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Economic evaluation of adding dapagliflozin to standard care in the treatment of chronic kidney disease: a systematic review

BMC Nephrology volume 25, Article number: 465 (2024) Cite this article

Abstract

Introduction

Chronic kidney disease is a significant public health issue. Dapagliflozin has been shown to improve the quality of life for patients with chronic kidney disease. This review aimed to systematically assess the cost-effectiveness of adding dapagliflozin to standard care compared with standard care alone for treating chronic kidney disease.

Methods

The relevant studies were searched in PubMed, Web of Science, Scopus, Embase, and Cochrane from the inception date to June 1, 2024. The titles, abstracts, and full texts were independently evaluated and screened by two authors. Additionally, the economic evaluation studies were assessed independently by two authors using the consolidated health economic evaluation reporting standards checklist.

Results

14 studies were included which were about the economic evaluations of adding dapagliflozin in the treatment of chronic kidney disease. The minimum consolidated health economic evaluation reporting standards score for the studies was 0.77, indicating very good quality. Adding dapagliflozin to the standard of care would be more effective and cost-saving in Mexico, Malaysia, Canada, Thailand, and China. The highest incremental cost-effectiveness ratio of dapagliflozin ($67962.75/QALY) originated from the USA. According to the available studies, adding dapagliflozin to standard of care for the treatment of chronic kidney disease is considered cost-effectiveness from both the healthcare system and the payer’s perspective.

Conclusion

Adding dapagliflozin to standard care in the treatment of chronic kidney disease is cost-effective from both the healthcare system and the payer’s perspective in well-developed countries.

Peer Review reports

Introduction

Chronic kidney disease (CKD) poses a significant public health problem associated with high morbidity, high mortality, high costs, and low quality of life [1]. CKD imposes a significant burden on societies and individuals globally. It was reported that there were 82 million adults with CKD in China from 2018 to 2019 [2]. The global median prevalence of CKD was 9.5%, with the highest prevalence of 12.8% in Eastern and Central Europe [3]. Kidney disease epidemiology showed that between 1990 and 2017, the global mortality rate attributed to CKD increased by 41.5% [4]. CKD imposes a substantial economic burden. In high-income countries, more than 2–3% of the annual healthcare budget is spent on treating end-stage kidney disease (ESKD) [5]. The general principles of managing CKD focus on correcting risk factors for the progression and complications of CKD, such as blood pressure management, lipid management, glycemic control, and weight control [6].

Sodium-dependent glucose transporters 2 (SGLT-2) inhibitors, can inhibit the kidney’s reabsorption of glucose, by binding to the receptor and causing the excess glucose to be excreted in the urine and reducing blood sugar, which are a new class of anti-diabetic drugs [7]. Currently, the main SGLT-2 inhibitors include dapagliflozin, empagliflozin, canagliflozin, and others [8]. Dapagliflozin has been approved for use in patients with CKD by the U.S. Food and Drug Administration (FDA) on April 30, 2021, and by the National Medical Products Administration (NMPA) in China on August 30, 2022, having been shown to reduce the risk of kidney function decline, kidney failure, cardiac death, and hospitalization for heart failure (HF) in adult patients with CKD [9, 10]. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) clinical trial demonstrated that dapagliflozin can delay the progression of renal disease, improve renal and cardiovascular outcomes, reduce all-cause mortality, and has a good safety profile in CKD patients with or without diabetes [11].

The economics are as important as the efficacy and safety. Several studies have been conducted on the pharmacoeconomic evaluation of dapagliflozin in the treatment of CKD patients. This study aims to systematically review the pharmacoeconomic assessment of dapagliflozin in treating CKD patients.

Methods

This systematic review was registered with PROSPERO (CRD42024560588) following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [12].

Cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) are the most common methods used for pharmacoeconomic evaluation [13]. The clinical outcomes were translated to quality-adjusted life years (QALYs), which accounted for both the quantity and quality of life. Specifically, QALYs are the product of the life years in each health state and the health utility value of that state.

