Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That
About this episode
John Butler discusses the disparity in innovation between rare kidney diseases and dialysis, exploring regulatory and reimbursement challenges.
Why are there over 400 phase three oncology programs but only one in dialysis? John Butler, who has spent over 30 years in the kidney disease space, breaks down the regulatory and reimbursement dynamics that have created a surge of innovation in rare kidney diseases while leaving dialysis patients behind, and what it would take to change that. John discusses how FDA clarity on endpoints transformed the rare kidney disease investment landscape, why the dialysis bundle makes innovation functionally impossible for providers, and how the Kidney Care Access Protection Act could be the first meaningful step toward a sustainable path for new dialysis therapies. A few of John's key takeaways: Regulatory clarity is the single biggest driver of rare kidney disease investment — FDA's work with industry to define approvable endpoints changed the entire landscape The dialysis bundle is structurally hostile to innovation — at $280 per session for all services, supplies, and drugs, there's no room for new therapies The Corsuva story is a cautionary tale — a good product at a reasonable price failed because the payment mechanism didn't work K-CAPA could change the calculus by extending the TDAPA…
More episodes of The Life Science Rundown
- TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
- Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
- Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
- Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
- Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
- Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
Explore listener stats, chart rankings, contacts and more on the The Life Science Rundown podcast page.