Webinar 3: Innovative Access Agreements for cell and gene therapy – A US and EU Perspective

In the last of the three webinar series on cell and gene therapy, P4A alongwith the MKO Group explored the role of access agreements in patient access. Payers are increasingly concerned over the high cost of cell and gene therapies accompanied by deep uncertainty in clinical data.

Market access tools are being developed to address these concerns that would eventually provide a platform to share imminent and long-term risks. Innovative (IAA) or alternative access agreements could hold the answer.

Of the five EU countries, Italy (AIFA) and England (NICE) have been at  the  forefront in the application of such tools, often where providing an IAA has become the only realistic way to negotiate expensive oncology drugs. Some interesting, although limited, examples of this approach can be found also in France and some Spanish regions. Germany, on the other hand, has always  remained  shy  of  testing this approach, in particular after the introduction of AMNOG in 2011 although select examples do exist within innovative sick funds.

In the US,  IAAs  experienced  a  different  direction. Interest  in  these  types of agreements has been very high for years. Some examples  can  be  found  among commercial payers, and pilot programs have been intensifying.

The webinar explored these in greater detail from both EU and US perspective.


Key topics discussed at the webinar were:

  • What are the available mechanisms to pay for gene therapy?
  • What is the impact of financial agreements in the UK and Germany?
  • Lessons learnt from Italy’s experience
  • Why have IAAs struggled to be implemented in the US?
  • What is the role of outcome-based agreements as IAAs?
  • Why are Gene/Cell therapies increasing interest in IAAs and what are the remaining complexities and risks associated with IAAs for these therapies?

Please use the registration form on the right to download the third webinar .

Date: January 15, 2019 | 17:00
Duration: 60 min


Sophie Schmitz

Managing Partner, Partners 4 Access

Sophie is a leading expert on orphan drugs, cell and gene therapy. She is heavily involved in advising orphan drug clients on price and market access strategies, with the ultimate goal of optimizing their launch. In a 20-year career span, Sophie has worked in various pharmaceutical therapy areas and medical devices focusing on key product launches in both strategic planning & implementation.

Gianluigi Casadei
Health Policy Consultant & Professor, University of Milan

A medicine graduate at the University of Milan, Gianluigi was responsible for clinical research and post-marketing studies within the Italian subsidiaries of multinational pharmaceutical companies. From 1997 to 2007, he extended his responsibilities to regulatory affairs and market access, developing a thorough expertise on health economics, pricing and reimbursement negotiations. Since 2008 he has focused his interest in health economics as an independent health policy consultant and in academia, where he serves as contract professor of HE at the University of Milan, School of Hospital Pharmacy. He is a visiting scientist at the Mario Negri Research Institute.

Camilla Gomiero 

Senior Consultant, MKO Group

Camilla is a value strategy consultant helping develop commercialization strategies for the biopharmaceutical industry. She has focused her career on development of pricing and market access strategies as well as asset valuations and business development support. She has over 9 years of experience across a wide range of therapeutic areas in both the hospital and retail settings, with a particular focus on orphan drugs.

Please register to download the webinar