Databases and search strategy

The databases PubMed, Web of Science, Scopus, Embase, and Cochrane were searched to find economic evaluation studies related to dapagliflozin and CKD. The search terms covered topics on economic evaluations, dapagliflozin, and CKD. The medical subject headings (MeSH) and text words were used to identify relevant studies. (Tab. S1). The studies were searched from the inception date to June 1, 2024. The articles published in English and Chinese were included in this systematic review.

Eligibility criteria

Economic evaluations, including cost-utility analyses, cost-effectiveness analyses, cost-benefit analyses, and cost-minimization analyses evaluating dapagliflozin were included. The review articles, editorials, and protocols were excluded. After removing duplicates, the title and abstract were examined independently by two authors, and then the full texts. When a disagreement arose, the involvement of a third researcher was necessary to discuss and resolve it.

Data extraction

The data was extracted independently by two authors. The following data was extracted: author, publication year, country, costing year, compared interventions, type of economic evaluation, the model type of the economic evaluation, perspective, time horizon, willingness-to-pay (WTP) threshold, discount rate, sensitivity analyses, total cost, mean quality-adjusted life years (QALY) or life years gained (LYG), and main outcomes.

Assessment of quality

The economic evaluation studies for the analysis were evaluated by two authors independently using the consolidated health economic evaluation reporting standards (CHEERS) checklist [12]. According to the CHEERS checklist, “Y” means “completely fulfilled” and is rated as “1”; “N” indicates that it is not fulfilled and is rated as “0”; “PA” stands for “partially fulfilled” and is rated as “0.5”. “NA” means “not applicable” [14]. Scores of 85% or more indicate excellent quality, 70–85% are very good quality, 55–70% denote good quality, and less than 55% suggest low quality [14].

Data Analysis

After evaluating the quality of the literature and completing the data extraction, the data were analyzed. The total cost and incremental cost-effectiveness ratio (ICER) were converted to 2022 USD ($) according to the Campbell and Cochrane Economics Methods Group (CCEMG) [15].

Results

Research results

A total of 440 studies were extracted, and after removing duplicates, 264 studies remained. Subsequently, 238 studies were excluded based on the titles and abstracts. Finally, 14 studies were included in the systematic review [1, 16,17,18,19,20,21,22,23,24,25,26,27,28]. (Fig. 1) Out of these, 2 studies were evaluated in Mexico [1, 16]. Additionally, 1 study was conducted in Malaysia [17], 1 in Canada [18], 1 in the UK [19], 1 in Japan [21], 1 in the USA [22], 1 in Thailand [23], and 1 in China [24]. 1 study was evaluated in the UK, Germany, and Spain [20], and another was conducted in the UK, Spain, Italy, and Japan [28]. 3 studies were conducted in Costa Rica, Dominican Republic, and Panama by Ordoñez J et al., respectively [25,26,27].

Fig. 1
figure 1

PRISMA flow chart for study selection

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Quality evaluation

The economic evaluation studies were assessed using the CHEERS checklist. 8 studies were evaluated [17, 18, 20,21,22,23,24, 28], while the other 6 studies were conference abstracts and did not assess for quality [1, 16, 19, 25,26,27].

According to the CHEERS checklist, the scores of 8 studies were all above 0.77. None of the 8 studies addressed the following 3 criteria: characterizing distributional effect, approach to engagement with patients and others affected by the study, and effect of engagement with patients and others affected by the study. Moreover, not all studies mentioned currency, price date, and conversion; specifically, 2 studies scored 0 points in these criteria [21, 24]. (Table 1; Fig. 2)

Table 1 Quality assessment results of the included studies
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Fig. 2
figure 2

Quality assessment results of the included studies

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Study characteristics

Out of the studies mentioned, 6 were conducted from the perspective of the health care system [16,17,18, 21, 22, 28], 6 were conducted from the perspective of the (third) payer [19, 20, 24,25,26,27], 1 was conducted from the societal perspective [23], while 1 study did not mention the perspective [1]. (Table 2) From the healthcare system’s perspective, only direct medical costs were considered. From the (third) payer perspective, direct medical costs within the insurance plan should be included. From the societal perspective, all direct medical costs and non-medical costs, as well as indirect costs, should be included [29].

