Understand Why Evidence That Follows Guidance Still Fails to Deliver Predictable Regulatory & HTA Outcomes

• Understand why aligning regulatory requirements for safety and efficacy with HTA expectations for value and cost remains inherently challenging, even with integrated evidence planning
• Identify how subjectivity, interpretation, and uncertainty in HTA committee decision-making drive divergence between published RWE guidance and real-world acceptance
• Design evidence strategies that realistically manage where alignment is possible, where divergence is unavoidable, and how predictability can be improved across markets and decision bodies

Speakers:

Patricia Dorling

Senior Director - Health Economics, Outcomes Research & Gene Therapy Portfolio Lead

Insmed