Increasingly, innovative medicines are coming to market introducing new modalities that are authorized under new trial designs and/or through accelerated marketing authorization pathways. Often, the clinical data package on the basis of which highly innovative medicines receive marketing authorization in Europe is not deemed meaningful enough by HTA bodies and payers. The panel will explore which avenues can be explored to ensure greater evidence requirement convergence between the US and the EU, a more targeted use of real-world evidence and ways of fostering earlier dialogues with HTA bodies and payers.

Session ID: 547583