DETERMINA 26 gennaio 2016 - Aggiornamento dell'elenco dei medicinali erogabili a totale carico del Servizio sanitario nazionale. (Determina n. 156/2016). (16A01145)
IL DIRETTORE GENERALE Vista la determinazione del 29 maggio 2007 che ha integrato l'elenco dei medicinali erogabili a totale carico del Servizio sanitario nazionale, ai sensi dell'art. 1, comma 4, del decreto-legge 21 ottobre 1996, n. 536, convertito dalla legge 23 dicembre 1996, n. 648, mediante l'aggiunta di una specifica sezione concernente i medicinali che possono essere utilizzati per una o piu' indicazioni terapeutiche diverse da quelle autorizzate, inserendo le liste costituenti gli allegati 1, 2 e 3, relative rispettivamente ai farmaci con uso consolidato sulla base dei dati della letteratura scientifica nel trattamento dei tumori solidi nell'adulto, nel trattamento dei tumori pediatrici e nel trattamento delle neoplasie ematologiche. Vista la determinazione 16 ottobre 2007 che ha istituito due nuove liste costituenti gli allegati 4 e 5, che costituiscono parte integrante della sezione concernente i medicinali che possono essere utilizzati per una o piu' indicazioni terapeutiche diverse da quelle autorizzate, relative rispettivamente ai farmaci con uso consolidato sulla base dei dati della letteratura scientifica, nel trattamento di patologie neurologiche e nel trattamento correlato ai trapianti. Vista la determinazione 18 maggio 2011 che ha istituito una nuova lista costituente l'allegato 6 che costituisce parte integrante della sezione concernente i medicinali che possono essere utilizzati per una o piu' indicazioni terapeutiche diverse da quelle autorizzate, relativa ai radiofarmaci con uso consolidato sulla base dei dati della letteratura scientifica. Visto il comunicato dell'AIFA, pubblicato nella Gazzetta Ufficiale n. 10 (Serie generale) del 14 gennaio 2016, relativo alla rimborsabilita', senza modifica di prezzo e delle condizioni negoziali attualmente vigenti del medicinale Tysabri (natalizumab), per la nuova indicazione di seguito riportata: «Tysabri» e' indicato come monoterapia disease-modifying nella sclerosi multipla recidivante-remittente ad elevata attivita' nei seguenti gruppi di pazienti: pazienti adulti di eta' uguale o superiore a 18 anni con un'elevata attivita' della malattia nonostante la terapia con interferone-beta o glatiramer acetato...
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