Cost-effectiveness comparison of dalpiciclib and abemaciclib Combined with an aromatase inhibitor as first-line treatment for HR+/ HER2− advanced breast cancer

doi:10.21203/rs.3.rs-3468411/v1

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Research Article

Cost-effectiveness comparison of dalpiciclib and abemaciclib Combined with an aromatase inhibitor as first-line treatment for HR+/ HER2− advanced breast cancer

https://doi.org/10.21203/rs.3.rs-3468411/v1

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published 12 Mar, 2024

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Background

Dalpiciclib and abemaciclib, both CDK4/6 inhibitors, have been approved by the China National Medical Products Administration for the first-line treatment of postmenopausal women with hormone receptor-positive (HR+) and human epidermal growth factor receptor-2 negative (HER2−) advanced breast cancer (ABC). As the first domestically developed CDK4/6 inhibitor in China, there has been no previous economic evaluation of dalpiciclib. This study aimed to assess the cost-effectiveness of dalpiciclib compared to abemaciclib when used in combination with letrozole for the first-line treatment of HR+/HER2 − ABC from the perspective of healthcare payers in China.

Methods

A Markov model with three health states was constructed to evaluate the health and economic outcomes of first-line treatment with dalpiciclib plus letrozole and abemaciclib plus letrozole for HR+/HER2 − ABC. The efficacy data was obtained from the MONARCH3 and DAWNA-2 trials, while utility data was derived from published reports. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) were calculated. Sensitivity analyses were performed to explore variations in the model results.

Results

Compared to abemaciclib plus letrozole, dalpiciclib plus letrozole resulted in 5.13 additional QALYs, with an ICER of $27,305/QALY. At a willingness-to-pay (WTP) threshold of the gross domestic product (GDP) per capita in China for 2022 ($38,223/QALY), the probability of dalpiciclib plus letrozole being cost-effective was 75%. Sensitivity analysis results were consistent with those of the base-case analysis.

Conclusions

From the perspective of Chinese healthcare payers, the combination of dalpiciclib and letrozole appears to be a more cost-effective strategy when compared to abemaciclib plus letrozole for the first-line treatment of patients with HR+/HER2 − ABC in China.

HR+/HER2 − advanced breast cancer

Dalpiciclib

Abemaciclib

Cost-effectiveness

Aromatase inhibitor

Global Cancer Statistics for 2020 presented that female breast cancer was the most commonly diagnosed cancer and the fifth leading cause of cancer-related deaths worldwide [1]. In China, breast cancer accounted for 16.72% of all new cancer cases, and breast cancer-related deaths accounted for 9.9% of all female cancer deaths [2]. The majority of breast cancer patients were initially diagnosed with localized disease (94–97%), and 3–6% had new metastatic disease at diagnosis. Additionally, 10–30% of early-stage breast cancer patients later developed systemic recurrence [3]. Approximately 70% of patients with metastatic breast cancer have the HR+/HER2 − subtype [4]. Unfortunately, advanced breast cancer (ABC) has a poor prognosis, with a 5-year survival rate of only 26% for distant HR+/HER2 − breast cancer [5]. Since ABC remains incurable, treatment goals should encompass not only improving survival but also maintaining the quality of life and palliation of symptoms [6, 7].

The main treatment for postmenopausal women with HR+/HER2 − ABC has been single-agent endocrine therapy, typically with aromatase inhibitors (AIs) such as letrozole or anastrozole. However, resistance eventually occurs [8]. Several studies have demonstrated that adding a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor to letrozole/anastrozole significantly enhances efficacy. Consequently, the combination of endocrine therapy and a CDK4/6 inhibitor has become the preferred first-line treatment for HR+/HER2 − ABC in most parts of the world [9–11]. Abemaciclib and dalpiciclib, both CDK4/6 inhibitors, were approved for first-line use in combination with AI for patients with HR+/HER2 − ABC by the Chinese National Medical Products Administration (NMPA) in 2020 and 2023, respectively. This approach is also recommended by the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment of Breast Cancer Guideline as the first-line treatment for HR+/HER2 − ABC [12].

