Acute myeloid leukemia (AML) primarily affects older adults, many of whom are unsuitable for intensive chemotherapy. The use of hypomethylating agents (HMA)—specifically intravenous (IV) decitabine and subcutaneous (SC) azacitidine—forms the cornerstone of treatment options but often necessitates repeated hospital visits and resource-intensive care. An alternative oral formulation, decitabine/cedazuridine (DEC-C), has emerged as a promising option that may alleviate these challenges by reducing hospital resource burden.
This study aims to estimate and compare the economic and organizational impacts of IV, SC, and oral administration of hypomethylating agents in AML patients who are unfit for intensive chemotherapy within the context of the Spanish National Health System. A micro-costing model was developed focusing on five domains: drug preparation and administration, treatment-related hospitalizations, medical transportation, catheter management, and infection management. Information was gathered through surveys conducted with healthcare professionals in 16 hospitals across Spain.
This analysis employed a cross-sectional micro-costing approach, evaluating the non-pharmacological costs associated with the administration of HMAs. The study structured a model that isolated various resource expenditures, excluding drug acquisition costs. This targeted methodology allowed for a coherent focus on how the route of administration impacts overall resource consumption within Spain's healthcare framework.
The study covered a full treatment cycle and adopted a deterministic Excel-based model to encode assumptions and calculations. Significant efforts were made to gather accurate data around resource use, including both primary data from healthcare professionals and secondary data from hospital tariffs.
Overall findings indicated that the non-pharmacological costs per patient were significantly lower for oral DEC-C compared to IV and SC routes. The costs were €9,998 for IV decitabine, €12,177 for SC azacitidine, and only €1,306 for oral DEC-C, indicating reductions of 87% and 89% for oral therapy relative to IV and SC, respectively. These savings were driven by substantial declines in hospitalization frequency (58–61%), transport need (13–22%), and infection-related costs (9%-12%).
The analysis revealed that transitioning to oral therapy could save 40-50 hours of healthcare professional time and reduce the number of inpatient days by 8-9, along with 4-8 fewer ambulance transports per patient. Additionally, catheter usage decreased by 33% along with an 87% reduction in infection risk when compared to IV and a 54% reduction against SC.
Direct comparisons highlighted the financial advantages of oral administration. By reducing the reliance on hospital facilities, oral administration of HMAs not only lessens direct healthcare costs but also enhances patient convenience. These factors represent substantial organizational efficiencies, particularly in a healthcare landscape characterized by limited resources.
The results signify that oral administration of ancient agents could represent a transformative approach, not only in reducing costs but also in improving the patient experience. Employing oral formulations may result in better adherence to treatment plans, broader accessibility, and ultimately, enhanced outcomes within healthcare systems.
The implications of this study extend beyond cost savings, addressing critical aspects related to the patient experience and healthcare resource management. By mitigating the need for frequent hospital visits, the oral form of HMAs not only supports patient autonomy but also aligns with the healthcare goal of providing care that respects patient preferences, promoting a shift to home-based treatment modalities.
In conclusion, oral administration of hypomethylating agents has demonstrated a considerable impact on reducing direct, non-drug costs associated with the treatment of patients with acute myeloid leukemia unfit for intensive chemotherapy. The findings specifically support the argument for integrating oral formulations into clinical practice pathways, thereby enhancing the sustainability of AML care within resource-constrained health systems.