At the same time, it launched a public consultation, inviting all stakeholders to submit comments and observations. The consultation ended on March 22, 2025.
Pharma Value’s point of view
Although the 2025 Finance Law initially seemed to expand access to the innovative drug fund—by including not only drugs with full innovativeness but also those with potential innovativeness—the new AIFA innovativeness criteria introduce stricter requirements to obtain this designation. The version published on AIFA’s website on March 12, 2025, which is open for public consultation until March 22, stipulates that innovativeness will be granted only to drugs addressing at least an “Important” therapeutic need, as well as demonstrating a level of added therapeutic value and quality of evidence of at least “Moderate.” This marks a significant change, considering that today, more than half of the indications with full innovativeness (16 out of 28) fall into categories with a lower therapeutic need.
Another key element is the introduction of a threshold linked to prevalence: only drugs intended for diseases with medium to low prevalence can be considered innovative. AIFA’s objective appears clear: to prevent the innovative drug fund from being excessively absorbed by high-prevalence indications, which could have a significant impact on the budget. It has not been clarified what the cut-off is between a medium-prevalence and a high-prevalence drug, as there is no recognized and shared regulatory reference.
As a result, drugs for which the need to establish a fund arose in 2015, such as sofosbuvir for the treatment of HCV, would no longer be eligible today. Sovaldi (sofosbuvir) was granted reimbursement in Italy on December 5, 2014, and precisely to support the cost of high-impact innovative drugs, such as those for the eradication of HCV, a dedicated fund was established through the 2015 Finance Law (Law No. 190 of December 23, 2014), with an allocation of €500 million for each of the years 2015 and 2016.
The introduction of the new innovativeness criteria, with the prevalence threshold as a requirement for access to the fund, shifts the focus more towards economic sustainability rather than enhancing innovation. As a result, drugs that could eradicate high-prevalence diseases risk being excluded from funding—not because they lack therapeutic value, but because their widespread use makes them too costly for the National Health Service.
This penalizes those drugs that would most require financial support. Innovative drugs for high-prevalence diseases, in fact, have a significant budget impact on the National Health Service and require adequate funding mechanisms to ensure patient access.
The new criteria also show a particular focus on orphan drugs and rare/ultra-rare diseases. Specifically, within the quality of evidence criteria, even “low” and “very low” levels of evidence will be accepted, acknowledging the inherent challenges in collecting robust data for these indications. Moreover, these drugs will be eligible for the fund, as they are intended for diseases with medium to low prevalence.
AIFA assesses not only the magnitude of the clinical benefit but also the validity of the endpoints, which must be clinically relevant, validated according to internationally recognized standards, and consistent with the disease and line of treatment.
The 2025 Finance Law will allow drugs that were previously considered to have conditional innovativeness and that meet new criteria to re-enter the Fund. However, for new assessments, there will no longer be a distinction between full and conditional innovativeness: the new regulation will simply determine whether a drug is innovative—granting it access to the Fund—or not innovative, in which case it will not be eligible for funding.
Focus on antibiotics
“Reserve” medicines from the WHO AWaRe list will have direct access to the Innovative Drug Fund, within a limit of €100 million, until the expiration of patent protection or data exclusivity. As a result, these medicines will not be assessed by AIFA.
The inclusion of an antibiotic in a dedicated funding mechanism could create a paradox: on one hand, it ensures access to innovative and necessary therapies to fight against antimicrobial resistance (AMR); on the other, it could unintentionally incentivize excessive or inappropriate use, contradicting antibiotic stewardship strategies.
If an antibiotic becomes more economically accessible through the fund, it could be prescribed more frequently, even in cases where it is not strictly necessary. This contradicts the primary objective of fighting antimicrobial resistance (AMR), which requires a targeted and controlled use of antibiotics, particularly those classified as “reserve”.
In any case, anti-infective agents for multidrug-resistant infections that are not included in the WHO AWaRe list can still apply for innovativeness under the current criteria.
