Cost-Effectiveness Analysis of Germline and Somatic BRCA Testing in Patients With Advanced Ovarian Cancer
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Background: BRCA testing is necessary for establishing a management strategy for ovarian cancer. Several BRCA testing strategies, including germline and somatic testing, are implemented in clinical practice in Korea. We aimed to comparatively evaluate their cost-effectiveness from patients’ perspective. Methods: We developed a decision model comprising five BRCA testing strategies implemented in Korea: (1) germline testing first, followed by somatic tumor testing for patients without a germline variant; (2) somatic testing first, followed by germline testing for patients with a variant detected by somatic testing; (3) both germline and somatic testing; (4) germline testing alone; and (5) somatic testing alone, with no testing as the comparator. One-way sensitivity analysis was conducted to test the uncertainty of key parameters. Results: Assuming a willingness-to-pay of $20,000 per progression-free life-year gain (PF-LYG), all five strategies were considered cost-effective. Strategy 4 was the most cost-effective option, with an incremental cost-effectiveness ratio (ICER) of $2,547.7 per PF-LYG, followed by strategy 1, with an ICER of $3,978.4 per PF-LYG. Even when the parameter values were varied within the possible range, the ICERs of all strategies did not exceed the willingness-to-pay threshold. Conclusions: Considering the importance of knowing a patient’s BRCA gene status, germline testing first, followed by somatic testing, may be a reasonable option.
Abstract
Background: BRCA testing is necessary for establishing a management strategy for ovarian cancer. Several BRCA testing strategies, including germline and somatic testing, are implemented in clinical practice in Korea. We aimed to comparatively evaluate their cost-effectiveness from patients’ perspective. Methods: We developed a decision model comprising five BRCA testing strategies implemented in Korea: (1) germline testing first, followed by somatic tumor testing for patients without a germline variant; (2) somatic testing first, followed by germline testing for patients with a variant detected by somatic testing; (3) both germline and somatic testing; (4) germline testing alone; and (5) somatic testing alone, with no testing as the comparator. One-way sensitivity analysis was conducted to test the uncertainty of key parameters. Results: Assuming a willingness-to-pay of $20,000 per progression-free life-year gain (PF-LYG), all five strategies were considered cost-effective. Strategy 4 was the most cost-effective option, with an incremental cost-effectiveness ratio (ICER) of $2,547.7 per PF-LYG, followed by strategy 1, with an ICER of $3,978.4 per PF-LYG. Even when the parameter values were varied within the possible range, the ICERs of all strategies did not exceed the willingness-to-pay threshold. Conclusions: Considering the importance of knowing a patient’s BRCA gene status, germline testing first, followed by somatic testing, may be a reasonable option.
참고문헌 (37)
- Daly MB, "Genetic", familial high-risk assessment: breast, ovarian, and pancreatic, version 2.2021, NCCN Clinical Practice Guidelines in Oncology, 2021, pp.19, 77~102
- Konstantinopoulos PA, "Germline and somatic tumor testing in epithelial ovarian cancer : ASCO guideline", J Clin Oncol, 38, pp.1222~1245 (2020)
- Armstrong DK, "Ovarian cancer, version 2.2020, NCCN Clinical Practice Guidelines in Oncology", J Natl Compr Canc Netw, 19, pp.191~226 (2021)
- US Preventive Services Task Force, "Risk assessment, genetic counseling, and genetic testing for BRCA-related cancer: US Preventive Services Task Force recommendation statement", JAMA, 322, pp.652~665 (2019)
- Fong PC, "Inhibition of poly(ADP-ribose)polymerase in tumors from BRCA mutation carriers", N Engl J Med, 361, pp.123~134 (2009)
- Moore K, "Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer", N Engl J Med, 379, pp.2495~2505 (2018)
- Banerjee S, "Maintenance olaparib for patients(pts)with newly diagnosed, advanced ovarian cancer(OC)and a BRCA mutation(BRCAm) : 5-year(y)follow-up(f", u)from SOLO1, 2020, pp.31, S613~
- González-Martín A, "Niraparib in patients with newly diagnosed advanced ovarian cancer", N Engl J Med, 381, pp.2391~2402 (2019)
- Annual report of cancer statistics in Korea in 2018, "Korea Central Cancer Registry National Cancer Center", Ministry of Health and Welfare, ~ (2020)
- Alsop K, "BRCA mutation frequency and patterns of treatment response in BRCA mutation-positive women with ovarian cancer : a report from the Australian Ovarian Cancer Study Group", J Clin Oncol, 30, pp.2654~2663 (2012)
