Real-World Outcomes and Economic Impact of Ribociclib in HR+/HER2- Advanced Breast Cancer: Evidence From the Portuguese REASSURE Cohort
Author(s)
Ana Sofia Patrão, MD1, Maria José Bento, MD, PhD2, Catarina M. Ferreira, PhD3, Daniel Bras, PharmD3, Marco Domingues, PhD3.
1Medical Oncology Department, IPO Porto, Porto, Portugal, Porto, Portugal, 2Group of Epidemiology, Results, Economy and Management in Oncology – Research Center, Porto Comprehensive Cancer Center (Porto.CCC) & RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto), Porto, Portugal, Porto, Portugal, 3Novartis Farma - Produtos Farmacêuticos S.A., Porto Salvo, Portugal, Porto Salvo, Portugal.
1Medical Oncology Department, IPO Porto, Porto, Portugal, Porto, Portugal, 2Group of Epidemiology, Results, Economy and Management in Oncology – Research Center, Porto Comprehensive Cancer Center (Porto.CCC) & RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto), Porto, Portugal, Porto, Portugal, 3Novartis Farma - Produtos Farmacêuticos S.A., Porto Salvo, Portugal, Porto Salvo, Portugal.
OBJECTIVES: CDK4/6 inhibitors have demonstrated efficacy in breast cancer and are currently used in different lines of treatment. The REASSURE study aimed to evaluate real-world use of ribociclib, including its effectiveness, safety, and healthcare resource utilization (HCRU), in patients with HR+/HER2- advanced or metastatic breast cancer (a/mBC).
METHODS: REASSURE was a European, non-interventional, retrospective study involving patients with a/mBC who were treated with ribociclib. The Portuguese cohort included patients from Instituto Português de Oncologia do Porto who initiated ribociclib between January 2018 and September 2021. Data were extracted from electronic medical records and Cancer Registry. Kaplan-Meier methods were used for time-to-event outcomes. HCRU and direct medical costs were estimated from recorded procedures, hospitalizations, and outpatient care.
RESULTS: A total of 81 patients were included (median age: 59 years), majority post-menopausal women (75.3%). Ribociclib plus letrozole was prescribed as first-line treatment in 84% of patients. Median real-world progression-free survival (rwPFS) for the overall ribociclib cohort was 31.2 months (Q1-Q3: 10.3-NA), and median OS was not reached. The overall response rate (ORR) was 39.5%, with a median time-to-treatment failure of 22.1 months. Treatment discontinuation occurred in 49.4% of patients, primarily due to progression (N<25) or toxicity (N=15). Annual treatment costs and number of admissions and procedures were similar between the overall cohort and the ribociclib plus letrozole subgroup. Costs were primarily driven by outpatient care and medication, with median values of €14,994.40 and €11,993.60, respectively, for the overall cohort. Median emergency admissions per patient was 2.0 (N=38) and the median number of outpatient appointments was 51.0.
CONCLUSIONS: Ribociclib demonstrated clinical benefit in this Portuguese cohort of patients with a/mBC. The economic analysis highlights that outpatient care and medication are the primary contributors to treatment costs. These findings provide valuable evidence for healthcare decision-makers regarding resource implications of ribociclib in routine clinical practice.
METHODS: REASSURE was a European, non-interventional, retrospective study involving patients with a/mBC who were treated with ribociclib. The Portuguese cohort included patients from Instituto Português de Oncologia do Porto who initiated ribociclib between January 2018 and September 2021. Data were extracted from electronic medical records and Cancer Registry. Kaplan-Meier methods were used for time-to-event outcomes. HCRU and direct medical costs were estimated from recorded procedures, hospitalizations, and outpatient care.
RESULTS: A total of 81 patients were included (median age: 59 years), majority post-menopausal women (75.3%). Ribociclib plus letrozole was prescribed as first-line treatment in 84% of patients. Median real-world progression-free survival (rwPFS) for the overall ribociclib cohort was 31.2 months (Q1-Q3: 10.3-NA), and median OS was not reached. The overall response rate (ORR) was 39.5%, with a median time-to-treatment failure of 22.1 months. Treatment discontinuation occurred in 49.4% of patients, primarily due to progression (N<25) or toxicity (N=15). Annual treatment costs and number of admissions and procedures were similar between the overall cohort and the ribociclib plus letrozole subgroup. Costs were primarily driven by outpatient care and medication, with median values of €14,994.40 and €11,993.60, respectively, for the overall cohort. Median emergency admissions per patient was 2.0 (N=38) and the median number of outpatient appointments was 51.0.
CONCLUSIONS: Ribociclib demonstrated clinical benefit in this Portuguese cohort of patients with a/mBC. The economic analysis highlights that outpatient care and medication are the primary contributors to treatment costs. These findings provide valuable evidence for healthcare decision-makers regarding resource implications of ribociclib in routine clinical practice.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO207
Topic
Clinical Outcomes, Economic Evaluation, Health Service Delivery & Process of Care
Topic Subcategory
Clinical Outcomes Assessment
Disease
Oncology