Budget Impact Analysis of the Use of Gilteritinib for the Treatment of Patients with Relapsed or Refractory FLT3+ Acute Myeloid Leukaemia in Public Healthcare Institutions in Mexico

INTRODUCTION: More than a third of patients with acute myeloid leukaemia (AML) have mutations in the FMS-like tyrosine kinase 3 gene (FLT3+). Patients with these mutations have a poor prognosis and are at high risk of refractory AML or treatment failure and relapse. In the last few years there have been several advances in treatment options available for relapsed/ refractory (R/R) FLT3+ AML patients, including gilteritinib. Although gilteritinib has demonstrated clinical efficacy in clinical trials, it has higher drug acquisition costs and the economic impact of including it as a new therapy is uncertain. This study aims to estimate the budget impact of the introduction of gilteritinib as an additional AML treatment on the public healthcare system in Mexico.

METHODS: The target population (adult AML patients with R/R FLT3+) was calculated assuming an incidence rate of 1/100,000 and 25/100,000 in individuals 18-79 years and 80+ years respectively, 57% of patients would be R/R and 33% FLT3 positive, 2% undergo haematopoietic stem-cell transplantation (HCST), and 72% have their treatment costs covered by public funding. The cost of current AML treatment (mitoxantrone, etoposide and cytarabine [MEC], and/or fludarabine, cytarabine, granulocyte-colony stimulating factor and idarubicin [FLAG-IDA]) was obtained from the Institute for Social Security and Services for State Workers in 2021. Costs were converted to 2022 costs using the Mexican inflation rate, and compared for the following 5 years (assuming 2022 costs remained unchanged), when including gilteritinib as an additional treatment regimen for AML. The budget impact analysis over a 5-year time horizon, included direct drug costs, post-progression treatment costs, resource utilization, HSCT, and grade ≥3 adverse events. All costs were converted to USD (1 USD=20.55 MxP).

RESULTS: Based on 2023 population estimates of a total 198 FLT3+ R/R AML patients, the projected consolidated treatment cost per patient is $36,848, $38,041, and $59,621 for MEC, FLAG-IDA and gilteritinib, respectively. When incorporated into a yearly estimate over 5 years, the addition of gilteritinib as a treatment option would result in a spending increase of $109,397 in 2023 rising to $475,761 in 2027. This would be an increase on the public healthcare budget of 0.0024% in 2023 to 0.0105% in 2027.

CONCLUSION: Introducing gilteritinib as an orphan drug in Mexico for the treatment of R/R FLT3+ AML would have a minimal impact on the public healthcare budget over the next 5 years.

Polanco:Astellas: Current Employment. Serrano:Pharmamanagement: Current Employment. Saturnino:Astellas: Current Employment. Flores:Pharmamanagement: Current Employment. Monsalve:Astellas: Current Employment. Pandya:ConcertAI: Other: Medical publication support; Astellas: Current Employment, Research Funding.