Projecting the Potential Effect of Using Paliperidone Palmitate Once-Monthly and Once-Every-3-Months Long-Acting Injections Among Medicaid Beneficiaries with Schizophrenia.

Abstract

Once-monthly and once-every-3-months long-acting injectable (LAI) formulations of paliperidone palmitate (PP1M and PP3M, respectively) are available for the treatment of patients with schizophrenia. However, information on the comparative effectiveness and costs of using these LAIs versus oral antipsychotics (OAs) is not available. The population effectiveness of using these treatments is also not known. To project the effect of using PP1M and PP3M LAIs on psychiatric (Psych) and all-cause (AC) hospitalization rates over 18 months in patients with schizophrenia receiving Medicaid and treated with OAs. A decision model, informed by data from 3 randomized controlled trials (PRIDE [NCT01157351], 3001 [NCT00111189], and 3012 [NCT01529515]), was developed to compare 3 strategies: (a) initiating OA and switching only to OA; (b) initiating with PP1M and continuing PP1M if the patient was stable at 6 months (or switching to OA if unstable; PP1M→PP1M); and (c) initiating with PP1M and switching to PP3M if the patient was stable at 6 months (or switching to OA if unstable; PP1M→PP3M). PRIDE data were used to inform the first 6-month outcomes; 3001 and 3012 data were used to inform outcomes in stable patients over the following 12 months. The primary outcome for this decision model study was Psych hospitalizations. AC hospitalizations and time to discontinuation were also assessed. Outcomes from each arm and time portions within an arm were reweighted to reflect the distribution of patient characteristics found in the real-world Medicaid sample with PRIDE trial inclusion/exclusion criteria applied. Several validation exercises were carried out to ensure that the reweighted results could reproduce observed outcomes in the Medicaid sample. Our final target real-world sample size was N=4,609. We found that in the Medicaid sample, compared with initiating treatments with OA, the PP1M→PP1M strategy was projected to produce a per patient decrease of 0.27 (95% CI = -0.43-0.97) and 0.28 (95% CI = -0.28-0.84) in Psych- and AC-related hospitalizations, respectively. Similarly, the PP1M→PP3M strategy was projected to produce a per patient decrease of 0.31 (95% CI = -0.27-0.87) in both Psych- and AC-related hospitalizations over OA. Validation exercises ensured that the reweighting methodology used could replicate observed outcomes in the Medicaid sample. These incremental reductions in hospitalization rates are worth about $3.4-$3.8 billion over an 18-month period in patients with schizophrenia receiving Medicaid. Our results suggest that using PP1M and PP3M treatment strategies for patients with schizophrenia receiving Medicaid could result in reduced hospitalizations. This finding, along with improvement to patients' health, should be considered when assessing the value of these LAIs. This study was supported by Janssen Scientific Affairs and by unrestricted funds from a consortium of 12 biomedical life sciences companies to the University of Washington. Janssen Scientific Affairs was responsible for the design and conduct of the study; the collection, management, analysis, and interpretation of data; the preparation, review, and approval of the manuscript; and the decision to submit the manuscript for publication. Basu received financial support from Janssen Pharmaceuticals, and his time on this project was also partly covered through unrestricted gift funds from the consortium of biomedical life sciences companies. Benson and Alphs are employees of Janssen Scientific Affairs and are stockholders of Johnson & Johnson. Opinions expressed here do not necessarily reflect those of the University of Washington. This study was presented as a poster at the AMCP Managed Care & Specialty Pharmacy 2017 Annual Meeting; March 27-30, 2017; Denver, CO.