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A new enabling act provides a "once-in-a-generation" opportunity to reform Italy's pharmaceutical legislation, with a focus on tackling regional access delays and preparing for high-cost gene therapies.

The Italian Medicines Agency's latest expenditure report reveals a significant overspend on medicines for the first third of the year, driven primarily by costs for new cancer drugs and cardiovascular therapies.

Italy’s Agency for Medicines (AIFA) has approved updated rules for its organisation and staffing, aiming to streamline medicine access and ensure financial sustainability and patient safety

Italy has abolished a decade-old mechanism that allowed pharmaceutical firms to avoid mandatory price reductions, signalling a more rigid approach to public healthcare expenditure and impacting international reference prices

New legislative measures in Italy have introduced structural price reductions for reimbursed medicines and established stricter renegotiation protocols for biological products.

Pharmaceutical manufacturers in Italy are facing a more intricate year-end financial reconciliation as the national regulator integrates a new rebate mechanism into the standard retail payback cycle.

Public pharmaceutical expenditure in Italy surged by nearly 8% in 2024 as a wave of high-cost innovative therapies reached the national market.

A fundamental restructuring of Italy's market access framework will require pharmaceutical companies to adopt a unified clinical and economic approach to secure medicine pricing

Pharmaceutical companies in Italy must now verify their medicine sales records to ensure the accurate calculation of the retail pharmacy payback for the first half of 2025.

A new digital update provides stakeholders with dynamic access to the latest trends in national pharmaceutical expenditure and usage.