Cost and Cost-Effectiveness in a Randomized Trial of Long-Acting Risperidone for Schizophrenia Reply

Health Economics Resource Center, VA Cooperative Studies Program, VA Palo Alto Health Care System, Menlo Park, CA 94025, USA.
The Journal of Clinical Psychiatry (Impact Factor: 5.5). 05/2012; 73(5):696-702. DOI: 10.4088/JCP.11m07070
Source: PubMed


The effect of long-acting injectable (LAI) risperidone on health care costs was determined in a multisite clinical trial.
Veterans Health Administration patients with unstable schizophrenia or schizoaffective disorder established by the Structured Clinical Interview for DSM-IV (N = 369) were randomized between 2006 and 2009 to long-acting risperidone or physician's choice of oral antipsychotic. Health care utilization and cost were tracked in administrative data. Medication administered by the trial was recorded on case report forms. Medication cost was based on unit costs to the US Medicaid program. Economic outcomes were assessed with the Quality of Well-Being instrument.
Participants randomized to LAI risperidone (n = 187) incurred $14,916 per quarter in total health care costs, which was not significantly different from the $13,980 cost incurred by the control group (P = .732) (n = 182). The LAI group incurred $3,028 per quarter in medication cost, significantly more than the $1,913 incurred by the control group (P = .003). Hospitalization costs were $7,088 in the experimental group and $6,891 in the control group (P = .943); outpatient costs were $11,888 in the experimental group and $12,067 in the control group (P = .639). LAI risperidone did not result in better outcomes as evaluated by a measure of schizophrenia symptoms or an assessment of health related quality of life and incurred more adverse events.
Patients with unstable schizophrenia were randomized in a practical trial of LAI risperidone. This antipsychotic significantly increased medication costs but did not reduce hospital or total health care cost or improve outcomes and was thus not cost-effective. identifier: NCT00132314.

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    ABSTRACT: The aim of the present article is to test at a meta-analytical level the efficacy and safety of second-generation long-acting antipsychotic injections (SGLAI) in schizophrenia. Thirteen randomized-controlled trials comparing SGLAI with either placebo or oral antipsychotics were included in a quantitative meta-analysis (6313 patients). Efficacy and safety measures as well as demographic and clinical variables were extracted from each publication or obtained directly from authors. Publication bias was assessed with funnel plots and Egger's intercept. Heterogeneity was addressed with the Q statistic and the I index. SGLAI were more effective than placebo injections [Hedges's g=0.336, 95% confidence interval (CI) 0.246-0.426, Z=7.325, P<0.001] in reducing the Positive and Negative Syndrome Scale (PANSS) scores, but no differences were observed compared with oral antipsychotics (Hedges's g=0.072, 95% CI -0.072 to 0.217, Z=0.983, P=0.326). There were more responders under SGLAI than placebo (47 vs. 24%, NNT 4, 95% CI 3-6), but no differences in comparison with oral antipsychotics [relative risk (RR)=0.962, P=0.094]. SGLAI and controls groups shared a common safety profile with respect to the number of deaths, overall number of treatment-adverse events, insomnia, QT prolongation, or pain in the injection site. There was a greater risk of developing extrapyramidal side effects with SGLAI than with placebo (RR=2.037, P<0.001) or with oral antipsychotics (RR=1.451, P=0.048). There was no evidence of publication bias (Egger's P=0.476), and sensitivity analysis confirmed the robustness of results. The present meta-analysis shows superior efficacy for the SGLAI over placebo on psychotic symptoms, although with a relatively small effect size; no evidence of superiority in efficacy over oral antipsychotics; and modest evidence of greater symptoms of extrapyramidal side effects. These data suggest that SGLAI lack an advantage in reducing psychotic symptoms over oral medications. Their potential effects on relapse prevention should be better addressed by future randomized-controlled trials.
    Full-text · Article · Nov 2012 · International clinical psychopharmacology
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