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Cost-effectiveness of sacituzumab govitecan for hormone receptor-positive human epidermal growth factor receptor 2-negative metastatic breast cancer based on the EVER-132-002 trial in China

Cost Effectiveness and Resource Allocation volume 23, Article number: 8 (2025) Cite this article

Abstract

Background

The EVER-132-002 trial demonstrated the significant efficacy and manageable safety of sacituzumab govitecan in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR + HER2-) metastatic breast cancer. This study evaluated the cost-effectiveness of sacituzumab govitecan compared with chemotherapy from the Chinese healthcare system perspective.

Methods

A partitioned survival model at 21-day intervals over a 10-year time horizon was developed to evaluate the total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) at willingness-to-pay (WTP) threshold of 3 times gross domestic product per capita ($38,042.49 per QALY). Clinical data were extracted from the EVER-132-002 trial; direct medical costs and utility values were obtained from public bid-winning databases, local charges or published literature. To determine the model’s robustness, scenario, one-way, two-way and probabilistic sensitivity analyses were performed.

Results

Compared with chemotherapy, sacituzumab govitecan generated an additional cost of $91,273.72, with an additional QALY of 0.43, resulted in an ICER of $211,948.62 per QALY. Patient weight was the most influential parameter on base-case results, and variations in each parameter did not substantially alter the conclusion. Probabilistic sensitivity analysis demonstrated that the probability of sacituzumab govitecan to be cost-effective was zero at the WTP threshold of $38,042.49 per QALY. Scenario analysis indicated that sacituzumab govitecan would be cost-effective versus chemotherapy only if its cost was reduced by 83% ($202.65 per unit) or more.

Conclusions

Sacituzumab govitecan might not be cost-effective compared with chemotherapy in the treatment for HR + HER2- metastatic breast cancer in China.

Background

Breast cancer is the second most frequently diagnosed cancer and the fifth leading cause of cancer mortality around the world in 2022, with an estimated 2.3 million new cases and 666,000 deaths globally [1]. In Chinese women, breast cancer approximately accounts for 16% of all estimated new cancers [2]. Hormone receptor-positive human epidermal growth factor receptor 2-negative (HR + HER2-) is the predominant molecular subtype of breast cancer, representing 70% of breast cancer cases [3, 4]. Currently, endocrine therapy plus cyclin-dependent kinase 4/6 (CDK4/6) inhibitor is the standard first-line regime for HR + HER2- metastatic breast cancer, and single-agent chemotherapy is initiated once endocrine resistance develops [5]. However, chemotherapy provids limited clinical benefit and high toxicity, signaling urgent needs for breakthrough treatment options [6].

Sacituzumab govitecan is a Trop-2-directed antibody conjugated to a topoisomerase I inhibitor (SN-38), has been approved for the treatment of HR + HER2- metastatic breast cancer based on the TROPiCS-02 trial in several countries [7]. As TROPiCS-02 trial enrolled few Asian patients, the EVER-132-002 trial was conducted to explore the efficacy and safety of sacituzumab govitecan in Asian patients [8]. The EVER-132-002 study indicated that sacituzumab govitecan significantly improved progression-free survival (PFS) [hazard ratio (HR): 0.67, 95% confidence interval (CI): 0.52–0.87) and overall survival (OS) (HR: 0.64, 95% CI: 0.47–0.88) versus chemotherapy in Asian patients with endocrine-resistant, previously treated HR + HER2- metastatic breast cancer [8]. Neutropenia, leukopenia and anemia were the most common treatment-related adverse events (AEs) in the chemotherapy and sacituzumab govitecan groups [8].

Although sacituzumab govitecan provided promising clinical benefits and manageable toxicity, the high cost could cause economic burden. Taking cost-effectiveness into account in healthcare decision-making is essential for clinicians and policy-makers to allocate limited health resources [9]. Previous studies have evaluated the cost-effectiveness of sacituzumab govitecan for the therapy of HR + HER2- metastatic breast cancer based on the TROPiCS-02 trial, and demonstrated that it was not cost-effective from the third-party payer perspective in the United States [10]. However, its potential economic burden remained unclear in China. Therefore, this study aimed to evaluate the cost-effectiveness of sacituzumab govitecan compared with chemotherapy in the treatment for HR + HER2- metastatic breast cancer from the perspective of Chinese healthcare system.

