Abstract
Introduction
Brigatinib and alectinib are anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (ALK-TKIs) approved in China in 2022 and 2018, respectively, for the treatment of patients with ALK-positive, advanced non‑small‑cell lung cancer (NSCLC). The objective of this study is to conduct a comparative pharmacoeconomic analysis of first-line drugs, brigatinib and alectinib, in patients with ALK-positive NSCLC from the perspective of the Chinese healthcare system.
Methods
A partitioned survival model with three health states was used to simulate the health outcomes and costs of brigatinib and alectinib with a 30-year time horizon. Indirect treatment comparisons (ITC) data were used to obtain the comparative efficacy of brigatinib and alectinib, owing to lack of head-to-head trials. As the health benefits were comparable between brigatinib and alectinib on the basis of the ITCs, cost-minimization analysis (CMA) was conducted. Cost-effectiveness analyses (CEA) were also conducted as scenario analyses using the different point estimates from the ITCs. Health state utilities and costs were obtained from public sources or clinical expert opinion. Direct medical costs and quality-adjusted life years (QALYs) were discounted at an annual rate of 5%. One-way sensitivity analyses were conducted for the CMA.
Results
The CMA showed that, over 30 years, brigatinib (63,539 USD) was associated with cost savings of 14,203 USD compared with alectinib (77,742 USD). One-way sensitivity analyses showed that drug costs were the most influential parameter but brigatinib remained cost-saving in all the analyses. In the CEAs, the total cost of brigatinib was lower in all scenarios and also resulted in higher QALYs in 60% of the CEA scenarios.
Conclusions
Brigatinib was a cost-saving (14,203 USD) treatment compared with alectinib in the CMA analysis for the first-line treatment of patients with ALK-positive advanced NSCLC in China.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40487-025-00361-3.
Keywords: Anaplastic lymphoma kinase (ALK), Non-small cell lung cancer, Brigatinib, Pharmacoeconomics, Tyrosine kinase inhibitor
Key Summary Points
| Why carry out this study? |
| Alectinib was approved in 2018, and Brigatinib was approved in 2022 in China, for the treatment of ALK-positive advanced non‑small‑cell lung cancer (NSCLC). |
| This study conducted a comparative pharmacoeconomic analysis of first-line drugs, brigatinib and alectinib, in patients with ALK-positive advanced NSCLC from the perspective of the Chinese healthcare system. |
| What was learned from the study? |
| Brigatinib (63,539 USD) was a cost-saving (−14,203 USD) treatment compared with alectinib (77,742 USD) in the cost-minimization analysis. |
| In the cost-effectiveness analyses, the total cost of brigatinib was lower in all scenarios and also resulted in higher QALYs in 60% of the CEA scenarios. |
Introduction
Lung cancer is the leading cause of cancer-related morbidity and mortality in China [1]. In 2022, an estimated 870,982 new cases and 766,898 deaths of lung cancer were reported in China [2]. Non-small cell lung cancer (NSCLC) accounts for 80–85% of cases, and adenocarcinoma is the most common histological subtype of NSCLC [3]. The majority of patients newly diagnosed with NSCLC are in stage III or IV, and the prognosis of NSCLC is poor [4, 5]. Anaplastic lymphoma kinase (ALK) gene rearrangement, a major oncogenic driver of NSCLC, is observed in approximately 3–7% of patients with NSCLC [6, 7].
An increasing trend in the rate of ALK screening has been observed in Chinese patients with lung cancer over the decade 2010–2019 [8]. Chinese Society of Clinical Oncology (CSCO) non-small cell lung cancer (2024) guidelines have recommended crizotinib, ceritinib, alectinib, brigatinib, ensartinib, lorlatinib, and iruplinalkib for advanced ALK-positive NSCLC [9]. Crizotinib is an oral inhibitor and the first to be approved by the National Medical Products Administration (NMPA) for the treatment of ALK-positive patients in 2013. The overall economic burden of lung cancer in China was estimated at around 25 billion US dollars in 2017 [10]. The average cost of treatment for Chinese patients with NSCLC over a 1-year period has been estimated at approximately 11,566 and 14,519 USD for patients in the progression-free state and disease-progression state, respectively [11].
Alectinib was approved in 2018 and is the most commonly used first-line treatment for advanced ALK-positive NSCLC patients in China. Brigatinib was another ALK-TKI approved in 2022 in China. This study evaluated brigatinib and alectinib as first-line treatments for ALK-positive NSCLC in China.
Methods
Model Construction
A partitioned survival model with a 28-day cycle length was developed in Microsoft Excel 2016 (Microsoft Corporation; Redmond, WA) to compare the cost-effectiveness of brigatinib versus alectinib as first-line treatment for patients with ALK-positive NSCLC in China. This model included three health states: progression-free (PF), progressive disease (PD), and death (Fig. 1).
