Implementation of Risk-Reducing Surgery for HBOC Under Public Insurance in Japan: A Single-Center Experience
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HirokoTerui-KohbataPh.D., C.G.C.
1,2,6✉Phone81-3-5803-4085/Fax: 81-3-5803-4725Emailkohbbec@tmd.ac.jp ErikoTakamine1
MarikoKomine1
MakiGau1,2
MakikoEgawa1,3
YusukeEbana1,2
TomoyukiAruga4
KimioWakana5
MasayukiYoshida1,2
1Department of Medical GeneticsInstitute of Science Tokyo HospitalTokyoJapan
2Department of Life Science and Bioethics, Graduate School of MedicineInstitute of Science TokyoTokyoJapan
3Department of Nutrition and Metabolism in Cardiovascular Disease, Graduate School of Medical and Dental SciencesInstitute of Science TokyoTokyoJapan
4Department of Breast SurgeryInstitute of Science Tokyo HospitalTokyoJapan
5Perinatal and Gynecological DepartmentInstitute of Science Tokyo HospitalTokyoJapan
6Life Science and Bioethics Research CenterTokyo Medical and Dental University1-5-45 Yushima113-8510Bunkyo, TokyoJapan
Hiroko Terui-Kohbata 1,2、Sayako Takahashi 1, Eriko Takamine 1, Mariko Komine1, Maki Gau1,2, Makiko Egawa 1,3, Yusuke Ebana 1,2, Tomoyuki Aruga 4, Kimio Wakana 5, Masayuki Yoshida 1,2
1. Department of Medical Genetics, Institute of Science Tokyo Hospital, Tokyo, Japan
2. Department of Life Science and Bioethics, Graduate School of Medicine, Institute of Science Tokyo, Tokyo, Japan
3. Department of Nutrition and Metabolism in Cardiovascular Disease, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan
4. Department of Breast Surgery, Institute of Science Tokyo Hospital, Tokyo, Japan
5. Perinatal and Gynecological Department, Institute of Science Tokyo Hospital, Tokyo, Japan
Corresponding Author:
Hiroko Terui-Kohbata, Ph.D., C.G.C.
Life Science and Bioethics Research Center, Tokyo Medical and Dental University,
1-5-45 Yushima, Bunkyo, Tokyo 113–8510, Japan
Tel: 81-3-5803-4085 / Fax: 81-3-5803-4725
E-mail: kohbbec@tmd.ac.jp
Abstract
Background
In Japan, BRCA1/2 genetic testing and risk-reducing surgeries for hereditary breast and ovarian cancer (HBOC) became covered by public insurance in 2018 and 2020, respectively. These policy changes have improved access to preventive care by lowering financial barriers. This study examined the clinical uptake and timing of risk-reducing salpingo-oophorectomy (RRSO) and mastectomy (RRM) among women with HBOC.
Methods
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We retrospectively reviewed clinical records of HBOC patients who underwent RRSO and/or RRM under public insurance at a single institution between April 2020 and December 2024. Descriptive statistics and chi-square tests were performed.
Results
Among 23 women, 15 (65.2%) underwent RRM, 18 (78.3%) underwent RRSO, and 10 (43.5%) received both. All had a history of breast cancer but had not developed ovarian cancer. The average interval from HBOC diagnosis to surgery was 6.5 months for RRM and 11.3 months for RRSO. BRCA2 carriers had significantly longer delays to RRSO than BRCA1 carriers (p = .02). Three women deferred RRSO due to desire for childbearing.
Conclusion
Insurance coverage facilitated preventive surgery uptake, underscoring the need for individualized counseling, particularly for BRCA2 carriers.
Keywords
hereditary breast and ovarian cancer
BRCA1/2
risk-reducing mastectomy
risk-reducing salpingo-oophorectomy
insurance coverage
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Introduction
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In Japan, BRCA1/2 genetic testing was publicly insured in 2018, followed by risk-reducing salpingo-oophorectomy (RRSO) in 2020 and risk-reducing mastectomy (RRM) in 2022. These policy changes significantly expanded access to hereditary cancer prevention. However, uptake and timing of these procedures remain influenced by clinical and personal factors. This study evaluated the implementation of RRM and RRSO under insurance coverage at a single center.
Methods
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We retrospectively reviewed clinical records of HBOC patients who underwent RRSO and/or RRM between April 2020 and December 2024. Descriptive statistics and chi-square tests were applied.
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Institutional ethics approval was obtained.
Results
Implementation of RRM and RRSO
During the study period, a total of 23 women with hereditary breast and ovarian cancer syndrome (HBOC) underwent risk-reducing surgery (RRM and/or RRSO) under the Japanese public health insurance system at Institute of Science Tokyo Hospital. All 23 patients had a history of breast cancer but had not developed ovarian cancer at the time of surgery. Among them, 15 patients (65.2%) underwent RRM, 18 patients (78.3%) underwent RRSO, and 10 patients (43.5%) received both procedures (Table 1).
