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

Abstract

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.

COVID-19 impact on the decision process of the Italian Medicine Agency: a quantitative assessment

“…On the other hand, there is uncertainty about the association of some explanatory variables with negotiation outputs. Indeed, as in our study, Lidonnici et al (13) confirmed the significant impact of the therapeutic area and the significant negative impact of the registry presence on TTM, while Prada et al (14) recognized drug innovativeness as the only significant element in the negotiation.…”

“…In a later publication based on the same data, Raimondo et al (15), found that TTM increased to 287 days in the 2018-2020 three-year period. Similarly, Prada et al (12,14), only including reimbursed new active substances approved from 2014 to 2019, estimated an average of 228 days and, when focusing on the reimbursed oncological drugs, estimated a time to reimbursement of 248 days.…”

“…This analysis was made possible by the richness of the IQVIA proprietary database on negotiation dynamics, where variables on the drug and disease, process, and negotiation outcomes from January 2015 are systematically collected and updated. Moreover, it contributes to the existing literature providing an update about the average TTM of drugs in Italy and of the main determinants of AIFA decisions (12)(13)(14)(15).…”

“…Moreover, it contributes to the existing literature providing an update about the average TTM of drugs in Italy and of the main determinants of AIFA decisions ( 12 , 13 , 14 , 15 ).…”

“…Second, to reduce the selection bias derived from the truncation of the post-COVID period, the analysis was performed only on data from May 2018, that is, setting the Pre COVID period equal to the post-COVID period. Lastly, since currently published literature studying average TTM ( 12 , 13 , 14 , 15 ) only refers to reimbursed drugs (class A and H drugs), we performed a sensitivity analysis excluding approved but not reimbursed medical products (class C drugs).…”