Cinacalcet adherence in dialysis patients with secondary hyperparathyroidism in Lombardy Region: clinical implications and costs

Background: Patients on dialysis often have secondary hyperparathyroidism (SHPT), a disorder associated with renal osteodystrophy, progressive vascular calcification, cardiovascular disease, and death. The objective of this retrospective observational study was to evaluate, in dialysis patients with SHPT, the impact of different levels of adherence to cinacalcet therapy on hospitalisations and direct healthcare costs charged to the Lombardy Regional Health Service (Italy). Methods: Data recorded in the administrative databases on all citizens undergoing dialysis between 1 January 2011 and 31 December 2011 were selected. For the aim of this study, patients with SHPT already on dialysis in the first 6 months of 2009 who had been treated with cinacalcet for at least 365 days were selected and retrospectively analysed through to end of 2012. Healthcare resource utilisation, cinacalcet adherence, and costs for medication, hospitalisations, and diagnostic/therapeutic procedures were estimated. Results: A total of 994 patients were identified (mean age 63.0 years, females 43.5%). The first patient tertile had an adherence to cinacalcet of <64.1%, whereas the third had an adherence of over 91.5%. Patients in the third adherence tertile experienced fewer all-causes hospitalisations than those in the first tertile (-19.2%; p=0.01423), fractures (-37.1%; p=0.59422), cardiovascular disease (-23.8%; p=0.04025), and sepsis (-32.3%; p=0.01386). The increase in costs for cinacalcet-adherent patients is almost completely offset by the reduction in costs for hospitalisations. Conclusions: The results of the analysis suggest that there may be some correlation between a high level of cinacalcet adherence and a decrease in hospitalisations

Evaluating targets and costs of treatment for secondary hyperparathyroidism in incident dialysis patients: the FARO-2 study

Results: Two prominent treatment groups were identified, ie, one on oral calcitriol (n=105) and the other on intravenous paricalcitol (n=33); the intravenous calcitriol and intravenous paricalcitol + cinacalcet combination groups were not analyzed due to low patient numbers. At baseline, serum PTH levels were significantly higher in the intravenous paricalcitol group (P<0.0001). At the second survey, the intravenous paricalcitol group showed a higher percentage of patients at target for PTH than in the oral calcitriol group without changing the percentage of patients at target for phosphate. Moreover, between baseline and the second survey, intravenous paricalcitol significantly increased both the percentage of patients at target for PTH (P=0.033) and the percentage of patients at target for the combined endpoint PTH, calcium, and phosphate (P=0.001). The per-patient weekly pharmaceutical costs related to SHPT treatment, erythropoietin-stimulating agents and phosphate binders accounted for 186.32\u20ac and 219.94\u20ac at baseline for oral calcitriol and intravenous paricalcitol, respectively, while after 6 months, the costs were 180.51\u20ac and 198.79\u20ac, respectively. Either at the beginning of dialysis or 6 months later, the total cost of SHPT treatment was not significantly lower in the oral calcitriol group compared with the intravenous paricalcitol group, with a difference among groups that decreased by 46% between the two observations. The cost of erythropoietin stimulating agents at the second survey was lower ( 1222%) in the intravenous paricalcitol group than in the oral calcitriol group (132.13\u20ac versus 168.36\u20ac, respectively)

End-stage renal disease costs for patients new to hemodialysis in Italy: The FARO-2 Study

Background: Increasing incidence and prevalence of end-stage renal disease (ESRD) together with the presence of several comorbidities in chronic kidney disease patients (CKD) could be associated with a relevant economic burden. Aim: The aim of this analysis was to estimate the direct healthcare costs of ESRD and its major comorbidities in Italian patients who were na\uefve to hemodialysis (HD) recruited for the FARO-2 study. Methods: The FARO-2 study was a retrospective observational study conducted in Italy that evaluated the patterns of treatment of secondary hyperparathyroidism (SHPT) and related costs in patients na\uefve to HD. The observational period was 2006\u20132008. Costs were measured in Euros (reference year: 2008). Resource use for the first 2 periods of 6 months of HD was monetized, with reimbursement calculated for SHPT drugs, phosphate binders, and erythropoietin-stimulating agents (ESAs); HD sessions; and hospitalizations due to ESRD and its major comorbidities. The analysis was performed by the Italian National Health Service (INHS) perspective. Results: 567 patients were observed for at least 2 periods of 6 months. During the first 12 months after the initiation of HD, average direct healthcare costs were assessed using the percentage of patients treated and the average daily dosages (for drugs), the percentage of patients hospitalized and the types of hospitalizations (for inpatients), and the average weekly frequency of HD sessions. Total per-patient yearly costs totaled 34,789.9 \u20ac: HD accounted for 66.1% of expenditures, with hospitalizations and drugs accounting for 12.9% and 21.0% of expenditures, respectively (including 17.1% for ESAs). Conclusions: Patients na\uefve to HD have a significant impact on Italian National Health Service expenditures, although only the costs related to treatment of ESRD and its comorbidities were calculated in the present study. The major cost drivers were HD and ESAs, while SHPT drugs and phosphate binders together accounted for only 3.9% of direct healthcare expenditures

Real world data on healthcare resource consumption and costs before and after kidney transplantation

End-stage renal disease (ESRD) is increasing worldwide as a consequence of population aging and increasing chronic illness. Treatment consists mostly of dialysis and kidney transplantation (KTx), and KTx offers advantages for life expectancy and long-term cost reductions compared to dialysis. This study uses the administrative database of the Lombardy Region to analyze the costs of a cohort of ESRD patients receiving KTx, covering a time period of 24 months before transplant to 12 months after. During 2011, 276 patients underwent kidney transplantation (8.7% preemptive and 91.3% non-preemptive). In the period before transplantation, the main cost driver was dialysis (66.6% for the period from -24 to -12 months and 73.8% for the period from -12 to 0 months), while in the 12 months after KTx, the most relevant cost was surgery. The total cost -24 to -12 months pre-KTx was 35,049.2\u20ac; the cost -12 to 0 months was 36,745.9\u20ac; and the cost 12 months after KTx was 43,805.8\u20ac. Non-preemptive patients showed much higher costs both pre- and post-KTx than preemptive patients. This study highlights how KTx modifies the resource consumption and costs composition of ESRD patients vs. those undergoing dialysis treatment and how KTx may be economically beneficial, especially preemptive intervention