Table 1
Characteristics of RRM and RRSO Patients by BRCA Status
| | RRM (N = 15) | p-value | RRSO (N = 18) | p-value |
|---|
BRCA1 n = 7 | BRCA2 n = 8 | BRCA1 n = 7 | BRCA2 n = 11 |
|---|
Age at HBOC diagnosis |
Mean | 46.0 | 42.9 | 0.65 | 46.6 | 46.5 | 0.12 |
Median | 44.0 | 39.0 | 44.0 | 46.0 |
Min–Max | 34–65 | 34–65 | 34–65 | 38–59 |
Age at surgery |
Mean | 46.8 | 43.3 | 0.72 | 47.3 | 47.7 | 0.09 |
Median | 45.0 | 39.0 | 45.0 | 47.5 |
Min–Max | 39–65 | 39–66 | 35–65 | 39–59 |
Time from HBOC diagnosis to surgery |
Mean | 6.5 | 6.4 | 0.71 | 6.4 | 15.2 | 0.02 |
Median | 7.5 | 6.0 | 6.0 | 12.5 |
Min–Max | 1–11 | 1–15 | 2–12 | 2–43 |
Of the 19 women diagnosed with HBOC at the Department of Medical Genetics, 10 patients (52.6%) ultimately underwent preventive surgery. Notably, four patients were diagnosed with HBOC through non-insured (self-funded) genetic testing, and all four cited the subsequent insurance coverage of these procedures as a primary factor in their decision to proceed with preventing surgery.
The mean age at RRM was 45.1 years (median: 41.0 years; range: 34–66), and the mean age at RRSO was 47.4 years (median: 47.5 years; range: 34–65). No significant differences in age at surgery were observed between RRM and RRSO, nor between BRCA1 and BRCA2 carriers.
The mean interval from HBOC diagnosis to surgery was 6.5 months (median: 7.0 months; range: 1–15) for RRM, and 11.3 months (median: 7.0 months; range: 2–43) for RRSO. While no significant difference was found between the two groups overall, further analysis revealed that the time to RRSO was significantly longer in BRCA2 carriers than in BRCA1 carriers (BRCA1: 6.4 months; BRCA2: 15.2 months; t-test: p = .02).
Deferred RRSO Due to Desire for Childbearing
Among the patients who wished to undergo RRSO but had not yet done so, all cases (3/3) cited future childbearing as the reason for deferral (Table 2). Two of them were unmarried at the time of HBOC diagnosis but had partners with whom they were planning to conceive, and some of the retrieved oocytes were cryopreserved as fertilized embryos.
Table 2
Clinical Background of Patients
Patient | History | BRCA1/2 pathogenic variant | Age at HBOC Dx | Family History | Marital/Child Status | RRM Status / Post-Diagnosis Course |
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A | Breast cancer (33y) | BRCA1 | 34y | Maternal side: Great-aunt (ovarian cancer, age 70) | Unmarried / No children | CRRM at time of primary surgery. First child born ~ 5 years after diagnosis. Considering RRSO by year-end. |
B | Breast cancer (33y) | BRCA2 | 33y | Maternal side: Mother (breast cancer at 40), aunt (40s), cousin (40) | Unmarried / No children | CRRM performed 6 months after primary surgery with implant replacement. 2.5 years post-op, tamoxifen paused for pregnancy. |
C | Breast cancer (34y) | BRCA2 | 35y | Paternal side: Aunt (breast cancer at 50, 55) | Married / 1 child | CRRM performed at time of primary surgery. 1.5 years post-op, chemotherapy ongoing. |
Discussion
Our findings demonstrate that public insurance coverage greatly facilitated the uptake of preventive surgery among HBOC women, with just over half undergoing RRSO and/or RRM. Notably, BRCA2 carriers experienced longer delays before RRSO, potentially due to later ovarian cancer onset and fertility considerations (1).
At our institution, only one to two RRSO procedures were performed annually before 2020, but the number increased markedly after insurance coverage. In contrast, RRM had rarely been performed prior to 2022 because the out-of-pocket cost, including reconstruction, exceeded one million JPY. Insurance reimbursement thus played a pivotal role in expanding access to both procedures. These results align with previous reports showing increased uptake after policy changes (2, 3).
The variability in timing underscores the importance of individualized counseling that integrates life planning, treatment status, and gene-specific risk. Broader multicenter studies are warranted to validate these findings.
Conclusion
Insurance coverage substantially increased uptake of RRM and RRSO in Japan. Delays among BRCA2 carriers highlight the importance of individualized decision-making.
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Author Contribution
H.TK. wrote the main manuscript text and prepared tables. All authors reviewed the manuscript.
References
1.Rebbeck TR, Kauff ND, Domchek SM (2009) Meta-analysis of risk reduction estimates associated with risk-reducing salpingo-oophorectomy in BRCA1 or BRCA2 mutation carriers. J Natl Cancer Inst 101(2):80–87
2.Abe A, Nomura H, Fusegi A et al (2024) Risk-reducing decisions regarding germline BRCA pathogenic variant: focusing on the timing of genetic testing and RRSO. J Med Genet 61(4):392–398
3.Konnai K, Fujiwara H, Kitagawa M et al (2023) Impact of lower co-payments on risk-reducing salpingo-oophorectomy and BRCA testing in Japan. Arch Public Health 81(1):32