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| Paliperidone Palmitate (e.g., Long-acting Injectables Invega Sustenna & Invega Trinza, Erzofri) | |
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| Description: |
The policy applies to the following medications: Paliperidone Palmitate (e.g., Long-acting Injectables Invega Sustenna & Invega Trinza, Erzofri).
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Policy/ Coverage: |
Prior Approval is required for paliperidone palmitate until May 19, 2026.
Effective May 20, 2026, palidperidone palmitate will no longer require Prior Approval.
INITIAL AND CONTINUATION APPROVAL will be for duration of treatment course or 12 months (whichever comes first). Approval timeframes may differ for members/participants of Self-Insured plans.
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Paliperidone Palmitate (e.g., Long-acting Injectables Invega Sustenna & Invega Trinza, Erzofri) meets member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes or for members with contracts without Primary Coverage Criteria, is considered
Medically Necessary and is covered when the following criteria are met:
Initial Approval and Continuation of Therapy:
Member receives a “recommended” determination from InterQual criteria review for Paliperidone Palmitate (e.g., Long-acting Injectables Invega Sustenna & Invega Trinza, Erzofri) based on diagnosis and requested product. Click the following link to view the InterQual® criteria:
https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc
Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria
Paliperidone Palmitate (e.g., Long-acting Injectables Invega Sustenna & Invega Trinza, Erzofri) does not meet member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered for any indication or circumstance not described above.
For contracts without Primary Coverage Criteria,
Paliperidone Palmitate (e.g., Long-acting Injectables Invega Sustenna & Invega Trinza, Erzofri) is considered
not Medically Necessary and is not covered or is investigational
for any indication or circumstance not described above. Not Medically Necessary or
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Please refer to a separate policy on Maximum Dosage and Frequency (policy #2025031) for pharmacologic/biologic medications.
Effective November 1, 2025 to February 10, 2026
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Long-acting injectable paliperidone palmitate (e.g., Invega Sustenna, Erzofri) as a
monthly formulation meets member benefit certificate primary coverage criteria for the treatment of:
INITIAL APPROVAL
Long-acting injectable paliperidone palmitate (e.g., Invega Trinza) as a
3-month formulation meets member benefit certificate primary coverage criteria for the treatment of adults with schizophrenia when the below criteria are met:
INITIAL APPROVAL
CONTINUATION OF THERAPY
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Long-acting injectable paliperidone palmitate for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For individuals with contracts without primary coverage criteria, long-acting injectable paliperidone palmitate for any indication or circumstance not described above is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of Invega Sustenna is not FDA approved for dementia-related psychosis and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For individuals with contracts without primary coverage criteria the use Invega Sustenna is not FDA approved for dementia related psychosis and is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
DOSAGE AND ADMINISTRATION
For FDA labeled indications, Paliperidone Palmitate (e.g., Long-acting Injectables Invega Sustenna, Invega Trinza, Erzofri) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified below.
Paliperidone palmitate (e.g., Invega Sustenna)
Paliperidone palmitate (e.g., Erzofri)
Paliperidone palmitate (e.g., Invega Trinza)
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
NOTE: Initial coverage duration will be for 12 months. Additional coverage after each 12 months period will require documentation indicating the individual has clinically benefited from treatment and remained compliant.
Effective March 19, 2025 to October 31, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of long-acting injectable paliperidone palmitate (e.g., Invega Sustenna, Erzofri) as a
monthly formulation meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of:
For FDA labeled indications, long-acting injectable paliperidone palmitate (e.g., Invega Sustenna, Erzofri) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUATION APPROVAL for 12 months:
The use of long-acting injectable paliperidone palmitate (e.g., Invega Trinza) as a
3-month formulation meets member benefit certificate primary coverage criteria for the treatment that there be scientific evidence of effectiveness in improving health outcomes of adults with schizophrenia when the below criteria are met:
For FDA labeled indications, long-acting injectable paliperidone palmitate (e.g., Invega Trinza) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.
INITIAL APPROVAL STANDARD REVIEW
for up to 12 months:
CONTINUATION APPROVAL for 12 months:
Dosage and Administration
Dosing per FDA Guidelines unless otherwise specified below.
