The burden of critical limb ischemia: a review of recent literature.

Peripheral arterial disease is a chronic vascular disease characterized by impaired circulation to the lower extremities. Its most severe stage, known as critical limb ischemia (CLI), puts patients at an increased risk of cardiovascular events, amputation, and death. The objective of this literature review is to describe the burden of disease across a comprehensive set of domains-epidemiologic, clinical, humanistic, and economic-focusing on key studies published in the last decade. CLI prevalence in the United States is estimated to be approximately 2 million and is likely to rise in the coming years given trends in important risk factors such as age, diabetes, and smoking. Hospitalization for CLI patients is common and up to 60% are readmitted within 6 months. Amputation rates are unacceptably high with a disproportionate risk for certain demographic and socioeconomic groups. In addition to limb loss, CLI patients also have reduced life expectancy with mortality typically exceeding 50% by 5 years. Given the poor clinical prognosis, it is unsurprising that the quality of life burden associated with CLI is significant. Studies assessing quality of life in CLI patients have used a variety of generic and disease-specific measures and all document a substantial impact of the disease on the patient's physical, social, and emotional health status compared to population norms. Finally, the poor clinical outcomes and increased medical resource use lead to a considerable economic burden for national health care systems. However, published cost studies are not comprehensive and, therefore, likely underestimate the true economic impact of CLI. Our summary documents a sobering assessment of CLI burden-a poor clinical prognosis translating into diminished quality of life and high costs for millions of patients. Continued prevention efforts and improved treatment strategies are the key to ameliorating the substantial morbidity and mortality associated with this disease.

Cost effectiveness of focal impulse and rotor modulation guided ablation added to pulmonary vein isolation for atrial fibrillation.

BACKGROUND: Although ablation with focal impulse and rotor modulation (FIRM), as an adjunct to pulmonary vein isolation (PVI), has been shown to decrease atrial fibrillation (AF) recurrence, cost-effectiveness has not been assessed. OBJECTIVE: We aimed to evaluate the cost effectiveness of FIRM-guided ablation when added to PVI in a mixed AF population. METHODS AND RESULTS: We used a Markov model to estimate the costs, quality-adjusted survival, and cost effectiveness of adding FIRM ablation to PVI. AF recurrence rates were based on 3-year data from the CONFIRM trial. Model inputs for event probabilities and utilities were obtained from literature review. Costs were based on Medicare reimbursement, wholesale acquisition costs, and literature review. Three-year total costs FIRM+PVI versus PVI alone were $27,686 versus $26,924. QALYs were 2.338 versus 2.316, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of $34,452 per QALY gained. Most of the cost (65-81%) was related to the index ablation procedure. Lower AF recurrence generated cost offsets of $4,266, primarily due to a reduced need for medications and repeat ablation. Probabilistic sensitivity analysis demonstrated ICER below $100,000/QALY in 74% of simulations. CONCLUSION: Based on data from the CONFIRM study, the addition of FIRM to PVI does have the potential to be cost-effective due to higher quality-adjusted life years and lower follow-up costs. Value is sensitive to the incremental reduction in AF recurrence, and FIRM may have the greatest economic value in patients with greater AF symptom severity. Results from ongoing randomized trials will provide further clarity.

Budget impact analysis of darbepoetin alfa every 3 weeks versus epoetin alfa every week for the treatment of chemotherapy-induced anaemia from a US payer's perspective.

OBJECTIVE: This analysis was conducted to compare the direct medical costs of treatment with darbepoetin alfa every 3 weeks (Q3W) and epoetin alfa every week (QW) in patients with chemotherapy-induced anaemia (CIA) from the payer's perspective. METHODS: An analysis was conducted from a US health plan perspective to compare the annual budget impact for CIA with darbepoetin alfa Q3W and epoetin alfa QW over a 16-week treatment period. Dosing regimens were obtained from registration clinical trials. RESULTS: Mean doses, including dose adjustments, were 375.6 microg Q3W for darbepoetin alfa and 43,187 U QW for epoetin alfa. Costs of medical resources included drug acquisition and administration costs. The base case analysis resulted in a per-patient budget impact of $8,544 and $8,667 for darbepoetin alfa and epoetin alfa, respectively. Per member per month cost was $0.90 for darbepoetin alfa and $0.91 for epoetin alfa, based on an estimate of 2,735 CIA patients in a health plan population of 2.17 million. The analysis was most sensitive to drug dose, treatment period and drug price. CONCLUSIONS: Results suggest that per-patient direct medical costs of CIA treatment, when initiated at labelled starting doses, are comparable for darbepoetin alfa Q3W and epoetin alfa QW.