Methods

The economic evaluation was based on modeling techniques, local charges, and published literatures, so ethics committee approval was exempted. This study followed the consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) [11] (Supplementary Table 1).

Patient characteristics and treatment regimes

Eligible patients had histologically or cytologically confirmed HR + HER2- metastatic or locally recurrent inoperable breast cancer, and received 2 to 4 prior systemic chemotherapy regimens [8]. Patients received sacituzumab govitecan (10 mg/kg on days 1 and 8) or physician’s choice chemotherapy [eribulin (1.4 mg/m2 on days 1 and 8); vinorelbine (25 mg/m2 on days 1 and 8); capecitabine (2,000 mg/m2 per day on a 2-week-on, 1-week-off schedule); gemcitabine (1,000 mg/m2 on days 1 and 8)] at 21-day cycles [8, 12]. Consistent with the EVER-132-002 trial, the eribulin, vinorelbine, capecitabine and gemcitabine were assigned according to the proportion of 79%, 8%, 7% and 6%, respectively [8]. Treatment continued until disease progression or unacceptable toxicity [8]. After disease progression, best supportive care was initiated, as third-line or above treatment options were not defined in clinical trials and the guidelines of the Chinese Society of Clinical Oncology (CSCO) [8, 12].

Model structure

A partitioned survival model was developed from the perspective of Chinese healthcare system using Excel 2019 and R 4.3.2 software with 3 mutually exclusive health states: PFS, progressive disease (PD) and death (Fig. 1). The cycle length of the model was set at 21-day with a 10-year time horizon. The primary outcomes included the total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). The ICER was defined as the incremental cost per additional QALY gained between sacituzumab govitecan and chemotherapy regimens [13]. An annual discount of 5% for costs and QALYs was implemented, and half-cycle corrections were applied to improve the precision of the model outcomes [14]. We used 3 times gross domestic product (GDP) per capita ($38,042.49) as the willingness-to-pay (WTP) threshold [14]. All costs were converted to 2024 US dollars with a currency exchange rate of $1 = RMB 7.0467 (average value for 2023).

Fig. 1
figure 1

The structure of the partitioned survival model

Full size image

Clinical data

The model utilized Kaplan-Meier (KM) curves per blinded independent central review from the EVER-132-002 trial to estimate the proportion of patients in each health state at various time points. GetData Graph Digitizer 2.26 was employed to digitize PFS and OS curves to obtain reconstructed individual patient data based on the algorithm from Guyot et al. [15]. To predict progression and survival beyond follow-up time of the clinical trial, seven parametric distributions were used to extrapolate the KM curves, including exponential, Weibull, Gamma, generalised Gamma, Gompertz, lognormal and log-logistic [16]. The best fitted distribution was determined by the Akaike information criterion, Bayesian information criterion, and visual inspection for clinical plausibility [17]. The parameters of the optimal distributions are shown in Supplementary Tables 2 and Supplementary Figs. 1–6.

Costs

Only direct medical expenditures were considered, which covered drugs, laboratory tests and radiological examinations, management of severe AEs, and subsequent treatment. The unit drug costs were determined by average winning bid prices from YaoZH database in 2024 [18]. To estimate the dosage of agents, the average patient weight of 57.37 kg and body surface area of 1.72 m2 was applied [19]. Surveillance was conducted per clinical guidelines, involving regular laboratory tests, computed tomography of the chest and abdomen, and bone scan performed every 6 months [12]. The costs of surveillance were derived from local charges for medical services. As the grade 1–2 AEs could be manageable with standard monitoring, only the grade 3–4 AEs with an incidence of 5% or more were included in the model, including neutropenia, anemia, leukopenia, diarrhea, fatigue, hypokalemia, and gamma-glutamyl transferase increased [8]. The costs of management of severe AEs and subsequent treatment were gathered from previously published literatures [19,20,21,22,23,24].

