Cost–Effectiveness of
            <i>BRCA1/2</i>
            Mutation Profiling to Target Olaparib Use in Patients with Metastatic Breast Cancer

Saito, Shota; Nakazawa, Katsuhito; Nagahashi, Masayuki; Ishikawa, Takashi; Akazawa, Kouhei

doi:10.2217/pme-2018-0141

Cited by 7 publications

(17 citation statements)

References 25 publications

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“…Recent studies have suggested that population-based genetic testing is more cost-effective than a strategy based on clinical criteria and family history [ 28 , 29 ]. Although a recent Japanese study of patients with MBC suggested that BRCA1/2 profiling combined with olaparib treatment provided a minimal incremental benefit versus standard chemotherapy alone [ 30 ], other studies have demonstrated cost-effectiveness of routine/mainstream genetic testing for all patients diagnosed with breast cancer to guide subsequent personalized therapy [ 31 , 32 ].…”

Section: Discussionmentioning

confidence: 99%

Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study

Koh

Ohsumi

Takahashi³

et al. 2021

Breast Cancer

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Background The multinational BREAKOUT study (NCT03078036) sought to determine the prevalence of germline BRCA1/2 (gBRCA1/2) and somatic BRCA1/2 (sBRCA1/2) mutations and mutations in other homologous recombination repair (HRR) genes in women with HER2-negative metastatic breast cancer (MBC) starting first-line chemotherapy. Methods Genetic testing for gBRCA, sBRCA, and HRR gene mutations was performed in patients who started first-line chemotherapy for MBC in the last 90 days (341 patients across 14 countries) who were not selected based on risk factors for gBRCA mutations. We report data from the Asian cohort, which included patients in Japan (7 sites), South Korea (10 sites), and Taiwan (8 sites). Results Of 116 patients screened, 104 patients were enrolled in the Asian cohort. The median age was 53.0 (range 25–87) years. gBRCA1/2, gBRCA1, and gBRCA2 mutations were detected in 10.6% (11/104), 5.8% (6/104), and 4.8% (5/104) of patients, respectively; none had mutations in both gBRCA1 and gBRCA2. gBRCA1/2 mutations were detected in 10.0% (6/60) and 11.6% (5/43) of patients with hormone receptor-positive and triple-negative MBC, respectively. HRR gene mutations were tested in 48 patients without gBRCA mutations, and 5 (10.4%) had at least one HRR mutation in sBRCA, ATM, PALB2, and CHEK2. Conclusion We report for the first time the prevalence of gBRCA and HRR mutations in an Asian cohort of patients with HER2-negative MBC. Our results suggest that BRCA mutation testing is valuable to determine appropriate treatment options for patients with hormone receptor-positive or triple-negative MBC. Study registration NCT03078036.

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Section: Discussionmentioning

confidence: 99%

Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study

Koh

Ohsumi

Takahashi³

et al. 2021

Breast Cancer

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“…Two studies investigated the cost-effectiveness of PARP inhibitor versus standard chemotherapies in these patients, and both deemed the former not cost-effective. Saito’s group in Japan compared the strategy of olaparib monotherapy after positive BRCA mutation profiling to the use of capecitabine, eribulin, or vinorelbine without testing and discovered that the former costs $131,047 per QALY, which was hardly cost-effective at the WTP threshold of $89,286 ( Saito et al, 2019 ). Regarding talazoparib, consistent findings were presented in a Spanish study by Lima and others, who obtained ICERs slightly above $280,000 per QALY in two scenarios compared with capecitabine or eribulin, which were ten-fold higher than the threshold of $23,945 ( Olry de Labry Lima et al, 2021 ).…”

Section: Resultsmentioning

confidence: 99%

“…ICERs were less sensitive to the costs of chemotherapies, hospital care, general adverse event management, and molecular testing. As for clinical estimates, models were more sensitive to the hazard ratios of PFS or the ratios used to project overall survival, time-receiving maintenance treatment, and utility values at progressive disease state ( Smith et al, 2015 ; Zhong et al, 2018 ; Guy et al, 2019 ; Saito et al, 2019 ; Armeni et al, 2020 ; Barrington et al, 2020 ; Su et al, 2020 ; Wu and Shi 2020 ; Leung et al, 2021 ).…”

