Beyond FEV1: Similar Efficacy, Different Outcome
What you'll learn
- How patient-centered endpoints (e.g. exacerbations, ED visits, steroid burden hospitalizations, treatment persistence) translate into payor-relevant outcomes that drive coverage decisions in competitive respiratory markets
- What payors and HTA bodies need to see in respiratory biologic evidence packages - and where current submissions often fall short
- Validated approaches for capturing real-world respiratory outcomes using remote diagnostics, where appropriate
- Practical examples of how evidence strategies have been structured to create competitive differentiation in crowded respiratory markets
In crowded respiratory markets - particularly asthma and COPD biologics - where multiple therapies show comparable FEV1 and exacerbation improvements, the assets best positioned for favorable coverage and reimbursement are those that can demonstrate real-world value payors, HTA bodies, and prescribers use in formulary decisions.
Generating that evidence means reaching populations that reflect real-world clinical practice - including comorbid, polypharmacy, and community-based patients less commonly represented in pivotal trial data. It means capturing outcomes such as ED visit reduction, steroid burden, and treatment persistence with sufficient rigor for payor and HTA submissions, on timelines that maintain competitive advantage in narrow launch windows. It also means deploying novel approaches - digital biomarkers and remote spirometry - that go beyond conventional evidence generation to differentiate with both payors and physicians.
This webinar provides a framework for doing that. Drawing on examples from respiratory biologic programs and real-world endpoint capture, panelists will discuss what payors and physicians require, how to design Phase 3b, 4, and prospective RWE studies that deliver it, and where remote diagnostics add value.
