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.