Costs associated with erythropoiesis-stimulating agent administration to hemodialysis patients.

BACKGROUND: Treatment of anemia in hemodialysis patients usually requires the use of expensive erythropoietic proteins. Cost analyses usually focus on drug acquisition costs. Other costs associated with anemia therapy include resources for anemia monitoring as well as preparation and administration of an erythropoiesis-stimulating agent. METHODS: The nonacquisition costs associated with subcutaneous administration of epoetin alfa were determined in a Canadian hemodialysis unit. A time-and-motion technique was used to determine the nursing time for preparation and administration. Fixed anemia costs were inventory control, monitoring, blood sampling, and laboratory analysis. Variable costs were those which varied with dosing frequency. The costs are expressed in Canadian dollars (2005). RESULTS: The mean time associated with preparation and administration was 3.2 min/injection. The annual nonacquisition per patient cost was CAD 2,290.04. Fixed costs were CAD 1,946.01, while the variable costs were CAD 344.03/year. Sensitivity analysis showed a decrease in cost to CAD 1,611.34, if iron monitoring were decreased from monthly to 3 monthly, and to CAD 2,090.66, if patients were converted to less frequent dosing using darbepoetin alfa. CONCLUSIONS: The nonacquisition costs associated with anemia therapy in hemodialysis patients are considerable. Less frequent monitoring of iron therapy and less frequent dosing could decrease costs by CAD 678.40 and CAD 199.38/patient/year, respectively.

Cost effectiveness of adding ezetimibe to atorvastatin therapy in patients not at cholesterol treatment goal in Canada.

INTRODUCTION: This analysis compared the cost effectiveness of adding ezetimibe to atorvastatin therapy versus atorvastatin titration or adding cholestyramine (a resin) for patients at high risk of a coronary artery disease (CAD) event who did not reach target cholesterol levels on their current atorvastatin dosage. The primary analysis focused on 65-year-old patients with low-density lipoprotein cholesterol (LDL-C) levels of 3.1 or 3.6 mmol/L with a treatment goal of <2.5 mmol/L, classified as very high risk according to the 2000 Canadian Guidelines for Management and Treatment of Hyperlipidaemia. METHODS: A previously developed Markov model was utilised to capture the cost and clinical consequences of lipid-lowering therapy in primary and secondary prevention of CAD. Comparisons between treatment strategies were made using ICERs (cost per QALY) from a Canadian Ministry of Health perspective. The effects of lipid-lowering therapies were based on clinical trial data. The risks of CAD events were estimated using Framingham Heart Study risk equations. Treatment costs and the costs of acute and long-term care for CAD events were included in the analysis. Costs (Canadian dollar, 2002 values) and outcomes were discounted at 5% per annum. RESULTS: Ezetimibe added to atorvastatin therapy compared with treatment with the most common fixed atorvastatin daily dosage (10 mg) or with common atorvastatin titration strategies (up to 20 mg daily; up to 40 mg daily) resulted in cost per QALY estimates ranging from 25,344 to 44,332 Canadian dollars. The addition of ezetimibe to atorvastatin therapy was less costly and more effective than the addition of cholestyramine (dominant). CONCLUSION: Our analysis suggests that adding ezetimibe to atorvastatin for patients not achieving treatment goals with their current atorvastatin dose produces greater clinical benefits than treatment with a fixed-dose atorvastatin or atorvastatin titration at an increased overall cost. The cost-effectiveness ratios provide strong evidence for the adoption of ezetimibe within the Canadian healthcare system.

Cost-effectiveness of becaplermin for nonhealing neuropathic diabetic foot ulcers.

Foot ulcers secondary to peripheral neuropathy and vascular disease are a commonly occurring complication for people with diabetes. Becaplermin, a genetically-engineered growth factor in a hydrogel vehicle, has been shown to be more effective than vehicle-only control in healing chronic foot ulcers of patients with adequate vasculature receiving best clinical care. To evaluate the cost-effectiveness of adding up to 20 weeks of becaplermin to a regimen of best clinical care, a 1-year decision-analytic model was developed and tested using data from a previously published controlled clinical study involving 251 people with diabetes (124 becaplermin/127 control) and adequate vasculature presenting with an infection-free ulcer that had failed to heal despite appropriate therapy. A 20-week healing rate was estimated based on the clinical trial data assuming becaplermin treatment was terminated at 10 weeks in non-responding ulcers, and follow-up data were extended to 1 year. Resource utilization was estimated by an expert panel using a modified Delphi approach. Using the model, it was found that incorporating becaplermin with best clinical care resulted in 26 fewer ulcer-days per patient per year compared to best clinical care alone with an incremental cost-effectiveness ratio of $6 per ulcer-day averted. Results were sensitive to becaplermin cost, efficacy, and effect on infection and recurrence rates. The clinical benefits of becaplermin deserve further investigation to enhance cost-effectiveness information for informed treatment decisions.

