Incremental Costs in Giant Cell Arteritis.

OBJECTIVE: To assess and compare direct costs between giant cell arteritis (GCA) patients and matched controls and to identify incremental cost drivers. METHODS: We carried out a population-based, retrospective cohort study using the French National Health Insurance System database. Cost analysis was performed from the French health insurance perspective and took into account direct medical and nonmedical costs (2014, €). Costs were evaluated according to different cost components and divided into periods of 6 months for the accurate assessment of care consumption. Longitudinal multivariate regression analyses using generalized estimating equations were used to adjust the effect of GCA on the mean cost over time. RESULTS: Analyses were performed on 96 incident GCA patients and 563 matched controls. The cumulative incremental cost due to GCA was €6,406 and €7,236 for 3 and 5 years, respectively. Total incremental costs were significant for the first 18 months, amounting to €1,342 for the first 6 months, €1,498 between 6 and 12 months, and €1,165 between 12 and 18 months (P = 0.012, P = 0.065, and P = 0.029, respectively). The most important cost drivers were paramedical procedures, inpatient stays, medication, and medical procedures. Multivariate analysis shows the significant effect of GCA on mean cost during the first 3 years of followup (relative risk [RR] 1.72 [95% confidence interval (95% CI) 1.31-2.27], P < 0.001) with significant cost reductions (RR 0.70 [95% CI 0.49-0.99], P = 0.05) at the end of followup. CONCLUSION: This study provides an accurate assessment of GCA costs during a 5-year period and gives useful information for future cost-effectiveness studies based on new expensive biotherapies.

Are adverse drug reaction patterns different between romiplostim and eltrombopag? 2009-2013 French PharmacoVigilance assessment.

BACKGROUND: Romiplostim and eltrombopag, the two marketed thrombopoietin receptor agonists (TPO-RAs), have distinct binding sites and might have distinct pharmacodynamic mechanisms. The aim of this study was to compare their adverse drug reaction (ADR) patterns. METHODS: We selected in the French PharmacoVigilance Database all ADRs associated with TPO-RAs from TPO-RA marketing until the 31st of December 2013. Medical charts were reviewed. We conducted disproportionality analyses comparing romiplostim exposure in the reports of a given ADR pattern (thrombosis, neurological, cutaneous, gastrointestinal or hematological) to romiplostim exposure in all other TPO-RA-related ADR reports. Reporting Odds Ratios (RORs) were adjusted for age and gender. We also compared the number of reports of a given ADR pattern per million daily defined doses (DDDs) dispensed in France during the study period. RESULTS: We described 45 reports (53 ADRs) with romiplostim and 26 reports (37 ADRs) with eltrombopag. There were 19 venous thromboses. At least one other risk factor was present in 83.3% of the cases. Ten (55.6%) patients had been splenectomized previously. There were eight arterial thromboses. Another risk factor was noticed in all cases. There was no signal for an excess risk of thrombosis with romiplostim versus eltrombopag (ROR: 1.45, 95% CI [0.48-4.45]). There was a signal for a higher risk of gastrointestinal ADRs with eltrombopag (ROR: 30.28, 95% CI [3.23-383.86]) and of hematological ADRs with romiplostim (ROR: 14.36, 95% CI [1.73-119.08]). Dispensing data-adjusted comparisons led to similar results. CONCLUSIONS: This study suggests different ADR patterns between romiplostim and eltrombopag.