Evaluating Extracorporeal Renal Replacement Therapies: Balancing Budgetary Considerations with Ethical Implications

Evaluating extracorporeal therapies for end-stage kidney disease (ESKD) requires balancing cost-effectiveness with patient-centered care. With dialysis costs exceeding EUR 2 billion annually in Italy and USD 29 billion in the USA, assessing the economic implications of emerging technologies against their clinical benefits is crucial. Cost-effectiveness analysis (CEA) and health technology assessment (HTA) are widely used to evaluate healthcare interventions, yet they often fail to capture qualitative improvements in patients' quality of life. Additionally, ethical considerations remain underrepresented in these frameworks, despite their importance in guiding equitable resource allocation.

This manuscript examines the landscape of extracorporeal therapies within the healthcare systems of Italy and the USA, highlighting the economic and ethical challenges in their evaluation. A novel two-dimensional framework is introduced, integrating bioethical principles - such as justice, equality, and equity - into CEA to ensure that interventions are assessed not only for their financial sustainability but also for their societal and ethical impact. By incorporating ethical considerations into CEA, the framework offers a more comprehensive approach to decision-making in healthcare resource allocation.

(1) Traditional CEA and HTA methods often overlook qualitative improvements in patient quality of life. (2) Ethical considerations, including justice and equity, should be integrated into economic evaluations of healthcare interventions. (3) A two-dimensional framework is proposed to balance economic viability with patient-centered outcomes. (4) Incorporating ethics into CEA enhances healthcare decision-making, fostering innovation and equitable patient care.