Utilities

Each health state should be assigned a health utility value anchored in 0 (death) and 1 (perfect health) [25]. The utility value of PFS state was derived from a multicenter, real-world study in China, which found that EQ-5D index score of HR + HER2- advanced breast cancer patients improved from 0.653 (95% CI: 0.622–0.684) to 0.819 (95% CI: 0.777–0.861) after receiving treatment [26]. Utility value for PD state and disutility values caused by severe AEs were retrieved from published literatures [20, 22, 24, 27]. We assumed that all adverse reactions occurred in the first cycle. The costs and utilities are presented in Table 1 and Supplementary Table 3.

Table 1 Model parameter
Full size table

Scenario analyses

First, the investigator-assessed PFS was used to explore the cost-effectiveness of sacituzumab govitecan. Second, we assumed that the price of sacituzumab govitecan and patient weight were reduced to explore the affordable range.

Sensitivity analyses

One-way (OWSA), two-way (TWSA) and probabilistic sensitivity analyses (PSA) were conducted to account for variability of input parameters. In the OWSA, parameters were independently varied within a plausible range either based on the reported 95% CI in the references or estimated by a ± 20% change from the base-case value. The results displayed using Tornado diagrams. At the same time, TWSA was conducted on the unit cost of sacituzumab govitecan and patient weight. We assumed that the unit cost of sacituzumab govitecan ranged from $0 to $1,192.05 and the patient weight ranged from 28.69 kg (50% decreased) to 86.06 kg (150% increased). PSA was performed based on Monte Carlo simulation with 10,000 iterations by simultaneously sampling the critical parameters from prespecified distributions. Gamma distributions were selected for costs, beta distributions were selected for the incidence rate of severe AEs, utility and disutility values [28]. The results were expressed as incremental cost-effectiveness scatter plot and cost-effectiveness acceptability curve (CEAC).

Results

Base-Case results

Compared with chemotherapy, sacituzumab govitecan provided incremental cost of $91,273.72, with additional QALY of 0.43, resulting in an ICER of $211,948.62 per QALY in the treatment for HR + HER2- metastatic breast cancer (Table 2).

Table 2 Base-case results
Full size table

Scenario analyses

When the investigator-assessed PFS was used, sacituzumab govitecan yielded a relatively lower ICER of $205,977.64 per QALY (Supplementary Table 4). Sacituzumab govitecan would be cost-effective versus chemotherapy when its cost was reduced by 83% ($202.65 per unit) or more, or when the patient weight was less than 9.71 kg (Supplementary Figs. 7–8). When the cost of sacituzumab govitecan was reduced by 90% to $119.20 per 180 mg, the ICER would reach $23,540.63 per QALY (Supplementary Table 5).

Sensitivity analyses

The results of the OWSA indicated that patient weight, the cost of sacituzumab govitecan, utility of PD, and discount rate were the most influential parameters on base-case results (Fig. 2). However, alterations of all parameters did not meaningfully alter the conclusion. The lowest and highest ICERs were $170,080.18 per QALY and $253,817.06 per QALY, respectively. For the majority of reasonable combinations for the unit cost of sacituzumab govitecan and patient weight, sacituzumab govitecan might not be cost-effective versus chemotherapy (Supplementary Fig. 9). Substantial price reductions would fundamentally reverse the results. The results of the PSA indicated that the probability of sacituzumab govitecan being cost-effective was 0% at the WTP threshold of 3 times GDP per capita ($38,042.49) (Figs. 3 and 4).

