The State of Market Access in Italy 2023

The event’s theme cited the problems on the table for market access in Italy. What is the most significant problem?

Definitely one of the most significant problems companies are facing in Italy is the issue of EUnetHTA, which will become official in 2025, creating one system to evaluate drugs across the EU. The question is, what are the implications of EUnetHTA for the Italian health system? What will the relationship be between Agenzia Italiana del Farmaco (AIFA)’s current processes and the new EUnetHTA processes? Everyone across Europe is asking, how different from my current domestic process will EUnetHTA be? Coming out of this conference, the prediction is that the AIFA model will not be too different from EUnetHTA. However, there was a lot of discussion around comparators, which will be a key difference. At the European Medicines Agency (EMA), like the Food & Drug Administration (FDA) in the U.S., they are focused on a risk-benefit analysis; if a drug offers more benefits than risks, the drug will be approved. At the domestic level in Italy, AIFA compares a new drug against available drugs (comparators) that are considered the Standard of Care (SOC). So that’s a very different focus.

Reimbursement for drugs is often a barrier to market access; is this true in Italy today?

Yes, absolutely. The challenge is that the there are two reimbursement processes in Italy – national reimbursement as part of AIFA’s approval, and the inclusion of new medicines in the regional list of drugs. So, a company can successfully go through the process of evaluation and approval with AIFA, including agreement for reimbursement at a specific price. But then you have to get market access at a regional level, which is not only a new battle but also a more complicated one. Italy has 20 regions, and most have their own approach. Plus, the regions each go through their own process of evaluating a drug. This decision is misguided because the AIFA evaluation is extremely thorough, looking at three points: unmet medical needs, added therapeutic value, and quality of clinical trial data. This is a unique approach – many other HTAs do not look at data quality in-depth. So the regional evaluation is pointless, and only serves to delay patient access to the drug. The AIFA evaluation takes 12 – 15 months, and then the regional process can take up to 15 months. So sometimes, it could be up to 30 months before a drug can reach the market, depending on the region.

The consensus coming out of the conference is that the regions should consider these questions: What resources are available to us? What are the prescription models adopted here? What are the distribution models here? What are the models for purchasing within our region? If the regions focused on these supply chain components rather than on evaluating drugs, which has already been done in great detail by AIFA, the time to market could be greatly reduced. The key is to educate stakeholders and regional leaders to increase understanding of this dilemma and the resulting delay in market access. If the regions are willing to forego the process of re-evaluating drugs and instead concentrate on how they can best get treatments to patients, everyone involved will benefit.

Pricing can also slow down market access; what’s the latest on that front?

Pricing presented another interesting topic of discussion at Conferenza Nazionale Sulla Farmaceutica; in particular, possible new models to be adopted for pricing and reimbursement of pharmaceutical drugs based on lifecycle stage. Today, a company will negotiate price and reimbursement with AIFA while launching a new product; later, if they add a new indication to that drug, they must renegotiate, and AIFA usually asks that they lower the price. Pharma companies want to change this because they feel that they are adding value to the product and should not have to lower the price. Instead of talking about volume discounts, pharmas want to switch to a model which attaches the price to the value of the product for that specific indication. In this scenario, a new indication would be evaluated and priced separately from the original drug, and the price would correspond to the indication. This is just one proposal that’s under discussion; the goal right now is to create awareness of this issue.

Was the topic of Early Access Programs (EAPs) in Italy under discussion at the conference?

Yes, EAPs were a hot topic. Italy currently has five different EAPs – Law 648/96, Cnn, Law 94/96, Fund 5%, and Compassionate Use, all mainly focused on providing access to drugs for rare and ultra-rare diseases. The outcome of the discussion at Conferenza Nazionale Sulla Farmaceutica was that EAPs do present opportunities, but currently, the major problem is that the money available from these EAPs is very limited. For example, if you have an ultra-rare disease drug in a Phase II trial which seems to qualify for reimbursement, even if you comply with all the rules of the EAP in question, you might not receive reimbursement because the program doesn’t have enough money. Another problem is that the program eligibility is not clear, the rules are complex and confusing, and if you are rejected, it’s difficult to know why. A major focus among all healthcare stakeholders should be on improving the clarity of the EAPs and their requirements. And at the government level, the issue of effectively funding the EAPs must be addressed.

Were there any other calls to action coming out of the conference?

The healthcare industry is one of the most important for the Italian economy, and it receives the highest amount of global investment in the country, creating a positive impact on the Italian Gross Domestic Product (GDP). This was very clear immediately after COVID-19, because investments had to be made in the whole healthcare system – and the GDP increased significantly as a result, as presented by Massimo Scaccabarozzi during the last day of conference. So the call to action is, let’s invest more in Italian healthcare companies because that generates value for the overall Italian economy.

How can Alira Health’s market access team help pharmaceutical companies to manage market access issues in Italy?

We can help by keeping you up-to-date on the latest developments at the EU and AIFA levels, including EUnetHTA and how you might need to adjust to a risk-benefit analysis approach to approvals. We advise clients on the best approach to reimbursement at the national and regional levels and advocate for policy change to better streamline the process and get products to market faster. If your drug targets a rare disease, we can also work with you on navigating the challenging EAPs that are available in Italy. Market access is a slow process in Italy, but we are here to help you move through it as fast as possible to get treatments in the hands of patients.