https://orcid.org/0000-0002-9567-6139
Abstract
Purpose
Relapse and treatment adherence to paliperidone palmitate once-monthly (PP1M) and three-monthly (PP3M) formulations in patients with schizophrenia were evaluated and compared using health claims data.
Patients and Methods
Data (June 2015─June 2018) obtained from the MarketScan® Multi-State Medicaid Database were retrospectively analyzed. Patients aged ≥18 years with ≥1 claim for schizophrenia diagnosis prior to and/or at index date (i.e., date of first PP3M prescription record for PP3M patients and same month/year as the matched PP3M patients for PP1M patients) and continuous enrollment in the insurance plan for ≥12 months prior to index date (baseline) were included. PP1M cohort included patients who received ≥4 PP1M doses. PP3M patients were matched with PP1M patients (1:3) using propensity score matching and prevalent new user design. Outcome measures were relapse rate, time to relapse, proportion of days covered (PDC), and level of treatment adherence defined by PDC in five levels. Time to relapse was compared by Kaplan–Meier survival curves and log-rank test with the hazard ratio calculated using Cox proportion hazards model; PDC by t-test, and relapse rate and PDC categories by chi-square test.
Results
A total of 1564 patients (428 PP3M and 1136 PP1M) were included. Relapse rate was lower in PP3M cohort (10.5%) compared with PP1M cohort (15.7%). Incidence rate of relapse was 8.98/100 person-years (PY) in PP3M cohort and 13.81/100 PY in PP1M cohort. After a mean (SD) follow-up of 456.1 (240.28) days in PP3M cohort and 465.4 (237.95) days in PP1M cohort, PP3M patients had a significantly lower relapse risk (hazard ratio: 0.65, 95% CI: 0.47, 0.90) than PP1M patients. Treatment adherence was significantly (p<0.0001) higher in PP3M versus PP1M cohort.
Conclusion
Risk of relapse was significantly lower, and treatment adherence was significantly higher in PP3M cohort compared with PP1M cohort. Higher treatment adherence was associated with lower relapse rate.
Abbreviations
HR, Hazard Ratio; HRU, Healthcare Resource Utilization; ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification; LAI, Long-acting Injectable Antipsychotics; MDCD, MarketScan® Multi-State Medicaid Database; PNUD, Prevalent New User Design; PP, Paliperidone Palmitate; PP1M, Paliperidone Palmitate Once-monthly; PP3M, Paliperidone Palmitate Three-monthly; PDC, Proportion of Days Covered; PY, Person-years; SD, Standard Deviation.
Data Sharing Statement
The data used in this study are stored with the MDCD and can be accessed by approaching MDCD.
Ethics Approval and Informed Consent
Use of the MDCD was reviewed by the New England Institutional Review Board and determined to be exempt from review board approval, as this study does not involve human subjects research. All data were de-identified and fully complied with the US Health Insurance Portability and Accountability Act of 1996 regulations.
Acknowledgments
The authors acknowledge Leo J. Philip, P. Pandey, G. Virya and Shweta Pitre (all from SIRO Clinpharm Pvt. Ltd.) for providing writing assistance and Ellen Baum, PhD (Janssen Global Services, LLC) for additional editorial support.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
All the authors were employees of Janssen and its subsidiaries during the study and may own stock or stock options. The authors report no other conflicts of interest in this work.