OBJECTIVES: In Italy, the National Healthcare Service is based on three different levels (National, Regional, Local) resulting in a decentralized and fragmented market access process. The national access is assured by AIFA, but Regions are autonomous in establishing the access within their areas. The aim of this research is to map the presence of formularies (Regional, Wide Area, Local) and assess the complexity and the centralization of the market access process within each Region.

METHODS: A desk research on institutional portals explored the dynamics of 10 Italian Regions, for the drug access process. Furthermore, a mapping of formularies led to the identification of steps required for the market access and the process complexity evaluation. The analysis was validated with insights collected through 20 interviews with key stakeholders. Three weighted drivers permitted to evaluate the level of centralization: presence of regional formulary, regional influence pressure and homogeneity of drug access across regional territories.

RESULTS: The presence of a single operative formulary at regional level markedly centralized the drug access process. Lombardy and Piedmont resulted decentralized, while five regions demonstrated a high level of centralization. Three Regions resulted in a mixed model with intermediate centralization: for example, Veneto revealed a decentralized access process, but keeping a strong regional coordination thanks to the lead of regional committees.

CONCLUSIONS: The complexity of the access process among Regions is highly variable and should be evaluated considering multiple aspects. It depends on the centralization level as the number of evaluation steps needed for the inclusion on the formulary and the area of influence of the formulary itself. The presence of a regional formulary can facilitate the drug access because it binds local level to the regional decision. On the other hand, additional local level formularies make this process more complex, due to interactions with multiple stakeholders.