Kerstin Noelle Vokinger, Simon Hediger, Raffaella Casolino, Dario Trapani, Elisabeth G E de Vries
These findings should be interpreted as evidence of associations not causality, suggesting differences in quantity uptake of essential cancer medicines along two structural dimensions: fewer countries showed uptake of essential cancer medicines in lower-GDP countries than in middle-GDP and high-GDP countries and medicines requiring complex genomic diagnostics had lower uptake, with the lowest uptake in lower-GDP countries. The results suggest that, as precision oncology medicines become increasingly represented in the WHO EML, EML inclusion alone could be insufficient to enable patient access.
BACKGROUND: New cancer medicines increasingly depend on molecular testing, from low-cost immunohistochemistry to expensive genomic diagnostics. The WHO Model List of Essential Medicines (EML) guides access to priority medicines. We aimed to analyse uptake trends for essential cancer medicines in 71 countries and two world regions with lower, middle, and high gross domestic product (GDP) per capita, distinguishing medicines that require immunohistochemistry, complex genomic diagnostics, or neither.
METHODS: In this retrospective observation study, we identified all cancer medicines newly included in the EML between 2002 and 2023 and categorised them into those for which immunohistochemistry is indicated, those for which complex genomics is indicated, and those for which neither immunohistochemistry or complex genomics is indicated. Uptake quantities for each medicine were extracted at the country-level from IQVIA MIDAS (Jan 1, 2002, to Dec 31, 2023). Given limited IQVIA coverage of low-income countries per World Bank definition, we grouped countries into three categories with an equal number of countries, resulting in three GDP groups (lower-GDP [$33 000] countries). Regression analyses were performed to assess the association between medicine type (requiring immunohistochemistry, complex genomic diagnostics, or none) and number of countries with uptake of at least one standard unit and quantities in uptake of standard units.
FINDINGS: 41 essential cancer medicines were included, of which six (15%) required immunohistochemistry, seven (17%) required complex genomic diagnostics, and 28 (68%) required neither. At EML inclusion, 20 (80%) of 25 lower-GDP countries used medicines requiring immunohistochemistry, 11 (44%) used medicines requiring complex genomic testing, and 16 (64%) used medicines without diagnostic requirements. In middle-GDP countries, uptake was reported in 23 (96%) of 24 countries for medicines requiring immunohistochemistry, 17 (71%) for those requiring complex genomic testing, and 21 (88%) for those not requiring diagnostics. In high-GDP countries, uptake was 24 (100%) of 24, 19 (79%), and 23 (96%), respectively. Standard-unit volumes were substantially lower in lower-GDP countries across all three medicine groups than in other GDP groups. Across all GDP groups, medicines requiring complex genomic diagnostics had, on average, 65% (regression coefficient -0·453 [95% CI -0·562 to -0·344]; p<0·0001) lower standard-unit uptake than those without.
INTERPRETATION: These findings should be interpreted as evidence of associations not causality, suggesting differences in quantity uptake of essential cancer medicines along two structural dimensions: fewer countries showed uptake of essential cancer medicines in lower-GDP countries than in middle-GDP and high-GDP countries and medicines requiring complex genomic diagnostics had lower uptake, with the lowest uptake in lower-GDP countries. The results suggest that, as precision oncology medicines become increasingly represented in the WHO EML, EML inclusion alone could be insufficient to enable patient access.
FUNDING: Swiss National Science Foundation.