Submitted:
01 December 2025
Posted:
02 December 2025
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Abstract
Keywords:
Plain Language Summary
Introduction
Conceptual Framework and Methodology
Conceptual Approach: Pricing Tools as Institutional Design Choices
Case Selection: Contrasting Governance Regimes (U.S., Canada, U.K.)
Data Sources: Policy, Regulatory, and Institutional Documents
Analytical Strategy: Trade-Off Matrix for Institutional Design
Scope and Design Constraints (Non-Outcome-Based Assessment)
Results: Comparative Trade-offs Across Systems
Results: Comparative Trade-offs Across Systems
United States: MFN-Style Proposals and Fragmented VBC Infrastructure
Canada: PMPRB-Based Price Regulation and Limited Outcome-Linkage
United Kingdom: NICE/VPAG and Integrated Value-Based Design
Cross-System Comparison: Institutional Fit and Relative Design Strengths
Discussion: Institutional Fit, Design Trade-Offs, and Policy Implications
Limitations of a Design-Focused Comparative Approach and Directions for Future Research
Conclusion and Recommendations: Designing Feasible, Value-Oriented Pricing Regimes
- Anchors negotiations on Medicaid drug prices around international reference pricing, not as strict ceilings, but as a basis for comparison to enhance transparency and bargaining power.1
- Expand outcome-based contracts with both public and private payers using real-world endpoints, indication-specific pricing, and performance thresholds for therapy. 7
- Revise patent and exclusivity regulations so that rewards reflect the therapy’s value, not just market monopoly or minor innovations. 4
Supplemental Files and Additional Information
- Appendix_E_Risks_Mitigation.xlsx – Expanded risk analysis and mitigation strategies by country.
- Tables_and_Figures.pdf – Summary tables, trade-off matrices, and PRISMA diagram.
- Appendices_B-D.pdf – Extended trade-off matrix, country-case summaries, and coding framework (read-only).
- Appendices_B-C.xlsx – Editable trade-off matrix and coding framework for replication and review.
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Written Informed Consent for Publication
Ethical Considerations
Ethical Approval
Acknowledgments
Competing Interests
Conflicts of Interest Statement
References
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| Dimension | U.S. (MFN/VBC) | Canada (PMPRB) | UK (NICE/VPAG) |
|---|---|---|---|
| Cost containment | 3/5 – Suspended MFN, fragmented VBC | 5/5 – Strong regulatory ceilings | 5/5 – NICE + revenue caps |
| Innovation incentives | 3/5 – Mixed; VBC supports R&D | 3/5 – Conservative pricing, weak VBC | 5/5 – Value-linked access |
| Equity | 2/5 – Fragmented coverage | 5/5 – Broad baseline access | 5/5 – NHS universalism |
| Feasibility | 2/5 – Legal and political hurdles | 4/5 – Provincial variation | 5/5 – Centralized integration |
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