Economic evaluation of the 70-gene prognosis-signature (MammaPrint®) in hormone receptor-positive, lymph node-negative, human epidermal growth factor receptor type 2-negative early stage breast cancer in Japan
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The 70-gene prognosis-signature is validated as a good predictor of recurrence for hormone receptor-positive (ER+), lymph node-negative (LN−), human epidermal growth factor receptor type 2-negative (HER2−) early stage breast cancer (ESBC) in Japanese patient population. Its high cost and potential in avoiding unnecessary adjuvant chemotherapy arouse interest in its economic impact. This study evaluates the cost-effectiveness of including the assay into Japan’s social health insurance benefit package. An economic decision tree and Markov model under Japan’s health system from the societal perspective is constructed with clinical evidence from the pool analysis of validation studies. One-way sensitivity analyses are also performed. Incremental cost-effectiveness ratio is estimated as ¥3,873,922/quality adjusted life year (QALY) (US$43,044/QALY), which is not more than the suggested social willingness-to-pay for one QALY gain from an innovative medical intervention in Japan, ¥5,000,000/QALY (US$55,556/QALY). However, sensitivity analyses show the instability of this estimation. The introduction of the assay into Japanese practice of ER+, LN−, HER2− ESBC treatment by including it to Japan’s social health insurance benefit package has a reasonable chance to be judged as cost-effective and may be justified as an efficient deployment of finite health care resources.
KeywordsAdjuvant therapy Breast cancer Cost-effectiveness Gene diagnosis 70-gene prognosis-signature
The study was funded by Japan’s Ministry of Health, Labour and Welfare research grant, ‘Reduction and lowering of recurrence risk, toxicity and pharmacoeconomic cost by prediction of efficacy for anti-cancer agents in breast cancer patients’, led by Masakazu Toi (H22-GANRINSHO-IPPAN-039), and was also supported by Grant-in-Aid for Scientific Research (C) by Japan’s Ministry of Education, Culture, Sports, Science and Technology (No. 22590451).
Conflict of interest
All authors declare that there is no possible conflict of interest.
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