Section: Resultsmentioning

confidence: 99%

Cost-Effectiveness of Poly ADP-Ribose Polymerase Inhibitors in Cancer Treatment: A Systematic Review

et al. 2022

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Background: PARP inhibitors have shown significant improvement in progression-free survival, but their costs cast a considerable financial burden. In line with value-based oncology, it is important to evaluate whether drug prices justify the outcomes.Objectives: The aim of the study was to systematically evaluate PARP inhibitors on 1) cost-effectiveness against the standard care, 2) impact on cost-effectiveness upon stratification for genetic characteristics, and 3) identify factors determining their cost-effectiveness, in four cancer types.Methods: We systematically searched PubMed, EMBASE, Web of Science, and Cochrane Library using designated search terms, updated to 31 August 2021. Trial-based or modeling cost-effectiveness analyses of four FDA-approved PARP inhibitors were eligible. Other studies known to authors were included. Reference lists of selected articles were screened. Eligible studies were assessed for methodological and reporting quality before review.Results: A total of 20 original articles proceeded to final review. PARP inhibitors were not cost-effective as recurrence maintenance in advanced ovarian cancer despite improved performance upon genetic stratification. Cost-effectiveness was achieved when moved to upfront maintenance in a new diagnosis setting. Limited evidence indicated non–cost-effectiveness in metastatic breast cancer, mixed conclusions in metastatic pancreatic cancer, and cost-effectiveness in metastatic prostate cancer. Stratification by genetic testing displayed an effect on cost-effectiveness, given the plummeting ICER values when compared to the “treat-all” strategy. Drug cost was a strong determinant for cost-effectiveness in most models.Conclusions: In advanced ovarian cancer, drug use should be prioritized for upfront maintenance and for patients with BRCA mutation or BRCAness at recurrence. Additional economic evaluations are anticipated for novel indications.

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“…In addition to pancreatic cancer, olaparib was also not cost-effective when used in patients with ovarian cancer in the USA or breast cancer in Japan. 17,18 In 2015, Smith built decision analysis models and found that the ICER was $258,864 per progression-free life-year saved for olaparib maintenance therapy in ovarian cancer patients with a BRCA mutation. Drug cost had the highest impact on the ICER; to achieve an ICER of less than $50,000, the cost of olaparib would have had to decrease to $2500 or less per month.…”

Section: Discussionmentioning

confidence: 99%

<p>Cost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/2 Mutation Based on the POLO Trial</p>

Zhan¹,

Zheng²,

Yu³

et al. 2020

CMAR

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Objective The phase III POLO trial demonstrated that olaparib as maintenance therapy for metastatic pancreatic cancer patients with a germline BRCA mutation had greater efficacy than placebo, but maintenance olaparib places an economic burden on patients. This study evaluated the cost-effectiveness of olaparib as maintenance therapy based on the POLO trial (NCT02184195). Methods A three-state Markov model (progression-free survival [PFS], progressive disease [PD] and death) based on data from the POLO trial was used to estimate the incremental cost-effectiveness ratio (ICER) of maintenance olaparib versus placebo for metastatic pancreatic cancer patients with a germline BRCA mutation. The cost was evaluated from the Chinese society’s perspective, and health outcomes were assessed in terms of quality-adjusted life years (QALYs). The primary outcome was the ICER gained in terms of 2019 US$ per QALY. Model robustness was explored with one-way and probabilistic sensitivity analyses. Results Compared with placebo, maintenance olaparib increased costs by $23,544.35 while gaining 0.69 QALYs, resulting in an ICER of $34,122.25 per QALY. The ICER was far higher than the commonly accepted willingness-to-pay threshold ($28,255.55 per QALY). Conclusion Compared with placebo, maintenance olaparib for metastatic pancreatic cancer patients with a germline BRCA mutation is not cost-effective in China.

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Cost–Effectiveness of BRCA1/2 Mutation Profiling to Target Olaparib Use in Patients with Metastatic Breast Cancer

Cited by 7 publications

References 25 publications

Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study

Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study

Cost-Effectiveness of Poly ADP-Ribose Polymerase Inhibitors in Cancer Treatment: A Systematic Review

<p>Cost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/2 Mutation Based on the POLO Trial</p>

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