Table 2 Study design and setting overview
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The time horizon of these studies varied from 12 months to the life-time horizon. The majority of the studies were simulated of a life-time horizon [1, 17,18,19,20, 22,23,24, 28], with 1 study covering a 15-year horizon [16], and 1 study spanning a 20-year horizon [21]. 3 studies by Ordoñez J et al. covered a 12-month, 24-month, and 36-month horizon [25,26,27]. (Table 2)

The willingness‑to‑pay (WTP) thresholds of 3 studies in the UK were $30333.83/QALY, $29437.17/QALY, and $28,777/QALY [19, 20, 28]. In Spain, the WTP thresholds of 2 studies were $37990.11/QALY and $39,063/QALY [20, 28]. Meanwhile, the two studies in Japan chose $53671.10/QALY and $53,671/QALY as the WTP thresholds [21, 28]. Additionally, the WTP thresholds in Malaysia, Canadian, Germany, USA, Thailand, China, Costa Rica, Dominican Republic, Panama, and Italy were $31789.91/QALY, $44404.88/QALY, $37990.11/QALY, $113271.25/QALY, $5779.51/QALY, $68466.33/QALY, $36,230/QALY, $21,805/QALY, $36,807/QALY, and $35,261/QALY, respectively [17, 18, 20, 22,23,24,25,26,27]. Furthermore, the discount rate ranged from 1.5 to 3.5%. (Table 2)

Study design

Markov model was used in all of the 14 studies. Markov models are mathematical models, which can be used to simulate the disease progression and evaluate the pharmacoeconomics for two different therapeutic schedules [30]. 1 study used the QALY to measure effectiveness but did not mention the concrete value [1]. Another 7 studies also used only the QALY as the measure of effectiveness [18, 20, 21, 24,25,26,27]. 5 studies used the QALY and LYG [17, 19, 22, 23, 28]. 1 study used the LYG as the measure of effectiveness but did not mention the concrete value [16].

Primary outcomes

Most of the analyses (8 studies) were carried out based on the clinical trial (DAPA-CKD) [1, 13,14,15,16,17, 20, 21, 26]. 3 studies were abstracts only, and it was not mentioned whether they were based on the DAPA-CKD trial, but the population characteristics were consistent with the DAPA-CKD trial [25,26,27]. 1 analysis was performed based on DAPA-CKD and CKD-JAC [21, 31, 32]. Additionally, 1 study was conducted based on the trials of DAPA-CKD and DECLARE-TIMI 58 [28, 33]. 1 study was performed on US patients with non-diabetic CKD [19].

The results of the total costs are presented in Table 3. Of the 14 studies, 6 found that adding dapagliflozin to the standard treatment can reduce the mean total cost [16,17,18, 23, 24]. The outcomes of QALY and LYG from the 14 studies can be found in Table 3; Fig. 3.

Table 3 Intervention cost and output results
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Fig. 3
figure 3

Incremental QALY and LYG of dapagliflozin plus standard therapy versus Standard therapy on the lifetime horizon

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2 studies were carried out in Mexico; only abstracts are available without specific total costs and QALY (LYG) [1, 16]. 1 study concluded that dapagliflozin was more effective and less expensive, while the other study found that the ICER was smaller than WTP, and dapagliflozin was considered cost-effective. Overall, according to the two studies, adding dapagliflozin to the standard treatment showed superiority over the standard treatment alone in Mexico.

In a study conducted in Malaysia, researchers found that the standard treatment yielded 8.35 QALYs with $20,644. When dapagliflozin was added to the standard treatment, the QALYs increased to 8.76 QALYs with $19,762. The LYGs were 10.01 and 9.55 in two groups, respectively [17]. Adding dapagliflozin to standard treatment would be more effective and less expensive in Malaysia.

In the study in Canada, from the healthcare system perspective of a life-time horizon, the dapagliflozin can produce 8.24 QALYs at a cost of $192512.92. In comparison, the standard treatment alone yields 6.81 QALYs at $216281.07. Adding dapagliflozin to standard treatment can lead to cost savings and yield more QALYs. The results of one-way sensitivity analysis (OWSA) and probabilistic sensitivity analyses (PSA) supported the base-case results. Adding dapagliflozin to standard treatment was less costly and more effective than standard treatment alone for patients with CKD and T2D [18].

