The Agenzia Italiana del Farmaco (Italian Medicines Agency) has published Determinazione DTS/88/2025 – Linee guida per la compilazione del dossier a supporto della domanda di rimborsabilità e prezzo di un medicinale(Guidelines for compiling the dossier supporting the Health Technology Assessment of a medicinal product for the purposes of pricing and reimbursement by the National Health Service). This document represents a one-off doctrinal shift, replacing the 2020 framework to align with a reformed agency structure and new European standards.
The primary change is the transition from a fragmented evaluation to an integrated Health Technology Assessment (HTA). Previously, pricing and reimbursement applications were assessed through separate clinical and economic reviews conducted by distinct committees. The resulting change mandates a single, multidimensional representation of value. This shift is driven by the merger of the agency’s clinical and pricing bodies into the Commissione Scientifica ed Economica del farmaco (Scientific and Economic Commission for Medicinal Products), which now evaluates scientific evidence and financial impact simultaneously.
Under the new guidelines, the evidentiary burden has increased significantly. Cost-effectiveness and cost-utility analyses are now mandatory for all new drugs, orphan products, and indication expansions. Furthermore, the agency has introduced stricter criteria for defining the ‘Best Standard of Care’, which now encompasses any pharmacological or surgical treatment, medical devices, or digital therapies that constitute the current optimal treatment pathway.
The guidelines also incorporate the requirements of Regolamento (UE) 2021/2282 (EU Regulation 2021/2282) on Joint Clinical Assessments. For drugs that have undergone a European-level review, the clinical description in the domestic dossier becomes optional, allowing the agency to focus on national economic negotiations. Additionally, the criteria for ‘Innovativeness’ have been refined, with status now assessed in parallel with price negotiations.
The measures were adopted by the Technical-Scientific Director on 23 December 2025 and are scheduled for full implementation on 1 April 2026. This transition period allows firms to reconfigure their internal market access processes.
The implications are profound. Market access teams can no longer treat efficacy and sustainability as separate workstreams. By enforcing standardised methodologies, the regulator aims to accelerate decision-making, though the higher bar for comparative evidence will likely necessitate more complex clinical trial designs and robust real-world evidence.
Source: Agenzia Italiana del Farmaco, AIFA
Link: Guidelines for compiling the dossier supporting the Health Technology Assessment of a medicinal product for the purposes of pricing and reimbursement by the National Health Service
Date: 23 December 2025