The Italian system requires drug companies to go through approvals at a national level with the Italian Medicines Agency (AIFA), only to then confront the country’s 21 regional authorities who independently manage the budget for territorial pharmaceutical expenditure and evaluate regional access. According to many industry stakeholders, this lengthy process results in varying levels of patient access across Italy’s regions and a lag with respect to the country’s European counterparts, although the country’s National Recovery and Resilience Plan aims to address some of these issues.
Italy’s Fragmented System
“In Italy market access discussions happen on a national level with the Italian Medicines Agency (AIFA), which takes care of pricing, reimbursement, and regulations. Italy’s particularity lies in regionalisation because there are 21 regions and each one of them drives its own healthcare system. This means that a national decision could be worked on differently by each region, which can lead to delays in patient access and also differences in patient access between the regions,” says Paivi Kerkola, country manager, managing director, president at Pfizer.
Many industry stakeholders complain about the complexity of this fragmented process: “[Even if] we have received a partial innovative status from the Italian Medicines Agency (AIFA), we have had to go through a long process including not only negotiations on a national level for reimbursement and setting of price but also to settle things on a regional level”, says Charles-Henri Bodin, GM at Pierre Fabre.
Others, like Nicoletta Luppi, senior VP & managing director, MSD Italy, make a case for centralisation: “Regions can maintain the responsibility of organising and providing services based on the resources they receive from the national level, but pharmaceutical spending must be centralised, and its governance as well. It is not acceptable that you have or do not have access to innovation depending on the region you live in.”
At the same time, AIFA, the national regulatory body, claims that it is making an effort to introduce more consistent barometers across the country: “AIFA has always favoured innovation and, in this context, has defined specific criteria with the aim of guaranteeing quick access to medicines. The goal is to harmonize the criteria in our national territory,” says Giorgio Palú, president of AIFA.
Focus, Shape, Enable
Pharma execs argue that because Italy’s multi-tiered procedure slows market access down, Italian patients often get medicines well after patients in other European countries. According to EFPIA Patients W.A.I.T. Indicator 2021 Survey from IQVIA, Italy is behind at least 12 other European countries with respect to time to availability.
“This process takes a very long time; after approval from the European Medicines Agency (EMA), it takes about a year and a half to get reimbursement at the national level. That means that for a year and a half, patients are waiting to get their medicines while the same medicines are already available in other European markets,” Soren Giese, general manager at Amgen bemoans.
The National Recovery and Resilience Plan is seen by many as an incentive to contend with these access issues and local authorities seem confident that it will help to address disparities: “The aim of that plan is to bridge the gap between territorial inequalities and offer greater integration between regional health services through innovative solutions,” says Domenico Mantoan, GM of AGENAS, the Italian National Agency for Regional Health Services.
“The expectation is that future provisions and legislation will acknowledge the industry’s request for new governance for the pharma sector, thereby ensuring that the best treatment options reach Italian patients equally. Different stakeholders must come together with a vision to reform the system and guarantee equal access; I cannot think of a reason why this cannot be done,” says Huzur Devletsah, president & GM Italy, Central Eastern Europe, Russia/CIS & Israel at Eli Lilly.
Yet with Italy’s current political uncertainty, there are still challenges ahead: “With respect to drug approvals in Italy, we are in a changing environment because of the new government that will come into effect in October. Submitting a dossier these days with this level of uncertainty is not easy,” says Tiziana Mele, managing director of Lundbeck Italy.