Presentation (CTI)

OBJECTIVES: Multi-company oncology combination therapies are expanding rapidly, yet existing HTA frameworks remain focused on single-agent therapies from a single manufacturer. As structural barriers remain poorly understood, this study compares policy responses across seven countries to map current levels of policy awareness and identify the structural barriers each country faces.
METHODS: Primary and secondary literature (January 2014-May 2026) were identified through HTA agencies, competition authority publications, legislative records and academic databases. Seven countries (UK, Belgium, Sweden, Germany, Canada, Australia, and South Korea) were selected based on HTA-based reimbursement systems and policy diversity. A three-level policy awareness level (PAL) framework (High, Intermediate, Low) was established based on awareness and formal policy discussions. Five structural obstacles were identified: value attribution methodology (VAM), data infrastructure, assessment governance, competition law, and commercial rules. Each barrier was classified as resolved, partially resolved, or unresolved.
RESULTS: PALs were High in the UK and Belgium, Intermediate in Germany, and Low in Sweden, Canada, Australia, and South Korea. High-PAL countries showed the most substantial institutional responses, securing competition authority guidance and initiating governance design. Intermediate-PAL Germany moved from proposal to implementation through a mandatory discount mechanism now facing repeal. Among the obstacles, VAM and data infrastructure remained unresolved across all countries. Governance of assessment and competition law rules were resolved only in the UK and Belgium, while commercial rules reached partial resolution only in the UK. Low-PAL countries left all obstacles unresolved, with Sweden's governance proposal stalling without legal safe harbor.
CONCLUSIONS: No country has yet produced a dedicated reimbursement listing for multi-company oncology combination therapies, indicating an early stage of policy development. As these combinations expand, structuring PAL and barrier profiles across HTA systems offers a basis for anticipating implementation challenges. As evidence accumulates and frameworks are refined through country-specific experience, sustainable reimbursement pathways for multi-company oncology combinations can be established.