Consulenza scientifica parallela EMA-HTA: sfide e opportunità

Name: Consulenza scientifica parallela EMA-HTA: sfide e opportunità
Brand: Edizioni Sapienza
SKU: 9786209808753
Price: 6921.0 INR
Availability: InStock

by Ulrike Fuchs

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ISBN13: 9786209808753
Binding: Paperback
Subject: N/A
Publisher: Edizioni Sapienza
Publisher Imprint: Edizioni Sapienza
Publication Date: March 27, 2026
Pages: 112
Original Price: USD 77.0
Language: Italian
Edition: N/A
Item Weight: 159 grams
BISAC Subject(s): General

About The Book

Rispetto alle agenzie regolatorie - che si concentrano sulla valutazione del rapporto rischi/benefici di un prodotto, tipicamente valutato nel contesto rigorosamente controllato degli studi randomizzati controllati con particolare attenzione alla validit� interna, alla sicurezza, all'efficacia e alla produzione - gli organismi di HTA hanno competenze diverse e, di conseguenza, requisiti di evidenza aggiuntivi. I criteri per le decisioni di rimborso variano da un paese all'altro, ma possono includere i bisogni medici non soddisfatti, l'efficacia e la sicurezza relative del farmaco, il prezzo del farmaco, l'impatto sul bilancio e il rapporto costo-efficacia. La progettazione di uno studio idoneo all'approvazione normativa potrebbe non tradursi sempre in dati idonei alle decisioni di rimborso, creando un divario di evidenze tra la domanda di autorizzazione e quella di rimborso e ponendo un ostacolo all'accesso dei pazienti ai nuovi farmaci in alcuni paesi. Infatti, anche quando si ottiene un'autorizzazione all'immissione in commercio, gli organismi di HTA e le decisioni sui prezzi e sul rimborso dei farmaci spesso ritardano l'accesso ai medicinali per i pazienti a livello nazionale o persino regionale. Per lo sviluppo di medicinali nuovi e innovativi � quindi essenziale avviare un dialogo tra l'industria, l'EMA e le agenzie di rimborso in una fase precoce.

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