For our Global Whispers webinar in October, Clare Foy (Director – Global Market Access, Mtech Access) spoke 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).
October 2023 sees the implementation of structural reforms at AIFA, the Italian Medicines Agency. The Scientific Technical Advisory Committee (CTS) and the Price and Reimbursement Committee (CPR) will be merged into a single body: the Scientific and Economic Commission (CSE). Whilst these reforms aim to slim down the reimbursement process, increase efficiencies, and reduce delays, some commentators have been critical of the changes. One key aspect is the reduction in the number of committee members, from 10 in both the CTS and CPR, to 10 in total in the CSE.
In this webinar, Italian HEOR expert and ex-payer, Prof. Fabrizio Gianfrate, outlines what these changes mean for market access in Italy and explores wider challenges that Pharmaceutical and Medical Device companies may face when launching in this market.
- 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)
More about our speaker
Prof. Fabrizio Gianfrate (Professor of HEOR and Italian Ex-Payer)
Fabrizio Gianfrate is an expert in the Italian market access landscape and an ex-national and regional payer. He is currently a Full Professor of HEOR in Rome.
Earlier in his career, he was a voting member of the Pricing and Reimbursement Committee at AIFA and a regional HTA and Formulary Committees member (5 big regions). He was also a Director at the Ministry of Health.
Fabrizio is a founding member of the European Access Academy and has authored more than 700 publications and 7 books on pharmaceutical economics and policies.
We are delighted to welcome Fabrizio to the Global Whispers webinar series.
The Global Whispers webinar series
This webinar is part of our Global Whispers series where we explore global market access trends and challenges facing the Pharmaceutical and Medtech industries and offer insights into key launch markets.
Our previous webinars are available on demand:
- August 2023: ‘Artificial intelligence (AI) in clinical trials: Implications for evidence synthesis and market access’ with guest speaker George Magrath (CEO, Lexitas)
- July 2023: ‘Market access in the German-speaking markets’ with guest speaker Dr Stefan Walzer (CEO, President & Founder at MArS Market Access & Pricing Strategy GmbH)
- June 2023: ‘Market access for digital therapies and digital medicines’ with guest speaker Shefali Shah (Global VP, Market Value and Commercial Effectiveness – MindMaze)
- May 2023: ‘A global market access journey: What it takes to bring a cannabinoid pharmaceutical to market’ with guest speaker Michael Sassano (CEO – SOMAÍ Pharmaceuticals)