Time Savings with Once-Monthly C.E.R.A.: A Time and Motion Study Conducted in 13 Haemodialysis Centres in Italy.

BACKGROUND: We sought to document the time required by health care professionals to administer erythropoiesis-stimulating agents (ESAs) and continuous erythropoiesis receptor activator (C.E.R.A.) in the management of renal anaemia. METHODS: A Time and Motion study was conducted in 13 centres in Italy. The time spent on preparation, distribution, and injection for both ESA and C.E.R.A. groups was measured. A multilevel model was run to account for the centre-clustering effect. RESULTS: The average number of ESA injections/patient/year was 89. The average uptake of C.E.R.A. was 26%. The average time per session was 1.54 min for ESA (95% CI 1.21-1.86) vs. 1.64 min for C.E.R.A. (95% CI 1.31-1.97). Estimated time/patient/year was 137 min for ESA and 20 min for C.E.R.A. Assuming a 100% uptake of C.E.R.A., annual time savings/centre would be 84% (194 h). CONCLUSIONS: Substantial annual time savings on frequent anaemia management-related tasks were found when a switchover was made from ESAs to C.E.R.A.

A budget impact model for paclitaxel-eluting stent in femoropopliteal disease in France.

PURPOSE: The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. METHODS: A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. RESULTS: The model estimated a net cumulative 5-year budget reduction of 6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. CONCLUSION: Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

Economic evaluation of duloxetine versus serotonin selective reuptake inhibitors and venlafaxine XR in treating major depressive disorder in Scotland.

BACKGROUND: Major depressive disorders (MDD) are responsible for substantial direct and indirect health care costs. Despite the availability of numerous treatments, the need for effective pharmacotherapy remains. Duloxetine is a relatively balanced serotonin norepinephrine reuptake inhibitor (SNRI) with favourable clinical and tolerability profile. The cost-effectiveness of duloxetine versus established SSRIs, venlafaxine XR and mirtazapine was estimated in the UK. METHODS: A decision analysis simulating clinical management of MDD was developed to estimate health and economic impacts of alternative treatments over one year. Patients on treatment experience remission, response without remission, no response, relapse or discontinue the initial regimen. Model outcomes were total treatment costs and quality-adjusted life years. Resource utilization data were derived from literature and practising UK psychiatrists and GPs. The robustness of findings with respect to modelling assumptions was assessed in extensive sensitivity analyses. RESULTS: With similar efficacy to venlafaxine XR but lower drug costs, duloxetine is less costly and marginally more effective than venlafaxine XR both in the overall MDD population and in a more severe subgroup. Duloxetine has a low cost-effectiveness ratio in primary care against SSRIs and mirtazapine, and was found cost-saving against mirtazapine in more severe patients. LIMITATIONS: Cost-effectiveness results are sensitive to changes in efficacy parameters and resource use data were collected from physician panel. CONCLUSIONS: Duloxetine represents an important option in the treatment of MDD in the UK that can be recommended on economic grounds. With similar efficacy and different side-effect profile to venlafaxine XR it represents a valuable choice to MDD patients.

Cost-effectiveness of linezolid versus vancomycin for hospitalised patients with complicated skin and soft-tissue infections in Germany.

This study used a decision analytic model approach to evaluate the cost-effectiveness of linezolid versus vancomycin in the empirical treatment of complicated skin and soft-tissue infection (cSSTI) due to suspected methicillin-resistant Staphylococcus aureus (MRSA) from the German hospital and health care system perspective. Clinical probabilities were obtained from trial data, resource utilisation and MRSA prevalence rates were obtained through German physician interviews, and costs from published sources were applied to resource units. Outcomes included total cost/patient and cure. The estimated first-line cure rate for linezolid-treated patients was 90.1% versus 85.5% for vancomycin; total cure rates after two lines of treatment were 98.4% and 98.1%, respectively. Average total cost/episode was 8,232 euro for linezolid versus 9,206 euro for vancomycin. The model outcomes were sensitive to changes in length of stay (LOS), isolation days, rate of confirmed MRSA and price of linezolid. Linezolid was expected to result in a shorter intravenous treatment duration and shorter LOS that offset its higher acquisition cost versus vancomycin in cSSTI in Germany.

Costs of managing anemia with erythropoiesis-stimulating agents during hemodialysis: a time and motion study.

Use of erythropoiesis-stimulating agents (ESAs) presents a significant time and cost burden in the management of anemia of chronic kidney disease (CKD). We conducted a prospective, observational, activity-based costing study to estimate the health care personnel time and resulting direct medical costs associated with administering epoetin 3 times weekly to patients with end-stage renal disease on dialysis. The study was conducted at 5 US hemodialysis centers. The personnel time and costs were derived from time and motion observations. Predicted time and cost savings were modeled for switching patients to once-monthly ESA therapy. Patients also completed a survey questionnaire to assess their level of CKD knowledge and information needs. Total per-patient-per-year (PPPY) time expended on anemia management with epoetin averaged 608 minutes (range 512-915 minutes), with an average PPPY cost of $548 (range $342-$651). Use of a once-monthly ESA, compared with epoetin, could decrease average PPPY time expenditure by 79% (127 minutes [range 96-173 minutes]) and reduce PPPY costs by 81% ($104 [range $79-$136]). The patient questionnaire reported insufficient education on CKD. Use of a once-monthly ESA to correct anemia in dialysis patients may provide substantial time, resource, and cost savings compared with current treatment practices.

