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| Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03) |
| Kondo M, Hoshi SL, Yamanaka T, Ishiguro H, Toi M |
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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 the 21-gene signature to predict recurrence and determine adjuvant treatment for patients with lymph node negative or positive, hormone receptor positive, early-stage breast cancer. The authors concluded that the routine use of the assay, in Japan, was cost-effective. The methods were adequate, but it was unclear if all the relevant evidence was analysed. The results were reported comprehensively and, given the scope of the analysis, the authors’ conclusions appear to be appropriate. Type of economic evaluation Study objective The objective was to assess the cost-effectiveness of the 21-gene signature to predict recurrence and determine adjuvant treatment for patients with lymph node negative or positive, hormone receptor positive, early-stage breast cancer. Interventions This study evaluated the 21-gene reverse transcriptase polymerase chain reaction (RT-PCR) signature assay in two scenarios: firstly, with lymph node negative, oestrogen receptor positive, early-stage breast cancer patients; and secondly, with lymph node negative or positive, oestrogen receptor positive, early-stage breast cancer patients. The assay was compared with no assay. Location/setting Japan/in-patient secondary care. Methods Analytical approach:A published decision analytic Markov model was used to assess the costs and effects of the intervention and comparator (Kondo, et al. 2008, see 'Other Publications of Related Interest' below for bibliographic details). The patient cohort was aged 55 years, which was the average age of similar patients in a Japanese nationwide cancer registry, and patients had completed adjuvant therapy. The time horizon was the lifetime of the patient. The authors reported that a societal perspective was adopted.
Effectiveness data:The clinical and effectiveness data were from several sources, including a Japanese validation study (Toi, et al. 2010, see 'Other Publications of Related Interest' below for bibliographic details). The main effectiveness estimates were the proportion of patients classified as having an indication for chemotherapy (using St Gallen 2009 criteria), and the five- and 10-year recurrence-free survival rates. This information was mostly from the Japanese validation study, which included 200 lymph node negative patients and 280 lymph node negative or positive patients. Some clinical estimates, such as the model probabilities, were from validation studies of the assay in the USA.
Monetary benefit and utility valuations:The utility estimates were from published studies.
Measure of benefit:The benefit measure was quality-adjusted life-years (QALYs) and these were discounted at an annual rate of 3%.
Cost data:The direct costs included those costs incurred by patients and by the Japanese health care system. The categories were the 21-gene RT-PCR assay, adjuvant therapy, treatment for toxicity, monitoring after adjuvant therapy, treatment for distant cancer recurrence, and end-of-life care. These costs were from published sources, such as the national medical care fee schedule, and a nationwide survey of Japanese experts and consensus guidelines. All costs were reported in Japanese yen (JPY) and future costs were discounted at an annual rate of 3%.
Analysis of uncertainty:One-way sensitivity analyses were undertaken to assess the stability of the model’s results to variations in the estimates for the probabilities, utility weights, and costs. Different cohort ages (45 and 65 years) were investigated. The results were presented in tables and tornado diagrams. Results For lymph node negative patients, the average cost per patient was JPY 3,627,193 with no assay, compared with JPY 3,867,876 with the 21-gene assay; an additional cost of JPY 240,683. The average QALYs were 19.48 with no assay, and 20.11 QALYs with the 21-gene assay; a gain of 0.63 QALYs. Compared with no assay, the incremental cost per QALY gained with the assay was JPY 384,828.
For lymph node negative or positive patients, the average cost per patient was JPY 3,818,952 with no assay, and JPY 4,088,987 with the 21-gene assay; an additional cost of JPY 270,035. The average QALYs were 18.82 with no assay, and 19.29 with the assay; a gain of 0.47 QALYs. Compared with no assay, the incremental cost per QALY gained with the assay was JPY 568,533.
Excluding the three most influential inputs, which included the cost of the assay and its additional effectiveness over no assay, the incremental cost-utility ratios varied by less than JPY 250,000 in all the scenarios evaluated in the sensitivity analyses. Authors' conclusions The authors concluded that the routine use of the assay, for patients who were lymph node positive or negative, in Japan, was cost-effective. CRD commentary Interventions:The interventions were described.
Effectiveness/benefits:The clinical and effectiveness data were from published sources. The main effectiveness estimates were from a Japanese validation study and the details were presented. For each parameter, the authors reported the mean value, range, and their sources, but they did not report if a systematic review was performed to identify these studies. This means it is not possible to determine if all the relevant information was included in the model. QALYs were an appropriate measure of benefit, given the impact of cancer on survival and quality of life. The authors did not report the methods used to elicit the utility values, but their sources were given. These data were from Western countries as Japanese data were unavailable.
Costs:The authors reported that a societal perspective was adopted, but they did not include patient time and productivity losses. It appears that a health care system perspective, including patient payments for drugs and treatments, was taken. It seems that all the major relevant costs were included for this perspective. The sources for the cost estimates were given. The time horizon and discount rate were reported, but the price year was not, which will hamper future inflationary exercises.
Analysis and results:The costs and outcomes were synthesised in a decision-analytic Markov model, which was published elsewhere. The model structure was reported, with a diagram. The uncertainty in the model was assessed in one-way sensitivity analyses. These analyses go some way towards examining the uncertainty, but probabilistic sensitivity analyses could have better assessed the overall model uncertainty. The authors reported that the main limitation to their study was that the model was reliant some data from Western countries.
Concluding remarks:The methods were adequate, but it was unclear if all the relevant evidence was analysed. The results were reported comprehensively and, given the scope of the analysis, the authors’ conclusions appear to be appropriate. Funding Funded by Japan's Ministry of Health, Labour and Welfare, and Japan’s Ministry of Education, Culture, Sports, Science and Technology. Bibliographic details Kondo M, Hoshi SL, Yamanaka T, Ishiguro H, Toi M. Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03) Breast Cancer Research and Treatment 2011; 127(3): 739-749 Other publications of related interest Kondo M, Hoshi SL, Ishiguro H, Yoshibayashi H, Toi M. Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan. Breast Cancer Research and Treatment 2008; 112(1): 175-187.
Toi M, Iwata H, Yamanaka T Masuda N, Ohno S, Nakamura S, Nakayama T, Kashiwaba M, Kamigaki S, Kuroi K, Japan Breast Cancer Research Group - Translational Research Group. Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population. Cancer 2010; 116(13): 3112-3118. Indexing Status Subject indexing assigned by NLM MeSH Breast Neoplasms /economics /genetics /pathology; Chemotherapy, Adjuvant; Cost-Benefit Analysis; Female; Humans; Japan; Lymphatic Metastasis; Neoplasm Staging; Quality-Adjusted Life Years; Reagent Kits, Diagnostic /economics; Receptors, Estrogen /genetics; Receptors, Progesterone /genetics; Reverse Transcriptase Polymerase Chain Reaction; Sensitivity and Specificity AccessionNumber 22011001103 Date bibliographic record published 12/10/2011 Date abstract record published 20/10/2011 |
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