PURPOSE: To evaluate the cost-effectiveness of recombinant human activated protein C (rhAPC) compared with usual therapy for patients with severe sepsis, and also to determine the influence that severity of illness exerts on cost-effectiveness. MATERIALS AND METHODS: We use a Markov model-based cost-effectiveness analysis of treatment strategies for patients with severe sepsis. Therapy includes treatment with either rhAPC and usual therapy, or usual therapy alone. Probabilities for clinical outcomes were obtained from a large randomized clinical trial comparing the use of rhAPC with placebo (PROWESS study) and from outcomes literature for patients with severe sepsis and its complications. Cost estimates were based on Medicare reimbursement rates, Health Care Financing Administration information and the literature. Outcome measures include life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness. RESULTS: Compared with usual therapy alone, rhAPC treatment for patients with very severe sepsis (APACHE II score > or = 25) was associated with an incremental cost-effectiveness ratio of $13 493/QALY. Treatment of patients with less severe sepsis with rhAPC (APACHE II score 25) had an incremental cost-effectiveness ratio of $403,000/QALY. For patients with very severe sepsis the incremental cost-effectiveness ratio for treatment with rhAPC remained under $30,000/QALY, over a broad range of variables, including costs of rhAPC, costs of acute care and costs and probabilities of complications of treatment. For patients with less severe sepsis, drug costs would need to fall well below current market price before achieving cost-effectiveness. A probabilistic sensitivity analysis comparing rhAPC treatment with usual therapy for patients with very severe sepsis showed that 1% of Monte Carlo simulations had incremental cost-effectiveness ratios > $50,000/QALY. CONCLUSIONS: The use of rhAPC for the treatment of patients with very severe sepsis, as determined by APACHE II score > or = 25, appears cost-effective, while treatment of patients with APACHE II score 25 is not cost-effective.

OBJECTIVE: Positron emission tomography (PET) is a high-cost imaging tool primarily used in oncology, cardiology, and neuropsychiatry. Accurate estimates of the cost of PET are needed to assess its cost effectiveness and determine the appropriate role for this modality in clinical applications. We performed a survey-based cost analysis of PET with FDG by estimating direct, indirect, and capital costs from eight PET centers. A breakdown of the operational budget of PET centers and FDG-compounding facilities is presented along with the costs per scan. Differences in costs between sites that purchase FDG and those that manufacture FDG are also examined. MATERIALS AND METHODS: We sent surveys to managers of eight Veterans Affairs and two non-Veterans Affairs PET scanning and FDG-compounding facilities. The survey included questions about service volume and the direct costs of equipment, personnel, space, supplies, and repairs needed for FDG compounding and PET scanning and interpretation. We estimated the indirect costs associated with FDG compounding, PET scanning, and PET interpretation. RESULTS: Of the eight sites that responded to our survey, three sites manufacture FDG on-site, three sites purchase FDG, and two sites do both. The total mean cost per scan using manufactured FDG is 1885 US dollars, and it is 1898 US dollars using purchased FDG. CONCLUSION: PET is expensive. The cost is similar when FDG is manufactured or purchased. Because both PET and cyclotron facilities have high fixed costs, increasing the number of scans obtained and the number of FDG doses manufactured may lead to a decrease in unit costs.

BACKGROUND: Positron emission tomography (PET) with 18-fluorodeoxyglucose (FDG) is a potentially useful but expensive test to diagnose solitary pulmonary nodules. OBJECTIVE: To evaluate the cost-effectiveness of strategies for pulmonary nodule diagnosis and to specifically compare strategies that did and did not include FDG-PET. DESIGN: Decision model. DATA SOURCES: Accuracy and complications of diagnostic tests were estimated by using meta-analysis and literature review. Modeled survival was based on data from a large tumor registry. Cost estimates were derived from Medicare reimbursement and other sources. TARGET POPULATION: All adult patients with a new, noncalcified pulmonary nodule seen on chest radiograph. TIME HORIZON: Patient lifetime. PERSPECTIVE: Societal. INTERVENTION: 40 clinically plausible combinations of 5 diagnostic interventions, including computed tomography, FDG-PET, transthoracic needle biopsy, surgery, and watchful waiting. OUTCOME MEASURES: Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. RESULTS OF BASE-CASE ANALYSIS: The cost-effectiveness of strategies depended critically on the pretest probability of malignancy. For patients with low pretest probability (26%), strategies that used FDG-PET selectively when computed tomography results were possibly malignant cost as little as 20 000 dollars per QALY gained. For patients with high pretest probability (79%), strategies that used FDG-PET selectively when computed tomography results were benign cost as little as 16 000 dollars per QALY gained. For patients with intermediate pretest probability (55%), FDG-PET strategies cost more than 220 000 dollars per QALY gained because they were more costly but only marginally more effective than computed tomography-based strategies. RESULTS OF SENSITIVITY ANALYSIS: The choice of strategy also depended on the risk for surgical complications, the probability of nondiagnostic needle biopsy, the sensitivity of computed tomography, and patient preferences for time spent in watchful waiting. In probabilistic sensitivity analysis, FDG-PET strategies were cost saving or cost less than 100 000 dollars per QALY gained in 76.7%, 24.4%, and 99.9% of computer simulations for patients with low, intermediate, and high pretest probability, respectively. CONCLUSIONS: FDG-PET should be used selectively when pretest probability and computed tomography findings are discordant or in patients with intermediate pretest probability who are at high risk for surgical complications. In most other circumstances, computed tomography-based strategies result in similar quality-adjusted life-years and lower costs.

Contemporary clinical trials commonly measure quality of life and medical costs to establish whether therapies are both effective and cost effective. Cost-effectiveness analysis, however, requires a measure of patient utility or preferences for various health states. Because utilities are not often measured directly, we sought to develop a method of translating standard quality-of-life scales into a patient utility measure.

Methods

Five hundred fifty-three patients enrolled in the Bypass Angioplasty Revascularization Investigation Study of Economics and Quality of Life completed a battery of quality-of-life measures and a time trade-off utility assessment an average of 7.3 years after random assignment.

Results

The mean time trade-off score was 8.54 (SD ? 2.53) out of a maximum of 10; median score was 9.95. The distribution of scores was skewed, with 12% of patients at the highest possible score of 10. Patients with recurrent angina had significantly lower time trade-off scores than patients without angina (mean 7.03 vs 8.70, P .05). Time trade-off scores were moderately correlated with each quality-of-life measure (Spearman coefficients 0.38-0.52). Time trade-off scores could be predicted by combinations of 4 (r² ? 0.29), 5 (r² ? 0.31), or 6 (r² ? 0.32) variables.

Conclusions

Time trade-off utility scores can be inferred from commonly used quality-of-life measures. Angina significantly reduces patient utility scores.