Introduction
The kidney care community has made stunning progress in the past decade developing and disseminating innovative drugs, diagnostics, devices, and care models. One superb example is the application of sodium-glucose cotransporter 2 inhibitors to attenuate the progression of CKD, an intervention already transforming the lives of patients with CKD, preventing or delaying the need for dialysis or kidney transplantation. In kidney care, the key areas of innovation include pharmaceutical discovery and development, device development, and design and implementation of new care delivery models. There are certain barriers to success that are common to all three, but each has its own unique barriers. For example, the regulatory barriers to success are particularly noteworthy, although somewhat different, for devices and pharmaceuticals and less important for care delivery innovation. For many developing drugs or devices, there is a bias toward traditional approaches to innovation.
Unfortunately, this approach often fails because of a fundamental gap in insights about the complex terrain, key stakeholders, the role of typical strategic partners (large pharmaceutical or device manufacturers or care providers), evolving patient consumer expectations, and challenges to successful commercialization. It is worth pointing out that the approach described and its frequent failures are not unique to innovation in kidney care; similar issues exist in biomedical innovation in a variety of disease states. In the case of kidney care, however, there is frequently an underestimation of the complexity posed by the numerous and sometimes disparate interests among stakeholders, including payers, Medicare, patient advocates, nephrologists, and others.
Finally, there is inexperience in execution of a clinical development or business plan that focuses on patient needs versus investor and regulator demands, underestimation of the cash required to power success, and the challenge of engaging dialysis organizations, particularly when the innovation involves drugs and devices or might be caught up in policy disagreements about reimbursement approaches. The small number of organizations in the United States that are the major customers, or in some cases, the manufacturers of equipment, and also oversee the clinical care represents a significant barrier to entry for new products.
Lack of acceptance of new drugs and/or devices by these organizations is seen by innovators and potential investors as a massive barrier to success that clearly discourages entrepreneurialism. As with most challenges, there is a path forward despite the barriers, and the promise to patients with kidney diseases of better clinical outcomes and lower costs of care can be realized. What are the concrete steps that can be undertaken now?
(1) Engage the general public as well as patients with kidney diseases and their insights in all aspects of innovation.
(2) Articulate the narrative of the clinical journey of patients with kidney disease as the framework for understanding current gaps in kidney care innovation. Emphasize early diagnosis and treatment of kidney diseases as a key to avoiding severe and costly CKD or kidney failure.
(3) Identify executable innovations, at each step along the journey, that will make a difference for patients (meaning in the marketplace and accessible) within the next 3–5 years.
(4) Educate key health sciences investors about opportunities in kidney care that both improve patients’ lives and result in a fair investment. Articulate the financial rewards of such opportunities along with intangibles, such as name recognition, to cultivate angel investors in this sector.
(5) Collaborate with key advocacy organizations (ASN, the National Kidney Foundation, KCP, AAKP, and others) to create legislation that authorizes reimbursement for new devices and pharmaceuticals with payments outside the dialysis care bundle.
(6) Widen efforts with other key federal health agencies, including the Veteran’s Administration and the Department of Defense, to leverage their history and expertise in accelerating innovations in care for patients with kidney diseases.
(7) Hammer home the message that new care models on the basis of patient care choice, value-based care, and fair reimbursement are innovations as important as new drugs and devices.
The kidney community has the momentum, passion, and will to act now to take kidney care to the next level, and we must embrace the challenge to win. We must broaden our base, include more diverse disciplines, educate investors on opportunities and unmet needs, and support policies that help innovators get transformative therapies to patients.
References:
1. Brown E, Heerspink HJL, Cuthbertson DJ, Wilding JPH: SGLT2 inhibitors and GLP-1 receptor agonists: Established and emerging indications. Lancet 398: 262–276, 2021.
2. Brosius FC, Cherney D, Gee PO, Harris RC, Kliger AS, Tuttle KR, Quaggin SE; DKD-Collaborative ASN Taskforce: Transforming the care of patients with diabetic kidney disease. Clin J Am Soc Nephrol 16: 1590–1600, 2021.
3. Daehn IS, Duffield JS: The glomerular filtration barrier: A structural target for novel kidney therapies. Nat Rev Drug Discov 20: 770–788, 2021.
4. Kidney Health Initiative: KHI’s mission. Available at: https://khi. asn-online.org. Accessed November 30, 2021.
5. Kidney X Innovation Accelerator: The next stage in the fight against kidney diseases. Available at: https://www.kidneyX.org. Accessed November 30, 2021.
6. American Association of Kidney Patients: AAKP Previews Decade of the Kidney at 50 Year Anniversary Meeting; Leaders in Kidney Medicine and Advocacy Receive National Awards, 2019. Available at: https://aakp.org/aakp-previews-decade-of-the-kidney-at-50-year-anniversary-meeting. Accessed December 3, 2021.
7. The White House: Advancing American Kidney Health. Fed Regist 84: 33817–33819, 2019.
8. Kidney Care Partners: Kidney Care First: A Framework for Improving Renal Disease Support & Treatments, 2018. Available at: https://kidneycarepartners. com/kidney-care-first. Accessed November 30, 2021.
9. Nissenson AR: Improving outcomes for ESRD patients: Shifting the quality paradigm. Clin J Am Soc Nephrol 9: 430–434, 2014.
