COMUNICATO - Comunicato relativo alla rimborsabilita', senza modifica di prezzo del medicinale per uso umano «Tysabri» (16A00137)
Specialita': TYSABRI. Si comunica che il Comitato prezzi e rimborso nella seduta del 28 e 29 ottobre 2015, ha espresso parere favorevole alla rimborsabilita', senza modifica di prezzo e delle condizioni negoziali attualmente vigenti, 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. Tali pazienti sono definiti come pazienti che hanno fallito nella risposta ad un ciclo terapeutico completo ed adeguato (di solito, almeno un anno di trattamento) con un interferone beta o glatiramer acetato. I pazienti devono avere avuto almeno 1 recidiva nell'anno precedente mentre erano in terapia e devono presentare almeno 9 lesioni iperintense in T2 alla risonanza magnetica (RM) cerebrale o almeno 1 lesione captante Gadolinio. Un paziente non-responder puo' anche essere definito come un paziente che presenta, rispetto all'anno precedente, un tasso di recidive invariato o aumentato o che presenta recidive gravi;
oppure pazienti adulti di eta' pari o superiore ai 18 anni con sclerosi multipla recidivante remittente grave ad evoluzione rapida, definita da due o piu' recidive disabilitanti in un anno e con 1 o piu' lesioni captanti Gadolinio alla RM cerebrale o un aumento significativo del carico lesionale in T2 rispetto ad una precedente RM...
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