Continuity of care among patients newly initiated on second-generation oral or long-acting injectable antipsychotics during a schizophrenia-related inpatient stay.

BACKGROUND: Maintaining continuity of care after schizophrenia-related hospitalization is challenging for patients and healthcare providers and systems. Prior evidence suggests that second-generation long-acting injectable antipsychotics (SGLAIs) may reduce the risk of treatment nonadherence and readmission versus oral atypical antipsychotics (OAAs). Therefore, quality measures were compared between patients initiated on SGLAIs and OAAs in the United States. METHODS: Adults newly initiated on an SGLAI or OAA during a schizophrenia-related inpatient stay were identified in HealthVerity databases (01/2015-12/2020); the index date was the hospital discharge date. Patients had continuous health insurance coverage for pharmacy and medical services for 6 months pre-admission and post-discharge from the inpatient stay and ≥1 pharmacy or medical claim (i.e. treatment as indicated by the observed insurance claims) for an antipsychotic other than the index SGLAI or OAA in the 6 months pre-admission. Antipsychotic use and adherence, and schizophrenia-related readmissions and outpatient visits were compared during the 6-month period post-discharge. Characteristics between cohorts were balanced using inverse probability weights. RESULTS: Post-discharge, only 36.9% and 40.7% of weighted SGLAI (N = 466) and OAA (N = 517) patients had ≥1 pharmacy or medical claim for the antipsychotic initiated during the inpatient stay, among whom SGLAI patients were 4.4 times more likely to be adherent to that antipsychotic compared to OAA patients (p < .001). Additionally, SGLAI patients were 2.3 and 3.0 times more likely to have a pharmacy or medical claim for and be adherent to any antipsychotic relative to OAA patients (including index antipsychotic; all p < .001). Within 7 and 30 days post-discharge, 1.7% and 13.0% of SGLAI patients and 4.1% and 12.6% of OAA patients had a readmission. Further, SGLAI patients were 51% more likely to have an outpatient visit compared to OAA patients (p = .044). CONCLUSIONS: Less than half of patients initiated on antipsychotics during a schizophrenia-related inpatient stay continued the same treatment post-discharge. However, SGLAI patients were more likely to be adherent to the initiated antipsychotic and to have an outpatient visit, which may suggest improved continuity of care post-discharge relative to OAA patients.

Projecting the economic outcomes of switching patients with schizophrenia from oral atypical antipsychotics to once-monthly, once-every-3-months, and once-every-6-months paliperidone palmitate.

BACKGROUND: Among patients with schizophrenia, nonadherence to oral atypical antipsychotics (OAAs) leads to increased risk of relapses, which entails substantial economic burden. OBJECTIVE: To evaluate the impact on health care costs and relapse rates of switching patients with schizophrenia from OAAs to once-monthly paliperidone palmitate (PP1M), with subsequent transitions to once-every-3-months (PP3M) and once-every-6-months paliperidone palmitate (PP6M). METHODS: A 36-month Markov model was developed from a Medicaid payer's perspective. Two non-mutually exclusive subpopulations of adults with schizophrenia who were nonadherent to OAAs were considered: (1) recently relapsed and (2) young adults (aged 18-35). Patients were assumed nonadherent to OAAs until switching treatments, which was permissible multiple times during the 36-month period. Patients switching to PP1M could subsequently transition to PP3M and PP6M. Relapse rates were assumed consistent across treatments based on patients' adherence. Model inputs were literature based. PP6M transition rates were assumed similar to PP3M. Cost savings were reported at the plan level and per patient switched. RESULTS: In a hypothetical health plan of 1 million Medicaid beneficiaries, an estimated 10,053 adults with schizophrenia were nonadherent to OAAs, among whom 7,454 were recently relapsed and 4,002 were young adults. Switching 5% of recently relapsed adults (N = 373) from OAAs to PP1M prior to subsequent relapse resulted in 541 relapses avoided and plan-level savings of $8.2M after 3 years. Incorporating transitions to PP3M/PP6M increased net savings to $9.1M and 631 relapses were avoided. Among young adults, switching 5% (N = 200) from OAAs to PP1M saved $1.8M at the plan level with 178 relapses avoided after 3 years. Including transitions to PP3M/PP6M, 3-year plan-level savings were $2.0M with 223 relapses avoided. Per recently relapsed patient switched to PP1M, and subsequently to PP3M/PP6M, cumulative 3-year cost savings were $22,100 and $24,300, respectively. Among young adults, corresponding 3-year cost savings per patient were $8,900 and $9,800. CONCLUSIONS: Switching nonadherent patients from OAAs to PP1M results in substantial cost savings and reduces relapse rates. Incorporating transitions to PP3M/PP6M leads to incremental cost savings and additional relapses avoided. DISCLOSURES: Financial support for this research was provided by Janssen Scientific Affairs, LLC. Ms Morrison, Ms Ghelerter, Ms Vermette-Laforme, Mr Lefebvre, and Mr Pilon are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC., which funded the development and conduct of this study and manuscript. Dr Lin and Ms Benson are employees of Janssen Scientific Affairs, LLC., and stockholders of Johnson & Johnson.