The clinical efficacy of abemaciclib in combination with a nonsteroidal AI (anastrozole or letrozole) was evaluated in the MONARCH 3 (NCT02246621) study [13–15]. MONARCH 3 was a randomized, phase III, double-blind study involving postmenopausal women with HR+/HER2 − locoregionally recurrent breast cancer who had not received prior systemic therapy. A total of 493 patients were assigned to receive either abemaciclib (150 mg twice daily continuously) (n = 328) or placebo (once daily) (n = 165), both in combination with 1 mg anastrozole or 2.5 mg letrozole daily. The primary objective was progression-free survival (PFS). The results of the study showed that the abemaciclib arm achieved a significantly longer median PFS compared to the placebo arm (28.18 months versus 14.76 months; hazard ratio, 0.54).

Efficacy data for dalpiciclib plus letrozole or anastrozole was derived from the DAWNA-2 (NCT03966898) study [16]. DAWNA-2 was a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial conducted in 42 hospitals in China. It assessed the efficacy and safety of dalpiciclib plus letrozole or anastrozole as first-line therapy for patients with HR+/HER2 − ABC who had not received prior systemic therapy in the advanced setting. A total of 456 patients were eligible and randomly assigned to either the dalpiciclib group (150 mg per day for 3 weeks, followed by 1 week off in a 4-week cycle) (n = 303) or the placebo group (once daily for 3 weeks, followed by 1 week off in a 4-week cycle) (n = 153). Both groups also received endocrine therapy with either 2.5 mg letrozole or 1 mg anastrozole orally once daily continuously. The primary endpoint was PFS, and results showed that the dalpiciclib group had a significantly longer median PFS compared to the placebo group (30.6 months versus 18.2 months; hazard ratio, 0.51). Serious adverse events were reported in 36 (12%) patients in the dalpiciclib group and 10 (7%) patients in the placebo group.

As the first domestically developed CDK4/6 inhibitor in China, there has been no previous economic evaluation of dalpiciclib. Therefore, the objective of this study was to assess the cost-effectiveness of dalpiciclib compared to abemaciclib when combined with AI for the first-line treatment of HR+/HER2 − ABC in China.

Model overview

This study adhered to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) reporting guidelines [17, 18]. We developed a Markov model to simulate the costs and health benefits associated with the treatment of HR+/HER2- ABC with abemaciclib and dalpiciclib plus letrozole/ anastrozole. The model incorporated three discrete health states that represented different stages of the disease: progression-free (PF), progressed disease (PD), and death (Fig. 1). Since the treatment schedule for dalpiciclib was 21 days followed by 7 days off, the cycle length in the Markov model was set to one month. The lifetime horizon was 15-years because the 5-year survival rate was 26% and the initial health status for all patients was progression-free survival [19, 20]. All patients entered the model in the PF state and remained in this state until disease progression or death. Patients in the PD state could either remain in this state or die.

The outcomes of this model included life years (LYs), quality-adjusted life years, and costs. According to Chinese guidelines for pharmacoeconomic evaluations, costs and QALYs were discounted at an annual rate of 5%. Incremental cost-effectiveness ratios (ICERs) were calculated, representing the cost per additional QALY gained. The cost-effectiveness threshold in China was set at $38,223 (3 times the per capita gross domestic product of China in 2022) [21, 22].

Clinical efficacy

Survival parameters were mainly obtained from the Kaplan–Meier (KM) curve of the MONARCH 3 and DAWNA-2 trials[13–16]. As patients in DAWNA-2 trials are followed for a limited period of time, with most patients not reaching the endpoint event by the trial's conclusion, we simulated overall survival (OS) curves to account for incomplete data. These OS curves predicted the median survival benefit of first-line treatment with CDK4/6 inhibitors plus aromatase inhibitors.