Paliperidone palmitate (e.g., Invega Sustenna)
Paliperidone palmitate (e.g., Erzofri)
Paliperidone palmitate (e.g., Invega Trinza)
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
NOTE: Initial coverage duration will be for 12 months. Additional coverage after each 12 months period will require documentation indicating the individual has clinically benefited from treatment and remained compliant.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Long-acting injectable paliperidone palmitate for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For individuals with contracts without primary coverage criteria, long-acting injectable paliperidone palmitate for any indication or circumstance not described above is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of Invega Sustenna is not FDA approved for dementia-related psychosis and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For individuals with contracts without primary coverage criteria the use Invega Sustenna is not FDA approved for dementia related psychosis and is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective August 2023 to March 18, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of long-acting injectable paliperidone palmitate (e.g., Invega Sustenna) as a
monthly formulation meets member benefit certificate primary coverage criteria for the treatment of:
INITIAL APPROVAL STANDARD REVIEW for up to 12 months when the below criteria are met:
The use of long-acting injectable paliperidone palmitate (e.g., Invega Trinza) as a
3-month formulation meets member benefit certificate primary coverage criteria for the treatment of adults with schizophrenia when the below criteria are met:
INITIAL APPROVAL for up to 12 months:
CONTINUATION OF THERAPY for 12 months:
Dosage and Administration
Dosing per FDA Guidelines
Paliperidone palmitate (e.g., Invega Sustenna)
Paliperidone palmitate (e.g., Invega Trinza)
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
NOTE: Initial coverage duration will be for 12 months. Additional coverage after each 12 months period will require documentation indicating the individual has clinically benefited from treatment and remained compliant.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Long-acting injectable paliperidone palmitate for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For individuals with contracts without primary coverage criteria, long-acting injectable paliperidone palmitate for any indication or circumstance not described above is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of Invega Sustenna is not FDA approved for dementia-related psychosis and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For individuals with contracts without primary coverage criteria the use Invega Sustenna is not FDA approved for dementia related psychosis and is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective August 2022 to July 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of long-acting injectable paliperidone palmitate (e.g., Invega Sustenna) as a
monthly formulation meets member benefit certificate primary coverage criteria for the treatment of:
INITIAL APPROVAL STANDARD REVIEW for up to 12 months when the below criteria are met:
The use of long-acting injectable paliperidone palmitate (e.g., Invega Trinza) as a
3-month formulation meets member benefit certificate primary coverage criteria for the treatment of adults with schizophrenia when the below criteria are met:
INITIAL APPROVAL for up to 12 months:
CONTINUATION OF THERAPY for 12 months:
Dosage and Administration
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
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 that there be scientific evidence of effectiveness.
For individuals 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.
The use of Invega Sustenna is not FDA approved for dementia-related psychosis and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For individuals with contracts without primary coverage criteria the use Invega Sustenna is not FDA approved for dementia related psychosis and is considered
investigational.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective April 1, 2022 to July 2022
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:
INITIAL APPROVAL STANDARD REVIEW for up to 12 months when the below criteria are met:
The use of long-acting injectable paliperidone palmitate (Invega Trinza) as a
3 month formulation meets member benefit certificate primary coverage criteria for the treatment of adults with schizophrenia when the below criteria are met:
INITIAL APPROVAL for up to 12 months:
CONTINUATION OF THERAPY for 12 months:
1. Member meets criteria for initial approval based on indication.
2. Member has experienced a positive clinical response to paliperidone palmitate.
3. Dosed in accordance with FDA labeling.
Dosage and Administration
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
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 that there be scientific evidence of effectiveness.
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.
The use of Invega Sustenna is not FDA approved for dementia-related psychosis and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria the use Invega Sustenna is not FDA approved for dementia related psychosis and is considered
investigational.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective August 2020 to March 31, 2022
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:
when the below criteria are met:
The use of long-acting injectable paliperidone palmitate (Invega Trinza) as a
3 month formulation meets member benefit certificate primary coverage criteria for the treatment of adults with schizophrenia when the below criteria are met:
Dosage and Administration
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
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 that there be scientific evidence of effectiveness.
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.
The use of Invega Sustenna is not FDA approved for dementia-related psychosis and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria the use Invega Sustenna is not FDA approved for dementia related psychosis and is considered
investigational.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective 8/26/2016 to July 2019
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:
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:
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.
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| Rationale: |
After full review and evaluation, the InterQual® Criteria has been adopted in part as Coverage Policy.
