Tempi di accesso ai farmaci in Italia nel periodo 2015-2017: Analisi delle tempistiche di valutazione dell’Agenzia Italiana del Farmaco:

Global & Regional Health Technology Assessment

DarioLidonnici¹ 

关键词: Price;    Reimbursement;    Innovative drugs;    Time-to-market;   

DOI  :  10.1177/2284240318792449

学科分类：医学（综合）

来源: Sage Journals

【 摘 要 】

Objectives:To describe the length of time taken by the Italian Medicines Agency (AIFA) to formulate pricing and reimbursement decisions for drugs approved via centralized procedures and to evaluate possible differences between categories of drugs (innovative drugs, oncological and rare disease drugs, products negotiated with Managed Entry Agreements and/or managed via registry).Methods:Monthly meeting reports of the Technical Scientific Committee (CTS) and the Price and Reimbursement Committee (CPR) as well European and Italian Official Journals were scrutinized from January 2015 to January 2018.Results:In the scrutinized period, 85 out of 190 drugs obtained reimbursement and were included in the analysis. Overall, time-to-market (CTS assessment opening to Official Journal) was 258 days. About one third of the whole procedure was dedicated to administrative steps, without significant differences between drug categories.Conclusions:Our analysis shows that transparency makes it possible to determine the len...

【 授权许可】

CC BY