Fig. 2
figure 2

The one-way sensitivity analyses of sacituzumab govitecan compared to chemotherapy in China. (Note: PD, progressive disease; PFS, progression-free survival; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life-year)

Full size image
Fig. 3
figure 3

The incremental cost-effectiveness scatter plot of sacituzumab govitecan compared to chemotherapy in China. (Note: PD, progressive disease; PFS, progression-free survival; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life-year)

Full size image
Fig. 4
figure 4

The cost-effectiveness acceptability curve of sacituzumab govitecan compared to chemotherapy in China. (Note: WTP, willingness to pay; QALY, quality-adjusted life-year)

Full size image

Discussion

Recently, the remarkable clinical benefits of sacituzumab govitecan have attracted intense attention from clinicians, policy makers, and patients [8]. Consequently, the cost-effectiveness of sacituzumab govitecan was worth considering, which related to the affordability for patients and the sustainability of national healthcare systems [29]. The ICER of sacituzumab govitecan was $211,948.62 per QALY, indicating that it was not cost-effective compared with chemotherapy at the current WTP threshold in the treatment for HR + HER2- metastatic breast cancer from the Chinese healthcare system perspective.

Patient weight, the cost of sacituzumab govitecan, utility of PD, and discount rate were the most influential parameters, but alterations in each parameter did not alter the conclusion. Our findings echoed three published economic evaluations [9, 19, 29], patient weight was the most pivotal parameter because sacituzumab govitecan was administered based on body weight. Thus, sacituzumab govitecan was unfavorable at all clinically plausible weights. Apart from patient weight, the price of sacituzumab govitecan was extremely expensive compared to chemotherapy, which became an essential parameter in dominating cost-effectiveness. Some measures, such as substantial price reduction, generous patient assistance programs, dosing strategy, etc., need to be taken to make it a cost-effective option for the treatment of HR + HER2- metastatic breast cancer [9, 24]. Notably, sacituzumab govitecan would be cost-effective when its price was below $202.65 per unit (180 mg) according to cost-threshold analysis. As a result, sacituzumab govitecan’s pricing exceeded the value that matched its improved efficacy.

At present, HR + HER2- and triple-negative metastatic breast cancers were the most prominent indications for sacituzumab govitecan [7, 8, 30]. Economic evaluation associated with sacituzumab govitecan in the treatment of HR + HER2- metastatic breast cancer was extremely limited. Shi et al. [10] estimated the cost-effectiveness of sacituzumab govitecan versus chemotherapy using a partitioned survival model based on the TROPiCS-02 trial, and demonstrated that sacituzumab govitecan was not cost-effective at the WTP threshold of $150,000 per QALY from the third-party payer perspective in the United States. The ICER and incremental net monetary benefit of sacituzumab govitecan were $612,772 per QALY and -$100,208 over chemotherapy, respectively [10]. Sacituzumab govitecan might be cost-effective when the cost was below $3.997/mg or the patient weight was less than 19.88 kg [10]. Although medical costs and health policies varied across countries, our study obtained consistent conclusions with this research. Compared to China, sacituzumab govitecan was more likely to be cost-effective and affordable in the United States, because of the relatively lower price reductions required. Our findings suggested that sacituzumab govitecan might be cost-effective when the cost was below $202.65 per unit or the patient weight was less than 9.71 kg.

For metastatic triple-negative breast cancer (TNBC), the ASCENT trial found that sacituzumab govitecan prolonged PFS (HR: 0.41; 95% CI: 0.32–0.52) and OS (HR: 0.48; 95% CI: 0.38–0.59) compared with chemotherapy. However, sacituzumab govitecan was unlikely to be a high-value option for metastatic TNBC in some countries, such as the United States [9, 29, 31], China [19, 31, 32] and Singapore [33], even though it had clinically significant advantages. In the United States, the ICER of sacituzumab govitecan compared with chemotherapy varied considerably, ranging from $494,479 per QALY to $1,252,295 per QALY in overall metastatic TNBC, and $702,281 per QALY to $1,177,171 per QALY in brain metastatic-negative TNBC [9, 29, 31]. In China, Wang et al. [19] and Chen et al. [31] developed partitioned survival model to investigate the cost-effectiveness of sacituzumab govitecan in patients with metastatic TNBC, the ICERs were $323,603.84 per QALY and $924,037 per QALY versus single-agent chemotherapy, respectively. Considering the WTP threshold of 3 times GDP per capita in 2023, the maximum unit cost of sacituzumab govitecan was $155.65 per 180 mg [19]. Therefore, the possibility of sacituzumab govitecan becoming a cost-effective regime for HR + HER2- metastatic breast cancer was potentially higher, compared to metastatic TNBC. In Singapore, Cher et al. [33] found that the ICER of sacituzumab govitecan was $237,816 per QALY compared with chemotherapy from the healthcare system perspective over 5 years. Adopting an 80% price reduction for sacituzumab govitecan resulted in an ICER of $57,839 per QALY, which was below the WTP threshold at $65,254.