Fig. 1.
Model structure
The average age of patients in the ALTA-1L study of brigatinib was 58 years [12], and the life expectancy of Chinese people is 78.2 years [13]. Thus, the time horizon was set as 30 years as a proxy for lifetime. Costs and quality-adjusted life years (QALYs) were discounted at an annual rate of 5%, according to China guidelines for pharmacoeconomic evaluations (2020) [14]
Clinical Data
The efficacy of brigatinib was modeled on the basis of progression-free survival (PFS) as assessed by the independent review committee (IRC) and overall survival (OS) obtained from the final results of the ALTA-1L trial [15]. Seven survival distributions were considered to fit and extrapolate the PFS and OS from the ALTA-1L trial: Exponential, Weibull, Log-normal, Gamma, Log-logistic, Gompertz, Gen. Gamma (Supplementary Figs. 1 and 2). The exponential distribution was chosen, consistent with a previously published cost-effectiveness analysis of brigatinib conducted from the payer perspective in the USA [16]. Treatment duration was set consistent with the label instructions for brigatinib and alectinib in China to administer treatment until disease progression [17, 18].
There are no head-to-head trials between brigatinib and alectinib in first-line treatment, so the clinical data from published indirect treatment comparisons (ITC) were considered in this study. The relative efficacy of brigatinib versus alectinib in terms of PFS by IRC and OS was based on previously published ITCs of brigatinib (ALTA-1L trial) and alectinib (ALEX trial) [19, 20]. The ITCs used Burcher, Anchored Matching-Adjusted Indirect Comparisons (MAIC) with crizotinib as common comparator, and unanchored MAICs, all of which showed that there were no statistically significant differences between brigatinib and alectinib in terms of PFS and OS in patients with ALK-TKI-naive NSCLC. Thus, the efficacy of brigatinib and alectinib was assumed to be the same in the base case analysis through cost-minimization analysis, and safety was also assumed equal between both treatments. It should be noted that, although in all the methods used in the published ITCs, no statistically significant differences were found between brigatinib and alectinib, the point estimates of the PFS and OS hazard ratios (HRs) may have sometimes favored brigatinib and sometimes alectinib. Thus, cost-effectiveness analyses were conducted as scenarios using different point estimates from the results of the previously published ITCs [19, 20].
Ethical Statement
This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.
Cost Parameters
This study adopted the perspective of China’s healthcare system. The costs considered in the model included the drug costs of brigatinib and alectinib, medical and healthcare resources before and after progression, adverse events management, concomitant medications, subsequent treatments, and palliative care. Costs were obtained from public sources, literature (costs converted using 2025 exchange rate [7.25 Yuan per 1 USD]), and clinical expert opinion. Consulted clinical experts are listed in Supplementary Table 1.
Drug Costs
Supplementary Table 2 presents the drug costs, usage, and dosage of brigatinib and alectinib. The recommended dosages were derived from the label instructions, among which brigatinib was 90 mg orally once daily (OD) for the first 7 days and then increased to 180 mg OD orally [18]; alectinib was 600 mg (4 capsules of 150 mg), orally twice daily (BID) [17].
Cost of Medical and Healthcare Resources Utilization
The healthcare resource utilization (HCRU) included medical oncology outpatient registration fees, laboratory tests, imaging, and electrocardiograms (ECGs). Considering that the patient’s disease state worsens after disease progression, the model assumed that the utilization of healthcare resources was different in the PF and PD states. Healthcare resource utilization and the corresponding unit costs were obtained from clinical expert opinion (Supplementary Tables 3–5).
Cost of Adverse Events Management
Consistent with previously published cost-effectiveness analyses of ALK-TKIs [21, 22], this study estimated and analyzed the treatment costs of severe adverse events (AEs) in patients receiving ALK-TKI therapy. This study calculated AE management costs, including grade ≥ 3 AEs, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and estimated the management costs with incidences. The AE management costs were obtained from clinical expert opinion (Supplementary Table 6).
Other Costs
Medications such as acetaminophen, metoclopramide, dexamethasone, loperamide hydrochloride, and amoxicillin were included in the ALTA-1L study [15]. Through clinical expert opinion, this pharmacoeconomic analysis study limited concomitant therapy to hepatoprotective drugs, which increase white blood cells, thymosin, and antiallergic drugs; the estimated cost of concomitant medications based on the clinical expert opinion was 20.97 USD per 28-day cycle for both brigatinib and alectinib.
According to the recommendation of the guideline of CSCO 2024 [9], the subsequent treatments for patients after progression on first-line treatment of second-generation TKI was lorlatinib. In this model, we assumed that the treatment used after the patient progresses was lorlatinib for a total of 5.6 months according to a trial in China [23]. Supplementary Table 7 summarizes the subsequent costs.
