Adnkronos (Adnkronos) – The 28th national congress of the Italian Association of Medical Oncology (AIOM) opens today in Rome, dedicated to "Equitable Innovation" and inequalities in access to innovative treatments. This is a key theme, given the €3 billion from the Fund for Innovative Medicines that remained unused between 2018 and 2025, the scientific society reports, with the share of resources spent dropping from 91% in 2018 to 53% in 2025.
Most of the therapies included in the Fund are oncological – emphasize the oncologists at AIOM – “they include 31 of the 55 indications for 2025, amounting to €353 million, more than half of the expenditure (€700 million). Failure to utilize them could result in the unavailability of innovative cancer treatments for patients, creating inequalities at the regional level.”
The time between reimbursement by the Italian Medicines Agency (AIFA) and the awarding of the procurement tender "can vary from 100 to 400 days in different Regions (the average time is 165 days)."
There are several reasons. "On the one hand, there remain 21 regional pathways, multiple procurement models, and local organizational choices, which contribute to inequity in access. On the other hand, the length of time spent in the Fund can also have an impact. The maximum duration of recognition of therapeutic innovation is three years, with no possibility of extension, even in the absence of more effective therapies."
But the failure to utilize these resources – AIOM points out – "is leading to a reduction in the Fund. The 2026 Budget Law established that they will be reduced by €140 million annually, starting in 2026." For this reason, AIOM is calling for a new innovation governance model that removes local bureaucratic and administrative obstacles to their immediate availability and allows, in some cases, treatments to remain in the Fund for up to five years.
"Innovation can only be fully realized if all citizens can benefit from it equally, regardless of where they live and are treated," explains Massimo Di Maio, president of AIOM. "Italy was among the first countries in the world to adopt a comprehensive regulatory framework for evaluating innovative drugs. AIFA's recognition of a treatment's full innovativeness entails direct access to the Fund's resources and automatic inclusion in regional therapeutic formularies. In reality, today, drugs that should be immediately available to all patients are in some cases not accessible to everyone."
The distribution of the Fund's resources is tied to dispensing in AIFA's monitoring systems, but there may be delays in activating the registers. "AIFA still provides limited information reporting to the Regions," Di Maio continues, "while, at the regional and local levels, communication of monthly Fund usage data to hospitals is not timely enough. These information gaps hinder effective spending and hospital planning. Therefore, regional expenditures are not reconstructed and reimbursed in a timely manner. Furthermore, some Regions, despite the publication in the Official Journal of the AIFA resolution establishing a drug's full innovative nature, pose additional obstacles, for example, reducing the number of prescribing centers, introducing different purchasing procedures for tenders, company authorizations, or centralizing phases of the process." The result is significant regional disparities in the time it takes for the therapies included in the Fund to be available. The most virtuous Regions are Sicily, Campania, and Tuscany; the slowest are Abruzzo, Marche, and Sardinia.
We have built a system capable of recognizing and funding innovation: now we must make it more capable of supporting it over time. We will only succeed if we place equity at the center of our decisions, recognizing it as a fundamental principle for combining the value of innovation with the sustainability and universality of the National Health Service. In oncology, the value of a treatment is not limited to the evidence available at the time of reimbursement: knowledge evolves, new benefits emerge, and we better understand which patients can benefit most. Our decisions—emphasizes Robert Nisticò, President of AIFA—must be able to reflect this evolution, including through evaluation and negotiation tools that are increasingly focused on the results achieved in clinical practice. And the national recognition of a new therapeutic opportunity must translate into effective access, regardless of geographical location. As AIFA, we are aware that recognizing the value of innovation is only part of our responsibility. The other is helping to create the conditions so that that recognition translates into a concrete treatment opportunity for every patient, wherever they live.
At the end of the 36 months, the drug remains reimbursed, but its cost is removed from the Fund and falls under direct regional purchasing, meaning it falls within the hospital pharmaceutical spending limit. "Innovation cannot have an expiration date independent of its clinical value," says Rossana Berardi, president-elect of AIOM. "In oncology, three years may not be enough to fully evaluate the benefits of a new therapy, especially when results consolidate over time. For this reason, we are requesting that, in the presence of specific clinical and scientific conditions, the permanence of drugs in the Innovative Medicines Fund be extended up to five years. This is a responsible choice, necessary to ensure therapeutic continuity, sustainability, and equitable access to the best treatment options." "But simply funding innovation isn't enough: we must make it truly accessible, without bureaucracy slowing down its delivery to patients," concludes Berardi. "We need clear national regulations, clear deadlines for the activation of prescribing centers and purchasing procedures, operational AIFA registries from the moment reimbursement is granted, and transparent monitoring tools that are also accessible to clinicians. We're not asking for fewer controls, but for more effective controls and more streamlined procedures. Our goal must be one: to ensure that the right to the best care doesn't depend on the region a patient lives in, nor on the length of bureaucracy."
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