Presentation (CTI)

OBJECTIVES: The Centers for Medicare and Medicaid Services (CMS) has recently proposed three international reference pricing (IRP) models. If implemented, US IRP is expected to increase pressure for price convergence, potentially reducing manufacturers' revenues or increasing fiscal pressure on referenced countries. This review evaluates potential strategies to mitigate the impact of IRP.
METHODS: Nine potential mitigation strategies were identified and qualitatively assessed according to their effectiveness against US IRP, impact on manufacturers, and implementation feasibility. The analysis considered the perspective of European policymakers.
RESULTS: The proposed strategies were grouped into three categories: (1) approaches that sever the link between US products and their ex-US counterparts (molecular analogue under different INN or formulation), (2) manufacturer-led commercial strategies (increasing list prices with constant net prices, delaying launch, reallocating volume to high-income countries, out-licencing), and (3) policies implemented by referenced countries (voluntary central procurement, EU central procurement, additional legal safeguards for net price confidentiality). Many strategies were unlikely to be effective across all proposed IRP models, since net and list prices can both be referenced by CMS. Others would require substantial investment (different INN or formulation), forfeiting revenue (launch delays or reallocating volume to high-income countries), or increased costs for referenced countries (increasing list prices). Centralised EU procurement incorporating a single price and a redistribution mechanism to handle price differences between Member States appeared as one of the more effective strategies. However, its feasibility is limited by Member States’ willingness to reach consensus and EU transparency regulations. Voluntary procurement collaborations among countries could achieve similar benefits without such limitations.
CONCLUSIONS: European policymakers should proactively evaluate strategies to mitigate the effects of US IRP and preserve timely access to innovative medicines. Voluntary joint procurement supported by confidential financial redistribution mechanisms may represent the most feasible and effective policy response.