We utilized the Engauge Digitizer software to extract digitized data points from the PFS and OS Kaplan–Meier curves of the MONARCH 3 and DAWNA-2 trials. Individual patient data were reconstructed using standard statistical analyses as described by Guyot, et al [23]. The following parametric survival functions were considered: the exponential distribution, the Weibull distribution, and the log-logistic distribution. The best-fitted distribution was chosen for the model based on the Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC), selecting the distribution with the smallest AIC or BIC value [24].

Cost estimates

This analysis adopted the perspective of healthcare payers in China, which considered only direct medical costs. These costs included first- and second-line treatment, management of treatment-related serious adverse events, disease management costs (including outpatient visits, hospitalizations, laboratory scans, and tests), and terminal care. Drug costs were estimated based on patient dosing schedules and unit costs, with costs calculated per cycle. Unit drug costs were obtained from the Shenzhen pharmaceutical trading platform [25]. Costs related to subsequent treatment, adverse event management, and end-of-life care were sourced from published literature [26–31]. Regarding subsequent treatment, we assumed that patients taking oral abemaciclib plus letrozole or anastrozole and dalpiciclib plus letrozole or anastrozole would receive the same subsequent treatment after progression of advanced breast cancer [15]. For adverse event management costs, only events of grade ≥ 3 in the MONARCH 3 and DAWNA-2 trials were included [14, 16]. All costs were adjusted to US dollars in 2022. Chinese Yuan was converted to US dollars by using the exchange rate formula: 1 US $ = 6.7261 CNY [32]. Key costs are shown in Table 1.

Table 1

Model parameters of clinical data,costs and utilities: baseline values, ranges, and distributions.
Parameters inputs	Baseline Value(Range)	Distribution	Reference
Survival model for Dalpiciclib plus letrozole
PFS*	AIC = 584.05, BIC = 592.79	Log-logistic	Estimated
OS*	AIC = 226.17, BIC = 234.22	Weibull	Estimated
Survival model for Abemaciclib plus letrozole
PFS*	AIC = 495.64, BIC = 501.00	Exponential	Estimated
OS*	AIC = 226.17, BIC = 534.22	Weibull	Estimated
Direct costs
PFS on Dalpiciclib plus letrozole	3079 (2463–3079)	Gamma	[25, 26–31]
PD on Dalpiciclib plus letrozole	3863 (3091–4636)	Gamma	[25, 26–31]
PFS on Abemaciclib plus letrozole	1179 (943–1179)	Gamma	[26–31]
PD on Abemaciclib plus letrozole	2088 (1671–2506)	Gamma	[26–31]
Management of SAEs * in Dalpiciclib plus letrozole	958 (766–1149)	Gamma	[17, 26–31]
Management of SAEs* on Abemaciclib plus letrozole	358 (286–429)	Gamma	[16, 26–31]
subsequent treatment	910 (728–1092)	Gamma	[15, 25]
Disease management Of PFS	614 (492–737)	Gamma	[26–31]
Disease management Of PD	1199 (959–1439)	Gamma	[26–31]
End-of-life	2155 (1724–2858)	Gamma	[26–31]
Utility values of Dalpiciclib plus letrozole
PFS* state	0.79 (0-0.79)	Beta	[36]
PD* state	0.45 (0-0.45)	Beta	[36]
Utility values of Abemaciclib plus letrozole
PFS* state	0.65 (0-0.65)	Beta	[35]
PD* state	0.56 (0-0.56)	Beta	[35]
Discount rate	0.05 (0–0.08)	Beta	[22]
*PFS Progression-free survival, OS Overall survival, SAEs Severe adverse events, PD Progressed disease

Utility estimates

Quality-adjusted life years (QALYs) were estimated using health state utility (HSU) values, and separate HSU values were estimated for patients in the PF and PD states.The HSU values for different health states were derived from patient-reported outcomes from the full MONARCH 3 population [18], utilizing the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Breast Cancer Questionnaire (BR23) to measure the health-related quality of life [33, 34]. The HSU values used in the model are summarized in Table 1.

Sensitivity analysis

In the base-case analysis, ICERs were presented as cost-effectiveness outcome measure and calculated as the incremental cost per additional LY. In accordance with Chinese guidelines for pharmacoeconomic evaluations, we adopted 3 times the per capita gross domestic product (GDP) of China in 2022 as the WTP threshold, equating to $38,223 per QALY [21, 22].