InterQual® Criteria may be adopted in part and customized to reflect differences in interpretation of or new evidence found in the current published evidence from peer-reviewed, published literature in recognized medical journals from PubMed or as a result of the review of information from the Agency for Healthcare Research and Quality (AHRQ), the Cochrane Library, FDA Drug Prescribing Information, evidence-based national physician specialty societies and associations specialty society guidelines, National Institute of Health and Care Excellence (NICE), appropriate government regulatory bodies including state and federal laws, input from external clinical experts and other evidentiary sources.
InterQual® Criteria are derived from the systematic, continuous review and critical appraisal of the most current evidence-based literature and include input from independent panel of clinical experts. To generate the most appropriate recommendations, a comprehensive literature review of the clinical evidence was conducted. Sources searched included PubMed, Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Reviews, AHRQ Technology Assessments, the Cochrane Library, Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations, FDA Drug Prescribing Information, and the National Institute of Health and Care Excellence (NICE). Other medical literature databases, medical content providers, data sources, regulatory body websites, and specialty society resources may also have been used. Relevant studies were assessed for risk of bias following principles described in the Cochrane Handbook. The resulting evidence was assessed for consistency, directness, precision, effect size, and publication bias. Observational trials were also evaluated for the presence of a dose-response gradient and the likely effect of plausible confounders.
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.
2019 Update
A literature search conducted through July 2019 did not reveal any new information that would prompt a change in the coverage statement.
2020 Update
Data from two multinational, double-blind (DB), randomized, controlled phase 3 studies including patients with schizophrenia (DSM-IV-TR) previously stabilized on paliperidone palmitate (PP1M/PP3M) (open-label [OL] phase) was analyzed for efficacy and safety. Patients were randomized to PP3M or PP1M (noninferiority study A) and PP3M or placebo (study B) in DB phase. The subgroup analysis included Latin American (Argentina, Brazil, Colombia, Mexico) patients. Primary efficacy endpoints were relapse-free rates (study A) and time-to-relapse (study B).
In study A, 63/71 (88.7%) and in study B 38/43 (88.4%) Latin American patients completed the DB phase. In study A, relapse-free percentage was similar in Latin America (PP3M: 97%, PP1M: 100%) and ROW (PP3M: 91%, PP1M: 89%). In study B, median time-to-relapse was not estimable in the Latin American subgroup for either placebo or PP3M groups, nor for the ROW PP3M group; the median time-to-relapse in the ROW placebo group was 395 days. Caregiver burden improved in patients switching from oral antipsychotics (OL baseline) to PP3M/PP1M in DB phase (Involvement Evaluation Questionnaire score mean ± SD change, -9.4±15.16; p < 0.001). Treatment emergent adverse events with PP3M during DB phase were similar in Latin America (study A: 24/34 [70.6%]; study B: 15/21 [71.4%]) and ROW (study A: 318/470 [67.7%]; study B: 84/139 [60.4%]) subgroups.
PP3M was efficacious and showed no new safety concerns in patients with schizophrenia from Latin America, corroborating ROW findings. (Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B., 2019)
2021 Update
A double-blind, parallel-group, multicenter, phase-3 study was designed to test the noninferiority of paliperidone palmitate 3-month formulation (PP3M) to the currently marketed 1-month formulation (PP1M) in patients (age 18-70 years) with schizophrenia, previously stabilized on PP1M.
After screening (≤3 weeks) and a 17-week, flexible-dosed, open-label phase (PP1M: day 1 [150mg eq. deltoid], day 8 [100mg eq. deltoid.], weeks 5, 9, and 13 [50, 75, 100, or 150mg eq., deltoid/gluteal]), clinically stable patients were randomized (1:1) to PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal) or PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal) for a 48-week double-blind phase.
Overall, 1016/1429 open-label patients entered the double-blind phase (PP3M: n=504; PP1M: n=512) and 842 completed it (including patients with relapse). PP3M was noninferior to PP1M: relapse rates were similar in both groups (PP3M: n=37, 8%; PP1M: n=45, 9%; difference in relapse-free rate: 1.2% [95% CI:-2.7%; 5.1%]) based on Kaplan-Meier estimates (primary efficacy). Secondary endpoint results (changes from double-blind baseline in positive and negative symptom score total and subscale scores, Clinical Global Impression-Severity, and Personal and Social Performance scores) were consistent with primary endpoint results. No clinically relevant differences were observed in pharmacokinetic exposures between PP3M and PP1M. Both groups had similar tolerability profiles; increased weight was the most common treatment-emergent adverse event (double-blind phase; 21% each). No new safety signals were detected.
