Abstract
PurposeTo estimate the resource gap in the polymerase chain reaction (PCR) monitoring for patients with chronic myeloid leukemia (CML) in low- and middle-income countries (LMICs).MethodsWe developed a model of demand and supply of PCR monitoring of CML patients in 60 LMICs. PCR testing was assumed to use Cepheid’s GeneXpert® IV system. We included costs of GeneXpert® instruments, uninterrupted power supplies, warranties, calibration kits, test cartridges, and shipping. We calculated the country-specific monetary gap in PCR monitoring, stratified by country priority defined as the availability of tyrosine kinase inhibitors (TKIs) through The Max Foundation initiatives.ResultsThe 5-year gap in PCR monitoring was $29.1 million across all countries, 22% ($6.4 million) in countries with all five TKIs available, 20% ($5.7 million) in countries with four TKIs available, 50% ($14.5 million) in countries with three TKIs available, 8% ($2.2 million) in countries with two TKIs available, and 1% ($0.3 million) in countries with one TKI available. The gap was highest in South Asia (52%; $15.1 million) and lowest in Latin America (6%; $1.9 million). Excluding labor costs, the bulk of the resource needs (86%; $25.2 million) were for procurement of BCR-ABL cartridges.ConclusionRemoving the 5-year gap in PCR monitoring capacity for CML in LMICs will require the mobilization of significant resources and will likely lead to better treatment outcomes and reduced treatment costs through optimization of treatment, discontinuation of therapy in appropriate patients, and facilitation of clinical research. Development of streamlined monitoring guidelines for resource-limited countries should be considered.
Highlights
The advent of tyrosine kinase inhibitors (TKIs) has transformed chronic myeloid leukemia (CML) from a near universally fatal disease into a chronic condition
Analytic overview We developed a Microsoft Excel-based demand, supply, and forecast model for the monitoring of CML patients in a selected group of countries and a selected group of patients in those countries covered by access initiatives and using preferential prices available through The Max
Over the 5-year period, the estimated gap in polymerase chain reaction (PCR) monitoring capacity was $29,143,083 across all countries covered by access initiatives
Summary
The advent of tyrosine kinase inhibitors (TKIs) has transformed chronic myeloid leukemia (CML) from a near universally fatal disease into a chronic condition. All have impressive results and CML patients experience life expectancy near that of the age matched general population [1]. CML is caused by the genetic juxtaposition of the BCR gene from chromosome 22 with the tyrosine kinase domains of the ABL gene from chromosome 9. This unique gene fusion creates the fusion BCR-ABL1 mRNA, which is the target for polymerase chain reaction (PCR) diagnostic and monitoring assays. The protein product of Rowley et al Cost Eff Resour Alloc (2021) 19:18
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