A retrospective, multicentric, observational, real-world evidence (RWE) study on cost impact, efficacy, and safety of generic palbociclib in HR+ve, HER2-ve metastatic breast cancer: An Indian perspective.

e13076 Background: Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, has proven efficacy in managing hormone receptor-positive (HR+ve), HER2-negative (HER2-ve) metastatic breast cancer (MBC). However, its high cost during the patent period created financial barriers, particularly in India. The introduction of affordable generics has improved accessibility while maintaining comparable efficacy and safety. This study evaluates the cost-effectiveness, clinical efficacy, and safety of generic Palbociclib in combination with endocrine therapy (Letrozole or Fulvestrant) in Indian patients with HR+ve HER2-ve MBC. Methods: A retrospective, multicentric, observational study was conducted using real-world data from four Indian healthcare centers (January 2019–August 2024) involving 200 HR+ve, HER2-ve MBC patients treated with generic Palbociclib plus endocrine therapy. Cost Inference Analysis (CIA) compared total healthcare costs for equivalent outcomes. Evaluated parameters included progression-free survival (PFS), overall response rate (ORR), duration of therapy (DOT), cost-impact analysis, and safety, including dose adjustments and neutropenia management. Results: Median PFS was 16.7 months, with 53.6% patients achieving partial response (PR) and 1.8% achieving complete response (CR) rates. Dose reductions were required in 9.6% of patients, while 71.7% maintained the initial dosage. Neutropenia was absent in 60.2% of patients, indicating good tolerability. The introduction of generic Palbociclib resulted in a 94.21% reduction in drug costs (from ₹95,000 to ₹5,495 per unit), significantly lowering the financial burden of breast cancer treatment, which typically ranges from ₹200,000 to ₹250,000 in direct costs. Conclusions: Generic Palbociclib, in combination with Letrozole or Fulvestrant offers effective, safe, and cost-efficient treatment for HR+ve, HER2-ve MBC in Indian patients. It improves progression-free survival, response rates, and affordability. The substantial cost reduction significantly alleviates the financial burden on patients, improving treatment accessibility. These findings support the continued use of generic Palbociclib as a cost-effective, safe, and effective alternative for managing metastatic breast cancer in India.