Italy’s national drug agency, AIFA, is preparing important changes to pharmaceutical pricing and access as the country’s healthcare system faces increasing financial strain from an aging population and rising costs. Agency president Robert Nisticò detailed plans for an automatic price renegotiation system-aimed at securing discounts based on drug profitability-and a potential expansion of state-funded obesity treatments. These moves come amid ongoing debate over regional implementation of national healthcare laws and internal agency discussions regarding policy direction.
Italy’s drug agency, AIFA, is preparing a new system for automatically renegotiating pharmaceutical prices and is considering expanding access to state-funded obesity treatments, according to agency President Robert Nisticò. These potential changes come as healthcare costs rise and the nation’s population ages, placing increasing strain on the country’s universal healthcare system.
Nisticò anticipates the new pricing mechanism, described as a “safeguard clause,” will be finalized by the end of the year. “After the approval of a drug, its revenue grows rapidly, doubling in two years from an average of €1.5 million to €3 million,” he explained. “To refine tools for controlling spending, we are working on a safeguard clause that provides for the automatic renegotiation of prices. This will lower prices through discounts based on the profits companies make on a particular product – the higher the profits, the larger the discount.”
According to Nisticò, the issue isn’t simply a matter of setting spending limits. “Raising the ceiling won’t be enough; the more it’s raised, the more spending will grow,” he said. He attributes rising costs to Italy’s aging population, which leads to increased medication use, and a cultural preference for seeking medical prescriptions over prioritizing preventative care.
Addressing these challenges requires a two-pronged approach, Nisticò stated. “We need to increase the appropriateness of prescriptions and focus on prevention. While healthcare is a right, prevention should be a civic duty. Many illnesses are preventable with healthy lifestyles, and prevention is truly fundamental – it should even be taught in schools.”
Nisticò also highlighted the evolving landscape of pharmacology, noting a shift from treatments that address symptoms to those that target the underlying mechanisms of disease. He cited gene therapies like CAR-T cell therapy as examples, acknowledging their high cost but also their potential to deliver long-term savings by resolving certain conditions.
Recent changes to the distribution of anti-diabetic medications, which some regions have challenged due to increased costs associated with pharmacy dispensing, were also addressed. Nisticò clarified that the agency is obligated to implement a national law regarding the change. However, he added that AIFA negotiated favorable pricing with manufacturers for a specific class of these drugs, gliflozins, and believes the new system could improve medication distribution and patient adherence.
A monitoring table is currently in operation to assess the impact of the new distribution system and provide a comprehensive evaluation.
Regarding access to new obesity medications, Nisticò emphasized that current therapeutic indications are specific and that the risk-benefit profile is unfavorable outside of those indications. “These drugs have side effects and shouldn’t be seen as a standalone solution; patients must also adopt lifestyle changes,” he cautioned.
However, expansion of access is being considered. “We will foresee new risk classes. It may be possible to extend access to severely obese, non-diabetic individuals, or those with weight problems and cardiac damage. But these medications won’t be state-funded for those seeking treatment solely for being overweight.”
Finally, Nisticò addressed a recent public dispute between AIFA’s administrative and scientific directors, for which the Minister of Health requested clarification. “I have already submitted the report to Orazio Schillaci. We have returned to working in a serene and collaborative atmosphere. We are accomplishing a great deal during this period. Of course, there are moments of heated debate, but a sense of responsibility for our important function remains strong among all of us.”
