Comparison of analytic approaches for the economic evaluation of new technologies alongside multicenter clinical trials

doi:10.1067/mhj.2003.3

American Heart Journal

Volume 145, Issue 3, March 2003, Pages 452-458

https://doi.org/10.1067/mhj.2003.3 Get rights and content

Abstract

Background In reporting economic evaluations of clinical trials, results are often stated without a description of the methodology used to derive the cost estimates. We compared methods for measuring costs from multicenter clinical trials to determine the extent to which the methodology affects results. Methods Patient-level data (n = 1849) from 3 multicenter clinical trials of percutaneous coronary revascularization were used to compare 4 methods of estimating costs: 1) hospital charges; 2) hospital charges converted to costs by use of hospital-level cost-to-charge ratios; 3) hospital charges converted to costs by use of department-level cost-to-charge ratios; 4) itemized catheterization laboratory costs with nonprocedural hospital costs generated from department-level cost-to-charge ratios. Results The method used to approximate costs did not affect the main results of the economic comparisons for any of the trials. The magnitude of the cost estimates and the cost differences between treatment groups varied considerably by method, however. Charges were approximately twice as high as hospital cost estimates. At the patient level, costs generated by use of method 1 were within 10% of those generated by use of method 4 for only 5% of patients, compared with 34% and 22% of patients with methods 2 and 3, respectively. Only method 3 produced estimates of between-group cost differences that were consistently within $500 of the reference standard. Conclusion Cost estimates derived from clinical trials in the cardiovascular arena vary substantially according to accounting methodology. Thus, in reporting the results of economic analyses, a detailed description of cost derivation is necessary, particularly when the absolute magnitude of the cost estimates is important to clinical decision-making or policy-level recommendations. For the purposes of group-level comparisons, conversion of hospital charges to costs on the basis of department-level cost-to-charge ratios appears to represent a reasonable compromise between accuracy and ease of implementation. (Am Heart J 2003;145:452-8.)

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Cited by (74)

