Criteria to appraise innovativeness (unmet need, added therapeutic value, and quality of the evidence) were introduced in Italy in 2017. Innovative status provides the relevant medicine/indication for some advantages, including a dedicated fund and immediate access to regional markets.

Our findings show that an innovativeness appraisal is driven by the added therapeutic value and quality of the evidence and that the appraisal process is highly transparent, internally consistent, and predictable.

A transparent and predictable appraisal process is very important for all stakeholders. In particular, it provides the industry with a clear message that an important added therapeutic value and high quality of evidence are needed to prioritize market access for their products.