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There are over 400 phase three oncology programs running right now. For dialysis, a therapy that roughly 550,000 Americans depend on three times a week, there’s one.
That’s not a data problem or a science problem. It’s a system design problem, and it sits at the intersection of regulatory uncertainty, a reimbursement structure that discourages innovation, and an investment community that has, reasonably, followed the incentives elsewhere.
Our Nick Capman recently had the privilege of sitting down with John Butler, President and CEO of Akebia Therapeutics, to unpack how the life science industry can overcome the dual challenges of regulatory uncertainty and reimbursement barriers that are stifling innovation and investment in kidney disease drug development (and what recent FDA, CMS, and congressional momentum might mean for the path forward).
John has been working in dialysis and kidney disease since 1991. He joined Amgen in a commercial role shortly after the introduction of Epogen and saw firsthand the impact that innovation could have on the lives of dialysis patients. He spent 13 years at Genzyme, much of it leading the renal division and later running the rare disease business.
He’s led Akebia as CEO for over 12 years, bringing two commercial products to market for dialysis patients: Auryxia, a phosphate binder, and Vafseo, an HIF-PHI for anemia in chronic kidney disease. He chaired the American Kidney Fund (and remains on its board) and chaired Kidney Care Partners, a coalition of manufacturers, providers, physician groups, and patient organizations that has driven the kidney innovation policy agenda on Capitol Hill.
He testified before the House Ways & Means health subcommittee in late March 2026 on dialysis innovation and reimbursement reform. Watch his testimony below.
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John's key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Kidney disease innovation is a tale of two cities. On the rare kidney disease side, there’s been a genuine surge in investment and development over the past five to ten years. IgA nephropathy is the poster child. There was virtually no development activity previously, but once the FDA worked with industry and academics to define a clear path to approvability (including proteinuria as an endpoint), the floodgates opened. There are now four or five approved products and more in late-stage development. A similar dynamic is emerging for FSGS through the Parasol group. On the dialysis side, it’s a desert. One phase three program, compared to 400-plus in oncology. The investment community has followed the incentives, and right now, those incentives point away from dialysis.
Regulatory clarity is the single biggest driver of rare kidney disease investment. Fifteen years ago, the investment wasn’t there because the regulatory path wasn’t clear. Was proteinuria truly an approvable endpoint? Were you looking at very long, very large trials that made it difficult to justify the capital? The transformation came when the FDA worked with industry, academics, and groups like the Kidney Health Initiative (a partnership between ASN and the FDA) to define clearer endpoints and more pragmatic paths to approval. John gives the FDA significant credit: that clarity is what gave investors the confidence to fund programs, and it’s why the rare kidney disease space is now seeing a level of activity it has never had before.
Investors are willing to take clinical risk, but they need a clear path to approval and to payment. This is the core tension. When the science works, investors want to believe two things: that there’s a defined regulatory path, and that there’s a sustainable reimbursement mechanism. In rare kidney diseases, both of those are increasingly in place. In dialysis, neither one has been reliable. That asymmetry is a major reason investment has shifted upstream toward rare and pre-dialysis kidney disease.
The dialysis bundle is structurally hostile to innovation. Dialysis reimbursement is unlike anything else in medicine. Since 2010, all services, supplies, and drugs associated with dialysis have been bundled into a single Medicare payment of about $280 per session. For four hours of intense medical care, three times a week. Dialysis providers have to deliver everything within that number, and introducing an innovative drug on top of it is, as John describes it, functionally impossible. The system incentivizes giving patients as little innovation as possible, because that’s how providers stay in business. In John’s words, dialysis is the only area of medicine where treating everyone the same is the most cost-efficient approach. That’s at odds with every other aspect of medicine today.
The Corsuva story is a cautionary tale for the entire ecosystem. CMS created TDAPA (Transitional Drug Add-on Payment Adjustment) around 2020 to allow innovative drugs to be used outside the bundle on an ASP basis for two years. The first drug through was Corsuva, from Cara Therapeutics, for uremic pruritus (severe, debilitating itching affecting roughly 50,000 dialysis patients). It was priced reasonably at about $27 per session. But physicians wouldn’t prescribe it during the two-year TDAPA window because they couldn’t start a patient on a therapy and then take it away when the payment mechanism expired. After the two years, the dollars were spread (”peanut buttered”) across every dialysis session nationwide, resulting in an add-on of $0.11 per session. A provider with 60 patients would need to dialyze 250 patients at that rate to cover treating one. Cara Therapeutics essentially wound down the business and reverse-merged. That outcome sent a clear signal to the investment community about the risks of developing for dialysis.
