(9) Improving Access and Equity in the United States Through a Uniform National Formulary

Background: : Prescription drug costs and access remain a concern in the U.S., particularly for patients requiring high-cost specialty treatments. Other countries, such as Australia and New Zealand, use centralized national formularies that combine price negotiations with standardized benefit structures to improve affordability and equity. These models differ substantially from the U.S. Medicare Part D system, which relies on private plan negotiations. Comparing these systems offers valuable insights into policy approaches that could address medication costs and disparities in the American healthcare landscape.

Objective: : To compare international formulary structures and pricing models, identifying policy elements that could enhance affordability, reduce disparities, and improve equitable access to essential medications in the U.S. healthcare system.

Methods: : A comparative policy review examined three systems: New Zealand’s Pharmac, Australia’s Pharmaceutical Benefits Scheme, and the U.S. Medicare Part D program. Data sources included government publications, peer-reviewed literature, and official pricing databases. Analysis focused on governance models, negotiation, and coverage criteria. Cystic fibrosis treatment with elexacaftor/tezacaftor/ivacaftor served as a case example to show differences in cost-sharing, coverage, and access restrictions. Key variables assessed were out-of-pocket costs, formulary inclusion processes, and equity implications for patients requiring expensive, life-sustaining therapies.

Results: : Centralized negotiation models in New Zealand and Australia were associated with lower, more predictable patient costs and consistent national coverage standards. In contrast, the U.S. system showed wide variation in pricing and benefits, with higher out-of-pocket expenses for specialty medications like elexacaftor/tezacaftor/ivacaftor. Price controls and fixed co-payments in centralized systems reduced financial barriers, whereas U.S. patients often faced coverage variability and additional authorization requirements, contributing to inequities, particularly for those managing chronic or rare diseases.

Conclusions: : International formulary models demonstrate that centralized negotiation, fixed co-payments, and uniform coverage rules can significantly improve affordability and equity. Applying selected features from these systems could reduce cost burdens and standardize access for U.S. patients. While implementation would require overcoming political and structural obstacles, such reforms offer a viable pathway toward a more sustainable, fair, and patient-centered prescription drug system.

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