Cost-effectiveness analysis of CDK4/6 inhibitors as first and second line treatments in patients with HR+ HER2- metastatic breast cancer

Keywords

cost-effectiveness analysis - Metastatic breast cancer - CDK4/6 inhibitors - healthcare economics - price negotiations

Background: Breast cancer remains highly prevalent among women globally, with a significant burden from metastatic disease. CDK4/6 inhibitors have transformed the treatment landscape for hormone receptor-positive, HER2-negative breast cancer. This study evaluates the cost-effectiveness of palbociclib, ribociclib, and abemaciclib within the Brazilian Unified Health System (SUS), focusing on their financial viability against the backdrop of required price reductions to meet cost-effectiveness thresholds.

Objective: To calculate the incremental cost-effectiveness of CDK4/6 inhibitors in both first and second-line settings for patients with metastatic HR+ HER2- breast cancer from the perspective of the Unified Health System (SUS).

Methods: Utilizing a Markov model over a 10-year horizon with data from phase 3 randomized trials, this study compares CDK4/6 inhibitors combined with endocrine therapy against endocrine therapy alone. The analysis incorporates life years gained (LYs) and incremental costs, framed within the SUS perspective. Sensitivity analyses were performed to address uncertainties and determine target prices that align with cost-effectiveness thresholds based on three times the Brazilian GDP per capita.

Results: The economic analysis revealed that while CDK4/6 inhibitors provide significant clinical benefits for metastatic HR+ HER2- breast cancer, their current pricing far surpasses the SUS's Willingness-To-Pay (WTP) threshold. To align with the established cost-effectiveness thresholds, substantial price reductions are required. Specifically, in the first-line setting, ribociclib would need a 71% discount, and palbociclib would require up to a 94% reduction. In the second-line setting, necessary discounts range from 62% to 65%. These adjustments are essential to achieve the incremental cost-effectiveness ratios proposed, highlighting the need for recalibrated pricing to meet SUS economic standards.

Conclusion: While CDK4/6 inhibitors offer significant therapeutic benefits for metastatic breast cancer, their adoption within the SUS at current prices is not economically sustainable. Substantial discounts are crucial to align with the cost-effectiveness criteria, highlighting the urgent need for drug price negotiations. This study provides crucial insights for policymakers, suggesting a strategic approach to pricing that ensures both clinical benefit and economic sustainability, ultimately enhancing patient access to these critical therapies.

Corresponding author: Andre Deeke Sasse (e-mail: [e-mail]).

 

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No conflict of interest has been declared by the author(s).

Publication History

Article published online:
06 May 2025