Taken together, PP3M with its 3-month dosing interval is a unique option for relapse prevention in schizophrenia. (Savitz AJ, Xu H, Gopal S, et.al., 2016)
An analysis of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study
(NCT01157351) compared outcomes after administration of once-monthly paliperidone palmitate (PP) vs conventional oral antipsychotics (COAs) or atypical oral antipsychotics (AOAs).
PRIDE was a 15-month study of 444 individuals with schizophrenia and a history of incarceration. They were randomly assigned to PP or to 1 of 7 commonly prescribed OAs. Primary endpoint was time to first treatment failure (TF). Event-free probabilities were estimated using the Kaplan-Meier method; treatment group differences (PP vs COAs, PP vs AOAs, and PP vs oral paliperidone/risperidone) were assessed using a log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional hazards regression models. No adjustment was made for multiplicity.
Compared with PP, risk for first TF was 34% higher with COAs (HR: 1.34; 95% CI: 0.80-2.25), 41% higher with AOAs (HR: 1.41; 95% CI: 1.06-1.88), and 39% higher with paliperidone/risperidone (HR: 1.39; 95% CI: 0.97-1.99). Incidences of extrapyramidal symptom-related adverse events (AEs) were 45.7%, 13.7%, and 10.6% in the COA, AOA, and oral paliperidone/risperidone groups vs 23.9% in the PP group. Incidences of prolactin-related AEs were 5.7%, 3.8%, and 3.5% vs 23.5%, and incidences of
≥7% weight increase were 11.4%, 14.9%, and 16.0% vs 32.4%.
Results suggest a lower risk of TF but a higher rate of some AEs after treatment with PP vs COAs, AOAs, and paliperidone/risperidone. Deselection of specific OAs and low patient-compliance rates with OAs likely biased the safety results. (Kim E, Correll CU, Mao L, et.al., 2016)
A study aimed to explore the safety, tolerability, and treatment response of paliperidone palmitate once-monthly in non-acute but symptomatic adult patients switched from previously unsuccessful monotherapy with frequently used oral atypical antipsychotics.
This was a post hoc analysis of a prospective, interventional, single-arm, international, multicenter, open-label, 6-month study.
The patients (N = 472) were switched to paliperidone palmitate once-monthly (PP1M) from daily oral treatment with either aripiprazole (n = 46), olanzapine (n = 87), paliperidone extended-release (n = 104), quetiapine (n = 44), or risperidone (n = 191). In all groups, mean Positive and Negative Syndrome Scale total (p < 0.0001) and Clinical Global Impression-Severity scores improved significantly (p = 0.0004 to p < 0.0001). An improvement of
≥50 % in the Positive and Negative Syndrome Scale total score was observed in 21.7 % (aripiprazole), 29.9 % (olanzapine), 29.8 % (paliperidone extended-release), 27.3 % (quetiapine), and 37.2 % (risperidone) of patients. The patients showed significant improvements in the Personal and Social Performance score (aripiprazole p = 0.0409, all others p
≤ 0.0015); Mini International Classification of Functionality, Disability and Health Rating for Activity and Participation Disorders in Psychological Illnesses total scores (all p < 0.01); and Treatment Satisfaction Questionnaire for Medication Global Satisfaction score (olanzapine and risperidone p < 0.0001, quetiapine p = 0.0465, paliperidone extended-release p = 0.0571, aripiprazole p = NS). Paliperidone palmitate once-monthly was well tolerated, presenting no new safety signals.
These data illustrate that stable, non-acute but symptomatic patients on oral antipsychotic monotherapy may show clinically meaningful improvement of symptoms, functioning, and treatment satisfaction after direct transition to PP1M. The findings are limited by the naturalistic study design; thus, further studies are required to confirm the current findings. (Schreiner A, Caspi A, Bergmans P, et.al., 2016)
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2024. No new literature was identified that would prompt a change in the coverage statement.
