L’ assessment e il valore del farmaco: una sintesi dei focus group della XXII Conferenza Nazionale sulla Farmaceutica

Abstract

The XXII National Conference on Pharmaceuticals, held in Catania from 29 February to 1 March 2024, involved the participation of representatives from more than forty pharmaceutical industries, national authorities, academia, clinicians and clinical pharmacists. The 22^nd edition represented a key forum for the analysis of value assessment of medicines, focusing on the impact of new European and National regulations, including the Italian Medicines Agency (AIFA) reform and the HTA regulation. This point of view summarizes insights from focus groups discussions that took place during the Conference, highlighting the pillar role of the new HTA regulation for homogenizing the evaluation across Europe, and the importance to strengthen the collaboration among the parties involved from an early phase, and implementing adaptive and flexible assessment, especially for orphan medicines. The re-evaluation of the innovativeness criteria and framework of the Pricing and Reimbursement (P&R) dossier are points raised among the different focus groups, especially for aligning these tools to the upcoming HTA regulation. The proposals emerged could be useful for AIFA, which is facing a reorganization aimed to optimizing the reimbursement process in Italy.

FIGURE 1 -

Proposte del focus group sull'aggiornamento dei criteri di innovatività.

FIGURE 2 -

Proposte del focus group sulle criticità regolatorie dei trial clinici.

FIGURE 3 -

Proposte del focus group sui farmaci per malattie rare e orfane.

FIGURE 4 -

Proposte del focus group sul Regolamento HTA.