Presentation (CTI)

OBJECTIVES: The second Trump administration has issued an executive order directing the Department of Health and Human Services to pursue international reference pricing (IRP). However, several proposed IRP initiatives remain proposals and still await implementation. This analysis aims to assess the likelihood that current and future US IRP initiatives will ultimately be implemented.
METHODS: A narrative review of executive orders, proposed regulations, regulatory guidance, legal proceedings, and publicly available policy documents was conducted to estimate the probability of IRP implementation. Given the novelty of these initiatives, the available evidence is limited and evolving, requiring the analysis to rely on policy interpretation alongside historical precedent.
RESULTS: The administration's executive order on IRP places policymakers between competing pressures. Pharmaceutical manufacturers regard IRP as an existential threat to US price architecture. The voters, conversely, have been primed with the expectation of radical price reductions. Experience from the first Trump administration show that IRP will likely face legal challenges, potentially delaying implementation. Several manufacturers have entered voluntary pricing agreements in exchange for temporary tariff exemptions, reducing the immediate pressure for mandatory reform. Because these exemptions extend for three years, key policy decisions may be deferred beyond the current presidential term. Taken together, these factors suggest that prolonged, structured delay represents the most likely outcome, which we estimate at a 40-45% probability. A more limited, narrowly targeted implementation intended to demonstrate progress while minimizing disruption to pharmaceutical revenues is estimated at 30-35%. Scaling up voluntary agreements, thus replacing IRP regulations is also a plausible scenario, estimated at 15-20%.
CONCLUSIONS: Full and durable implementation of comprehensive IRP models within the next three years appears unlikely. As the affordability of medicines remains a key priority, the issue is expected to stay and needs consideration by policymakers outside the US.