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Cost-effectiveness analysis of adjuvant therapy for node positive breast cancer in Korea: docetaxel, doxorubicin and cyclophosphamide (TAC) versus fluorouracil, doxorubicin and cyclophosphamide (FAC) |
Lee SG, Jee YG, Chung HC, Kim SB, Ro J, Im YH, Im SA, Seo JH |
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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. CRD summary The objective was to assess the cost-effectiveness of docetaxel, doxorubicin, and cyclophosphamide compared with fluorouracil, doxorubicin, and cyclophosphamide for node-positive breast cancer patients. The authors concluded that the docetaxel regimen appeared to be cost-effective in the management of early breast cancer in Korea. The methods were adequate and they and the results were satisfactorily reported, but the main trial contained no Korean patients and these results might not be generalisable to Korea. Type of economic evaluation Cost-effectiveness analysis, cost-utility analysis Study objective The objective was to assess the cost-effectiveness of docetaxel, doxorubicin, and cyclophosphamide compared with fluorouracil, doxorubicin, and cyclophosphamide for node-positive breast cancer patients. Interventions The two adjuvant therapies were docetaxel, doxorubicin, and cyclophosphamide; and fluorouracil, doxorubicin, and cyclophosphamide. Location/setting South Korea/secondary care. Methods Analytical approach:A Markov decision-analytic model was constructed to project the lifetime clinical outcomes and costs of the two interventions. The authors reported that the combined perspective of the Korean National Health Insurance Corporation and patients was adopted.
Effectiveness data:The clinical and effectiveness data were derived from a randomised controlled trial (RCT) and supplemented with data from published literature. The main outcomes were the disease-free survival, overall survival, and the incidence of adverse events (diarrhoea, mucositis, infections, and febrile neutropenia). These data were from the trial, which included 1,491 early breast cancer patients, who were randomised after primary surgery to either the docetaxel regimen or the fluorouracil regimen.
Monetary benefit and utility valuations:The utility values were from a published study.
Measure of benefit:Quality-adjusted life-years (QALYs) gained and life-years gained were the measures of benefit. As they could be generated over the lifetime of the patient, future benefits were discounted at an annual rate of 5%.
Cost data:The direct costs were those of: adjuvant chemotherapy; prophylactic prevention of febrile neutropenia; adverse events; follow-up; and relapse, including diagnostic examination, chemotherapy and follow-up, and supportive care. The resource use and cost data were derived from the raw data for all medical claims from women with breast cancer who were treated at three Korean hospitals. The price year was 2005 and costs were reported in Korean won (KRW). As they could be incurred over the lifetime of the patient, future costs were discounted at an annual rate of 5%.
Analysis of uncertainty:: A sensitivity analysis was performed by varying the model parameters over extreme ranges. A probabilistic sensitivity analysis was also performed on the reduction in risk of relapse with the docetaxel regimen. Results The average life-years gained with the docetaxel regimen were 13.9 compared with 13.0 with the fluorouracil regimen. The average QALYs gained with the docetaxel regimen were 11.6 compared with 10.8 with the fluorouracil regimen. The average cost per patient was KRW 22,610,436 with the docetaxel regimen compared with KRW 15,146,369 with the fluorouracil regimen.
Compared with the fluorouracil regimen, the docetaxel regimen was associated with an additional cost per life-year gained of KRW 8,025,879, and an additional cost per QALY gained of KRW 8,885,794.
The most sensitive parameter was the proportion of patients receiving prophylactic granulocyte colony stimulating factor in the docetaxel arm. In the probabilistic sensitivity analysis of disease-free survival with the docetaxel regimen, when the lower bounds were applied, the incremental cost per life-year gained ranged from KRW 7,839,314 to KRW 19,496,500 and the incremental cost per QALY gained ranged from KRW 8,896,300 to KRW 20,996,231. Authors' conclusions The authors concluded that the docetaxel regimen appeared to be cost-effective in the management of early breast cancer in Korea. CRD commentary Interventions:The interventions were reported clearly and in detail, and the usual practice appears to have been included.
Effectiveness/benefits:The effectiveness data were mainly derived from a RCT, with some from published literature. The authors reported brief details of this trial, including the outcomes measured and the study sample. They acknowledged that it included no Korean patients. The main effectiveness estimates appear to have been internally valid, but no systematic review of the literature was performed and it is unclear if all the relevant evidence was included. The methods used to derive the utility data for the disease states were not reported, but the source was referenced.
Costs:The authors reported that the perspective of both the health care system and the patient was adopted. This joint perspective was adopted because 30% to 40% of hospital fees were paid by patients in Korea. All the major cost categories relevant to this perspective appear to have been included, as were all the relevant costs. All the resource quantities and costs were obtained, with the help of medical oncologists, from a review of the medical claims of breast cancer patients in three hospitals. The price year, time horizon, discount rate, and currency were all appropriately reported.
Analysis and results:All the evidence on costs and outcomes was synthesised in a Markov model. The full details of the model structure, including a diagram, were provided. The authors reported that a probabilistic sensitivity analysis was undertaken to assess the impact of uncertainty, but this was only undertaken for one model parameter and many of the details, such as the functional form of the distribution and the number of simulations, were not reported. The authors stated that the main limitation of their study was the fact that the trial used for the effectiveness measures did not contain any Korean patients.
Concluding remarks:: The methods were adequate and, generally, both the methods and the results were satisfactorily reported, but as the main trial contained no Korean patients, these results might not be generalisable to Korea. Funding Funded by a grant from sanofi-aventis Korea. Bibliographic details Lee SG, Jee YG, Chung HC, Kim SB, Ro J, Im YH, Im SA, Seo JH. Cost-effectiveness analysis of adjuvant therapy for node positive breast cancer in Korea: docetaxel, doxorubicin and cyclophosphamide (TAC) versus fluorouracil, doxorubicin and cyclophosphamide (FAC) Breast Cancer Research and Treatment 2009; 114(3): 589-595 Indexing Status Subject indexing assigned by NLM MeSH Adult; Antineoplastic Combined Chemotherapy Protocols /economics /therapeutic use; Breast Neoplasms /drug therapy /economics; Clinical Trials as Topic /economics; Cost-Benefit Analysis /economics; Cyclophosphamide /administration & Disease-Free Survival; Doxorubicin /administration & Female; Fluorouracil /therapeutic use; Humans; Korea; Middle Aged; Taxoids /administration & Treatment Outcome; dosage; dosage /therapeutic use; dosage /therapeutic use AccessionNumber 22009101100 Date bibliographic record published 09/09/2009 Date abstract record published 13/10/2010 |
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