Introduction

Palbociclib, a CDK4/6 inhibitor, is effective for the treatment of hormone receptor-positive (HR+ve), human epidermal growth factor receptor 2-negative (HER2-ve) metastatic breast cancer (MBC). The excessive costs during the patent period created significant financial obstacles for patients in India, but the introduction of affordable generics has improved accessibility to treatment while ensuring continued efficacy and safety.

Aim

Evaluate the cost-effectiveness, efficacy & safety of generic Palbociclib in combination with endocrine therapy (Letrozole or Fulvestrant) in Indian patients with HR+ve HER2-ve MBC.

Patient Profile

Patients with HR+ve, HER2-ve MBC.

Methods

• Retrospective, multicentric, observational study
• Conducted across four Indian healthcare centers (Jan 2019–Aug 2024). 
• 200 HR+ve HER2-ve MBC patients were included.
• Patients were treated with generic Palbociclib plus endocrine therapy (Letrozole or Fulvestrant). 
• Progression-free survival (PFS), overall response rate (ORR), duration of therapy (DOT), cost-impact analysis, safety, including dose adjustments and neutropenia management were evaluated
• Cost Inference Analysis (CIA) compared total healthcare costs for equivalent outcomes.

Results

Efficacy & Safety

• The median PFS was 16.7 months, with 53.6% of patients experiencing a partial response  and 1.8% achieving a complete response .
• Dose reductions were necessary for 9.6% of patients, while 71.7% continued initial dosage.
• Neutropenia was not observed in 60.2% of patients, suggesting favorable tolerability of the treatment.

Cost Impact

• Generic Palbociclib reduced drug costs by 94.21% significantly lowering the financial burden of treatment. 

Conclusion

• The combination of generic Palbociclib with Letrozole/ Fulvestrant offers an effective, safe & affordable treatment option for HR+ve, HER2-ve MBC in Indian patients, leading to improved PFS & response rates.
• The substantial cost reduction of generic Palbociclib significantly eases the financial burden on patients, enhancing treatment accessibility and reinforcing its role as a cost-effective alternative for managing metastatic breast cancer in India.

Reference

J Clin Oncol 2025; 43;16; e13076