Session (CTI)

ISSUE: Value assessment of a medicine at the middle or end of its lifecycle could benefit from much richer evidence base compared to launch and should be heavily informed by real-world evidence (RWE) on the patients who actually used the treatment in practice. Yet, there remains significant variability in how RWE is used to inform the value of pharmaceuticals post-launch. In the US, IRA negotiations involve submission of comparative RWE, with the extent of its use in CMS pricing decisions remaining unclear. In ex-U.S. markets, use of RWE in HTA reassessments and “living HTA” are increasingly of interest, with experience so far revealing the potential for these extensions of HTA to significantly change from value assessment at launch. This panel will propose a roadmap outlining how innovators can strategically plan post-launch RWE generation to meet long term evidence needs across the product lifecycle in US and key ex-US markets. OVERVIEW: Moderator will begin with presentation on the overview of the Issue. Panelist 1 will discuss US IRA experience on comparative RWE evaluation within the context of Price Negotiations. Panelist 2 will discuss role of RWE in HTA reassessments and as a component of living HTA. Panelist 3 will provide ISPOR and HEOR community perspective in the convergence of RWE and HTA activities. All Panelists will present their perspectives on the critical elements of a roadmap to anticipate post-launch RWE needs and how to streamline this process.