Developing a robust strategy to address real-world evidence needs early in the pre-launch phase for drugs, diagnostic agents and medical devices is key to “seamless integration of health economics and outcomes research to support product value and market access,” Pharmerit’s Shelby Corman writes in a THEORetically Speaking blog post.
The following are key elements involved in deploying a real-world evidence generation plan for the length of a product’s lifecycle, according to Corman:
- Start with the “aspirational” product value story and work backwards;
- Establish the disease burden;
- Identify current treatment patterns and unmet needs;
- Determine the key economic drivers; and
- Support clinical effectiveness.
“Understanding the role of real-world evidence in the overall product value strategy and coming up with a solid plan early in the product development process can help justify the need for resources to conduct these studies in the face of competing priorities,” Corman writes.