Adherence, Persistence, Readmissions, and Costs in Medicaid Members with Schizophrenia or Schizoaffective Disorder Initiating Paliperidone Palmitate Versus Switching Oral Antipsychotics: A Real-World Retrospective Investigation.

INTRODUCTION: Long-acting injectable antipsychotic agents have been suggested to improve adherence and patient outcomes in schizophrenia or schizoaffective disorder. The purpose of this study was to assess medication use patterns (i.e., medication adherence, persistence), hospital and emergency department readmissions, and total direct medical costs of Oklahoma Medicaid members with schizophrenia or schizoaffective disorder switching from an oral antipsychotic (OAP) to once-monthly paliperidone palmitate (PP1M) or to another OAP (OAP-switch). METHODS: A historical cohort analysis was conducted from 1 January 2016 to 31 December 2020 among adults aged ≥ 18 and ≤ 64 years with schizophrenia or schizoaffective disorder who were previously treated with an OAP. The first claim for PP1M or a new OAP defined the study index date. Members who transitioned from PP1M to 3-month formulation (PP3M) were included (i.e., PP1M/PP3M). Proportion of days covered (PDC), 45-day treatment gaps, 30-day readmissions to hospitals or emergency department, and total direct medical costs were assessed using multivariable, machine-learning least absolute shrinkage, and selection operator (Lasso) regressions controlling for numerous demographic, clinical, mental health, and provider characteristics. RESULTS: Among 295 Medicaid members meeting full inclusion criteria, 183 involved PP1M/PP3Ms (44 PP1M cases transitioned to PP3M) and 112 involved an OAP-switch. The multivariable-adjusted odds of readmission were significantly associated with a 45-day treatment gap (p < 0.05) and non-adherence (i.e., PDC < 80%) (p < 0.05). Relative to PP1M/PP3Ms, the multivariable analyses also indicated that OAP-switch was associated with an 18.5% lower PDC, 92.3% higher number of 45-day treatment gaps, and an approximately 90% higher odds of all-cause 30-day readmission (p < 0.05). The adjusted pre- to post-index change in cost was approximately 49% lower for OAP-switches versus PP1M/PP3Ms (p < 0.001), although unadjusted post-index costs did not differ between groups (p = 0.440). CONCLUSION: This real-world investigation of adult Medicaid members with schizophrenia or schizoaffective disorder observed improved adherence and persistence with fewer readmissions with PP1M/PP3Ms versus OAP-switches.

A 10-year mirror-image study of effectiveness and cost of long-acting paliperidone palmitate injectable in patients with schizophrenia or schizoaffective disorder.

Acute episodes of Schizophrenia and Schizoaffective Disorder often require hospitalizations and/or psychiatry emergency room (PER) visits, with significant economic burden. Long-acting injectables (LAI), such as the once-monthly Palmitate Paliperidone LAI (1MPP) are effective in suppressing symptoms and raise treatment adherence. This study is the first aimed at evaluating long-term efficacy of initiation of 1MPP. This was a mirror-image study with a total 10 year observational length. Sample was divided into five different groups according to time span of observation: 2,4,6,8, and 10 years. Number of participants per group was 162, 129, 95, 77 and 35, respectively. Main outcomes were number and length of hospitalizations and number of PER visit. Significant reductions in these outcomes after initiation of 1MPP were found in all groups. Subgroups consisting only of patients with full adherence were evaluated, and these had better outcomes. A cost evaluation was also performed, which demonstrated decreases every year, for all main outcomes. Sensitivity analysis in the 2-year group showed results in this time-frame are independent of gender, diagnosis, previous LAI or 1MPP initiation setting. Initiation of 1MPP reduces number and length of hospitalizations up to 5 years, decreasing associated costs. This study increases evidence supporting use of 1MPP in patients with Schizophrenia or Schizoaffective disorder.

Antipsychotic Adherence, Resource Use, and Costs Before and After the Initiation of Once-monthly Paliperidone Palmitate Therapy Among Medicaid Beneficiaries With Prior Schizophrenia Relapse.

