|Economic evaluation of a randomized clinical trial comparing vinorelbine, vinorelbine plus cisplatin, and vindesine plus cisplatin for non-small-cell lung cancer
|Smith T J, Hillner B E, Neighbors D M, McSorley P A, Le Chevalier T
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.
Three regimens of chemotherapy (vinorelbine, vinorelbine plus cisplatin, vindesine plus cisplatin) for the treatment of metastatic non-small-cell lung cancer
Economic study type
European patients with non-small-cell lung cancer who had participated in a previous trial.
The economic analysis was carried out in the USA.
Dates to which data relate
The years during which the data were collected for the effectiveness analysis and resource use were not stated. Although the clinical trial on which they were based was published in 1994, the article stated that the data have been updated from that study. The dates of the prices used were not stated.(Correspondence with the authors subsequent to this abstract has indicated that clinical data were from 1992-93 and cost data from 1993).
Source of effectiveness data
Link between effectiveness and cost data
The costing was undertaken retrospectively on the same patient sample as that used in the effectiveness study.
612 patients enrolled in Europe. Power calculations determined the sample size.
Randomised clinical trial based at 45 different sites in eight countries in Europe. All patients were treated until disease progression, unacceptable toxicity, stable disease for 18 weeks, or patient refusal.
Analysis of effectiveness
The analysis of the clinical study was based on intention to treat. The primary health outcome used was mean survival time for each of the treatment arms.
Vinorelbine alone resulted in a mean survival time of 41.6 weeks of survival; vinorelbine plus cisplatin added a mean survival benefit of 56 days; vindesine plus cisplatin added 19 days to the mean survival time. Compared with vindesine plus cisplatin, vinorelbine plus cisplatin gave an additional 37 days of mean survival.
The efficacy data support the use of vinorelbine plus cisplatin rather than vinorelbine alone or vindesine plus cisplatin.
Measure of benefits used in the economic analysis
The outcome measure used in the economic analysis was life years gained. Mean survival time for each treatment was estimated using the Kaplan-Meier method.
Costs were not discounted, as more than 90% of patients were dead at 2 years. The estimation of quantities was based on published information from the European trial. However, because the European trial did not prospectively collect economic data, financial data from the USA were used to estimate treatment costs. All patients were assumed to have similar costs for palliative radiation therapy, hospice care, and terminal care. All patients received identical supportive care regardless of which, if any, chemotherapy was given. The efficacy or cost of second-line chemotherapy or supportive terminal care was not calculated. Inpatient and outpatient charge data on similar NSCLC patients being treated on clinical trials, including vinorelbine, and local ratios of cost to charge were used to calculate single and total treatment and toxicity costs.
Sensitivity analyses were performed on all important variables, including clinical efficacy, treatment costs and toxicity costs.
Estimated benefits used in the economic analysis
Vinorelbine alone resulted in a mean survival time of 41.6 weeks of survival; vinorelbine plus cisplatin, compared with vinorelbine added a mean survival benefit of 56 days. Vindesine plus cisplatin added 19 days to the mean survival time. Compared with vindesine plus cisplatin, vinorelbine plus cisplatin gave an additional 37 days of mean survival.
Vinorelbine alone had the lowest costs, because its use required fewer antiemetic drugs and less laboratory monitoring, and did not have the additional cost of cisplatin. Vinorelbine plus cisplatin had the highest drug and overall treatment costs.
The total cost per 100 persons for vinorelbine alone was $448,257;
for vindesine + cisplatin it was $563,054;
and for vinorelbine + cisplatin it was $719,767.
The incremental cost per patient of vinorelbine + cisplatin versus vindesine + cisplatin was $1,570;
the incremental cost per patient of vindesine + cisplatin versus vinorelbine alone was $1,150;
and the incremental cost per patient of vinorelbine + cisplatin versus vinorelbine alone was $2,700.
The only toxicity that would incur significant cost, febrile neutropenia requiring hospitalization, occurred only 20 times during more than 9,000 weeks of chemotherapy experience and did not vary significantly among the three treatment arms. The cost of the two toxicities accounted for less than 5% of the total cost, regardless of regimen.
Synthesis of costs and benefits
Vinorelbine plus cisplatin, compared with vinorelbine alone, added 56 days at an incremental cost-effectiveness of $48 per day, or $17,700 per year of life gained.
Similarly, vindesine plus cisplatin compared with vinorelbine alone added 19 days at an incremental cost-effectiveness of $60 a day, or $22,100 per year of life gained.
Vinorelbine plus cisplatin, compared with vindesine plus cisplatin, added an additional 37 days at $42 per day, or $15,500 per year of life gained.
The sensitivity analysis showed that the cost-effectiveness of vinorelbine plus cisplatin always remains below or within the range of $20,000 to $100,000 per year of life gained.
Both the efficacy and cost-effectiveness data supported the use of vinorelbine plus cisplatin, rather than vinorelbine alone or vindesine plus cisplatin. The data showed that the cost-effectiveness of non-small-cell lung cancer chemotherapy was within the accepted benchmark for medical interventions (about $50,000 per year of life gained) under nearly all clinically relevant assumptions.
This was a post-hoc economic analysis which used effectiveness data from a large multi-centred European trial and cost data from the USA, and, as the authors noted, caution should be used when interpreting such economic analyses, although they believe that the care and costs in the USA are no different from other tertiary and community hospitals. The authors noted that their study was hampered by lack of data onlong-term resource use and cost to society, and lack of data on what chemotherapy or progressive disease did to the lives of the patients.
Source of funding
Supported in part by a grant from the Agency for Health Care Policy and Research (RO1 HS 07614)(TJS, BEH) Rockville, MD; a grant from the Office of Cancer Communications, National Cancer Institute Bethesda, MD (RFP CO 94388-63)(TJS); an unrestricted research award from Burroughs Wellcome Co, Research Triangle Park, NC (TJS, BEH); a Career Development Award from the American Cancer Society (TJS), Atlanta; and a Faculty Research Award from the American Cancer Society (BEH), Atlanta GA.
Smith T J, Hillner B E, Neighbors D M, McSorley P A, Le Chevalier T. Economic evaluation of a randomized clinical trial comparing vinorelbine, vinorelbine plus cisplatin, and vindesine plus cisplatin for non-small-cell lung cancer. Journal of Clinical Oncology 1995; 13(9): 2166-2173
Subject indexing assigned by NLM
Aged; Antineoplastic Combined Chemotherapy Protocols /economics /therapeutic use; Carcinoma, Non-Small-Cell Lung /drug therapy /economics /mortality; Cisplatin /administration & Cost-Benefit Analysis; Health Care Costs; Humans; Lung Neoplasms /drug therapy /economics /mortality; Middle Aged; Survival Rate; Vinblastine /administration & Vindesine /administration & derivatives /economics; dosage /analogs & dosage /economics; dosage /economics
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