The Italian Medicines Agency (Agenzia Italiana del Farmaco) (AIFA) released its position paper, Precision Medicine and the Appropriateness of Pharmacological Prescription (Medicina di Precisione e l’Appropriatezza della Prescrizione Farmacologica), on 16 March 2026. This document is the output of the Technical Panel on Prescriptomics (Tavolo Tecnico sulla Prescrittomica) (TTP), a multidisciplinary group established in November 2024 to modernise drug governance. Robert Nisticò, President of the agency, has described the framework as an ethical duty and a vital investment to ensure the future of the National Health Service (Servizio Sanitario Nazionale) (SSN).
The strategy addresses the structural challenges of a demographic shift where nearly 24% of Italian citizens are now over 65 years of age. Data show that 68% of this group take at least five medicines, while 28.5% take ten or more. This high prevalence of polypharmacotherapy increases the risk of drug interactions and therapeutic failure. Consequently, AIFA is moving pharmaceutical oversight away from population-averaged models toward an integrated assessment of the relationship between the patient and their disease.
The TTP introduces prescriptomics as the integrated application of multi-omic data and artificial intelligence to personalising therapeutic choices. A central proposal involves codifying pharmacogenomic (PG) consultations as an Essential Level of Care (Livello Essenziale di Assistenza) (LEA). The agency envisions a lifetime pharmacogenomic passport for citizens to guide every prescription. This move aims to ensure that treatments for oncology or cardiology are matched to individual genetic profiles from the outset.
To support this transition, AIFA proposes a National Health Dataset (Dataset Sanitario Nazionale). This repository will combine longitudinal health records with molecular data to train predictive models. The infrastructure will enable the use of digital twins – dynamic computer-based patient representations – to perform in silico clinical trials. Such models allow the agency to simulate drug responses for molecules such as siponimod (Mayzent®) or atazanavir (Reyataz®) before human exposure .
The strategy emphasises the systematic use of Real-World Evidence (Evidenze del mondo reale) (RWE) to monitor prescribing appropriateness in clinical practice. AIFA stipulates that all digital decision-support tools must be explainable . Furthermore, these algorithms must comply with the energy efficiency standards established by the Assisi Theorem (Teorema di Assisi) .
The TTP identifies five strategic stages for this national operational model . These include establishing a unified data infrastructure and creating specialised training pathways for healthcare professionals. The final phase involves full integration into clinical workflows through regional task forces . This transition indicates that future clinical evidence will be evaluated not just on trial data but on its demonstrable appropriateness within specific genomic subgroups.
Source: Italian Medicines Agency.
Link: Medicina di Precisione e l'Appropriatezza della Prescrizione Farmacologica (Precision Medicine and the Appropriateness of Pharmacological Prescription).
Date: 16 March 2026
