Cost-Effectiveness Analysis of Gemtuzumab Ozogamicin for First-Line Treatment of Patients with Cd-33 Positive Acute Myeloid Leukaemia in Spain

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.

Cost-effectiveness analysis of gemtuzumab ozogamicin for the treatment of de novo CD33-positive Acute Myeloid Leukaemia (AML) in Italy

“…Despite different acquisition costs and settings, the results of this Italian analysis are in line with those from other published economic analyses in other countries, UK [ 31 ], Spain [ 32 ], Portugal [ 33 ], which used a similar model to conduct the evaluation. Overall, the fact that GO has been reimbursed in most European countries and has been recommended by several health technology assessment bodies worldwide, for example National Institute for Health and Clinical Excellence (NICE) in England [ 34 ]; Scottish Medicines Consortium (SMC) in Scotland [ 35 ]; Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada [ 36 ], proves that GO has been extensively acknowledged as a cost-effective option in previously untreated, de novo CD33 AML.…”