Cost-effectiveness of a targeted disinfection program in household kitchens to prevent foodborne illnesses in the United States, Canada, and the United Kingdom.

Foodborne illnesses impose a substantial economic and quality-of-life burden on society by way of acute morbidity and chronic sequelae. We developed an economic model to evaluate the potential cost-effectiveness of a disinfection program that targets high-risk food preparation activities in household kitchens. For the United States, Canada, and the United Kingdom, we used published literature and expert opinion to estimate the cost of the program (excluding the educational component); the number of cases of Salmonella, Campylobacter, and Escherichia coli O157:H7 infections prevented; and the economic and quality-of-life outcomes. In our primary analysis, the model estimated that approximately 80,000 infections could be prevented annually in U.S. households, resulting in 138 million dollars in direct medical cost savings (e.g., physician office visits and hospitalizations avoided), 15,845 quality-adjusted life-years (QALYs) gained, 788 million dollars in program costs, and a favorable cost-effectiveness ratio of 41,021 dollars/QALY gained. Results were similar for households in Canada and the United Kingdom (21,950 dollars Can/QALY gained and 86,341 pounds sterling/QALY gained, respectively). When we evaluated implementing the program only in U.S. households with high-risk members (those less than 5 years of age, greater than 65 years of age, or immunocompromised), the cost-effectiveness ratio was more favorable (10,163 dollars/QALY gained). Results were similar for high-risk households in Canada and the United Kingdom (1,915 dollars Can/QALY gained and 28,158 pounds sterling/QALY gained, respectively). Implementing a targeted disinfection program in household kitchens in the United States, Canada, and the United Kingdom appears to be a cost-effective strategy, falling within the range generally considered to warrant adoption and diffusion (<100,000 dollars/QALY gained).

A cost analysis of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion.

An economic model was developed to compare costs of stand-alone anterior lumbar interbody fusion with recombinant human bone morphogenetic protein 2 on an absorbable collagen sponge versus autogenous iliac crest bone graft in a tapered cylindrical cage or a threaded cortical bone dowel. The economic model was developed from clinical trial data, peer-reviewed literature, and clinical expert opinion. The upfront price of bone morphogenetic protein (3380 dollars) is likely to be offset to a significant extent by reductions in the use of other medical resources, particularly if costs incurred during the 2 year period following the index hospitalization are taken into account.

Economic evaluation of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion: an evidence-based modeling approach.

STUDY DESIGN: Economic evaluation provides a framework to explicitly measure and compare the value of alternative medical interventions in terms of their clinical, health-related quality-of-life, and economic outcomes. Computerized economic models can help inform the design of future prospective studies by identifying the cost-drivers, the most uncertain parameter estimates, and the parameters with the greatest impact on the results and inferences. OBJECTIVE: An economic analysis of bone morphogenetic protein versus autogenous iliac crest bone graft for single-level anterior lumbar fusion poses several methodologic challenges. This article describes how such an economic evaluation may be framed and designed, while enumerating challenges, offering some solutions, and suggesting an agenda for future research. SUMMARY OF BACKGROUND DATA: An evidence-based modeling approach can incorporate epidemiologic, clinical, and economic data from several sources including randomized clinical trials, peer-reviewed literature, and expert opinion. Sensitivity analyses can be conducted by varying key parameter estimates within a reasonable range to assess the impact on the results and inferences. RESULTS: Preliminary results suggest that from a payer perspective, the upfront price of bone morphogenetic protein is likely to be entirely offset by reductions in the use of other medical resources. That is, bone morphogenetic protein appears to be cost neutral. The cost offsets were attributable largely to prevention of pain and complications associated with autogenous iliac crest bone graft, as well as reduction of the costs associated with fusion failures. CONCLUSIONS: Future research should focus on quantifying the health-related quality-of-life impact of bone morphogenetic protein relative to autogenous iliac crest bone graft, as well as the impact on lost productivity.