There are several limitations worth discussion. First, long-term efficacy was extrapolated by parametric survival models, with inherent methodological uncertainties, which required additional validation with updated follow-up data. Second, the management costs and disutility values associated with grade 3 or above AEs were calculated into the model, which might underestimate the total costs and overestimate the health outcomes of treatment regimens. Nevertheless, OWSA revealed that the model results were insensitive to AEs-related parameters. Third, since health utility values were not reported in the EVER-132-002 trial, this model was estimated based on palbociclib-related cohort study. Further studies should be initiated based on the health utility values of different treatments. Fourth, as subsequent treatment strategies were not defined in the EVER-132-002 trial and clinical guidelines, we hypothesized that best supportive care was the predominant option, which might be distinct from realistic treatment choices.

Conclusion

In summary, sacituzumab govitecan might not be cost-effective compared with chemotherapy in the treatment for HR + HER2- metastatic breast cancer employed WTP threshold of 3 times GDP per capita in China. Substantial price reductions could make it a cost-effective treatment option.

Data availability

No datasets were generated or analysed during the current study.

Abbreviations

HR + HER2-:

Hormone receptor-positive human epidermal growth factor receptor 2-negative

CDK4/6:

Cyclin-dependent kinase 4/6

PFS:

Progression-free survival

HR:

Hazard ratio

CI:

Confidence interval

OS:

Overall survival

AEs:

Adverse events

CHEERS 2022:

Consolidated health economic evaluation reporting standards 2022

CSCO:

Chinese Society of Clinical Oncology

PD:

Progressive disease

QALYs:

Quality-adjusted life-years

ICER:

Incremental cost-effectiveness ratio

GDP:

Gross domestic product

WTP:

Willingness-to-pay

KM:

Kaplan-Meier

OWSA:

One-way sensitivity analyses

PSA:

Probabilistic sensitivity analyses

TNBC:

Triple-negative breast cancer

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Acknowledgements

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Authors and Affiliations

  1. Centre for Health Management and Policy Research, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, China

    Shixian Liu, Hao Chen, Ziming Wan, Lei Dou & Shunping Li

  2. NHC Key Laboratory of Health Economics and Policy Research (Shandong University), Jinan, 250012, China

    Shixian Liu, Hao Chen, Ziming Wan, Lei Dou & Shunping Li

  3. Center for Health Preference Research, Shandong University, Jinan, 250012, China

    Shixian Liu, Hao Chen, Ziming Wan, Lei Dou & Shunping Li

  4. Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan, 250014, China

    Kaixuan Wang

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Contributions

Conception and design: SXL, KXW, HC, ZMW, LD and SPL. Data collection: SXL, KXW, HC, and ZMW. Methodology: SXL, KXW, LD and SPL. Software: SXL and HC. Supervision: LD and SPL. Validation: KXW and ZMW. Writing-original draft: SXL. Writing-review and editing: SXL, KXW, HC, ZMW, LD and SPL. All authors have read and approved the final version of the article.

Corresponding author

Correspondence to Shunping Li.

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Liu, S., Wang, K., Chen, H. et al. Cost-effectiveness of sacituzumab govitecan for hormone receptor-positive human epidermal growth factor receptor 2-negative metastatic breast cancer based on the EVER-132-002 trial in China. Cost Eff Resour Alloc 23, 8 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12962-025-00613-z

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  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12962-025-00613-z

Keywords

Cost Effectiveness and Resource Allocation

ISSN: 1478-7547

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