Analysis of the gap in PCR monitoring availability for patients with chronic myeloid leukemia in 60 low- and middle-income countries

Abstract

Purpose To 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). Methods We 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. Results The 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. Conclusion Removing 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.

A Ten-Year Experience of Treating Chronic Myeloid Leukemia in Rural Rwanda: Outcomes and Insights for a Changing Landscape

“…In Rwanda and many other LMICs, routine molecular monitoring has been cost-prohibitive, limiting our evaluation of clinical failure. 30 Recently, although, second-generation TKIs have become available through GIPAP, making the case for investment in routine molecular monitoring and resistance testing to identify patients early on who are most likely to benefit from switching TKIs. 9 Various strategies could be implemented to incorporate newly available second-generation TKIs within a low-resource CML care delivery program.…”

Leveraging Molecular Diagnostic Technologies to Close the Global Cancer Pathology Gap

“…The Max Foundation partnered with Cepheid to make GX technologies available at a preferential price in more than 60 LMICs and facilitate in-country BCR-ABL monitoring. 16,17 The expansion of on-site point-of-care BCR-ABL testing has streamlined appropriate tyrosine kinase inhibitor selection for patients in the Max Access Solutions program. 16 Despite investments and efforts to scale GX technology for CML management, BCR-ABL testing continues to be a primary barrier for optimal CML outcomes in many LMICs.…”

“…16,17 The expansion of on-site point-of-care BCR-ABL testing has streamlined appropriate tyrosine kinase inhibitor selection for patients in the Max Access Solutions program. 16 Despite investments and efforts to scale GX technology for CML management, BCR-ABL testing continues to be a primary barrier for optimal CML outcomes in many LMICs. Logistical challenges of importation and shelf life, limited access to technical support, and lack of local registration of the test have contributed to persistent gaps in molecular testing for CML.…”

“…Testing was performed by shipping blood or bone marrow samples to other countries—an approach that was costly, time-consuming, and difficult to scale. 16 In 2006, the first version of a semiautomated Xpert BCR-ABL cartridge-based reverse transcriptase PCR assay designed for CML monitoring became commercially available. A more sensitive version, Xpert BCR-ABL Ultra, followed several years later.…”

“… 16 , 17 The expansion of on-site point-of-care BCR-ABL testing has streamlined appropriate tyrosine kinase inhibitor selection for patients in the Max Access Solutions program. 16 …”