In 3 studies in the UK, dapagliflozin is cost-effective [19, 20, 28]. The ICER was $ 8822.59/QALY, $8860.06/QALY, and $10,676/QALY, respectively. According to McEwan et al.’s study in 2021, adding dapagliflozin is more expensive ($117185.64 vs. $109822.11) and more effective (8.72 QALYs vs. 7.88 QALYs; 15.69 LYG vs. 13.90 LYG). Phil McEwan et al. evaluated the cost-effectiveness of dapagliflozin in the UK, Germany, and Spain using DAPA-CKD trial data in 2022 [20]. The QALYs for the group receiving dapagliflozin in the three countries were 8.68, 10.32, and 9.79, respectively. For the group receiving standard treatment alone, the QALYs were 7.86, 9.32, and 8.83 in the same countries. The total costs were $117273.58, $272413.13, and $175540.13 in the UK, Germany, and Spain with dapagliflozin, respectively. Meanwhile, the total costs were $109973.67, $253504.22, and $163570.51 in the UK, Germany, and Spain with standard treatment, respectively. The ICER was $8860.06/QALY, $18857.55/QALY, and $12505.71/QALY in the respective countries. In the study by Phil McEwan et al. in 2024, the health-economic analysis was conducted in the UK, Spain, Italy, and Japan [28]. Treatment with dapagliflozin led to increased mean total costs compared with standard treatment in the UK ($63243 vs. $58232), Spain ($156466 vs. $148659), Italy ($67999 vs. $63593), and Japan ($88386 vs. $79115). Adding dapagliflozin was more effective than standard treatment in terms of QALYs and LYGs in all four countries. In the UK, it resulted in 9.56 QALYs and 12.51 LYGs compared to 9.09 QALYs and 11.91 LYGs with standard treatment. In Spain, it led to 10.75 QALYs and 13.00 LYGs compared to 10.21 QALYs and 12.36 LYGs with standard treatment. In Italy, it resulted in 11.16 QALYs and 13.09 LYGs compared to 10.60 QALYs and 12.43 LYGs with standard treatment. In Japan, it led to 11.70 QALYs and 14.75 LYGs compared to 11.03 QALYs and 13.91 LYGs with standard treatment. These two studies by Phil McEwan et al. also suggested that dapagliflozin is cost-effective in Spain [20, 28]. The studies also indicated the cost-effectiveness of adding dapagliflozin in Germany and Italy, respectively [20, 28].

In addition to the study by McEwan et al. in Japan in 2024, Kodera et al. also assessed the cost-effectiveness of dapagliflozin for CKD in Japan [21, 28]. In the CKD 3a patients, the total costs were $108415.62 and $95534.56 in the two groups, while the QALYs were 16.9 and 16.6. For the 3b patients, the total costs were $137398.02 and $136324.60 in the two groups, with QALYs of 16.2 and 15.6. The ICER was $43258.91/QALY and $1288.11/QALY in patients of CKD 3a and CKD 3b. Dapagliflozin was cost-effective in Japan.

The other 3 studies were carried out in the US, Thailand, and China [22,23,24]. In the US, treatment with dapagliflozin led to an additional cost of $89484.29, 1.31 QALYs, and 2.00 LYGs. The ICER was $67962.75/QALY. The study assessed the impact of dapagliflozin on non-diabetic CKD in patients in the US [22]. Subgroup analysis indicated that “for cohorts aged 70 and younger, cost-effectiveness was more favorable for patients in more advanced CKD stages.” In 40-year-old patients with stage 4 CKD, the addition of dapagliflozin was found to be both more effective and less costly. In Thailand, adding dapagliflozin resulted in a cost reduction of $89484.29, an extra 0.30 QALYs and 0.35 LYGs. Adding dapagliflozin to standard treatment would be more effective and less costly in Thailand [23]. The results of the scenario analysis, OWSA, and PSA all indicated that the findings were robust. A study in China showed that dapagliflozin is not only a cost-saving therapy ($95281.81 vs. $104709.85) but also more effective (13.70 QALYs vs. 13.37 QALYs). The sensitivity analysis further confirmed the robustness of these results. These findings suggest that adding dapagliflozin may be a better choice for CKD [24].