One-way deterministic and probabilistic sensitivity analyses were performed to assess the uncertainty of the results. In the one-way deterministic sensitivity analyses (DSA), key model input parameters were adjusted one-by-one to their respective low and high values, as detailed in Tables 1. The ranges for the parameters were determined based on credible intervals or by assuming a variance of 20% from the base-case values. The results of the one-way sensitivity analyses are presented in a Tornado diagram. For the probabilistic sensitivity analyses (PSA), parameters were sampled using the Monte Carlo method, generating 1000 replicated outcomes. Results were presented on a cost-effectiveness plane and cost-effectiveness acceptability curve. Each parameter was put into the model with diferent distribution types: Gamma distributions for costs related to disease management, drug acquisition, monitoring, and adverse events, and Beta distributions for the utility weights assigned to PF and PD states [37].

Base-case analysis

The results of the deterministic analysis are presented in Table 2. In the HR+/HER2 − ABC patients, when compared to abemaciclib plus letrozole, dalpiciclib plus letrozole yielded an additional 5.13 QALYs (44.43 QALYs vs. 39.3 QALYs), corresponding to an incremental cost of $140000. The ICER was calculated to be $27305/QALY gained, which was lower than the WTP of three times the GDP per capita in China.

Table 2

Summary of results of the base-case analysis.
Regimens	Costs ($)	QALYs*	Incremental Cost ($)	Incremental QALYs*	ICER*
Dalpiciclib plus letrozole	437502.1206	44.4297	140000.1756	5.1273	27304.5694
Abemaciclib plus letrozole	297501.9450	39.3023	NA	NA	NA
* QALYs: Quality-adjusted life years, ICER:Incremental cost-efectiveness ratio

Sensitivity analysis

The one-way deterministic sensitivity analyses suggested that the results of the model were more sensitive to the utility of PD and PFS for dalpiciclib plus letrozole group and abemaciclib plus letrozole group(Fig. 2). For PSA, the cost-effectiveness plane illustrated the results of 1,000 Monte Carlo iterations (Fig. 3). Comparing dalpiciclib plus letrozole with abemaciclib plus letrozole, the cost-effectiveness acceptability curve indicated a nearly 75% probability of cost-effectiveness at the WTP threshold of $38,223/QALY, consistent with the base-case analysis result (Fig. 4).

In this study, we constructed a Markov model to assess the cost-effectiveness of dalpiciclib plus letrozole versus abemaciclib plus letrozole as the first-line treatment for HR+/HER2 − ABC patients in China from the perspective of the Chinese healthcare system. Our results indicated that the therapy of dalpiciclib plus letrozole produced an additional 5.13 life years and 44.43 QALYs compared to abemaciclib plus letrozole. The calculated ICER was $27,305/QALY gained, which was below the WTP threshold of three times GDP per capita in China. this finding indicated that dalpiciclib plus letrozole strategy was a cost-effective option. The probabilistic sensitivity analysis also demonstrated robustness of this result, and the conclusion was further strengthened by the deterministic sensitivity analysis.

For an indirect comparison between the abemaciclib plus letrozole and dalpiciclib plus letrozole treatments, it's essential to ensure comparable baselines between the groups. According to the baseline characteristics of patients reported in the MONARCH 3 study and DAWNA-2 study, the proportion of Disease-free interval (De novo metastatic,41% vs. 41%), Visceral metastases at study entry (61% vs. 55%) in the two groups were similar. Nonetheless, certain disparities were observed, such as the proportion of prior endocrine therapy, median age, Post-menopausal status, and the inclusion of letrozole as an endocrine therapy partner [13–16]. The DAWNA-2 study, conducted in China, provided insights into the local epidemiological nuances of advanced breast cancer. Compared to western counterparts, Chinese patients tend to be younger and exhibit a lower frequency of prior endocrine therapy and Post-menopausal status, indicative of a more favorable prognosis.

