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Economic implications of hepatic arterial infusion chemotherapy in treatment of nonresectable colorectal liver metastases |
Durand-Zaleski I, Roche B, Buyse M, Carlson R, O'Connell M J, Rougier P, Chang A E, Sondak V K, Kemeny M M, Allen-Mersh T G, Fagniez P L, Le Bourgeois J P, Piedbois P |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Using hepatic arterial infusion (HAI)of 5-fluoro-2'-deoxyuridine versus supportive care or intravenous chemotherapy in the treatment of nonresectable liver metastases from colorectal cancer.
Economic study type Cost-effectiveness analysis.
Study population Patients with nonresectable liver metastases resulting from colorectal cancer.
Setting Hospital. The economic study was carried out in Paris, France, and Palo Alto, California, USA.
Dates to which data relate The effectivenessdata were derived from seven studies published in 1986, 1987, 1989, 1990, 1992, and a meta-analysis published in 1994. Resource utilisation data were collected in 1995. 1995 prices were used.
Source of effectiveness data The evidence for the final outcomes was derived from a synthesis of previously completed studies.
Link between effectiveness and cost data The costing was not undertaken on the same patient sample as that used in the effectiveness study.
Outcomes assessed in the review The outcome assessed in the meta-analysis was mean survival.
Study designs and other criteria for inclusion in the review Randomized controlled trials based on the intention to treat principle.
Sources searched to identify primary studies Criteria used to ensure the validity of primary studies Not stated although the study containing the meta analysis stipulated its own inclusion criteria.
Methods used to judge relevance and validity, and for extracting data The original data were extracted from the primary studies and the life expectancy outcome was estimated by the mean survival obtained from applying Kaplan-Meier methods to that data.
Number of primary studies included Seven studies were included.
Methods of combining primary studies Investigation of differences between primary studies Five studies used the intravenous chemotherapy option whereas the other two studies used the option of symptom palliation or ad libitum intravenous chemotherapy with, in most cases, fluorouracil alone.
Results of the review The HAI group had a mean survival time of 16.3 (SE 0.7) months versus 13.1 (SE 0.7) months for the control (no HAI) group (logrank P= 0.0009).
Measure of benefits used in the economic analysis Gain in life expectancy was used as the benefit measure. A 5% discount rate was applied to the life years gained.
Direct costs Quantities were not reported separately from costs. The cost items were reported separately and the costs were discounted. The cost analysis was based on costs associated with the initial procedure, chemotherapy cycles, and main complications for the duration of the patient follow-up. Overhead and capital costs were included, whereas protocol-driven costs were excluded. The cost analysis was performed from the perspective of a health care system. The source of resource utilisation data was data from the two study sites in Paris and Palo Alto. The source of unit cost data was actual data from two centres (Paris and Palo Alto), each analysed separately. The price date was 1995. The costs of symptom palliation were omitted since they were believed to be common to the study groups.
Sensitivity analysis A sensitivity analysis was conducted by excluding the data for those patients receiving the symptomatic palliation option only. This was equivalent to omission of two of the studies with such a comparator, so that only five studies were included in the meta-analysis used to derive the estimates of effectiveness.
Estimated benefits used in the economic analysis The mean gain in life expectancy by the hepatic arterial infusion group (relative to the control and using a 5% discount rate) was 3.2 months.
Cost results Using a 5% discount rate, the mean total cost in France was $29,562, for the intervention, and $9,926 for the control. For Palo Alto, USA, the corresponding figures were $25,208 and $5,928.
Synthesis of costs and benefits An incremental analysis was performed. The cost-effectiveness ratios, incremental (discounted) cost per (discounted) life year gained by the intervention relative to the control, in Paris were $73,635 and in Palo Alto were $72,300. These figures were derived using the price base of 1995 and a 5% discount rate for both costs and benefits. The sensitivity analysis yielded cost-effectiveness ratios of $73,680 for Paris and $87,012 for Palo Alto.
Authors' conclusions The cost-effectiveness of localized chemotherapy for colorectal liver metastases is within the range of accepted treatments for serious medical conditions, although it may be considered borderline by policy-makers in some countries.
CRD COMMENTARY - Selection of comparators The reason for the choice of comparators is clear. They represented the standard practice in the treatment of colorectal cancer. You should consider whether they are widely used health technologies in your own setting.
Validity of estimate of measure of benefit The estimate of the benefit measure is likely to be internally valid even though the differences between studies (for example,in terms of the patient population and the way in which the outcomes were measured) and their potential effects on the results were not analysed.
Validity of estimate of costs Quantities of resource use were not analysed separately from the costs. Adequate details of methods of cost estimation were provided in the paper. The indirect costs were not included in the economic study.
Other issues The conclusions were justified given the uncertainties in effectiveness and unit cost data. The issue of generalisability was addressed by the sensitivity analysis, with the results showing small relative variations between the health systems of France and California, USA.
Implications of the study As the authors recognized, further prospective studies are warranted, which consider additional aspects such as quality of life and costs (savings) associated with early return to work due to the administration of hepatic arterial infusion. Nevertheless, the present study yields some evidence of the potential benefits associated with such an intervention strategy.
Bibliographic details Durand-Zaleski I, Roche B, Buyse M, Carlson R, O'Connell M J, Rougier P, Chang A E, Sondak V K, Kemeny M M, Allen-Mersh T G, Fagniez P L, Le Bourgeois J P, Piedbois P. Economic implications of hepatic arterial infusion chemotherapy in treatment of nonresectable colorectal liver metastases. Journal of the National Cancer Institute 1997; 89(11): 790-795 Indexing Status Subject indexing assigned by NLM MeSH Antimetabolites, Antineoplastic /administration & Colorectal Neoplasms /economics /pathology; Cost-Benefit Analysis; Decision Making; Drug Screening Assays, Antitumor; Drug Therapy /economics; Floxuridine /administration & Hepatic Artery; Humans; Infusions, Intra-Arterial; Liver Neoplasms /drug therapy /economics /secondary; dosage /economics; dosage /economics AccessionNumber 21997000829 Date bibliographic record published 31/01/1999 Date abstract record published 31/01/1999 |
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