PURPOSE: Patients with schizophrenia often struggle with medication adherence and may benefit from the use of a long-acting injectable antipsychotic, including once-monthly paliperidone palmitate (PP1M), which was previously demonstrated to improve outcomes compared with oral antipsychotics. This study assessed the impact of initiating PP1M therapy on medication adherence, health care resource use (HRU), and costs among Medicaid beneficiaries with schizophrenia and a prior schizophrenia relapse. METHODS: A 6-state Medicaid database (from quarter 1 of 2009 to quarter 1 of 2018) was used to identify adults with ≥2 schizophrenia diagnoses who started PP1M therapy on or after January 1, 2010. The index date was the first PP1M claim. Patients had ≥12 months of continuous Medicaid enrollment before and after the index date, ≥1 oral antipsychotic claim in the 12 months before the index date, and ≥1 relapse (proxied as a schizophrenia-related inpatient admission or emergency department [ED] visit) during the 12 months before the index date. Generalized estimating equations were used to compare adherence to antipsychotics (proportion of days covered ≥80%), HRU, and costs (reported in 2018 US dollars) in the 12 months after versus before the index date. Sensitivity analyses were conducted (1) accounting for the minimum and cumulative price inflation Medicaid rebates for pharmacy costs of branded psychiatric medications, (2) among patients with ≥2, ≥3, and ≥4 prior schizophrenia-related inpatient admissions or ED visits, (3) among patients not adherent to antipsychotic treatment before the index date, and (4) among patients switching to PP1M directly from oral risperidone or paliperidone. FINDINGS: A total of 1725 patients met the study inclusion criteria (mean age, 39.5 years; 43% female). After versus before the index date, patients were 93% more likely to be adherent to antipsychotic treatment (P < 0.01). The likelihood of inpatient admissions and ED visits decreased by 89% and 49% (all P < 0.01) after initiating PP1M therapy. The number of inpatient days decreased by 31% (P < 0.01) and the number of ED visits by 16% (P = 0.03). Pharmacy costs increased by $514 per-patient-per-month (PPPM), whereas medical costs, driven by inpatient costs, decreased by $391 PPPM (all P < 0.01). Sensitivity analyses yielded similar trends. Notably, total health care cost savings of $231 PPPM were observed after accounting for the cumulative Medicaid rebate for costs of branded psychiatric medications (P < 0.01). IMPLICATIONS: In Medicaid beneficiaries with relapsed schizophrenia, transitioning from oral antipsychotics to PP1M was associated with improved adherence to antipsychotics and decreased use of inpatient and ED services. Increased pharmacy costs after the initiation of PP1M were offset by decreased medical costs. After applying the cumulative Medicaid rebate, including the price inflation rebate for costs of branded psychiatric medications, initiation of PP1M therapy resulted in statistically significant health care cost savings.

Risk of subsequent relapses and corresponding healthcare costs among recently-relapsed Medicaid patients with schizophrenia: a real-world retrospective cohort study.

AIMS: To compare adherence, rates of subsequent schizophrenia-related relapses, healthcare resource utilization, and healthcare costs among Medicaid beneficiaries with schizophrenia who initiated once-monthly paliperidone palmitate (PP1M) versus a new oral atypical antipsychotic (OAA) following a recent schizophrenia-related relapse. METHODS: Six-state Medicaid data (01/2009-03/2018) were used to identify adults with schizophrenia initiated on PP1M or OAA (index date) within 30 days following a schizophrenia-related relapse (defined as a schizophrenia-related inpatient or emergency room visit). Patients were required to have 12 months of continuous eligibility before (baseline) and after (observation) the index date. Differences in baseline characteristics between PP1M and OAA patients were accounted for using 1:3 matching. RESULTS: After matching, characteristics were well-balanced between PP1M (N=208, mean age=39 years, 35.6% female) and OAA patients (N=624, mean age=40 years, 34.6% female). During the 12-month observation period, the mean proportion of days covered for the index medication was 41.2% in the PP1M cohort and 34.7% in the OAA cohort (p=.008). Relative to the OAA cohort, PP1M patients were 33% (p=.013) less likely to have a subsequent relapse and had 29% (p=.004) fewer all-cause inpatient admissions per-patient-per-year (PPPY). Consequently, a significant mean reduction of $6273 in medical costs PPPY (p=.028) was observed, which fully offset the $4770 (p<.001) increase in pharmacy costs PPPY and resulted in a numerical but not statistically significant, decrease in total healthcare costs of $1503 PPPY (p=.621) relative to OAA patients. CONCLUSIONS: Among patients with a recent schizophrenia-related relapse, PP1M was associated with a lower risk of subsequent relapse while remaining a cost neutral therapeutic option compared to OAAs.

Medication adherence, healthcare resource utilization, and costs among Medicaid beneficiaries with schizophrenia treated with once-monthly paliperidone palmitate or once-every-three-months paliperidone palmitate.