Modelled cost-effectiveness of high cut-off haemodialysis compared to standard haemodialysis in the management of myeloma kidney.

BACKGROUND: Approximately 10-20% of multiple myeloma patients experience dialysis-dependent renal failure. This is principally due to myeloma kidney, a tubulointerstitial injury caused by high circulating concentrations of monoclonal free light chains. Studies have found that between 3% and 37% of patients with myeloma kidney requiring dialysis recover renal function. In-vivo studies indicate that extended haemodialysis using high cut-off dialysers (HCO-HD) can remove significant quantities of free light chains and is associated with a renal recovery rate of 63-74% in these patients. OBJECTIVE: The objective of this study was to assess the cost-effectiveness of HCO-HD compared to standard HD in the management of myeloma kidney. METHODS: The study used a lifetime Excel-based decision tree model that followed all patients from treatment of the initial presentation with myeloma kidney requiring dialysis to death. It was populated with published clinical data, United Kingdom costs and expert opinion, using a National Health Service perspective and 3.5% annual discounting. RESULTS: HCO-HD was dominant to standard HD, meaning it was both more effective (greater life years and quality adjusted life years) and less costly, due to a greater increase in the proportion of patients recovering renal function. The model projected lifetime costs of £31,345 per patient for patients treated with standard haemodialysis only and £24,845 for the new treatment (discounted). The model predicted an average survival of 19.92 months for patients on standard HD and 33.90 months for the new therapy (discounted). CONCLUSIONS: The analysis found that treatment of myeloma kidney using an extended schedule of HCO-HD may substantially improve renal recovery in multiple myeloma patients compared to standard HD, resulting in greater life expectancy and cost savings due to avoided chronic dialysis. Limitations of the study include those common to rare diseases including small study sizes and limited natural history data.

How many cardiovascular events can be prevented with optimal management of high-risk Canadians?

BACKGROUND: Strong evidence exists to support the use of statins, acetylsalicylic acid (ASA) and angiotensin-converting enzyme inhibitors (ACEI) in patients at high risk of cardiovascular (CV) events; however, current practice pattern data indicate that a significant care gap exists between evidence and practice. OBJECTIVES: To quantify the reduction in CV events that may be obtained with the optimal use of vascular protection therapy in Canadians at high risk of cardiovascular events. METHODS: Canadian Community Health Survey data from 2003 were used to estimate the prevalence of heart disease and/or diabetes, which were applied to an age-specific population in Canada to calculate the total number of high-risk patients. The number of events over 10 years was estimated using a state transition model, published risk equations, practice pattern data from Canadian registries and published therapy efficacy from clinical trials. RESULTS: Among 2.2 million high-risk Canadians, current care with statin, ASA and ACEI therapy has reduced the estimated occurrence of CV events over the next 10 years by approximately 400,000 from 1.01 million. Universal use of combination statin, ASA and ACEI therapy for high-risk patients, compared with current care, would prevent as many as 143,000 more CV events over the next 10 years. CONCLUSIONS: Great advances in the management of CV disease have been made; however, CV disease remains a substantial burden to patients and to the Canadian health care system. Canadian physicians have the opportunity to further reduce this burden through optimal management of high-risk patients based on clinical guidelines.

The burden of illness of severe nausea and vomiting of pregnancy in the United States.

OBJECTIVE: Our purpose was to determine the extent to which nausea and vomiting of pregnancy affects a woman's quality of life (QOL), ability to function, and health care resource use. STUDY DESIGN: We conducted an observational, multicenter, prospective cohort study by gathering data on the symptoms, QOL, and health care resource use from women who have nausea and vomiting of pregnancy. RESULTS: All 8 domains of health measured by the Short Form-36 QOL survey were limited by patient symptoms. This limitation manifested itself as patient-time loss from work and other normal activities, unpaid caregiver-time loss from work, and use of health care resources (eg, hospitalization). All types of time loss were correlated to severity of symptoms. CONCLUSIONS: Nausea and vomiting of pregnancy can severely reduce a woman's QOL and ability to function. The degree of limitation is associated with the severity of symptoms.