Estimation of HER2-Negative Metastatic Breast Cancer Population Eligible for Innovative Treatments in France
Author(s)
Maria Spanggaard, MSc1, Suyuan Zhang, PhD2, Tara Harding, BSc, MSc3, Sabrina Wang, PharmD4, Mark Chalmers, PhD5, Mette Boegelund, MSc1.
1EY, Frederiksberg, Denmark, 2Daiichi Sankyo Inc., New Hope, PA, USA, 3AstraZeneca, Potton, United Kingdom, 4DAIICHI SANKYO, Somerville, NJ, USA, 5EY, Dublin, Ireland.
1EY, Frederiksberg, Denmark, 2Daiichi Sankyo Inc., New Hope, PA, USA, 3AstraZeneca, Potton, United Kingdom, 4DAIICHI SANKYO, Somerville, NJ, USA, 5EY, Dublin, Ireland.
OBJECTIVES: Reimbursement processes for innovative metastatic breast cancer (mBC) treatments in France require estimating the eligible patient population, based on presence or absence of hormone receptors (HR) and human epidermal growth factor receptor 2 (HER2). This study aimed to calculate the size of different HER2-negative mBC subpopulations in France from published literature.
METHODS: A targeted literature review identified epidemiological inputs to calculate the number of individuals in France with HER2-negative mBC, stratified by HR status and categorized as HER2-IHC 0, HER2-ultralow, and HER2-low. These inputs were applied proportionally to national breast cancer incidence to estimate the number of patients in each subpopulation and eligible for different treatment lines.
RESULTS: From the 2023 incident breast cancer population in France, 13,552 individuals had HER2-negative mBC (82% HR+ and 18% HR-). Among the 11,113 HR+ patients, an estimated 22.5% (2,500) were HR+/HER2-IHC 0; 15.6% (1,734) were HR+/HER2-ultralow; and 61.9% (6,879) were HR+/HER2-low. An estimated 56.8% (1,386) and 43.2% (1,053) of the 2,439 HR- patients were HR-/HER2-low and HR-/HER2-ultralow or IHC 0, respectively. Based on the distribution of treatment/survival patterns from the Epidemiological Strategy and Medical Economics Database in France, an estimated 9,771 mBC patients (72.1%) received 2L treatment, 7,007 (51.7%) received 3L treatment and 4,825 (35.6%) received 4L treatment in 2023. Innovative mBC treatments (excluding chemotherapy and endocrine therapy) are typically available in later lines depending on previous treatment and mBC type. Innovative treatments have been documented to result in longer progression-free survival, demonstrating that they have the potential to increase life expectancy for individuals with mBC.
CONCLUSIONS: This study maps the distribution of HER2-negative mBC subpopulations across different lines of treatment. Despite a growing eligible patient population, a low share of patients reach 3L and 4L, underscoring the need for earlier access to innovative treatments to ultimately improve outcomes for mBC individuals.
METHODS: A targeted literature review identified epidemiological inputs to calculate the number of individuals in France with HER2-negative mBC, stratified by HR status and categorized as HER2-IHC 0, HER2-ultralow, and HER2-low. These inputs were applied proportionally to national breast cancer incidence to estimate the number of patients in each subpopulation and eligible for different treatment lines.
RESULTS: From the 2023 incident breast cancer population in France, 13,552 individuals had HER2-negative mBC (82% HR+ and 18% HR-). Among the 11,113 HR+ patients, an estimated 22.5% (2,500) were HR+/HER2-IHC 0; 15.6% (1,734) were HR+/HER2-ultralow; and 61.9% (6,879) were HR+/HER2-low. An estimated 56.8% (1,386) and 43.2% (1,053) of the 2,439 HR- patients were HR-/HER2-low and HR-/HER2-ultralow or IHC 0, respectively. Based on the distribution of treatment/survival patterns from the Epidemiological Strategy and Medical Economics Database in France, an estimated 9,771 mBC patients (72.1%) received 2L treatment, 7,007 (51.7%) received 3L treatment and 4,825 (35.6%) received 4L treatment in 2023. Innovative mBC treatments (excluding chemotherapy and endocrine therapy) are typically available in later lines depending on previous treatment and mBC type. Innovative treatments have been documented to result in longer progression-free survival, demonstrating that they have the potential to increase life expectancy for individuals with mBC.
CONCLUSIONS: This study maps the distribution of HER2-negative mBC subpopulations across different lines of treatment. Despite a growing eligible patient population, a low share of patients reach 3L and 4L, underscoring the need for earlier access to innovative treatments to ultimately improve outcomes for mBC individuals.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH90
Topic
Epidemiology & Public Health, Health Technology Assessment
Disease
Oncology