OBJECTIVE: Antipsychotics with reduced dosing frequency may improve adherence and clinical outcomes for patients with schizophrenia. This study compared treatment patterns, healthcare resource utilization (HRU), and costs between Medicaid beneficiaries with schizophrenia treated with once-monthly paliperidone palmitate (PP1M) and those who transitioned to once-every-three-months paliperidone palmitate (PP3M). METHODS: Adults with schizophrenia were identified in a four-state Medicaid database (18 May 2014 to 31 March 2019). The index date was the first PP3M claim (PP3M cohort), or a random PP1M claim (PP1M cohort), following ≥4 months of continuous PP1M treatment among patients with ≥12 months of continuous Medicaid enrollment pre- and post-index. Adherence (proportion of days covered by the index treatment ≥80%), persistence (no gap >90/30 days in the PP3M/PP1M supply), HRU, and costs were compared during the 12-month post-index period between cohorts matched 1:1. RESULTS: Among 2374 patients identified, 374 remained in each cohort after matching (mean age 42 years; 30.5% female). Compared to the PP1M cohort, the PP3M cohort was 2.39 times more likely to be adherent (p < .001), 4.63 times more likely to be persistent (p < .001), 33% less likely to have ≥1 hospitalization (p = .011), and 32% less likely to have ≥1 day with home care services (p = .012). Mean annual medical costs were similar between cohorts ($24,970 in the PP3M cohort and $25,736 in the PP1M cohort; p = .854). CONCLUSIONS: Medicaid beneficiaries who transitioned to PP3M had higher adherence and persistence, and a reduced likelihood of hospitalization relative to those who continued treatment with PP1M. The results suggest potential clinical value to transitioning eligible patients to PP3M.

[The pharmacoeconomic efficacy of lurasidone in the treatment of schizophrenia]. / Farmakoekonomicheskaya effektivnost' primeneniya preparata Lurazidon pri lechenii shizofrenii.

OBJECTIVE: To conduct a comprehensive pharmacoeconomic evaluation of lurasidone for the treatment of patients with schizophrenia under Russian healthcare system conditions and inclusion in EDL (Essential Drugs List) and Medication List for the Certain Categories of Citizens. MATERIAL AND METHODS: A retrospective study of lurasidone in the treatment of patients with schizophrenia was performed. Methods of pharmacoeconomic analysis were: cost analysis, budget impact analysis and cost-effectiveness analysis. RESULTS: Use of lurasidone for the treatment of patients with schizophrenia requires 50.04% less costs than the use of paliperidone and 46.69% less costs than the use of sertindole allowing to provide additional therapies to 100.1 and 87.6% of patients, respectively. The cost minimization analysis results are stable when prices fluctuate in the range of ±30%. Considering the current volume of antipsychotic drug supply, replacing 100% of paliperidone with lurasidone from the first year will reduce the cost of antipsychotics for patients who received paliperidone by 39.79 or by 360.81 million rubles over 3 years. Replacing 100% of sertindole with lurasidone from the first year will reduce the cost of antipsychotics for patients who received sertindole by 37.21 or 173.87 million rubles over 3 years. The results of the budget impact analysis are resistant to changes in prices for compared drugs in a wide range. CONCLUSION: Lurasidone is a more effective drug for treatment of schizophrenia from a pharmacoeconomic point of view in comparison with paliperidone and sertindole. With comparative efficacy with paliperidone and sertindole the use of lurasidone can significantly reduce the burden on budget of state programs of compensation for certain categories of citizens.

Health Care Cost in Patients With Schizophrenia Treated With Brexpiprazole Versus Other Oral Atypical Antipsychotic Therapy.

PURPOSE: Brexpiprazole is an oral atypical antipsychotic (OAA) for the treatment of schizophrenia (SCZ). This study compared all-cause and psychiatric inpatient hospitalization and medical costs in adult patients with SCZ newly treated with brexpiprazole versus other US Food and Drug Administration-approved OAAs in a real-world setting. METHODS: This retrospective cohort study analyzed data from: (1) the IBM MarketScan Commercial and Medicare Supplemental databases, and the MarketScan Multi-State Medicaid database; and (2) the de-identified Optum Clinformatics Datamart. Adult patients were identified if they had SCZ and initiated either brexpiprazole or another OAA during the study identification period (July 1, 2015, to September 30, 2016, for MarketScan Commercial and Medicare Supplemental and for Optum; July 1, 2015, to June 30, 2016, for MarketScan Multi-State Medicaid) and had ≥12 months of continuous enrollment before (baseline) and after (follow-up) the first treatment date. Linear regression analyses were performed to test associations between treatment groups (brexpiprazole vs another OAA) and costs (total and medical); negative binomial regression models were used to estimate number of hospitalizations per year, adjusting for baseline characteristics and medication adherence to index treatment during the 12-month follow-up. FINDINGS: The final study sample consisted of 6254 patients with SCZ: 176 initiated brexpiprazole; 391, ziprasidone; 453, paliperidone; 523, lurasidone; 786, aripiprazole; 1234, quetiapine; 1264, olanzapine; and 1427, risperidone. Controlling for baseline characteristics and medication adherence, the adjusted number of hospitalizations (both all-cause and psychiatric), all-cause total costs, and all-cause medical costs did not differ across groups. Brexpiprazole users had the lowest mean psychiatric costs among all OAA users ($12,013; 95% bootstrap CI, 7488-16,538). Compared with brexpiprazole users, paliperidone (incidence rate ratio [95% CI], 1.52 [1.05-2.19]; P = 0.027) and quetiapine (incidence rate ratio [95% CI], 1.47 [1.04-2.07]; P = 0.029) users had more psychiatric hospitalizations per year. Paliperidone had higher psychiatric costs than brexpiprazole (total, $32,066 [95% bootstrap CI, 28,779-35,353] vs $23,851 [18,907-28,795]; medical, $19,343 [16,294-22,392] vs $12,013 [7488-16,538]). Psychiatric medical costs were also $6744 higher in olanzapine users (95% bootstrap CI, 1694-11,795; P = 0.009) than in brexpiprazole users. IMPLICATIONS: Patients with SCZ treated with brexpiprazole had fewer psychiatric hospitalizations and lower psychiatric costs than those treated with paliperidone. Differences in the number of all-cause hospitalizations and medical costs among treatments were not statistically significant. Although treatment decisions are driven by a number of factors (eg, clinical circumstances and drug costs), choice of OAA may affect health care costs.

