The timelines for the price and reimbursement authorization in Italy 2018-2020.

ABSTRACT:

Objective

This investigation aimed to guarantee the principles of transparency in public administration; to inform citizens about the time to patient access to reimbursed medicines; to assess the duration of the P&R process for the first time in the period 2018-2020; and to evaluate whether and how the SARS-CoV-2 (COVID-19) pandemic affected the P&R activity. This study analyzed the timelines of pricing and reimbursement procedures submitted in Italy by the pharmaceutical marketing authorization holder (MAH) from 2018 to 2020.

Methods

The analysis was run through an AIFA web-based platform that collects data about P&R procedures for each step of the Italian Price and Reimbursement (P&R) procedure, including dates of the Technical Scientific Committee (CTS) and Price and Reim

SUBMITTER: Gallo V 

PROVIDER: S-EPMC9810802 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature