxyrisperidone, is a dopamine antagonist and 5-HT2A antagonist of the atypical antipsychotic class of medications.  Paliperidone palmitate is also active as an antagonist at alpha 1 and alpha 2 adrenergic receptors and H1 histaminergic receptors, which may explain some of the other effects of the drug. Paliperidone palmitate was approved by the FDA for treatment of schizophrenia on December 20, 2006. Invega is an extended release formulation of paliperidone palmitate that uses the OROS extended release system to allow for once-daily dosing developed by Janssen Pharmaceutical.
 
Paliperidone palmitate (trade name Invega Sustenna, named Xeplion in Europe and other countries) is a long-acting injectable formulation of paliperidone palmitoyl ester indicated for once-monthly injection after an initial titration period with an oral form of paliperidone.
 
A new formulation of paliperidone palmitate was approved the FDA on May 18, 2015 under the brand name of Invega Trinza as an extended-release injectable suspension for 3 months as indicated for 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.

Policy/
Coverage:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The use of long-acting injectable paliperidone palmitate (Invega Sustenna) as a monthly formulation meets member benefit certificate primary coverage criteria for the treatment of schizophrenia when the below criteria are met:
      • Documentation of tolerability has been established with oral paliperidone or oral risperidone; AND
      • The member has a history of noncompliance with oral antipsychotics resulting in decompensation, or a rationale is provided indicating why the member requires an injection approach; AND
      • Member is at least 18 years of age; AND
      • Dosage, frequency, and dose initiation conversions between different formulations are within the FDA-approved range
 
NOTE:  Initial coverage duration will be for 12 months.  Additional coverage after each 12 months period will require documentation indicating the patient has clinically benefited from treatment and remained compliant.
 
The use of long-acting injectable paliperidone palmitate as a 3 month formulation meets member benefit certificate primary coverage criteria for the treatment of schizophrenia when the below criteria are met:
      • Documentation of tolerability to a 1 month formulation of long-acting paliperidone extended-release injectable for at least 4 months; AND
      • The member has a history of noncompliance with oral antipsychotics resulting in decompensation, or a rationale is provided indicating why the member requires an injection approach; AND
      • Member is at least 18 years of age; AND
      • Dosage, frequency, and dose initiation conversions between different formulations must be within the FDA-approved range.
 
NOTE:  Initial coverage duration will be for 12 months.  Additional coverage after each 12 months period will require documentation indicating the patient has clinically benefited from treatment and remained compliant.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of long-acting injectable paliperidone palmitate for any other indication than those listed above does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria the use of long-acting injectable paliperidone palmitate for any other indication than those listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
Alphs et al published a multicenter  15-month clinical trial of 450 patients with schizophrenia, who had been taken into custody by the criminal justice system at least two times in the previous two years, randomly assigned them to open-label treatment with paliperidone-LAI or one of seven daily oral antipsychotics. The primary end point was time to treatment failure, which included arrest/incarceration, psychiatric hospitalization, suicide, inadequate efficacy, discontinuation due to tolerability, or increased services to prevent imminent hospitalization. After 15 months, fewer subjects receiving paliperidone-LAI experienced treatment failure compared to patients receiving oral antipsychotics (39.8 versus 53.7 percent). Median time to first treatment failure was longer for paliperidone-LAI compared oral antipsychotics (416 versus 226 days). The most common reasons for treatment failure were arrest/incarceration and psychiatric hospitalization. No differences were seen between groups on measures of social functioning or severity of illness. Patients taking paliperidone-LAI were more likely to experience extrapyramidal symptoms, weight gain, and prolactin elevation compared with patients taking oral antipsychotic drugs. Medication adherence rates, to the extent that they could be measured or estimated, were higher in the paliperidone-LAI compared with oral antipsychotics as measured by prescriptions or pharmacy refills (95.2 versus 77.2 or 24.3 percent).
 
2018 Update
A literature search conducted using the MEDLINE database did not reveal any new
literature that would prompt a change in the coverage statement.
 
 2017 Update
A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.

CPT/HCPCS:
J2426Injection, paliperidone palmitate extended release, 1 mg

References: Alphs L, Benson C, Cheshire-Kinney K, et al.(2015) Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study J Clin Psychiatry. 2015 May;76(5):554-61.

FDA Full Prescribing Information.(2016) Invega Sustenna. Accessed at http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022264s019lbl.pdf. Last accessed Aug. 26, 2016.

FDA Full Prescribing Information.(2016) Invega Trinza. Accessed at http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207946s001lbl.pdf. Last accessed Aug 26, 2016.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.