In this model, the total cost of palliative care for patients with NSCLC was 1801.33 USD on the basis of the published data that evaluated the cost effectiveness of ceritinib and alectinib versus crizotinib in the Chinese healthcare setting [21].
Utility Parameters
The utility value used in the model was according to Shen et al. [24]. The utility value of progression-free state in the model was 0.856, and the utility value of disease progression state was 0.768. Disutility due to AEs and getting older were included in the utility estimation. In this model, the incidence of AEs (grade ≥ 3) was adjusted for the cycle length, and the QoL loss was 0.024 for each adverse event based on a previously published cost-effectiveness analysis of brigatinib conducted from the payer perspective in USA [16]. In addition, the model included a utility decrement associated with increasing age [16, 25].
Sensitivity Analysis
Like most pharmacoeconomic analyses, one-way sensitivity analysis was conducted in the CMA. The model uncertainty was assessed by varying all costs included in the model (Supplementary Table 8).
Results
For Chinese patients with advanced ALK-positive NSCLC, the CMA showed that, over 30 years, the total cost associated with brigatinib was 63,539 USD versus 77,742 USD for alectinib, resulting in brigatinib being cost-saving (−14,203 USD) compared with alectinib, driven by the lower drug cost of brigatinib.
One-way sensitivity analysis showed that the drug costs of brigatinib and alectinib were the most influential parameters in the results. However, brigatinib remained cost-saving versus alectinib in all the one-way sensitivity analyses conducted for the CMA (Fig. 2).
Fig. 2.
One-way sensitivity analysis of CMA. AE adverse events, CMA cost-minimization analysis
In the CEA scenarios, when using different HRs, the total costs of brigatinib remained lower in all the scenarios, but the total QALYs were higher or lower versus alectinib when the point estimate of HR favored brigatinib or alectinib, respectively. In 9 out of the 15 CEA scenarios, brigatinib was dominant over alectinib, meaning that brigatinib resulted in a lower total cost and higher total QALYs than alectinib. In the other six CEA scenarios, brigatinib resulted in a lower total cost but also lower total QALYs than alectinib. However, in three of these six scenarios, the incremental cost-effectiveness ratio indicated that alectinib would not be a cost-effective alternative versus brigatinib for the Chinese healthcare system using a willingness-to-pay (WTP) threshold of 36,976 USD equivalent to three times the per capita gross domestic product of China in 2023; in the other three scenarios, alectinib may be a cost-effective treatment option versus brigatinib (Supplementary Table 9).
Discussion
This study evaluated the comparative pharmacoeconomics of brigatinib and alectinib in the first-line treatment of ALK-positive advanced NSCLC from the perspective of the China healthcare system. The results of our study suggest that brigatinib can be a cost-saving treatment option compared with alectinib for first-line treatment of patients with ALK-positive advanced NSCLC in China.
The selection of clinical efficacy data is critical in model construction. Hazard ratios for OS and PFS were used to estimate survival in the alectinib and brigatinib arms of the model and to derive QALYs. Since head-to-head trial data were lacking, efficacy data could only be determined by ITC. Considering several factors such as study duration, as well as included clinical trials and methodologies, the data used in this study were obtained from the ITC studies conducted using the final results from ALTA-1L and the latest results from ALEX clinical trial [18, 19]. All approaches used in these ITCs showed that there were no statistically significant differences between brigatinib and alectinib in terms of PFS and OS in patients with ALK-TKI-naive NSCLC [17, 18].
Central nervous system (CNS) metastases remain the leading cause of mortality in patients with NSCLC, with only 4% of patients surviving 5 or more years [26]. Results of the ALTA-1L trial showed that brigatinib has superior intracranial efficacy compared with crizotinib, reducing the risk of intracranial progression or death by 56% (HR 0.44, 95% CI 0.30–0.65) in all patients [15]. However, since the CNS-PFS data are not publicly available from the ALEX trial, it was not considered as a health state in this study as it was done in a previously published cost-effectiveness analysis of brigatinib in the USA [16].
