Presentation (CTI)

OBJECTIVES: To identify major reimbursement challenges associated with Advanced Therapy Medicinal Products and to examine innovative payment models reported across healthcare systems.
METHODS: A scoping review following PRISMA-ScR guidelines was conducted via PubMed for English-language studies (2016-2026) addressing ATMP reimbursement, HTA,and market access. Clinical and non-reimbursement-focused studies were excluded. Extracted data were categorized by reimbursement challenges, payment models,and stratified geographically to identify regional variations.
RESULTS: Twenty-one studies were included. The most frequently reported reimbursement challenges were high upfront costs (n=12) and HTA-related evidence limitations (n=11),followed by access inequalities (n=9) and budget impact concerns (n=9). Clinical uncertainty regarding long-term effectiveness was identified in seven studies. Outcome-based agreements were the most frequently reported payment approach (n=9),followed by early access programs (n=7) and managed entry agreements (n=6). Studies were distributed across Europe (n=9), cross-regional analyses (n=6), North America (n=5), and Asia (n=1). Geographic stratification revealed regional variation in ATMP reimbursement challenges and innovative payment approaches across healthcare systems.
CONCLUSIONS: Traditional reimbursement frameworks appear poorly aligned with the clinical and economic characteristics of ATMPs, particularly regarding high upfront costs and uncertainty surrounding long-term outcomes. Outcome-based agreements, managed entry agreements,and early access programs emerged as the most frequently reported approaches to address these challenges. Furthermore, the utilization of innovative frameworks highly depends on regional healthcare infrastructure; while European studies frequently highlight managed entry agreements and early access pathways, North American literature places greater emphasis on commercial risk-mitigation and bundled reimbursement structures. This underscores the need for locally tailored market access solutions rather than a one-size-fits-all global approach. These findings suggest that future reimbursement strategies may benefit from greater use of risk-sharing mechanisms and real-world evidence generation to support sustainable patient access while managing payer uncertainty across diverse healthcare settings.