A GATEWAY TO FUTURE INNOVATIONS: REAL OPTION VALUE (ROV) OF FIRST-LINE CDK4/6 INHIBITORS IN HR+/HER2-NEGATIVE METASTATIC BREAST CANCER
Author(s)
Cynthia L. Gong, PharmD, PhD1, Adam B. Kasle, BS2, Sarah Katsandres, MPH2, Kristen Migliaccio-Walle, BS2, Timothy J. Pluard, MD3, Yanyu Wu, PhD4, Justin Doan, MPH, MSc, DrPH5, David L. Veenstra, PharmD, PhD2.
1Senior Research Associate, Curta, Seattle, WA, USA, 2Curta, Seattle, WA, USA, 3Center for Advanced Breast Cancer, University of Missouri - Kansas City, Kansas City, MO, USA, 4Pfizer, New York, NY, USA, 5Pfizer, Farragut, TN, USA.
1Senior Research Associate, Curta, Seattle, WA, USA, 2Curta, Seattle, WA, USA, 3Center for Advanced Breast Cancer, University of Missouri - Kansas City, Kansas City, MO, USA, 4Pfizer, New York, NY, USA, 5Pfizer, Farragut, TN, USA.
OBJECTIVES: Real option value (ROV), extending survival to benefit from future treatments, is underutilized in value assessment, particularly for therapies in rapidly evolving therapeutic landscapes. We quantified the ROV of CDK4/6i for first-line (1L) treatment of HR+/HER2-negative advanced/metastatic breast cancer (a/mBC), where new advances in treatment make this analysis especially relevant.
METHODS: We estimated the ROV benefit of 1L CDK4/6i vs. aromatase inhibitors (AI) using a Markov model (progression-free, progression, and death health states) informed by real-world data (RWD).To derive ROV, a scenario without future second-line (2L) drug innovation was compared to one with anticipated 2L innovations as of October 2025 (index). Innovations were chosen based on competitive landscape reports post October 2025. Key ROV parameters (innovation effect size, timing of access to innovation, probability of approval success, and rate of uptake) were estimated from the literature, clinical data, clinicaltrials.gov, and previous oncology drug trial success and timing (2021-2025). A differential rate of uptake was assumed between CDK4/6i and AI based on RWD, expert opinion, and trial inclusion criteria for 2L innovations. A low, middle, and high value was specified per parameter to generate a range of ROV outcomes including incremental life years (LYs) and quality-adjusted life years (QALYs).
RESULTS: Without future innovation, the LY (QALY) difference for CDK4/6i vs. AI was 1.58 (1.11). With innovation, LY (QALY) differences increased in the low, middle, and high scenarios to 1.68 (1.17), 1.85 (1.27), and 2.18 (1.48), resulting in an ROV LY (QALY) gain of 6.3% (5.6%), 16.9% (15.2%), and 37.7% (34.0%) respectively.
CONCLUSIONS: Beyond their direct survival benefit, 1L CDK4/6i provide patients with a meaningful opportunity to access future therapeutic innovations — an ROV that increases estimated QALY gains by 6-36% in realistic innovation scenarios. Capturing this effect is essential to comprehensively characterize treatment value, particularly as the HR+/HER2- a/mBC pipeline continues to expand.
METHODS: We estimated the ROV benefit of 1L CDK4/6i vs. aromatase inhibitors (AI) using a Markov model (progression-free, progression, and death health states) informed by real-world data (RWD).To derive ROV, a scenario without future second-line (2L) drug innovation was compared to one with anticipated 2L innovations as of October 2025 (index). Innovations were chosen based on competitive landscape reports post October 2025. Key ROV parameters (innovation effect size, timing of access to innovation, probability of approval success, and rate of uptake) were estimated from the literature, clinical data, clinicaltrials.gov, and previous oncology drug trial success and timing (2021-2025). A differential rate of uptake was assumed between CDK4/6i and AI based on RWD, expert opinion, and trial inclusion criteria for 2L innovations. A low, middle, and high value was specified per parameter to generate a range of ROV outcomes including incremental life years (LYs) and quality-adjusted life years (QALYs).
RESULTS: Without future innovation, the LY (QALY) difference for CDK4/6i vs. AI was 1.58 (1.11). With innovation, LY (QALY) differences increased in the low, middle, and high scenarios to 1.68 (1.17), 1.85 (1.27), and 2.18 (1.48), resulting in an ROV LY (QALY) gain of 6.3% (5.6%), 16.9% (15.2%), and 37.7% (34.0%) respectively.
CONCLUSIONS: Beyond their direct survival benefit, 1L CDK4/6i provide patients with a meaningful opportunity to access future therapeutic innovations — an ROV that increases estimated QALY gains by 6-36% in realistic innovation scenarios. Capturing this effect is essential to comprehensively characterize treatment value, particularly as the HR+/HER2- a/mBC pipeline continues to expand.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE680
Topic
Economic Evaluation, Methodological & Statistical Research, Study Approaches
Topic Subcategory
Novel & Social Elements of Value
Disease
Oncology