Introduction:: Dedicated Funds for Innovative Medicines were introduced in 2017 for cancer and non-cancer drugs in Italy. After three years, their impact on patient access to the relevant treatments and critical issues about their management has been poorly investigated.
Aims and scope.: This paper aims at bridging the literature gap and providing possible reforms scenarios.
Methods:: Our analysis relied on a qualitative approach. The personal opinions of twelve Italian experts coming from the Ministry of Economy and Finance, the Scientific Committee of the Italian Medicines Agency, the Regions and Patient Associations, the Oncologists’ Scientific Societies and Hospital Pharmacists were elicited through a Delphi approach. A consensus on final recommendations was reached in two rounds.
Results:: Experts were in favour of maintaining dedicated Funds for Innovative Medicines and had a distinct preference for a single Fund. Most of them suggested to extend access to Funds to more than three years, if, for the relevant indication, there are no alternatives to the innovative drug and provided that this does not represent a barrier to new entries. Responders advocated for Funds being covered by on top resources and the production of more evidence on their impact. They finally claimed a speeder flow of information to the regions on expenditure for innovative treatments and an enhancement of controls on prescribing behaviour, to avoid prescriptions be dependent on Funds capacity.
Conclusions:: The consensus document provides for eight recommendations that could be taken into account for possible reforms and future research on this topic.