Forecasting asparaginase quantity required to treat pediatric ALL in LMICs using ACCESS FORxECAST.

Authors

null

Terence M. Hughes

Icahn School of Medicine at Mount Sinai, New York, NY

Terence M. Hughes , Brianna Empringham , Sumit Gupta , Zachary J. Ward , Jennifer Yeh , Anita K. Wagner , Lewis B. Silverman , Lindsay Lindsay Frazier , Avram Denburg

Organizations

Icahn School of Medicine at Mount Sinai, New York, NY, Children’s Hospital of Eastern Ontario, Ottawa, ON, Canada, The Hospital for Sick Children, Toronto, ON, Canada, Harvard T.H. Chan School of Public Health, Boston, MA, Boston Children's Hospital and Harvard Medical School, Boston, MA, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, Dana-Farber Cancer Institute/Boston Children's Hospital, Boston, MA, Dana-Farber Cancer Institute, Boston, MA, Hospital for Sick Children, Toronto, ON, Canada

Research Funding

Other
Boston Children’s Hospital, Dana Farber Cancer Institute, Dana Farber/Boston Children’s Hospital Global Health Initiative, and the Division of Haematology/Oncology at The Hospital for Sick Children

Background: Asparaginase (ASN) is a crucial component of pediatric acute lymphoblastic leukemia (ALL) protocols. ASN is available in three enzyme formulations: native from Escherichia Coli (E. coli), PEGylated from E. coli (PEG), and native erwinia from Erwinia chrysanthemi (Erwinase). PEG is typically preferred in high-income countries, while E. coli is more accessible in low and middle income countries (LMICs). Erwinase is reserved for patients who develop hypersensitivity. Short shelf lives, high prices, intermittent availability, and concern for substandard formulations in LMICs have created a need for proactive ASN demand estimates, particularly in LMICs. Methods: We modified FORxECAST, a publicly available tool that forecasts pediatric cancer drug quantity and cost, to estimate ASN quantity required to treat pediatric ALL in 2021 across all LMICs. Incidence data is based on the Global Childhood Cancer microsimulation model, which extrapolates country registries to estimate diagnosed pediatric ALL patients. We forecast ASN quantity for both a base regimen (BR), recommended by the International Pediatric Oncology Society (SIOP), and a more aggressive regimen (AR) used in some LMICs with more advanced supportive care capacity. For both BR and AR, we estimate ASN quantity across four scenarios, outlining how quantity would vary based on formulation and ability to switch in cases of hypersensitivity. Results: The estimated quantity of ASN required to treat all children diagnosed with ALL in LMICs in 2021, across scenarios and regimens, is provided (Table). If E. coli were used to treat all diagnosed pediatric ALL patients across LMICs, required quantity would range from 1,198 M IU (BR) to 1,661 M IU (AR) (Scenario 1). If PEG were used, required quantity would range 150 M IU (BR) to 473 M IU (AR) (Scenario 2). Accounting for hypersensitivity would require 77 M IU (BR) to 137 M IU (AR) Erwinase (Scenarios 3 and 4). Conclusions: We adapted FORxECAST to be ASN-specific and estimated demand in LMICs for a range of scenarios, including for second line Erwinase; accounting for hypersensitivity is particularly important because discontinuation typically results in lower cure rates. We also estimated how quantity of ASN required would increase with treatment intensity. These results provide the first quantification of ASN need for pediatric ALL in LMICs, creating a demand estimate that can inform private and public efforts to produce a reliable supply of high quality ASN for all children with ALL.

ASN Quantity for Diagnosed Pediatric ALL in LMICs (2021).

Scenario
BR
AR
1. E. coli

[no hypersensitivity planning]
1,198
1,661
2. PEG

[no hypersensitivity planning]
150
473
3. E. coli> Erwinase

[hypersensitivity planning]
E. coli: 1,198

Erwinase: 77
E. coli: 1,661

Erwinase: 137
4. PEG > Erwinase

[hypersensitivity planning]
PEG: 150

Erwinase: 77
PEG: 473 M

Erwinase: 137

Quantities in millions of international units (M IU).

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Pediatric Oncology

Track

Pediatric Oncology

Sub Track

Leukemia/Lymphoma

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 10031)

DOI

10.1200/JCO.2021.39.15_suppl.10031

Abstract #

10031

Poster Bd #

Online Only

Abstract Disclosures