Market access in Italy: Reforms at AIFA

Pharma Market Access Insights - from Mtech Access

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)
This episode was first broadcast as a live webinar in October 2023. Learn more at: https://mtechaccess.co.uk/italy-market-access-aifa-reforms/

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1. Market access in Italy: Reforms at AIFA (00:00:00)

2. Overview of Italian market for medicines (00:02:03)

3. AIFA committees: the CTS, CPR and new CES (00:05:00)

4. Planned changes at AIFA (00:07:30)

5. Impact of changes, e.g. reduced number of committee members (00:13:29)

6. How Pharma can respond to these changes, e.g. managed entry agreements (00:20:56)

7. Impact of AIFA changes on advanced therapy / gene therapy / cell therapy products (00:24:58)

8. Changes to early access programmes in Italy (00:27:16)

9. Impact on Pharma market access and pricing strategy (00:31:00)

10. Impact on the wider European landscape (00:33:06)

11. Regional HTA in Italy (00:39:06)

12. Strategic considerations for market access in Italy and Europe (00:40:58)