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In this Global Whispers webinar, Clare Foy (Director – Global Market Access, Mtech Access) speaks to Italian market access expert Prof. Fabrizio Gianfrate (Professor of Health Economics and Outcomes Research [HEOR] and Ex-Payer) about the market access landscape in Italy, particularly regarding changes at the Agenzia Italiana del Farmaco (AIFA). We explore: The nature of the Italian market and the reimbursement process Pricing and market access considerations when launching in Italy What the reforms at AIFA mean for market access and managed entry agreements How the AIFA changes specifically impact innovative products Changes to early access programmes in Italy Impact of these changes on international pricing, particularly with the introduction of the EU Joint Clinical Assessment (JCA) Learn more about this webinar at: https://mtechaccess.co.uk/italy-marke... This webinar was first broadcast live in October 2023. Jump to: 00:00 - Welcome 02:03 - Overview of Italian market for medicines 05:00 - AIFA committees: the CTS, CPR and new CES 07:30 - Planned changes at AIFA 13:29 - Impact of changes, e.g. reduced number of committee members 20:56 - How Pharma can respond to these changes, e.g. managed entry agreements 24:58 - Impact of AIFA changes on advanced therapy / gene therapy / cell therapy products 27:16 - Changes to early access programmes in Italy 31:00 - Impact on Pharma market access and pricing strategy 33:06 - Opportunities to engage with AIFA 36:07 - Impact on the wider European landscape 39:06 - Regional HTA in Italy 40:58 - Strategic considerations for market access in Italy and Europe