Treatment discontinuation of long-acting injectables or oral atypical antipsychotics among Medicaid recipients with schizophrenia.

Aims: Among patients with schizophrenia, poor adherence and persistence with oral atypical antipsychotics (OAA) often results in relapse and hospitalization. Second-generation antipsychotic long-acting injectables (SGA LAI) have demonstrated higher adherence than first-generation antipsychotic LAI and OAA therapies. This study aimed to determine whether SGA LAIs are associated with better persistency compared to OAA among Medicaid recipients with schizophrenia. Materials and methods: From the MarketScan Medicaid Database (January 1, 2010-June 30, 2016), patients aged ≥18 years with schizophrenia and ≥2 pharmacy claims more than 90 days apart for the same SGA LAI or OAA were selected. New users of the specific antipsychotic agent were classified, based on their index agent, as: OAA, paliperidone palmitate LAI (PPLAI), aripiprazole LAI (ALAI), and risperidone LAI (RLAI). Discontinuation during 1 year of follow-up was defined as a ≥ 60-day gap in the index OAA or SGA LAI medication past the exhaustion of the previous claim's supply. Inverse probability of treatment weights (IPTW) balanced the cohort characteristics, and weight outliers (<0.1 or >0.9) were excluded. IPTW-weighted Cox proportional hazards regression estimated hazard ratios for discontinuation. Results: Cohorts included 7,029 OAA, 4,302 PPLAI, 586 ALAI, and 1,456 RLAI patients. Mean age was 38.0-41.0 years and 44.0-46.6% were female. Persistence was significantly longer in the SGA LAI cohorts than in the OAA cohort. Adjusted hazard ratios (95% confidence intervals) for discontinuation were 0.60 (0.56-0.64) for PPLAI, 0.69 (0.60-0.79) for ALAI, and 0.70 (0.64-0.77) for RLAI vs OAA. Limitations: Results may not be generalizable to patients covered by commercial or Medicare insurance, and limitations inherent to any claims-based retrospective analysis apply. Conclusions: SGA LAI may be a valuable option for treating schizophrenia given the improvement in persistence.

Factors Associated with the Initiation of Long-Acting Injectable Paliperidone Palmitate Versus Aripiprazole Among Medicaid Patients with Schizophrenia: An Observational Study.

INTRODUCTION: Factors underlying the selection of antipsychotics for patients with schizophrenia are poorly understood. This study investigated variables associated with initiation of treatment with the long-acting injectables paliperidone palmitate (LAI-PP) and aripiprazole LAI (LAI-AP) in Medicaid patients with schizophrenia. METHODS: Adults with at least one medical or pharmacy claim for LAI-PP or LAI-AP from 1 January 2013 to 31 December 2016 were selected from the IBM® MarketScan® Medicaid Database. The date of the first LAI-PP or LAI-AP claim was the index date. Patients who had at least two medical claims, on different days, for a schizophrenia diagnosis and at least 12 months of continuous health plan enrollment prior to index date were included in the analysis. Multivariable logistic regression was performed to determine the factors associated with the initiation of LAI-PP versus LAI-AP. RESULTS: Of included patients, 5501 initiated LAI-PP and 1449 initiated LAI-AP. Patients more likely to initiate LAI-PP versus LAI-AP were older, male, or African American (all p < 0.01). Patients with obesity (odds ratio [OR] 0.84; 95% confidence interval [CI] 0.71, 0.98), post-traumatic stress disorder (OR 0.76; 95% CI 0.63, 0.92), or prior oral antipsychotic use (OR 0.66; 95% CI 0.55, 0.79) were less likely to initiate LAI-PP; whereas, patients with nonorganic psychoses (OR 1.35; 95% CI 1.18, 1.55) or prior use of other injectable antipsychotics (OR 1.26; 95% CI 1.09, 1.47) were more likely to initiate LAI-PP versus LAI-AP. Patients with at least two all-cause hospitalizations were 1.37 times more likely to initiate LAI-PP vs LAI-AP (OR 1.37; 95% CI 1.18, 1.60). CONCLUSION: Factors associated with initiating LAI-PP and LAI-AP differed. Notably, patients who initiated LAI-PP had greater prior use of medical services than LAI-AP patients. Understanding prescribing practices may help optimize treatment strategies and improve disease management. FUNDING: Janssen Scientific Affairs, LLC.

