Event

The U.S. Inflation Reduction Act (IRA) grants the Centers for Medicare & Medicaid Services (CMS) the authority to directly negotiate drug prices with pharmaceutical companies. This process incorporates drug- and indication-specific real-world evidence (RWE) to assess clinical value and cost-effectiveness for selected innovative therapies that have been on the U.S. market for several years. While this approach marks a paradigm shift in U.S. policy, there is currently no published documentation detailing how CMS has operationalized RWE in its initial pricing negotiations. 

In parallel, the European Union is implementing the Joint Clinical Assessment (JCA) under the new EU HTA Regulation, which aims to harmonize clinical value assessments across Member States. Although the JCA currently focuses on randomized clinical trial evidence, there is growing interest in how RWE—particularly at the indication level—may be incorporated in future evaluations, especially for oncology and advanced therapies. 

By contrast, many HTA agencies in Asia continue to assess evidence primarily at the therapeutic-area level at the time of product launch, with limited use of drug- or indication-specific RWE. The growing emphasis on such evidence under both the IRA and JCA frameworks could have significant ripple effects in Asia—potentially influencing the timing, granularity, and methodological expectations for RWE generation and submission. 

This webinar will explore how these transatlantic shifts in evidence standards—driven by the IRA and JCA—may reshape HTA practices, pricing negotiations, and reimbursement policies in Asia.