K-CAPA could be the first real step toward fixing dialysis innovation economics. The Kidney Care Access Protection Act, introduced in both the Senate and House, would make two critical changes to TDAPA: extending the window from two years to three (consistent with every other Medicare special payment program, and reflecting the reality that physicians don’t figure out how to use a product in two years), and shifting from the peanut butter model to a pay-per-use model where providers only receive payment when they actually administer the drug, at a discount. The total cost to the government doesn’t change; the same pot of dollars is just allocated differently. John testified in support of K-CAPA at a House Ways & Means health subcommittee hearing in late March 2026, the first congressional hearing focused on dialysis in at least 20 years. He described the reception as encouraging.
FDA and CMS coordination is a delicate issue, and John thinks they’re generally better when they don’t try to coordinate. FDA decisions should be based on science and benefit-risk, not on potential costs to the system. What John wants to see is more pragmatism from the FDA — and he’s seeing it. He pointed to the oncology division as one that has always been pragmatic, and noted that the cardiorenal division under Elisa Thompson is increasingly engaged with ASN, KHI, and industry. On the CMS side, the challenge is the uniqueness of the dialysis market: 80% of patients dialyzed by two providers, a payment structure that hasn’t been fundamentally revisited since 1972, and a system that most people involved would like to redesign from scratch but lack the appetite to do so.
Akebia’s own experience illustrates both the problem and the available remedies. When John joined Akebia in 2013, the company was only developing Vafseo for the non-dialysis population because the board didn’t know how a dialysis product would get paid for. John pushed to expand to dialysis patients, arguing you can’t have a product available before dialysis and not after. Vafseo then went through a Complete Response Letter from the FDA that Akebia disagreed with, and they successfully used the formal dispute resolution process (which John notes he didn’t even know existed after 30 years in the business) to ultimately get the product approved. The experience underscored both the regulatory challenges in dialysis and the tools available when sponsors believe their data support approval.
Another regulatory friction point: Vafseo, a nephrology drug for anemia, is reviewed by the non-malignant hematology division, not cardiorenal. Having hematologists who don’t specialize in dialysis reviewing a drug for dialysis patients makes the process significantly more challenging. It’s a structural mismatch that adds complexity beyond the science itself.
The science and the investment landscape are moving upstream, and that’s both good and necessary. Companies, including Akebia, are increasingly investing in rare kidney disease and pre-dialysis interventions. SGLT-2 inhibitors and GLP-1s are showing growing impact on slowing progression to dialysis. Dialysis growth rates are lower than historical norms, partly due to disproportionate COVID mortality among the sickest patients and partly because of genuine therapeutic progress upstream. From a venture and development standpoint, the rare kidney space is attracting more early-stage investment than at any point in the past. John describes it as a golden age of investment in kidney disease therapeutics, driven by the FDA’s work to define approvable endpoints with clarity.
The whole community needs to keep pushing and there’s a model for how. Kidney Care Partners, which John chaired for four years, brings together manufacturers, dialysis providers, physician groups (ASN, RPA), and patient organizations under one umbrella. When KCP brings something to Congress, it carries the weight of the entire community’s endorsement. Patient advocacy groups — American Kidney Fund, NKF, AAKP, Renal Support Network — are critical not just for financial aid and patient services, but for being present in the legislative process and advocating for policy changes like K-CAPA.
John is cautiously optimistic about the next decade. The rare kidney disease path is working. The brainpower and capital being committed to kidney disease drug development are at their highest levels ever. If K-CAPA passes and a permanent, innovation-friendly payment is established for dialysis, more products will follow. Emerging science (porcine kidney transplants at Mass General, wearable kidneys, home hemodialysis advances) could further reshape the landscape. The future for kidney disease patients, John believes, has never been brighter. At least since 1972.
John Butler is President and CEO of Akebia Therapeutics, where he has led the company for over 12 years, bringing two commercial products to market for dialysis patients: Auryxia and Vafseo. He has worked in dialysis and kidney disease since 1991, beginning at Amgen after the launch of Epogen and spending 13 years at Genzyme, where he served as President of the Cardiometabolic and Renal Disease division and President of Rare Diseases. John chaired the American Kidney Fund (one of the nation’s largest kidney patient advocacy organizations) and remains on its board, and chaired Kidney Care Partners, a coalition of kidney community stakeholders that has driven innovation policy on Capitol Hill.
Connect with John on LinkedIn here.
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