OBJECTIVES: Despite multiple studies confirming International Reference Pricing (IRP) as a central strategic policy tool for pharmaceutical cost controls worldwide, a cross-country analysis of its potential relevance within the medical device space remains an under-researched area. The aim of our research is to understand if and for which markets IRP could feature as one of the influential factors informing pricing and/or reimbursement of medical devices.

METHODS: Desk research based on academic and grey literature was conducted to sense check the regulated or unregulated nature of pricing and reimbursement (P&R) settings for medical devices across 46 markets globally. For the markets showing potential for IRP application, a more comprehensive analysis of regulatory details in legal documents and other relevant ruling was performed.

RESULTS: In total, 20 markets displayed some level of centralized P&R regulation, mainly targeting the maximum reimbursement amount rather than the actual market price. 17 markets showed unregulated pricing frameworks, while it was inconclusive for the remaining 10. Among regulated markets, internal reference, cost-plus pricing, external reference, cost-effectiveness represent the main influential factors. Among the 9 countries that were subject to regulatory deep dive, relevance of external reference was confirmed for Croatia, Greece, Japan, Latvia, Slovakia. Affected medical device categories and specific rules differ by country. IRP exerts the most influence in Greece, with the average of the three lowest purchase prices in the EU impacting the maximum “compensation price”.

CONCLUSIONS: While IRP continues to thrive for pharmaceuticals as a cost-containment policy tool worldwide, its application for medical devices remains less obvious. However, it is confirmed to play a role in P&R evaluations of some medical device categories in several countries, including Croatia, Greece, Japan, Latvia, Slovakia. Integrating the above considerations within the launch planning phase can help optimize market access strategy in those markets.