The Italian Medicines Agency (AIFA) has recently adopted the new “Document for the Harmonization of Procedures for Simplifying the Price and Reimbursement Negotiation Process“, with the aim of making the process of market access for medicines faster and more efficient.
The reform is part of a broader path of administrative simplification and optimization, aimed at reducing evaluation times and ensuring more timely patient access to reimbursed therapies. In this context, AIFA has introduced a distinction between two main types of accelerated procedures: simplified procedures and fast track procedures.
Simplified procedures, which do not require review by the Scientific and Economic Committee (CSE), concern standardized cases such as generics, biosimilars, indication extensions, and packaging modifications, allowing for a more streamlined and direct process.
Fast track procedures, on the other hand, while including CSE evaluation, are characterized by accelerated timelines through the application of predefined criteria and parameters, as in the case of dosage variations, fixed combinations, or targeted renegotiations.
These innovations represent a significant change for pharmaceutical companies, which will benefit from more predictable and rapid pathways, provided specific negotiation conditions are met.
To support an operational understanding of the new framework, SCF has prepared a dedicated focus that summarizes the main characteristics of simplified and fast track procedures, their implementation methods, and access conditions: Simplified and Fast Track Procedures
