Cost Effectiveness of Gemtuzumab Ozogamicin in the First-Line Treatment of Acute Myeloid Leukaemia in the UK

Abstract

Background and ObjectiveThe phase III ALFA-0701 study demonstrated the efficacy and safety of gemtuzumab ozogamicin (GO) versus standard of care (SOC) chemotherapy (daunorubicin and cytarabine) for the treatment of adult patients with de novo CD33+ acute myeloid leukaemia (AML). This study analysed the cost-effectiveness of GO from the perspective of the UK health care payer. Methods A cohort state-transition model was developed to estimate direct health care costs and quality-adjusted life-years (QALYs) over a lifetime time horizon from AML diagnosis to death using monthly cycles. Data on complete remission, overall survival, relapse-free survival (RFS), haematopoietic stem-cell transplantation, and adverse events for GO plus SOC versus SOC were obtained from the ALFA-0701 study. Overall survival and RFS were extrapolated beyond the trial horizon using mixture cure models. Unit costs were obtained from standard national sources. Utilities were identified in a systematic literature review. Costs and outcomes were discounted at 3.5%. Analyses were performed for the base-case population, excluding patients with an unfavourable cytogenetic profile, and the overall population. Results For the base-case and overall populations respectively, incremental per-patient costs (£13,456 and £14,773) and QALYs (0.99 and 0.68) for GO plus SOC versus SOC resulted in incremental cost-effectiveness ratios (ICERs) of £13,561 and £21,819 per QALY gained. The mean probabilistic ICERs were £14,217 and £23,245, respectively. Univariate sensitivity analyses supported the robustness of the results. Conclusions The ICERs for both populations met NICE's £20,000-£30,000 willingness-to-pay threshold for medicines and supported the current approval for GO.

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.…”