Time to reimbursement and negotiation condition in Italy for drugs approved by the European Medicines Agency during the period 2014-2019


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Title Time to reimbursement and negotiation condition in Italy for drugs approved by the European Medicines Agency during the period 2014-2019
Creator Prada, Mariangela
Rossi, Letizia
Mantovani, Matteo
Description Introduction: The main purpose of this study was comparing median time (TTR, time to reimbursement) between the first Agenzia Italiana del Farmaco (AIFA) pricing and reimbursement (P&R) dossier’s evaluation and patient access in Italy and to observe the key P&R negotiation results for all new active substances approved by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use between January 2014 and December 2019. We analysed the different factors influencing TTR.
Methods: A panel of medicines for human use approved by the EMA in the period 2014-2019 was considered. All information about authorisation and reimbursement in Italy, including timelines and results from the negotiation, were gathered through EMA and Italian Official Journal databases.
Results: Of 213 new active substances approved from January 2014 to December 2019, 137 obtained reimbursement in Italy, with a median TTR of 7.6 months (228 days). Even if orphan designation, oncology indication, application of Managed Entry Agreements (MEAs; both outcome and financial based) or a discount did not show an impact on TTR, recognition of full innovativeness (n = 27; 20%) was associated with a reduction of 1 month in median TTR. Interestingly, drugs reimbursed with a lower price/daily defined dose showed a reduced TTR (−22%).
Conclusions: Even if the lack of impact of some negotiation conditions was predictable (e.g. oncology indication or orphan status) or the application of a MEA helped to manage possible uncertainties, it did not lead to a quicker completion of the negotiation procedure. Likewise, full innovative drugs showed a shorter TTR underlying the AIFA commitment in recognising, promoting and rewarding innovation.
Publisher AboutScience srl - Piazza Duca d'Aosta 12 - 20124 Milano MI (Italy)
Date 2020-12-18
Type info:eu-repo/semantics/article
Original Research Article
Format application/pdf
Identifier https://journals.aboutscience.eu/index.php/aboutopen/article/view/2184
Source AboutOpen; Vol 7 No 1 (2020): January - December 2020; 89-94
AboutOpen; V. 7 N. 1 (2020): January - December 2020; 89-94
Language eng
Relation https://journals.aboutscience.eu/index.php/aboutopen/article/view/2184/2219
Rights Copyright (c) 2020 The authors

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