OPERATIONAL COMPLEXITY AS A DETERMINANT OF EQUITABLE ACCESS TO HEALTH TECHNOLOGIES: EVIDENCE FROM THE KIDNEY TRANSPLANT AND ORPHAN DRUG PARADOX IN COLOMBIA

 

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OPERATIONAL COMPLEXITY AS A DETERMINANT OF EQUITABLE ACCESS TO HEALTH TECHNOLOGIES: EVIDENCE FROM THE KIDNEY TRANSPLANT AND ORPHAN DRUG PARADOX IN COLOMBIA

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Adriana
Robayo
Adriana Robayo arobayog@unal.edu.co Instituto de evaluación tecnológica en salud Equity in health Bogota Colombia *
Javier Eslava-Schmalbach jheslavas@unal.edu.co Universidad Nacional de Colombia Equity in health Bogota Colombia -
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Following WHO’s 2025 resolution on kidney health emphasizing improved transplant access, systematic barriers persist that traditional health technology assessment fails to explain. Evidence from Colombia reveals a striking paradox: kidney transplantation (≈USD 16,000 first year) faces significantly greater access barriers than orphan drugs such as eculizumab for atypical hemolytic uremic syndrome (≈USD 1,200,000 lifetime)—an 80:1 cost ratio with inverse access patterns. This study introduces operational complexity—the multidimensional difficulty of coordinating, implementing, and sustaining health interventions—as a critical, independent determinant of access.

Through comparative analysis of therapeutic pathways for kidney transplantation versus eculizumab in Colombia’s universal health system (eliminating insurance as a confounding variable), we developed the Health Operational Complexity Index (ICOS).
ICOS integrates five dimensions grounded in implementation science (CFIR framework; Fixsen et al., 2005): inter-institutional coordination, critical temporal dependencies, specialized infrastructure requirements, expert knowledge requirements, and process variability (inverse of standardization, where more stars indicate greater complexity).
Each dimension was evaluated using a five-level qualitative scale (very low ★ to very high ★★★★★). Analysis integrated Colombian National Health Institute data (2023), international systematic reviews, and cross-case structural comparison.

Kidney transplantation exhibited extremely high operational complexity (Global ICOS ★★★★★):
coordination ★★★★★ (multi-institutional 24/7 networks),
temporal dependencies ★★★★★ (6–12 h window),
infrastructure ★★★★ (limited availability),
expertise ★★★★ (highly specialized teams),
and process variability ★★★★ (low standardization, fragmented protocols).

Eculizumab showed low-moderate complexity (Global ICOS ★★):
coordination ★, temporal dependencies ★★, infrastructure ★★, expertise ★★, and process variability ★ (high standardization, manufacturer support).

Colombian data confirm transplant waits > 3.2 years—below regional averages—while atypical HUS patients access eculizumab within weeks despite 80-fold higher cost. International evidence (UK Transplant Access Audit 2023; Ebel et al., 2024) corroborates organizational barriers as primary determinants of inequity.
Across cases, access varied inversely with ICOS scores, supporting the Inverse Operational Law.

Operational complexity functions as a measurable, powerful determinant of health equity. The ICOS framework enables HTA and policy processes to integrate implementation feasibility into decision-making. Simplifying processes may democratize access more effectively than cost-reduction strategies alone. Future priorities include ICOS validation across diverse systems, evaluation of complexity-reducing interventions, and development of “operational equity adjustments” to compensate high-complexity technologies. Without explicit attention to operational complexity, health systems risk perpetuating inequities under apparently neutral paradigms. Ensuring that access depends on medical need—not on the ability to navigate systemic labyrinths—must become a core equity principle of global health.

Kewords