- Norquist BM, "Inherited mutations in women with ovarian carcinoma", JAMA Oncol, 2, pp.482~490 (2016)
- Pennington KP, "Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas", Clin Cancer Res, 20, pp.764~775 (2014)
- Cunningham JM, "Clinical characteristics of ovarian cancer classified by BRCA1, BRCA2, and RAD51C status", Sci Rep, 4, pp.4026~ (2014)
- Jaeeun Yoo, "Clinical Validity of Next-Generation Sequencing Multi-Gene Panel Testing for Detecting Pathogenic Variants in Patients With Hereditary Breast-Ovarian Cancer Syndrome", Annals of Laboratory Medicine, 40(2), pp.148~154 (2020), 대한진단검사의학회[DOI]
- "Health Insurance Review and Assessment Service, Health insurance benefit cost (2022.02)" (2022)[URL]
- World Health Organization, "Republic of Korea health system review: WHO Regional Office for the Western Pacific", xviii~102 (2015)
- Muennig P, "Cost-effectiveness analysis in health: a practical approach", pp.199~222 (2016), Jossey-Bass
- Song HJ, "Evaluation of willingness to pay per quality-adjusted life year for a cure: A contingent valuation method using a scenario-based survey", Medicine(Baltimore), 97, pp.e12453~ (2018)
- Moya-Alarcón C, "Cost-utility analysis of germline BRCA1", 2 testing in women with high-grade epithelial ovarian cancer in Spain, 2019, pp.21, 1076~1084
- Eccleston A, "A cost-effectiveness evaluation of germline BRCA1 and BRCA2 testing in UK women with ovarian cancer", Value Health, 20, pp.567~576 (2017)
- Kwon JS, "BRCA mutation testing for first-degree relatives of women with high-grade serous ovarian cancer", Gynecol Oncol, 152, pp.459~464 (2019)
- Zhong L, "Cost-effectiveness of niraparib and olaparib as maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer", J Manag Care Spec Pharm, 24, pp.1219~1228 (2018)
- Gonzalez R, "Cost-effectiveness analysis comparing ‘PARP inhibitors-for-all’ to the biomarker-directed use of PARP inhibitor maintenance therapy for newly diagnosed advanced stage ovarian cancer", Gynecol Oncol, 159, pp.483~490 (2020)
- Penn CA, "Cost-effectiveness of maintenance therapy based on molecular classification following treatment of primary epithelial ovarian cancer in the United States", JAMA Netw Open, 3, pp.e2028620~ (2020)
- Muston D, "Cost-effectiveness of olaparib as a maintenance treatment for women with newly diagnosed advanced ovarian cancer and BRCA1", 2 mutations in the United States, 2020, pp.159, 491~497
- David SP Tan, "Cost-effectiveness of olaparib versus routine surveillance in the maintenance setting for patients with BRCA-mutated advanced ovarian cancer after response to first-line platinum-based chemotherapy in Singapore", Journal of Gynecologic Oncology, 32(2), pp.1~14 (2021), 대한부인종양학회[DOI]
- Vos JR, "Universal tumor DNA BRCA1", 2 testing of ovarian cancer : prescreening PARPi treatment and genetic predisposition, 2020, pp.112, 161~169
- Mafficini A, "BRCA somatic and germline mutation detection in paraffin embedded ovarian cancers by next-generation sequencing", Oncotarget, 7, pp.1076~1083 (2016)
- de Jonge MM, "Validation and implementation of BRCA1", 2 variant screening in ovarian tumor tissue, 2018, pp.20, 600~611
- Fumagalli C, "Tumor BRCA test for patients with epithelial ovarian cancer : the role of molecular pathology in the era of PARP inhibitor therapy", Cancers, 11, pp.1641~ (2019)
- Rivera D, "Implementing NGS-based BRCA tumour tissue testing in FFPE ovarian carcinoma specimens : hints from a real-life experience within the framework of expert recommendations", J Clin Pathol, 74, pp.596~603 (2021)
- Kofanova O, "Standardization of the preanalytical phase of DNA extraction from fixed tissue for next-generation sequencing analyses", N Biotechnol, 54, pp.52~61 (2020)
- Hofreiter M, "DNA sequences from multiple amplifications reveal artifacts induced by cytosine deamination in ancient DNA", Nucleic Acids Res, 29, pp.4793~4799 (2001)
- Do H, "Dramatic reduction of sequence artefacts from DNA isolated from formalin-fixed cancer biopsies by treatment with uracil-DNA glycosylase", Oncotarget, 3, pp.546~558 (2012)
- Wong SQ, "Sequence artefacts in a prospective series of formalin-fixed tumours tested for mutations in hotspot regions by massively parallel sequencing", BMC Med Genomics, 7, pp.23~ (2014)
- 김윤정, "An optimized BRCA1", 2 next-generation sequencing for different clinical sample types, 2020, pp.31(1), 1~14[DOI]
- 정성미, "Trends in Risk-Reducing Mastectomy and Risk-Reducing Salpingo-Oophorectomy in Korean Carriers of the BRCA1", 2 Mutation, 2020, pp.23(6), 647~655[DOI]