3 studies by Ordoñez J et al. in 2022 in Costa Rica, the Dominican Republic, and Panama, with time horizons of 12, 24, and 32 months, showed that dapagliflozin is a cost-effective strategy for treating CKD in these countries. Patients receiving dapagliflozin experience fewer life-threatening and costly complications compared to those who do not receive it [25,26,27].

The results of the studies included in this review indicate that dapagliflozin is cost-effective for CKD patients in all the countries studied.

Sensitivity analysis

The sensitivity analysis, which includes scenario analyses, one-way sensitivity analysis (OWSA), and probabilistic sensitivity analysis (PSA), was conducted in 12 of the 14 articles [16,17,18, 20,21,22,23,24,25,26,27,28]. The OWSA indicated that the following factors were most sensitive to the results: time horizons [17, 20, 28], the decline in estimated glomerular filtration rate (eGFR) [18], the utility of CKD, the costs of hemodialysis [21], the costs of dapagliflozin [22], the probability of progression from CKD stage 3b to dialysis of SoC [23], and the utilities for CKD stages 2–4 [24]. The OWSA analyses indicated that the results were generally robust, except in the studies by Tisdale et al. and Kodera et al. In the study of Tisdale et al., an increase in the price of dapagliflozin may result in it being not cost-effective [22]. Conversely, Kodera et al.’s study revealed that a decrease in the utility value of CKD could also render the addition of dapagliflozin not cost-effective [21].

The PSA showed that the probability of dapagliflozin being cost-effective ranged from 52.6 to 100% [17, 20,21,22, 28]. The scenario analyses demonstrated that the results are generally robust. (Table 4)

Table 4 Sensitivity analyse
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Subgroup analysis

3 studies also conducted subgroup analyses (Table S2). These analyses focused primarily on patients with and without type 2 diabetes (T2D), patients with a low or high urinary albumin creatinine ratio (UACR), and different ages. Across all analyzed subgroups, dapagliflozin was found to be cost-effectiveness [20, 22, 28].

According to McEwan et al.’s study, the ICER of patients without T2D, with an eGFR of less than 45 ml/min/1.73 m2, aged 65 or older, and with UACR of 300 mg/g or higher was notably lower than patients with T2D, an eGFR of 45 ml/min/1.73 m2 or higher, aged under 65, and a UACR below 300 mg/g [20]. In Tisdale et al.’s study, cost-effectiveness was more favorable for patients in more advanced CKD stages and in the younger age [22]. Another analysis showed that ICERs for the subgroup with higher UACR and without T2D were the lowest [28].

Characteristics of 8 full articles

The conference abstracts have been incorporated into this article. Although the impact of conference abstracts can be unclear and may sometimes help mitigate the publication bias [34, 35]. Indeed, some recent systematic reviews also included the conference abstracts [12, 36]. To provide the readers with the most comprehensive perspective, the conference abstracts were included.

In 8 full articles, 6 conducted the economic evaluation in Malaysia, Canada, Japan, the USA, Thailand, and China. The remaining 2 articles were conducted across 4 countries (the UK, Spain, Italy, and Japan) and 3 countries (the UK, Germany, and Spain). Out of the 8 full articles, 4 studies showed that adding dapagliflozin to SoC would be more effective and less costly in Malaysia, Canada, Thailand, and China [17, 18, 23, 24]. In the remaining 4 full articles, the ICER ranged from $1288.11/QALY to $67962.75/QALY, both of which are below WTP thresholds [20,21,22, 28]. According to the studies, dapagliflozin was proved to be a cost-effective option for patients with CKD in these countries.

Discussion

This systematic review reviewed 14 studies (8 original studies and 6 meeting abstracts) on the economic evaluation of dapagliflozin in CKD patients. The results indicate that dapagliflozin is cost-effective for CKD patients.

