Is IRA Becoming America’s HTA?

Background:The IRA Medicare drug price negotiation program introduces a negotiation mechanism for US drug pricing with HTA-like features. This raises the question of whether IRA is a de-facto HTA body - requiring clinical, economic, and RWE in a manner reminiscent of established HTA systems, and potentially shortening the profitable lifecycle for branded products. Content:-Compare the IRA maximum fair prices (MFP) process with key global HTAs to highlight similarities (e.g., requirement for comparative clinical, economic, and real-world data) and differences (e.g., US focus on a “fair price” rather than explicit cost-effectiveness thresholds).-Show how the branded product lifecycle may be shortened by presenting a high-level overview (e.g., a table of top 20 blockbusters) indicating when products could enter negotiation.-Summarize lessons learned from the first round of negotiations. Call to action:Manufacturers must adapt to a more HTA-like level of rigor in data collection and economic analyses, including scenario planning, early stakeholder engagement, and robust budget-impact modeling. By developing comprehensive multi-indication evidence and fostering cross-functional alignment among HEOR, Access & Pricing, and commercial teams, companies can mitigate the compressed timeline for revenue generation and better position themselves within the evolving and uncertain US pricing landscape. Even those products not directly named on the MFP list should prepare robust evidence and differentiation strategies to counter potential class-based pricing pressures. Sponsored by Corporate Partner, Genesis Research Group