Epidemiology

Breast Cancer Research and Treatment

, Volume 112, Issue 1, pp 175-187

Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan

  • Masahide KondoAffiliated withDepartment of Health Care Policy and Management, Graduate School of Comprehensive Human Sciences, University of TsukubaClinical Research Division, Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital Email author 
  • , Shu Ling HoshiAffiliated withDoctoral Program in Human-Care Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba
  • , Hiroshi IshiguroAffiliated withDepartment of Translational Clinical Oncology, Graduate School of Medicine, Kyoto University
  • , Hiroshi YoshibayashiAffiliated withDepartment of Surgery, Graduate School of Medicine, Kyoto University
  • , Masakazu ToiAffiliated withDepartment of Surgery, Graduate School of Medicine, Kyoto University

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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 ¥/QALY (26,065 US$/QALY) in the comparison between NCCN guided-treatment vs. the assay-guided treatment, and as 1,239,055 ¥/QALY (10,774 US$/QALY) in the comparison between St Gallen guided-treatment vs. the assay-guided treatment. Budget impact is estimated as ¥2,638 million (US$23 million) to ¥3,225 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.

Keywords

Breast cancer Budget impact Cost-effectiveness Gene diagnosis 21-gene signature Tailor-made medicine