Presentation (CTI)

OBJECTIVES: Cost-effectiveness models (CEMs) provide crucial evidence in health technology assessments (HTAs) to demonstrate the value of new health interventions. After launching therapeutics in the United States, United Kingdom, and high-income European countries, manufacturers often encounter challenges in the HTA process for low- and middle-income countries (LMICs). This analysis explores the key learnings and identifies strategies to adapt global CEMs for LMICs.
METHODS: A retrospective analysis was conducted on 12 completed CEM adaptations for LMICs across the globe. The process involved: 1) stepwise review of completed CEM adaptations across multiple therapeutic areas; 2) systematic categorization of challenges encountered during model adaptations; and 3) synthesis of learnings and identification of best practices.
RESULTS: Adapting global CEMs for LMICs presents several challenges. These include sparse or incomplete data for resource utilization estimates and unit costs specific to the local context. Viewing and programming restrictions within the global CEM must be disabled to make the necessary model modifications for regional adaptations. Another limitation is the availability or comprehensiveness of national, regional, or local economic evaluation guidelines for HTA submission requirements. Strategies to address these challenges include executing regional costing studies and/or including key opinion leaders for elicitation of clinical expert and real-world knowledge. Early collaboration with the global team in the CEM adaptation process has been shown to standardize communication and facilitate dissemination at the local level. Additionally, conducting a targeted review and analysis on previous regional reimbursement decisions can help to provide a framework for HTA submissions.
CONCLUSIONS: Market access in LMIC requires planning and local knowledge, but implementation of these recommendations will allow manufacturers operating in LMICs to improve the quality and credibility of global CEMs adapted for the local context and increase the likelihood of launch success.