Journal of Pharmacovigilance

Healthcare system across Europe and USA: The market-access agreement experience

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

E Allocati, M Ciulla and A Di Stefano

G. d�??Annunzio�?� University of Chieti-Pescara, Italy

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

Progress in health technology and innovative medicines, jointly with the world population ageing, have increased the attention of the national healthcare systems concerning the availability of higher quality therapies at reasonable costs, finding a fair balance between the improvement of the patients quality of life and the economic investment. On the other hand, achieving a compromise with the healthcare payers on the drug�??s price and reimbursement status is of fundamental importance for the pharmaceutical companies, in order to reduce the possibility of failure for expensive pharmaceutical products under cost-effectiveness analysis. The aim of this study is the evaluation of the Market-Access Agreement in the European and USA pharmaceutical market as a harmonization process between pharma industries and national healthcare systems. Different type of analysis adopted by FDA and EMA for the analysis of safety, efficacy, likewise new drugs quality data and the following regulatory decision, are evaluated. Moreover, useful tools such as the Health Technology Assessment (HTA) can be investigated to determine which approach might be best to apply for a specific medicine and which might yield the greatest benefits for the cost-effectiveness evaluation of innovative therapies. In the poster session, we will compare the existing, new, and emerging pathways, strategies, and approaches regarding the Market-Access Agreement that have been or are being implemented by regulatory agencies and/or HTA organizations.

Biography :

E Allocati has completed her Master’s degree in Pharmacy from “G. D’Annunzio” University of Chieti-Pescara. She attended her last semester at Nazareth College in Rochester, NY after winning a competition announcement in her university. Her thesis study as part of her Master’s degree was about pharmacoeconomic aspects concerning the access of innovative treatments into market.

Email: eleonora.a.91@gmail.com