The model used in this study showed that brigatinib resulted in cost savings of 14,203 USD versus alectinib over 30 years, on the basis of the CMA. In all the CEA scenarios, brigatinib resulted in lower total costs versus alectinib, and in most of these scenarios (9 of 15), brigatinib also resulted in higher total QALYs. Brigatinib had the potential to be a dominant treatment option compared with alectinib. These findings align with a cost-effectiveness study conducted in the USA, which showed that brigatinib was associated with cost savings of 8546 USD compared with alectinib [16]. In addition, a cost-effectiveness study conducted in Italy found a gain of 0.216 QALYs and a reduction in treatment costs of 85,635 EUR with brigatinib compared with alectinib [27]. Six of the 15 CEA scenarios showed that brigatinib gained lower QALYs compared with alectinib, then incremental cost-effectiveness ratios (ICERs) would be the results of alectinib versus brigatinib. Alectinib will be cost-effective (50%) or not cost-effective (50%) under the WTP (36,976 USD). The commonality of these last three scenarios is that OS data without crossover adjustments from ALTA-1L were used. Crossover from crizotinib to brigatinib was offered after progression in ALTA-1L, but in ALEX, crossover between trial groups was not allowed.
One study compared the cost-effectiveness of the six ALK-TKIs as first-line treatment for patients with advanced ALK-positive NSCLC from the perspective of the Chinese healthcare system, including brigatinib and alectinib [28]. Although this study did not directly compare brigatinib with alectinib, it listed the final total costs and QALYs of different TKIs, and the results are not consistent with the results of most CEA scenarios in our study. The reasons for the inconsistencies are: first, the price of brigatinib was not yet available at the time, so the Hong Kong price was used; second, several clinical trials of alectinib such as ALESIA and J-ALEX were included (not only ALEX) that recruited only Asian and Japanese patients; third, the network meta-analysis used in the study did not include the final ALTA-1L data.
Zhang et al. [29] also assessed the cost-effectiveness of six TKIs as first-line treatments for patients with ALK-positive NSCLC from the perspective of the Chinese healthcare system. The conclusion suggested that brigatinib emerged as the most cost-effective treatment among all the options considered. But it is necessary to note that the trial of alectinib used in Zhang et al. [29] was J-ALEX, and the dosage in J-ALEX was different from the label instruction of alectinib. As of 1 January 2025, the latest medical insurance list has come into effect, and the price of alectinib has been reduced by 13%.
This study has limitations. Owing to the lack of head-to-head trials, the primary efficacy parameters for alectinib were derived from published studies on indirect treatment comparisons [19, 20] for the CEA scenarios. Since our study was conducted from a healthcare system perspective, indirect costs were not considered. Patients receiving ALK-TKI treatment exhibit complex treatment patterns following disease progression. Therefore, this study made assumptions regarding treatment modality after progression; only lorlatinib as a subsequent treatment option was considered. Owing to limited data availability, certain model parameters utilized in this study were determined through clinical expert opinion. Despite efforts to interview clinical experts from various provinces, the data may not fully reflect healthcare resource utilization nationwide. However, a one-way sensitivity analysis was conducted to assess the impact of the parameters in the CMA, and brigatinib remained cost-saving versus alectinib in all the scenarios.
Conclusions
Brigatinib showed a cost-saving (−14,203 USD) treatment compared with alectinib in the cost-minimization analysis. Overall, brigatinib should be the preferred treatment option compared with alectinib from the perspective of Chinese healthcare system to efficiently utilize the healthcare resources in the first-line treatment of Chinese patients with ALK-positive advanced NSCLC. Real-world studies from China are encouraged to further understand the relative pharmacoeconomics of these two drugs.
Supplementary Information
Below is the link to the electronic supplementary material.
Acknowledgements
Takeda Pharmaceutical Company Limited has provided a scientific review of the manuscript.
Medical Writing/Editorial Assistance
Medical writing and editorial support for the development of this pharmacoeconomic analysis under the direction of the authors was provided by Ravi Kiran Ammu, PhD, Roopashree Subbaiah, PhD and Deepak P, PhD, of Indegene Private Limited, Bangalore, India and funded by Takeda (China) International Trading Company, in accordance with Good Publication Practice (GPP3) guidelines.
Author Contributions
Qingqing Chai was responsible for study design, data acquisition, model development, analysis, and manuscript review; Congling Gu and Yan-Jun Zhang were responsible for study design, analysis, and manuscript review; Luis Hernandez was responsible for study design, interpretation of the work and manuscript review. All the authors read the final version of this article and agree to be accountable for the accuracy or integrity of the work presented here.
Funding
The study and the journal’s Rapid Service Fee were funded by Takeda (China) International Trading Co., Ltd.
Data Availability
The data used and analyzed during the current study are available from the corresponding author on reasonable request.
Declarations
Conflict of Interest
Congling Gu, Luis Hernandez, and Yan-Jun Zhang are employees of Takeda. Luis Hernandez and Yan-Jun Zhang hold Takeda stocks. Qingqing Chai declares that she has no competing interests.
Ethical Approval
This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.
Footnotes
Prior Presentation: The preliminary research work was submitted as an abstract to WCLC 2023. The results presented in WCLC 2023 were preliminary and are different from the current manuscript.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The data used and analyzed during the current study are available from the corresponding author on reasonable request.