Assessing the Potential Health Impact of Delays in Access to Innovative Medicines in Low- and Middle-income Countries: A Modelling Approach in Colombia

Thesis (Master's)--University of Washington, 2022Background: Access to safe, effective, and quality pharmaceuticals is unequal worldwide. Low- and middle-income countries (LMICs) face a reduced and delayed supply as well as regulatory barriers and intrinsic health system capacity limitations. The long waiting times to access innovative therapies have been previously described: however, measurement of the impact on population health outcomes has received much less attention. This study aims to explore the health impact of innovative medicine delay in Colombia, an upper-middle-income country. Methodology: We analyzed 5 medicines for health conditions with a high burden of disease in Colombia: bevacizumab, dapagliflozin, dolutegravir, indacaterol, and ticagrelor. These medicines were recently introduced into healthcare systems and offer the potential for significant health gains. We conducted a systematic literature review for each product to establish their potential aggregate incremental health outcome gains in terms of quality-adjusted life-years (QALYs) and incremental cost. The uptake and utilization of each medicine were calculated using the Colombian domestic market (SISMED Spanish acronym) and MarketScan® data set for the United States. The potential health outcomes lost were calculated as the health outcome lost due to delayed approval and uptake. Finally, a cost analysis was included for both countries. Results: There were identified 761 cost-effectiveness analyses for the five products of interest: 47 were included in the quantitative review after applying inclusion and exclusion criteria. Most studies used QALYs as a health outcome measure (61%), were located in high-income countries (85%), and were funded by industry sponsors (82%). The delayed access in Colombia led to a potential of 34,161 QALYs lost in Colombia for the five products analyzed in a lifetime horizon, equivalent to 67% of the country’s GDP. Conclusion: LMICs face significant losses in health due to delayed access to medicines. Further research is needed to determine the causal mechanism and to strengthen the incentives for different stakeholders to pursue collaborative efforts at the global, regional, and national levels towards improving the access to medicines globally and locally