With China increasingly emphasizing economic evaluation evidence in medical insurance coverage negotiations, executing cost-effectiveness analyses for innovative medications to furnish a holistic decision-making foundation has become paramount. Zeng N et al. showed that, in comparison with Palbociclib plus AI and ribociclib plus AI, only abemaciclib plus AI proved cost-effective at a WTP of $38,029/QALY from the Chinese payers' perspective [38]. however, the economic evidence of dalpiciclib plus AI versus abemaciclib plus AI in China is currently lacking. To our knowledge, this is the first analysis attempting to evaluate the economic outcomes of these treatment regimens for HR+/HER2 − ABC patients.

This study has several limitations that should be mentioned. (1) Lack of local utility data for HR+/HER2 − ABC patients from the DAWNA-2 study, Consequently, the accuracy of the model will require updating when such data become available in China. (2) The OS curve in the DAWNA-2 study was not yet fully mature, leading to the utilization of parameter distribution fitting for simulation. While this approach enhances result accuracy, it's important to recognize that it introduces an element of estimation. (3) As there were some inconsistencies in the baseline characteristics, the heterogeneity of baseline characteristics cannot be well balanced, which might increase the bias of the results. It is crucial to note that this analysis is based on updated data published in 2023. We will revisit and update our results once the final data are accessible for analysis.

This study demonstrated that dalpiciclib plus letrozole is potentially more cost-effective option than abemaciclib plus letrozole for the first-line treatment of HR+/HER2- ABC from the perspective of the Chinese healthcare system at a WTP threshold of $38223/QALY. This finding could guide clinicians and health policymakers towards more informed decisions for the management of HR+/HER2- ABC.

HR + Hormone receptor-positive

HER2 − Human epidermal growth factor receptor-2 negative

ABC Advanced breast cancer

QALYs Quality-adjusted life-years

ICER Incremental cost-effectiveness ratio

CDK4/6 Cyclin-dependent kinase 4/6

NMPA National Medical Products Administration

CSCO Chinese Society of Clinical Oncology

AIs Aromatase inhibitors

PFS Progression-free survival

HR Hazard ratio

CHEERS Consolidated Health Economic Evaluation Reporting Standards

PF Progression-free

PD Progressed disease

LYs Life years

KM Kaplan– Meier

OS Overall survival

AIC Akaike Information Criterion

BIC Bayesian Information Criterion

HSU Health state utility

EORTC European Organization for Research and Treatment of Cancer

QLQ-C30 Quality of Life Questionnaire Core 30

BR23 Breast Cancer Questionnaire

GDP Gross domestic product

WTP Willingness-to-pay

DSA Deterministic sensitivity analyses

PSA Probabilistic sensitivity analys

Acknowledgments

Not applicable.

Author contributions

X.Z.Z and M.J conceived and designed the study protocol. C.T.J and X.Z.Z retrieved and collected the data, C.T.J ,X.Z.Z and H.J conducted the statistical analysis and interpretation of the results. H.J and X.Z.Z completed the drafting of the article, and revised the manuscript. All authors read and approved the final manuscript.

Funding

This work is supported by Shenzhen High-level Hospital Construction Fund, Guangdong Pharmaceutical Association Comprehensive Drug Evaluation fund (Grant no. 2022-1115-29), and Shenzhen Pharmaceutical Association Hospital Pharmacy Research Fund (Grant no. sz2022A28), and China Medical Education Association Research Fund (Grant no. 2023WSJSPGZXKT-12).

The sponsors had no roles in the study process.

Availability of data and material

Datasets are available through the corresponding author upon reasonable request.

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no conflict of interest.

Author details

¹Department of pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China. ²Department of Pharmacy, Boai Hospital of Zhongshan, Zhongshan, China

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No competing interests reported.

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published 12 Mar, 2024

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Cost-effectiveness comparison of dalpiciclib and abemaciclib Combined with an aromatase inhibitor as first-line treatment for HR+/ HER2− advanced breast cancer

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Introduction

Methods

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Clinical efficacy

Cost estimates

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Sensitivity analysis

Results

Base-case analysis

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