The New AIFA Algorithm For Assessing ‘Innovativeness’ Of New Products In Italy: So What?

In April 2017, AIFA (Agenzia Italiana del Farmaco, Italian Medicines Agency) released a new algorithm to assess and evaluate the level of innovativeness of new drugs aimed to get reimbursement by the SSN (Sistema Sanitario Nazionale, National Health System) through the EUR 1 billion fund made available by the Italian…

AVASTIN in AMD: Justifying Discretionary Use and Reimbursement in FRA and ITA

Since the mid 2000s, GENENTECH / NOVARTIS’ LUCENTIS™ (ranibizumab) has enjoyed regulatory approval and funding across the USA and major EU markets for age-related macular degeneration (AMD). With strong efficacy and safety profiles as well first-to-market timing of marketing authorisation and funding, LUCENTIS is a presumptive market leader in the…