Healthcare resource utilization for anemia management: current practice with erythropoiesis-stimulating agents and the impact of converting to once-monthly C.E.R.A.

UNLABELLED: Background andMethods: A prospective, observational study in 12 German and UK dialysis centers which quantified personnel time for anemia treatment using erythropoiesis-stimulating agents (ESAs). Tasks directly observable were measured through the time-and-motion method; time for non-observable tasks was estimated by healthcare staff. Using activity-based costing methods, time was converted into monetary units. Modeling was used to estimate potential time and cost savings using once-monthly C.E.R.A., a continuous erythropoietin receptor activator. RESULTS: For current ESAs in Germany and the UK, respectively: mean observed time was 1.67 and 2.67 min/patient/administration, corresponding to 31 and 42 days/year/center/100 patients; mean total time/center/100 patients/year was estimated at 79 and 95 days, equivalent to EUR 17,031 and GBP 18,739. Assuming 100% once-monthly C.E.R.A. uptake, the observed time/patient/year may decrease by 79 and 84% in Germany and the UK, respectively, compared with traditional ESAs. CONCLUSION: Conversion to once-monthly C.E.R.A. may offer the potential to reduce time spent on ESA administration in hemodialysis centers.

Cost-effectiveness of oral ibandronate versus IV zoledronic acid or IV pamidronate for bone metastases in patients receiving oral hormonal therapy for breast cancer in the United Kingdom.

BACKGROUND: Oral ibandronate is a single-nitrogen bisphosphonate whose efficacy is similar to that of IV ibandronate for the treatment of bone metastases. OBJECTIVE: The aim of this study was to compare the cost-effectiveness of oral ibandronate with zoledronic acid and generic pamidronate (both administered by IV) for the treatment of bone metastases in patients with breast cancer receiving oral hormonal therapy in the United Kingdom. METHODS: A global economic model was adapted to the UK National Health Service. Patients were assumed to receive oral hormonal therapy for 50% of their projected 14.3-month survival. The primary outcome was incremental cost per quality-adjusted life-year (QALY). Bisphosphonate efficacy data for relative risk reduction of skeletal-related events (SREs) were obtained from clinical trials. Resource use data and costs associated with IV bisphosphonate infusions were derived from published studies and a unit cost database; monthly drug acquisition costs were obtained from the British National Formulary. Utility scores were applied to time with or without an SRE to adjust survival for quality of life. Therefore, differences in QALYs were driven by utility weights rather than survival time. Model design and inputs were validated through expert UK clinician review. The absence of comparative efficacy and safety data from clinical trials for the different bisphosphonates was a model limitation that we addressed by supporting our assumptions with UK expert clinician opinion and with expert clinician opinion outside of the United Kingdom, and by conducting sensitivity analyses. RESULTS: The projected total cost per patient was pound307 less with oral ibandronate compared with zoledronic acid, and pound158 less compared with the use of generic pamidronate (due to a reduction in staff time for infusions, avoidance of renal safety monitoring visits, and, in the case of IV generic pamidronate, a reduction in the number of SREs). Oral ibandronate was estimated to lead to a gain of 0.02 QALY, making it the economically dominant treatment option. CONCLUSIONS: In this study, we found that oral ibandronate was cost-effective for the management of bone metastases from breast cancer among patients receiving oral hormonal therapy in the United Kingdom. Oral ibandronate provided effective SRE and bone-pain management while avoiding resource use and costs associated with regular IV bisphosphonate infusions. Due to uncertainty surrounding the model assumptions, it would be valuable to repeat the analyses using data from comparative bisphosphonate trials, once they become available.

Hepatitis B management costs in France, Italy, Spain, and the United Kingdom.

GOALS: To estimate the costs associated with the management of chronic hepatitis B (CHB) and its sequelae in France, Italy, Spain, and the United Kingdom from the perspective of the healthcare payer. BACKGROUND: The World Health Organization estimates that the disease sequelae related to hepatitis B account for 1 million deaths annually worldwide. Northern Europe is a low endemic area, while Mediterranean regions are classified as intermediate endemic areas. The introduction of vaccination programs in France, Italy, and Spain in recent years has lowered the hepatitis B incidence rates. STUDY: The purpose of this study was to identify the medical management patterns of CHB patients in France, Italy, Spain, and the United Kingdom and estimate the economic burdens of CHB-related disease states for each country. A central questionnaire was used to collect data from specialist physicians in four countries, and responses were collated into management patterns for chronic active hepatitis, compensated and decompensated cirrhosis, and hepatocellular carcinoma. RESULTS: The average cost by disease state for each European country was found to increase across the identified disease states reflecting disease progression. Year-2001 average annual disease state costs per patient were estimated to be as follows: CHB, 1,093 euro-3,396 euro; compensated cirrhosis, 1,134 euro-3,997 euro; decompensated cirrhosis, 5,292 euro-8,842 euro; hepatocellular carcinoma, 3,731 euro-9,352 euro; and, from published sources, liver transplant surgery, 25,165 euro-84,568 euro. CONCLUSION: The cost of CHB is variable both within and between European countries. The association of disease progression with increased cost of disease management suggests that measures to prevent or delay its progression would be economically beneficial.