Regional Time To Market Of Innovative Drugs In Italy

Abstract

Pharmaceutical products subjected to health technology assessments (HTAs) in the EU5 since 2011 were identified. Products that were launched in at least four out of five markets were selected. Countries were ranked (1-5) in order of launch, with automatically rate 5 when a product was not launched. The year of first launch was use to categorize products into four periods: A) prior to 1999, B) 1999-2003, C) 2004-2008 and D) 2009 onwards. Launches in the same month were considered simultaneous launches and were given the same rank. Results: 305 products met the inclusion criteria. France was mostly the last country in row (rank 4 or 5 in 77%). Germany's first launches increased: the country was first or second for 29% of products from period A (1999-), but this rate increased to 56% for products from period D (2009+). The UK's first launches peeked between 1999 and 2003, but the rate of first-or-second to market decreased to a stable level in the two most recent periods. ConClusions: The order of launch across the EU5 has changed over time. Germany's dominance in first-in-row increased from average to first or second in more than half of all launched products. Meanwhile, the rate of simultaneous launches in multiple markets increased drastically over time, implying a change in strategy by grouping launches.

Regional Formularies in Italy: current state and future perspectives

“…Un secondo contributo ( 4 ) ha misurato i tempi di penetrazione del farmaco sulla popolazione target, vale a dire l’incidenza dei pazienti eleggibili al trattamento effettivamente trattati nel tempo, evidenziando come la quota di pazienti in trattamento nel medio-lungo periodo (due anni) sia condizionata molto più da politiche nazionali (presenza di accordi di rimborso condizionato dalla risposta del paziente, con effetti positivi sull’accesso) che da PTR (che non risultano essere un fattore predittivo rilevante delle differenze interregionali). Gli unici dati esistenti cross-patologia sono stati pubblicati su un abstract ( 5 ) e si riferiscono, anche in questo caso, alla prima data di acquisto per 39 farmaci. L’analisi evidenzia tempi medi di accesso di 2,8 mesi (inferiori quindi a quelli rilevati da Prada et al), con valori più alti nelle Regioni del Sud e per i farmaci oncologici.…”