Paliperidone palmitate in short- and long-term treatment of schizophrenia.

Poor adherence to treatment remains a major problem in the management of patients with schizophrenia. In the 60s, first generation antipsychotics in depot formulation have been introduced on the market with the aim to improve adherence to therapy. However, the limited effectiveness on negative symptoms and the tendency to induce extrapyramidal side effects has limited their use. Currently there are five second-generation antipsychotic long-acting formulations and the use of these drugs has definitely changed perspective: they are no more restricted as compounds intended to improve compliance, but they can be considered first-line drugs with proven efficacy and good tolerability. In this narrative review the efficacy and tolerability of paliperidone palmitate, as well as the economic impact of the use of this particular molecule, have been evaluated in the short- and long-term treatment of schizophrenia. Taking into account the results of different studies, paliperidone, especially in his long-acting formulation, can be considered a viable and effective treatment for patients with schizophrenia, both in the short- and in the long term.

The prospective economic impact of once monthly paliperidone palmitate versus oral atypical antipsychotics in Medicaid patients with schizophrenia.

OBJECTIVES: Multiple real-world studies have reported potential cost savings associated with second-generation antipsychotic long-acting injectable therapies (SGA-LAIs), including once monthly paliperidone palmitate (PP1M). Yet, only about 12% of Medicaid patients with schizophrenia initiate SGA-LAIs, with poor adherence contributing to frequent relapse among patients on oral atypical antipsychotics (OAAs). The objective of this study was to project the economic impact when an incremental proportion of non-adherent patients with a recent relapse switched from OAAs to PP1M. METHODS: A 12 month decision-tree model was developed from a Medicaid payers' perspective. The target population was non-adherent OAA patients with a recent relapse. At equal adherence, risk of relapse was equal between PP1M and OAAs, and OAA patients remained non-adherent until treatment switch. Outcomes included number of relapses, relapse costs and pharmacy costs. RESULTS: Based on a hypothetical health plan of 1 million members, 3037 schizophrenia patients were non-adherent on OAAs with a recent relapse. Compared to continuing OAAs, switching 5% of patients (n = 152) to PP1M resulted in net schizophrenia-related cost savings of $674,975 at a plan level, $4445 per patient switched per year and $0.0562 per member per month, with a total of 92 avoided relapses over 12 months. Total annual plan level schizophrenia-related costs were $114.1 M when all patients switched to PP1M before any subsequent relapse (n = 3037), $123.4 M when patients switched to PP1M after a first subsequent relapse (n = 2631), and $127.6 M when all patients continued OAAs. Switching all patients to PP1M before any subsequent relapse averted 917 relapses, at a lower cost per patient switched ($37,559) compared to switching after a first subsequent relapse ($45,089) or continuing OAAs ($42,005). CONCLUSION: Over 12 months, pharmacy costs associated with switching patients from OAAs to PP1M were offset by reduced relapse rates and schizophrenia-related healthcare expenditures, with earlier use of PP1M projected to generate greater cost savings.

Real-world evidence of improved healthcare utilization in patients with schizophrenia or schizoaffective disorder after early treatment of paliperidone palmitate once-monthly treatment in Hong Kong.

BACKGROUND: Very few data are available to demonstrate the economic benefit of early paliperidone palmitate once-monthly long-acting injectable (PP1M) treatment in patients with schizophrenia or schizoaffective disorder. METHODS AND MATERIALS: This study has retrospectively compared the healthcare utilization and associated costs of pre- and post-PPIM treatment in 413 patients with schizophrenia or schizoaffective disorder recruited from three major public hospitals providing psychiatric services in Hong Kong. Patients were categorized into early treatment (≤3 years since diagnosis) and chronic (>3 years) groups, and also whether they were receiving polypharmacy (POP). RESULTS: It was found that patients who were started on early therapy with no POP had the most favourable outcomes. Overall results of the entire cohort, including both early and late treatments, indicate that there was a slight increase in annual in-patient days (IP) per patient and outpatient visit (OP) by 3.18 and 1.87, respectively, and a decrease in emergency room visit (ER) of 0.9 (p < 0.05). For non-polypharmacy (NP) patients receiving early PP1M therapy, there was a significant decrease in IP and ER of 21.56 (p < 0.05) and 1.15 (p < 0.05), respectively, but an increase in OP of 1.88 (p < 0.05). For patients with POP, there was an all-across increase in IP and all-across decrease in OP and ER. In monetary terms, a NP patient receiving early therapy may have an overall saving of HKD40,878 (USD5,241, 1USD = 7.8HKD) per year compared to HKD6,224 (USD798) in patients where therapy was given after 3 years. For patients with POP, there was an all-across increase in overall spending despite reductions in OP and ER. CONCLUSIONS: From the 413 patients studied, potential annual savings is higher by early administration of PPIM in patients with NP. Analysis using multivariate linear regression based on generalized estimating equations and sensitivity analysis using a linear mixed model supported the findings.

