OBJECTIVES

Despite having clear pricing and reimbursement (P&R) pathways for medicines, some European countries lack similar clarity in the process for hospital medical devices especially when combined with procedures. We sought to understand the key opportunities and challenges in EU5 markets, define country archetypes and identify optimal go-to-market strategies.

METHODS

Secondary research generated hypotheses of key opportunities and challenges faced by medical devices intended for hospital settings. Primary research, including qualitative interviews with 5 payers and 3 KOLs in each EU5 country, explored market dynamics impacting the pricing and access of novel hospital medical devices.

RESULTS

The level of structure in P&R process varied across markets. Clear, centralized P&R pathways were identified in France and UK, whereas Germany, Italy and Spain needed a regional or hospital-by-hospital approach. Centralized processes provided fast access when the clinical data package was compelling. Additionally, UK has recently implemented an accelerated access pathway for innovative technologies, offering a more rapid pathway for new devices.

However, when the data package was less compelling, hospital-by-hospital approaches provided a lower-risk access approach compared to centralized countries, due to the low risk of formal HTA review. Moreover, in Germany, NUB funding could also encourage hospital adoption of novel medical devices and procedures.

CONCLUSIONS

Go-to-market strategies for novel medical devices depend on the quality and comprehensiveness of the clinical data available. Manufacturers should prioritize markets based on risk of P&R limitations and HTA reviews. If data is limited, the low chance of HTA review and the opportunity for local or regional negotiations in Germany, Italy and Spain increase the price and access potential. On the other hand, if the data set is robust, the centralized processes of France and UK ensure fast access to market.