NEW YORK – Proposing a new risk-sharing arrangement earlier this month, startup RenalytixAI and dialysis service firm DaVita hope to woo US healthcare providers and payors with a unique end-to-end model that they believe will minimize the progression of chronic kidney disease (CKD) in intermediate- and high-risk patients.
Leveraging RenalytixAI's diagnostic testing platform for kidney disease, the firms will launch a pilot program in three undisclosed metropolitan locations later this year and collect real-time risk-assessment data from at least 2,000 patients per area. According to Tom McLain, chief operating officer of London-based RenalytixAI, DaVita approached the firm in early 2020, seeking a partner that would provide an assessment for at-risk patients that it could then connect with its care management program.
"We know that from statistics on disease progression [and] the number of patients going onto dialysis … the [current] model … is not working today, and that the primary care physician needs more support," McLain said. "DaVita had developed care coordination capabilities for later-stage kidney disease patients, but they also knew that intervention with the disease in early stages would [help] change patient trajectories."
By offering an end-to-end workflow, the firms believe they can prevent or delay renal disease progression, as well as lower the number of patients who will need dialysis or a kidney transplant.
As part of the collaboration, RenalytixAI will provide lab services — including testing blood samples from stages I to III CKD patients — and educate clinicians about the KidneyIntelX in vitro diagnostic platform. The test combines machine-learning algorithms, patient-specific biomarkers, and electronic health record data to produce a risk score for progressive kidney function decline or failure.
For intermediate- and high-risk patients, RenalytixAI will connect the provider with Denver-based DaVita's care management resources.
Mahesh Krishnan, group VP of research and development at DaVita, explained that the firm's patient management program involves a network of doctors, nurse practitioners, and nutritionists who will work with the patients' primary care physician to ensure they are receiving the correct therapies, education, and nutritional support.
"Most people currently think of us as a dialysis-based firm … but as part of our plan to be a 'total renal' company, we need to understand how we can help patients upstream," Krishnan explained. "This project is specifically about helping early-stage kidney disease and diabetic kidney disease patients."
Krishnan said that clinicians typically target three key areas to slow down kidney disease and failure. Nephrologists may work with patients to manage comorbidities that can lead to CKD, such as hypertension, type 2 diabetes, and rare genetic conditions that can trigger renal disease.
In addition, nephrologists also attempt to manage patient compliance to medications that slow down renal disease progression, such as recently developed sodium-glucose cotransporter-2 (SGLT2) inhibitors.
While the partners have not made a decision as to which markets they will launch the pilot program in later this year, McLain said that the model's concept is "something that is received very well by payors, and health systems are seeing how it addresses some of their fundamental limitations with CKD."
To demonstrate the benefit of early CKD intervention, McLain's team will need to evaluate at least 2,000 patients in each metropolitan area. While the group aims to collect data on far more patients, McLain pointed out that the real number will ultimately depend on which health providers and payors the group partners with, as well as the number of patients in each system.
Even though the pilot project does not have a specific timeline, Krishnan expects to continually evaluate its progress in real-time as the group signs risk-sharing arrangements with healthcare systems.
"If [the project] seems like its moving well or if there's a customer or payor that is interested in going faster, we will move faster," Krishnan said. "As the data comes in, we will continue to refine it and make decisions about expansions when the time is right."
Krishnan believes that the unique model will appeal to both payors and patients. He highlighted that the model integrates both a diagnostic and follow-up workflow in one single cost, where the "upfront fee is easier for people to understand."
RenalytixAI will also compensate DaVita as part of the cost-management model. While DaVita is funding most of the project, McLain said that the revenue RenalytixAI receives from performing the KidneyIntelX assay will be "more than enough" to cover its undisclosed contribution to the risk-sharing arrangement.
If the pilot project shows that using both KidneyIntelX and DaVita's patient management system is cost-effective for healthcare systems, Krishnan believes that there is a possibility to expand internationally. However, the group does not have any concrete plans to branch outside the US for now.
"Once we understand whether [KidneyIntelX] can achieve this goal from an iterative perspective, we will think about broader contract-based arrangements," Krishnan said. "We do believe there is a lot of demand for this progression [-inhibiting] solution, since payors and others are interested in keeping the stage of kidney disease where it is."
McLain highlighted that the risk-sharing model with DaVita is one of multiple ways that his team hopes to expand adoption of KidneyIntelX in the clinical space. The firm is also exploring other models to drive test adoption, such as its collaboration with Mount Sinai Health System to predict kidney events in COVID-19 patients.
While acknowledging that providing a risk score for patients may not motivate them to alter their lifestyle, McLain noted that treatment recommendations like the recently-developed SGLT2 inhibitors could encourage patients to listen and enroll in DaVita's patient care management program.
"The thought is that if you look in the long term, [SGLT2 inhibitors] will be instrumental in preventing progression as well," McLain said. "These novel therapeutics now being developed [will] help change the landscape of CKD."
Krishnan emphasized that DaVita has established a proven patient care management infrastructure that it has deployed at-scale across the US.
"As we think about what the patients and payors want, we see great potential for this [pilot program] and assay in the entire patient care continuum, from CKD to dialysis and transplants," Krishnan said. "If you put those two things together, you just need to find someone interested in solving these problems."