Palmitato de paliperidona para el tratamiento de pacientes con esquizofrenia / Paliperidone palmitate for the treatment of patients with schizophrenia

INTRODUCCIÓN: a) Cuadro clínico: La esquizofrenia es un trastorno mental grave caracterizado por la distorsión del pensamiento, la percepción y el afecto. Tiene una variedad de síntomas, entre los más comunes están las alucinaciones, delirios, conducta extravagante, discurso desorganizado y alteraciones de las emociones entre otros. El objetivo del tratamiento de la esquizofrenia es disminuir la sintomatología, prevenir recaídas y aumentar el funcionamiento adaptativo del paciente para que pueda integrase a la sociedad. Junto con psicoterapia, los antipsicóticos de segunda generación son los fármacos de elección para esquizofrenia, pero muchas veces se observa la poca adherencia a este tratamiento. Una alternativa a este problema, son los antipsicóticos de larga duración. b) Tecnología sanitaria: El palmitato de paliperidona (PP) es un antipsicótico atípico que está indicado para el tratamiento agudo y de mantenimiento de esquizofrenia en adultos. El PP se hidroliza a paliperidona que es el principal metabolito activo de la risperidona. Se desconoce el mecanismo de acción de la paliperidona. Sin embargo, se ha propuesto que la actividad antipsicótica es mediada a través de la combinación de antagonismo de los receptores dopaminérgicos (D2) y serotoninérgicos (5HT2A). Se trata de un inyectable intramuscular que se podría administrar mensualmente. OBJETIVO: Evaluar la eficacia y seguridad, así como documentos relacionados a la decisión de cobertura de palmitato de paliperidona para el tratamiento de pacientes con esquizofrenia. METODOLOGÍA: Se realizó una búsqueda en las principales bases de datos bibliográficas: MEDLINE (PubMed), LILACS, COCHRANE, así como en buscadores genéricos de Internet incluyendo Google Scholar y TRIPDATABASE. Se seleccionaron ensayos clínicos aleatorizados (ECAs), revisiones sistemáticas (RS) y evaluaciones económicas (EE) de la región. Adicionalmente, se hizo una búsqueda en las principales instituciones internacionales de psiquiatría y agencias de tecnologías sanitarias que realizan RS, evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC). RESULTADOS: Se seleccionaron dos RS, tres GPC y cuatro ETS. Los resultados de las RS recabadas se describen de acuerdo con el comparador (placebo, rispedirona o antipsicóticos orales). No se encontraron EE de la región. CONCLUSIONES: Existe consenso con respecto a la eficacia y seguridad de PP contra placebo. Sin embargo, no se encontró diferencia del PP frente a risperidona de acción prolongada con respecto a la frecuencia de recaídas de síntomas psicóticos. Existe evidencia disponible con respecto al PP versus antipsicóticos orales de segunda generación en los que se determina que PP presenta mayor tiempo a recaída y los dos grupos serían igual de seguros. Las GPC recabadas coinciden en recomendar antipsicóticos de acción prolongada en pacientes con esquizofrenia; tres de ellas recomiendan antipsicóticos de acción prolongada, entre ellos PP, en pacientes con esquizofrenia y con pobre adherencia al tratamiento antipsicótico, sin preferir alguno sobre otro. Todas la ETS seleccionadas no recomiendan PP en el tratamiento de pacientes con esquizofrenia.

[Cost-effectiveness analysis of aripiprazole once-monthly versus paliperidone palmitate once-monthly in the treatment of schizophrenia in France]. / Analyse coût-efficacité de l'aripiprazole injectable à libération prolongée (AILP) comparé au palmitate de palipéridone (PP) dans le traitement de la schizophrénie en France.

