Is AIFA on the verge of significant reforms?

By Andrea Bernardini, Senior Analyst

Email: [email protected]

Nicola Magrini, the General Director of the Italian Medicines Agency’s (AIFA) has just suggested that significant changes are on the horizon for AIFA. It appears that there will likely be an imminent overhaul of AIFA’s structure, changes in the evaluation of the innovative status as well as the dedicated innovative drugs fund (IDF).

During the 14th National Pharma Forum organised by the Italian Pharmacology Society (SIF), Magrini stressed AIFA’s duty of granting fast access to innovative drugs. He stated: “[…]it is incorrect to say that everything that is innovative it is highly effective […]. Between AIFA and innovation there is a privileged relationship, which makes it possible to give priority […] to ensure quick access to treatment”.To be able to do this, three main changes could be on the agenda.

Firstly, the technical-scientific (CTS) and pricing and reimbursement (CPR) commissions are to be merged into a single commission (Commissione Unica). AIFA’s general director finally confirmed this rumour that has been circulating for the past few months although no specific timeframe was mentioned.

In fact, the latest Milleproroghe decree approved in February has further extended the mandate of the two current commissions until June 2022. All of this leaves few doubts over the fact that AIFA has been delaying the nomination of new committee members in view of this potential change in its general structure (in line with our previous opinion here). Under the proposed structure of a single commission, the current back-and-forth dynamic between the two commissions will be avoided. This could result in an much rapid process that will hopefully offer to manufacturers an opportunity to access to the Italian market faster.

Secondly, a revision of the current dedicated funds for innovative drugs was also called for by the director. Specifically, the potential linking of the innovative drugs fund (IDF) to early access was mentioned. No further details were given on the topic so one can only speculate what this “early-access link” would mean for the current funds.

Recently the IDF was subject to a few changes such as the merging of the innovative oncological drugs fund with the innovative non-oncological drugs fund, and the increase in its financial endowment until 2024 (see our previous opinions here and here ). Hopefully, these latest updates were made to facilitate the entry of the imminent next generation of innovative drugs as other distinctive steps had already been taken to optimise the use of the different funds for early access programs (EAP) (see our previous opinion here). Therefore, it seems unlikely that the “early-access link” will translate into using the IDF.

This “early-access link” could suggest that drugs with successful EAPs could have a more streamlined passage from EAP funds to the IDFs, needing less time, resources and bureaucratic steps. This eventuality is more likely to fit into the overall message of “faster and more efficient access” mentioned by Director Magrini. This could strengthen the importance of EAPs for manufacturers looking at the Italian market, where this type of entry route is well established.

Thirdly, given the future treatment landscape, Magrini also called for the innovative status criteria to be updated and more flexible as well as needing additional criteria to better answer the current challenges of the Italian healthcare system (e.g., antibiotic resistance). Currently, only orphan drugs receive benefit of a relatively more lenient and flexible approach when undergoing evaluation of innovativeness, regarding the quality of evidence presented. However, it could be that some sort of leniency will be enlarged to a wider group of drugs.

Therefore, manufacturers of drugs that address a therapeutic unmet need and bring added therapeutic value with supporting evidence could have more opportunities of being classified as innovative even if some level of uncertainty over their efficacy persists. The product could then achieve immediate inclusion in the regional formularies (a notoriously time-consuming process) and faster access to the IDF, which is set to increase. It could be that more drugs are granted full innovative status, if able to demonstrate at least a promise of innovativeness, but it could also be that more drugs will be granted only a conditional innovation status instead.

Even if details are scarce, it is certain that big news lie ahead for Italy. An imminent change in AIFA structure aims to bring more flexible evaluation procedure and more streamlined funding for innovative drugs.

We have been tracking these trends over the past two years and they do not come as a major surprise. All in all, manufacturers should already have been preparing their access strategies to seize the mentioned opportunities that such announced changes will bring in Italy. With more details likely to be available soon, P4A will keep monitoring the situation to best advise our partners to react, plan and adapt to the changing Italian market.


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