https://orcid.org/0000-0001-7726-9030
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Abstract
Objective
To assess the incremental cost–utility ratio (ICUR) of gemtuzumab ozogamicin (GO) + standard of care (SOC) vs SOC alone for treatment of patients with de novo AML from a Spanish Health Service perspective.
Methods
A cohort state-transition model, with 12 health-states, was used to estimate the lifetime accumulated cost and benefits in terms of quality-adjusted-life-years (QALYs) in AML patients with favourable, intermediate, and unknown cytogenetic profiles. Patient profile was defined based on the ALFA-0701 trial. Therapeutic regimens were defined by 5 haematologists. SOC was assumed to be idarubicin and cytarabine, the combination most used in Spain. QALYs were estimated by applying utilities for the time spent by the cohort in each health-state and utility decrements associated with adverse events (AE). Total cost (€,2020) included drug-acquisition, hematologic stem-cell transplantation, disease management, AE management and end-of-life costs. Unit costs were derived from local databases. All parameters were validated by haematologist. Costs and outcomes were discounted (3%/year).
Results
Higher cost/patient (€177,618 vs €151,434) and greater QALYs (5,70 vs 4,62) were obtained with GO+SOC vs SOC. The ICUR was €24,203/QALY gained.
Conclusion
This simulation suggests that GO + SOC could be a cost-effective option for treatment of patients with de novo AML in first line.
Data Sharing Statement
The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request and with permission of Pfizer.
Ethics Statement
Not applicable. Ethics approval is considered unnecessary according to national regulations since it is not a study but an economic evaluation. As our work is not related to patients since it is not a study, informed consent does not apply.
Disclosure
Pau Montesinos, Patricia Font, Jorge Sierra, Adolfo de la Fuente and José María Guinea have received honoraria from Pfizer for advocacy tasks related to this project. Patricia Font is also the advisory board for BMS and Menarini. Jorge Sierra reports personal fees from Novartis, Astellas, Jazz Pharmaceuticals, and AbbVie, during the conduct of the study. María Mareque and Itziar Oyagüez are currently employed at PORIB, a consultant company specialized in economic evaluation of health interventions, which received financial support from Pfizer for the development of this study. Javier Soto, Tamara Iglesias and Julia Llinares are employees of Pfizer Spain. James Brockbank is employed of RTI Health Solutions. The authors report no other conflicts of interest in this work.