March 2025 Update
The safety of ERZOFRI for the treatment of schizophrenia in adults and schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants is based upon adequate and well-controlled studies of another once-a-month paliperidone palmitate extended-release injectable suspension (also referred to as “PP1M”). The data described are derived from a clinical trial database consisting of a total of 3,817 individuals (approximately 1,705 patient-years exposure) with schizophrenia who received at least one dose of PP1M in the recommended dose range of 39 mg to 234 mg and a total of 510 individuals with schizophrenia who received placebo. Among the 3,817 PP1M-treated individuals, 1,293 received PP1M in four fixed-dose, double- blind, placebo-controlled trials (one 9-week and three 13-week studies), 849 received PP1M in the maintenance trial (median exposure 229 days during the initial 33-week open-label phase of this study, of whom 205 continued to receive PP1M during the double-blind placebo-controlled phase of this study [median exposure 171 days]), and 1,675 received PP1M in five non-placebo controlled trials (three noninferiority active- comparator trials, one long-term open-label pharmacokinetic and safety study, and an injection site [deltoid-gluteal] cross-over trial). One of the 13-week studies included a 234 mg PP1M initiation dose followed by treatment with either 39 mg, 156 mg, or 234 mg every 4 weeks. (Erzofri, 2024)
The safety of PP1M was also evaluated in a 15-month, long-term study comparing the other PP1M to selected oral antipsychotic therapies in adult individuals with schizophrenia. A total of 226 individuals received PP1M during the 15-month, open-label period of this study; 218 individuals received selected oral antipsychotic therapies. The safety of PP1M was similar to that seen in previous double-blind, placebo-controlled clinical trials in adult individuals with schizophrenia. The safety of PP1M was also evaluated in a long-term study in adult individuals with schizoaffective disorder. A total of 667 individuals PP1M during the initial 25-week open-label period of this study (median exposure 147 days); 164 individuals continued to receive PP1M during the 15-month double-blind placebo-controlled period of this study (median exposure 446 days). Adverse reactions that occurred more frequently in the PP1M group than the placebo group (a 2% difference or more between groups) were weight increased, nasopharyngitis, headache, hyperprolactinemia, and pyrexia. (Erzofri, 2024)
2025 Update
The safety of ERZOFRI for the treatment of schizophrenia in adults and schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants is based upon adequate and well-controlled studies of another once-a-month paliperidone palmitate extended-release injectable suspension (also referred to as “PP1M”). The data described are derived from a clinical trial database consisting of a total of 3,817 individuals (approximately 1,705 patient-years exposure) with schizophrenia who received at least one dose of PP1M in the recommended dose range of 39 mg to 234 mg and a total of 510 individuals with schizophrenia who received placebo. Among the 3,817 PP1M-treated individuals, 1,293 received PP1M in four fixed-dose, double- blind, placebo-controlled trials (one 9-week and three 13-week studies), 849 received PP1M in the maintenance trial (median exposure 229 days during the initial 33-week open-label phase of this study, of whom 205 continued to receive PP1M during the double-blind placebo-controlled phase of this study [median exposure 171 days]), and 1,675 received PP1M in five non-placebo controlled trials (three noninferiority active- comparator trials, one long-term open-label pharmacokinetic and safety study, and an injection site [deltoid-gluteal] cross-over trial). One of the 13-week studies included a 234 mg PP1M initiation dose followed by treatment with either 39 mg, 156 mg, or 234 mg every 4 weeks.
The safety of PP1M was also evaluated in a 15-month, long-term study comparing the other PP1M to selected oral antipsychotic therapies in adult individuals with schizophrenia. A total of 226 individuals received PP1M during the 15-month, open-label period of this study; 218 individuals received selected oral antipsychotic therapies. The safety of PP1M was similar to that seen in previous double-blind, placebo-controlled clinical trials in adult individuals with schizophrenia. The safety of PP1M was also evaluated in a long-term study in adult individuals with schizoaffective disorder. A total of 667 individuals PP1M during the initial 25-week open-label period of this study (median exposure 147 days); 164 individuals continued to receive PP1M during the 15-month double-blind placebo-controlled period of this study (median exposure 446 days). Adverse reactions that occurred more frequently in the PP1M group than the placebo group (a 2% difference or more between groups) were weight increased, nasopharyngitis, headache, hyperprolactinemia, and pyrexia.
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| References: |
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