AIFA time-to-reimbursement: a comparison between the last two committees from 2015 to 2020

Abstract

Objective. To compare the time-to-reimbursement of the last two committees of the Italian Medicines Agency (AIFA), respectively appointed in 2015 and in 2018.
 Methods. The analysis was run through a specific internal database created by MA-Provider. The database was populated with information regarding European Medicines Agency (EMA) approved new drugs, including each step of the Italian Price and Reimbursement (P&R) process reported in the monthly outcomes of Technical Scientific Committee (CTS) and Price and Reimbursement Committee (CPR) meetings from September 2015 to April 2020.
 Results. The 2015 and the 2018 committees have reimbursed respectively 39 and 28 drugs by comparing their initial 19 months of activity. Significant differences have been observed in negotiated economic conditions, in particular an increase in the number of drugs with confidential discount (2018-committee: 96.4% vs 2015-committee: 64.1%; p = 0.003) and a reduction in the application of Managed Entry Agreements (MEAs) (2018-committee: 10.7% vs 2015-committee: 33.3%; p = 0.036). The average duration of the P&R procedure managed by the 2018-committee has increased by 45 days compared to the 2015-committee (287 days vs 242 days; p = 0.071) and this trend of delay is associated to the active scientific/economic assessment phase by CTS and CPR (particularly by the latter) and not to administrative phases (e.g. Official Journal publications).
 Conclusions. The observed differences between committees may be explained by the higher number of oncological and/or innovative drugs assessed by the 2018-committee (regarding the time delay, probably linked to greater difficulties in finding a win-win agreement able to satisfy both AIFA and Pharmaceutical Company).

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

“…Lidonnici et al ( 13 ) reported 258 days as average TTM, considering a shorter period than our study (2015-2018) and only including reimbursed drugs (class A and H). 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.…”

“…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).…”

Time to market access in Italy: duration of the P&R process for rare disease drugs

“…Se confrontiamo i risultati di questa analisi con quanto pubblicato negli anni passati con approcci simili ( 9 ), i dati mostrano un sostanziale aumento dei tempi impiegati tra l’apertura CTS e la determina in GU. Questa dilatazione dei tempi si è verificata sia rispetto ai tempi impiegati dalla stessa Commissione nel periodo 2018-2020 (durata media 287 giorni) sia rispetto alla Commissione precedente in carica nel periodo 2015-2018 (durata media 242 giorni vs 341 giorni nell’analisi attuale per l’anno 2022 ( Tabella Supplementare A ) considerando di escludere 118 giorni mediani per apertura CTS per rendere paragonabile questo valore con il medesimo periodo degli anni precedenti pubblicati) ( 9 ). Questo risulta evidente anche nella nostra analisi considerando l’andamento annuo delle tempistiche AIFA su tutte le categorie iniziali.…”

“…Altri studi a livello nazionale hanno cercato di analizzare le specifiche tempistiche legate all’accesso regionale ( 8 ), alla comparazione tra le Commissioni che hanno gestito la fase di valutazione in periodi differenti ( 9 ) o al potenziale impatto che ha avuto la pandemia di SARS-CoV-2 ( 5 ). A oggi, a nostra conoscenza, poco è stato pubblicato relativamente ai farmaci orfani e alle determinanti delle tempistiche necessarie per l’approvazione e la messa a disposizione di questa particolare categoria di medicinali.…”