IVD Pricing Power: The Post-Market Data Payers Demand

This episode delves into the critical post-market data strategies required to secure and defend reimbursement for innovative in-vitro diagnostics (IVDs). We explore the distinct evidence that persuades U.S. insurers versus EU payers, moving beyond initial regulatory approval to focus on long-term value demonstration. Learn about the types of real-world evidence, registry studies, and economic data that are most effective for renegotiating coverage and justifying premium pricing in these key global markets. • What type of real-world evidence is most convincing to a U.S. insurer? • How do the data requirements of EU HTA bodies differ from U.S. payers? • Is a registry study or an economic analysis more powerful for defending price? • How does the EU's In-Vitro Diagnostic Regulation (IVDR) of May 2022 impact payer evidence requirements? • What is "clinical utility" and why is it essential for reimbursement negotiations? • How can you design a post-market study to demonstrate direct budget impact? • When should you begin planning your post-market data collection strategy? • Why is U.S.-specific claims data so persuasive for American payers? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.