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. 2025 Jun;42(6):2767-2781.
doi: 10.1007/s12325-025-03164-0. Epub 2025 Apr 8.

A Cost-Effectiveness Analysis of Abemaciclib in Combination with Adjuvant Endocrine Therapy for HR+, HER2-, Node-Positive, High-Risk Early Breast Cancer

Alison Davie  1 , Sory Traoré  2 , Waleed Badreldin  3 , Astrid Torstensson  4 , Esra Cakar  5 , Anuja C McCullough  6 , Susan Tempelaar  7 , Elisabeth Fenwick  8 , Peter S Hall  9
Affiliations

A Cost-Effectiveness Analysis of Abemaciclib in Combination with Adjuvant Endocrine Therapy for HR+, HER2-, Node-Positive, High-Risk Early Breast Cancer

Alison Davie et al. Adv Ther. 2025 Jun.

Abstract

Introduction: The monarchE trial demonstrated that the addition of 2 years of abemaciclib to adjuvant endocrine therapy (ET) significantly reduced the risk of disease recurrence in patients with hormone receptor positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-), node-positive early breast cancer (EBC) at high risk of disease recurrence. Abemaciclib meets a critical unmet need for more effective adjuvant therapy for this patient population. This study evaluates the cost-effectiveness (CE) of abemaciclib plus ET compared to ET alone.

Methods: A five-state cohort transition model, which presents a United Kingdom (UK) perspective, is parameterized using data from the monarchE trial and literature. Cost-effectiveness results are presented in terms of cost/quality-adjusted life year (QALY) over a lifetime time horizon. Various assumptions were tested through sensitivity and scenario analyses and uncertainty was assessed through probabilistic analysis.

Results: Patients receiving abemaciclib plus ET were predicted to experience higher QALYs (11.16 compared to 10.42) at an increased cost (£87,541 compared to £48,625), leading to an incremental cost-effectiveness ratio (ICER) of £52,317 per QALY gain compared to ET alone. The increased costs associated with the addition of abemaciclib were partially offset by a reduction in distant disease recurrence and associated costs. The scenario and sensitivity analyses supported robust base case results.

Conclusion: Despite the ICER exceeding usual willingness-to-pay (WTP) levels in the UK, a consequence of using list prices, the CE model utilizing the latest data cut from the monarchE trial, demonstrated that the upfront cost of abemaciclib reduces the risk of a terminal breast cancer prognosis and its associated cost and quality of life impact. The addition of 2 years of abemaciclib provides an option for the treatment of HR+, HER2-, node-positive, high-risk EBC.

Keywords: Abemaciclib; Cost-effectiveness analysis; Early breast cancer; Endocrine therapy; HER2–; HR+.

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Conflict of interest statement

Declarations. Conflict of Interest: Alison Davie, Sory Traoré, Waleed Badreldin and Astrid Torstensson are all employees of Eli Lilly and Company. Peter S Hall has disclosed an advisory role with Eli Lilly and Company Ltd.; for which an honorarium was received for consultancy in the development of this study. Esra Cakar and Anuja C. McCullough were employees of OPEN Health HEOR & Market Access at the time that the work was undertaken. Esra Cakar is now an employee of Pfizer. Anuja C. McCullough is now an employee of the National Institute for Health and Care Excellence. Susan Tempelaar and Elisabeth Fenwick are employees of OPEN Health HEOR & Market Access. OPEN Health HEOR & Market Access received funding from Eli Lilly and Company Ltd. for consultancy and study development. Ethical Approval: This study was based on a previously conducted randomized, open-label phase 3 study and does not contain any new data evaluating human participants or animals. Eli Lilly and Company Ltd. approve the use of these data.

Figures

Fig. 1
Fig. 1
Model overview. ET endocrine therapy, IDFS invasive disease-free survival. aET-resistant: Disease recurrence while receiving or within 12 months of completing prior adjuvant ET.bET-sensitive: Disease recurrence at least 12 months after completing prior adjuvant ET. cA fixed payoff approach was used to accrue life years, QALYs and costs
Fig. 2
Fig. 2
IDFS Kaplan–Meier curves and loglogistic extrapolation for abemaciclib plus ET and ET alone (OS IA3; ITT population). ET endocrine therapy, IDFS invasive disease-free survival, ITT intention-to-treat, KM Kaplan–Meier, OS IA3 overall survival interim analysis 3
Fig. 3
Fig. 3
Crossing of IDFS hazard rate with general population mortality hazard rate for the UK. ET Endocrine therapy, IDFS Invasive disease-free survival, UK United Kingdom
Fig. 4
Fig. 4
Total discounted costs per category. ET endocrine therapy
Fig. 5
Fig. 5
Deterministic sensitivity analysis tornado plot for abemaciclib plus ET vs. ET alone: impact of parameter variations on ICER. ABE abemaciclib, CDK4&6i cyclin-dependent kinase 4/6 inhibitor, ET endocrine therapy, ETR endocrine therapy resistant, ETS endocrine therapy sensitive, FUL fulvestrant, IDFS invasive disease-free survival, ICER incremental cost-effectiveness ratio, LY life years, NMR non-metastatic recurrence, NSAI nonsteroidal aromatase inhibitor, PFS progression-free survival, PFS1 progression-free survival first-line advanced breast cancer, PFS2 progression-free survival second-line advanced breast cancer, PPS post-progression survival, PAL palbociclib, Prop proportion, REM remission, RIBO ribociclib, TMX Tamoxifen
Fig. 6
Fig. 6
Incremental cost-effectiveness plane: abemaciclib plus ET vs. ET alone. QALY quality-adjusted life-year
Fig. 7
Fig. 7
Multiway cost-effectiveness acceptability curve: probability of abemaciclib plus ET vs. ET alone being cost-effective. ET endocrine therapy, QALY quality-adjusted life-year
See this image and copyright information in PMC

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