The sensitivity analysis results were highly consistent among the 14 studies reviewed. Both the OWSA and scenario analyses demonstrated the robustness of the results. Tisdale et al.’s study showed that the cost-effectiveness of dapagliflozin is influenced by its pricing [22]. Higher prices in some countries may affect cost-effectiveness. The lower price of dapagliflozin would lead to more favorable cost-effectiveness.

The analyses by Kodera et al. showed that the addition of dapagliflozin in many scenario analyses was not considered cost-effective for patients with CKD stage 3a in Japan [21]. The cost-effectiveness probability of dapagliflozin was 52.6% in this population. The lower probability observed in Japan, compared to other studies, may result from differences in event incidence and the specific patient populations targeted. In patients with CKD stage 3a, the rate of introduction of hemodialysis was 0.45%/year, and few patients needed to initiate hemodialysis. Therefore, the cost-effectiveness of dapagliflozin in patients with low hemodialysis may be limited. More researches are needed in the future. In 9 out of 10 studies, the probability of dapagliflozin being cost-effective was greater than 85%, indicating that the model results are robust to joint uncertainty in the input parameters.

The results of subgroup analysis showed that dapagliflozin in CKD patients without T2D or UACR ≥ 300 mg/g or more advanced CKD stages may be more cost-effective, which was also consistent with Kodera et al.’s study [20, 22, 28].

Several studies have found that adding dapagliflozin to standard treatment can be less costly and more effective. Research conducted in Mexico, Malaysia, Canada, Thailand, and China showed that adding dapagliflozin to standard treatment resulted in lower mean total costs compared to standard treatment alone. This may be because while adding dapagliflozin can increase drug acquisition costs, it can reduce the costs associated with hospitalization for heart failure (HHF), acute kidney injury (AKI), and renal replacement therapy (RRT) [16,17,18, 23, 24].

Overall, adding dapagliflozin to standard treatment was cost-effective. Cost-effectiveness was more favorable in CKD patients without T2D or UACR ≥ 300 mg/g or more advanced kidney disease or the lower price of dapagliflozin.

Nevertheless, there are some limitations in our review. Firstly, the economic evaluation in this systematic review is based on articles published in English and Chinese, which represents a potential limitation. Second, most of the studies were conducted in well-developed countries, making it possible that the results cannot be generalized to low- and middle-income countries. Additional research using data from low- and middle-income countries is essential. The economic evaluation of dapagliflozin in CKD patients needs to be explored in these regions. Third, different time horizons in various studies may lead to variations in the results, limiting the capacity to compare between countries. Fourth, most of the studies were carried out from a healthcare perspective or payer perspective. The only analysis from the wider societal perspective only considered direct medical costs and direct non-medical costs, without taking into account indirect costs. Fifth, most of the results of economic evaluations were based on the clinical trials and may not reflect reality. Long-term real-world observational studies are needed. Finally, the economic evaluations published only as conference abstracts were included, the inclusion of conference abstracts that were not published in full have unclear impact.

Conclusions

This paper presents a systematic review of economic evaluations of adding dapagliflozin to standard care in the treatment of CKD. The results of this systematic review indicate that dapagliflozin is cost-effective for CKD patients from the healthcare perspective or payer perspective in well-developed countries. More economic evaluations of dapagliflozin from the societal perspective or in low- and middle-income countries are needed.

Data availability

No datasets were generated or analysed during the current study.

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  1. Lu Wang and Yinglin Wang are contributed equally to this work.

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  1. Department of Pharmacy, Yantai Yuhuangding Hospital, Yantai, 264000, Shandong Province, China

    Lu Wang, Yinglin Wang & Quan Zhao

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Contributions

All authors (L.W., Y.W., and Q. Z.) contributed to the study’s conception and design. Material preparation, title and abstract screening, data extraction, and data analysis were performed by L.W. and Y. W. The first draft of the manuscript was written by L.W. and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Wang, L., Wang, Y. & Zhao, Q. Economic evaluation of adding dapagliflozin to standard care in the treatment of chronic kidney disease: a systematic review. BMC Nephrol 25, 465 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12882-024-03901-7

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BMC Nephrology

ISSN: 1471-2369

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