“Failure-to-Cross” in Patients Undergoing Percutaneous Peripheral Intervention: The Nonreimbursed Procedure
2021, Annals of Vascular Surgery
Citation Excerpt :
Patients undergoing tibiopedal retrograde access, sometimes favored in lesions that cannot be accessed antegrade, were excluded. The presented financial data are admittedly derivative and tabulated from a specific, proprietary accounting system that may not be relevant in other institutions.17 In summary, patients undergoing PPI whose lesions cannot be crossed fare worse than patients undergoing successful percutaneous recanalization.
Percutaneous peripheral intervention (PPI) is often the first mode of therapy for patients with symptomatic arterial occlusive disease. Technical success generally remains high although “failure-to-cross” still complicates 5–20% of cases. Extended efforts to cross long, occlusive lesions can utilize significant hospital and practitioner resources. The hospital is typically reimbursed for this effort as facility fees are charged by the hour and materials are charged per use. However, given the lack of a CPT® code for “failure-to-cross,” practitioners are rarely appropriately compensated. The purpose of this study is to analyze the predictors, technical details, outcomes, and costs of “failure-to-cross” during PPI.
All PPI procedures over a 2-year period at a single institution were retrospectively reviewed. Clinical characteristics, results, costs, and reimbursements obtained from hospital cost accounting were compared among successful therapeutic interventions, crossing failures, and diagnostic angiograms without attempted intervention.
A total of 146 consecutive PPIs were identified; the rate of “failure-to-cross” was 11.6% (17 patients). The majority of patients with “failure-to-cross” were male (82%) with single-vessel runoff (53%). Compared to successful interventions, the incidences of chronic limb-threatening ischemia (82% vs. 70%, P = 0.34) and infrapopliteal occlusive disease were similar (47% vs. 31%, P = 0.20). “Failure-to-cross” procedures were just as long as successful procedures; there were no significant differences in fluoroscopy time (27 ± 10 vs. 24 ± 14 min, P = 0.52), in-room time (106 ± 98 vs. 103 ± 44 min, P = 0.84), or contrast dye volume utilization (73 ± 37 vs. 96 ± 54 mL, P = 0.12). As expected, “failure-to-cross” procedures incurred far higher hospital charges and costs compared to noninterventional diagnostic angiograms (charges $13,311 ± 6,067 vs. $7,690 ± 1,942, P < 0.01; costs $5,289 ± 2,099 vs. $2,826 ± 1,198, P < 0.01). Despite the additional time and effort spent attempting to cross difficult lesions, the operators were reimbursed at the same low rate as a purely diagnostic procedure (average fee charge $7,360; average reimbursement $992). After 1 year, the 17 patients in whom lesions could not be crossed were treated with advanced interventional procedures with success (n = 2), surgical bypass grafting (n = 5), extremity amputation (n = 4), or no additional intervention in their salvaged limb (n = 6).
Patients whose lesions cannot be crossed during PPI fare worse than patients undergoing successful interventions. Hospital costs and charges appropriately reflect the high technical difficulty and resource utilization of extended attempts at endovascular therapy. For practitioners, crossing lesions during PPI is truly a “pay-for-performance” procedure in that only successful procedures are reasonably reimbursed.
In-Hospital Costs and Costs of Complications of Chronic Total Occlusion Angioplasty: Insights From the OPEN-CTO Registry
2019, JACC: Cardiovascular Interventions
The aim of this study was to describe the costs of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and the association of complications during CTO PCI with costs and length of stay (LOS).
CTO PCI generally requires more procedural resources and carries higher risk for complications than PCI of non-CTO vessels. The costs of CTO PCI using the hybrid approach have not been described, and no studies have examined the impact of complications on in-hospital costs and LOS in this population.
Costs were calculated for 964 patients in the 12-center OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry using prospectively collected resource utilization and billing data. Multivariate models were developed to estimate the incremental costs and LOS associated with complications. Attributable costs and LOS were calculated by multiplying the independent cost of each event by its frequency in the population.
Mean costs for the index hospitalization were $17,048 ± 9,904; 14.5% of patients experienced at least 1 complication. Patients with complications had higher mean hospital costs (by $8,603) and LOS (by 1.5 days) than patients without complications. Seven complications were independently associated with increased costs and 6 with LOS; clinically significant perforation and myocardial infarction had the greatest attributable cost per patient. Overall, complications accounted for $911 per patient in hospital costs (5.3% of the total costs) and 0.2 days of additional LOS.
Complications have a significant impact on both LOS and in-hospital costs for patients undergoing CTO PCI. Methods to identify high-risk patients and develop strategies to prevent complications may reduce CTO PCI costs.
Longitudinal analysis of hospital charges following injury in a level 1 pediatric trauma system
2018, Journal of Pediatric Surgery
The treatment of injured children contributes substantially to the financial burden of a health care system. The purpose of this study was to characterize these charges at a level-1 pediatric trauma center.
Financial data for children (< 14 years) admitted for traumatic injury from 1/2009 to 12/2014 were analyzed. The charges of the index admission and first two years following discharge were evaluated.
5853 trauma patients were included with average annual charges of $11,128,730. The most common mechanisms of injury were fall (44%), sports (12%), and bike (9%). The median ISS was 6 (IQR 4–10) with a mortality rate of 1.8% and Z-score of 13.04 (p < 0.001). The overall total charges per patient during the index admission were $9513. Spinal cord and major abdominal injuries had the greatest charges per patient ($55,560 and $23,618 respectively) primarily owing to hospital LOS. During the first year after discharge, the total charges per patient were $1733, of which spinal cord injury resulted in highest overall ($19,426), owing to inpatient rehabilitation. For all other injury patterns, mean total charges per patient were $2376 (range $791-$3573).
The value proposition in health care requires us to define outcomes relative to costs. Injury severity, major injury location, and hospital length of stay are the highest contributors for the financial burden of pediatric traumatic injury, while inpatient readmissions and inpatient rehabilitation drove higher charges in the years following discharge.
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Cost-effectiveness analysis in cardiac surgery: A review of its concepts and methodologies
2018, Journal of Thoracic and Cardiovascular Surgery
Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial
2017, JACC: Cardiovascular Interventions
Citation Excerpt :
Nonprocedural hospital care costs were estimated from a regression model based on ABSORB III–eligible patients who underwent elective PCI procedures performed between 2012 and 2013 and whose data were included in the Medicare Provider and Review database (n = 290,776) (12). Hospital charges were converted to costs using hospital- and cost center-specific cost-to-charge ratios (13,14). A linear regression model was then developed, with total index hospitalization cost as the outcome and length of stay and in-hospital complications (including repeat PCI, MI, coronary artery bypass graft surgery, stroke, atrial or ventricular arrhythmia, pacemaker placement, vascular complication, or death) as predictors.
The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention.
The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown.
We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees).
Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups.
Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906)
Cost-Effectiveness of Endovascular Femoropopliteal Intervention Using Drug-Coated Balloons Versus Standard Percutaneous Transluminal Angioplasty: Results From the IN.PACT SFA II Trial
2016, JACC: Cardiovascular Interventions
The aim of this study was to evaluate the cost-effectiveness of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA).
Recent trials have reported lower rates of target lesion revascularization with DCB angioplasty versus standard PTA. However, the cost-effectiveness of DCB angioplasty is unknown.
A prospective economic study was performed alongside the IN.PACT SFA II (IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA]) trial, which randomized 181 patients with femoropopliteal disease to the IN.PACT DCB versus standard PTA. Resource use data were collected over 2-year follow-up, and costs were assigned using resource-based accounting and billing data. Health utilities were assessed using the EuroQol 5-dimensions questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a decision-analytic model on the basis of empirical data from the trial assuming identical long-term mortality.
Initial costs were $1,129 per patient higher with DCB angioplasty than standard PTA, driven by higher costs for the DCB itself. Between discharge and 24 months, target limb–related costs were $1,212 per patient lower with DCB angioplasty such that discounted 2-year costs were similar for the 2 groups ($11,277 vs. $11,359, p = 0.97), whereas QALYs tended to be greater among patients treated with DCBs (1.53 ± 0.44 vs. 1.47 ± 0.42, p = 0.40). The probability that DCB angioplasty is cost-effective compared with standard PTA was 70% using a threshold of $50,000 per QALY gained and 79% at a threshold of $150,000 per QALY gained.
For patients with femoropopliteal disease, DCB angioplasty is associated with better 2-year outcomes and similar target limb–related costs compared with standard PTA. Formal cost-effectiveness analysis on the basis of these results suggests that use of the DCB angioplasty is likely to be economically attractive.

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^☆: Supported in part by a Clinician-Scientist Award from the American Heart Association (D.J.C.) and by unrestricted grants from Guidant (Santa Clara, Calif) and Possis Medical (Minneapolis, Minn)

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Clinical Investigations: Outcomes, Health Policy, and Managed CareComparison of analytic approaches for the economic evaluation of new technologies alongside multicenter clinical trials☆

Abstract

Clinical Investigations: Outcomes, Health Policy, and Managed Care
Comparison of analytic approaches for the economic evaluation of new technologies alongside multicenter clinical trials☆