OBJECTIVE: The aim of the study was to estimate the cost-effectiveness ratio of aripiprazole once-monthly compared to once-monthly injectable paliperidone palmitate in the treatment of schizophrenia in France on the basis of results and data from the QUALIFY study. METHODS: Consumed resources data measured with a dedicated questionnaire and results on the quality of life scales from the QUALIFY study were combined with French standard unit costs of each collected consumed resources during QUALIFY to estimate the cost-effectiveness ratios of the two products. Multivariate sensitivity analyses were performed to test the combined impact of the different assumptions. RESULTS: Findings of the study showed greater efficacy on the quality of life (QLS) and psychiatric evaluation scales (CGI-S and CGI-I) observed in QUALIFY of aripiprazole compared with paliperidone palmitate. Findings also suggest a trend (P=0.0733) in the reduction of total costs linked to a statistical decrease (P<0,0001) in drug costs in the aripiprazole group. These findings are reinforced by the probabilistic sensitivity analyses. CONCLUSION: Aripiprazole appeared to be more cost-effective than paliperidone palmitate in the French context. Limits of this study are mainly related with the duration of the clinical trial and to assumptions on the transposability of measured consumed resources in the international clinical trial to the French healthcare system.

A comparison of treatment patterns, healthcare resource utilization, and costs among young adult Medicaid beneficiaries with schizophrenia treated with paliperidone palmitate or oral atypical antipsychotics in the US.

BACKGROUND: Much of the burden associated with schizophrenia is attributed to its early onset and chronic nature. Treatment with once monthly paliperidone palmitate (PP1M) is associated with lower healthcare utilization and better adherence as compared to oral atypical antipsychotics (OAAs). This study aimed to evaluate real-world effectiveness of PP1M and OAA therapies among US-based adult Medicaid patients with schizophrenia, overall and among young adults aged 18-35 years. METHODS: Adult patients with a diagnosis of schizophrenia and at least two claims for PP1M or OAA between January 1, 2010 and December 31, 2014 were selected from the IBM Watson Health MarketScan Medicaid Database. Treatment patterns and healthcare resource utilization and costs were compared between PP1M and OAA treatment groups following inverse probability of treatment (IPT) weighting to adjust for potential differences. Utilization and cost outcomes were estimated using OLS and weighted Poisson regression models. RESULTS: After IPT weighting, the young adult PP1M and OAA cohorts were comprised of 3,095 and 3,155 patients, respectively. PP1M patients had a higher duration of continuous treatment exposure (168.2 vs 132.5 days, p = .004) and better adherence on the index medication (proportion of days covered ≥80%: 19.0% vs 17.1%, p < .049). Young adults treated with PP1M were 37% less likely to have an all-cause inpatient admission (odds ratio [OR] = 0.63, 95% confidence interval [CI] = 0.53-0.74) and 33% less likely to have an ER visit (OR = 0.67, 95% CI = 0.55-0.81) compared to OAA young adult patients, but 27% more likely to have an all-cause outpatient office visit (OR = 1.27, 95% CI = 1.02-1.56). PP1M patients incurred significantly lower medical costs as compared to OAA patients. CONCLUSIONS: Medicaid patients with schizophrenia treated with PP1M have higher medication adherence and have fewer hospitalizations as compared to patients treated with OAAs. PP1M may lead to reduced healthcare utilization and improved clinical outcomes.

The current data on the 3-month paliperidone palmitate formulation for the treatment of schizophrenia.

INTRODUCTION: A three-month injection of paliperidone palmitate (PP3M) has been gradually introduced in the market since 2015. Recently, and due to different reasons, there is an increase in the LAIAs prescription rates, including patients in early phases of psychotic disorders. Areas covered: The following article provides an overview of the antipsychotic market before providing the reader with an overview of the efficacy and tolerability data of the 3-month paliperidone palmitate formulation for the treatment of schizophrenia. The authors take into account the current state of knowledge, as well as the needs not covered by other therapeutic tools at our disposal at this time. Expert opinion: PP3M offers a substantially longer dosing interval than other options, which may be a potential advancement to reduce nonadherence in some patients. Future research, both from randomized controlled trials and large pragmatic studies in real-world settings, will identify which subpopulation and disease stages may obtain greater benefit from this new formulation.

Adherence and economic impact of paliperidone palmitate versus oral atypical antipsychotics in a Medicare population.

Aim: To compare adherence, healthcare utilization and costs among real world, Medicare-eligible patients with schizophrenia using long-acting injectable paliperidone palmitate (PP) versus oral atypical antipsychotics. Patients & methods: Historical cohort study used Medicare Advantage claims data. Inverse probability of treatment weighting was applied to adjust for baseline differences. 12-month adherence, healthcare utilization and costs were compared. Results: Patients using PP were more adherent (proportion of days covered ≥0.8; 48.1 vs 32.6%; p < 0.001), had lower odds of hospitalization (odds ratio [OR]: 0.81; 95% CI: 0.68-0.96) and lower medical costs ($11,095; 95% CI: $10,374-11,867 vs $15,551; 95% CI: $14,584-16,583), but higher pharmacy costs ($14,787; 95% CI: $14,117-15,488 vs $5781; 95% CI: $5530-6043). Conclusion: Compared with patients using oral atypical antipsychotics, PP had lower hospitalizations and medical costs with greater medication adherence accompanied by higher pharmacy costs.