Access times to medicines in Italy in the period 2015-2017: Analysis of the evaluation times of the Italian Medicines Agency

Authors

  • Dario Lidonnici Market Access Provider, Milano (MI), Italy
  • Virginia Ronco Market Access Provider, Milano (MI), Italy
  • Martina Isernia Market Access Provider, Milano (MI), Italy
  • Elena Lanati Market Access Provider, Milano (MI), Italy
  • Claudio Jommi Cergas, SDA Bocconi, Milano, Italy
  • Pier Luigi Canonico Università degli Studi del Piemonte Orientale, Dipartimento di Scienze del Farmaco, Novara, Italy
  • Armando A. Genazzani Università degli Studi del Piemonte Orientale, Dipartimento di Scienze del Farmaco, Novara, Italy

DOI:

https://doi.org/10.33393/grhta.2018.433

Keywords:

Price and Reimbursement, Innovative drugs, Time-to-market

Abstract

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 length of time taken by AIFA to conclude the Price and Reimbursement (P&R) process. It also suggests that administrative procedures may still be optimized to allow faster access to treatments for patients and provides a starting point to determine future policies in this area.

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Published

2018-08-02

How to Cite

Lidonnici, D., Ronco, V., Isernia, M., Lanati, E., Jommi, C., Canonico, P. L., & Genazzani, A. A. (2018). Access times to medicines in Italy in the period 2015-2017: Analysis of the evaluation times of the Italian Medicines Agency. Global and Regional Health Technology Assessment, 5(1). https://doi.org/10.33393/grhta.2018.433

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Original Research Articles

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