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