title: Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan.
abstract: The 21-gene reverse transcriptase-polymerase chain reaction assay with a patented algorithm is validated as a good predictor of prognosis and potential benefit from adjuvant chemotherapy for lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer, while its high cost raises concern about how to finance it. Cost-effectiveness analysis comparing prevalent National Comprehensive Cancer Network (NCCN) guideline/St Gallen recommendation-guided treatment with the assay-guided treatment is carried out with budget impact estimation in the context of Japan's health care system. Incremental cost-effectiveness ratios are estimated as 2,997,495 yen/QALY (26,065 US$/QALY) in the comparison between NCCN guided-treatment vs. the assay-guided treatment, and as 1,239,055 yen/QALY (10,774 US$/QALY) in the comparison between St Gallen guided-treatment vs. the assay-guided treatment. Budget impact is estimated as yen2,638 million (US$23 million) to yen3,225 million (US$28 million) per year. The routine use of the assay is indicated as cost-effective. And the budget impact could be judged as within fundable level.
authors: Department of Health Care Policy and Management, Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8577, Japan. mkondo@md.tsukuba.ac.jp
authors: Masahide
authors: M
authors: Kondo
authors: Shu Ling
authors: SL
authors: Hoshi
authors: Hiroshi
authors: H
authors: Ishiguro
authors: Hiroshi
authors: H
authors: Yoshibayashi
authors: Masakazu
authors: M
authors: Toi
mesh_terms: D001943:Breast Neoplasms / Q000191:economics* / Q000235:genetics* / Q000473:pathology; D003362:Cost-Benefit Analysis; D003663:Decision Trees; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009010:Monte Carlo Method; D009363:Neoplasm Proteins / Q000235:genetics*; D009367:Neoplasm Staging; D011379:Prognosis; D012333:RNA, Messenger / Q000235:genetics / Q000378:metabolism; D011960:Receptors, Estrogen / Q000378:metabolism*; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000191:economics*; D012680:Sensitivity and Specificity
chemical_list: D009363:Neoplasm Proteins; D012333:RNA, Messenger; D011960:Receptors, Estrogen