Impact assessment projects on the payer’s budget Significant savings


NEW YORK and SALT LAKE CITY, Aug 26, 2021 (GLOBE NEWSWIRE) – Renalytix Plc (NASDAQ: RNLX) (LSE: RENX) today announced the release of the results of an external budget impact analysis on kidney disease patients projecting $ 1.1 billion in 5-year savings for a population of 100,000 type 2 diabetes (T2DKD) and chronic kidney disease patients tested with the Renalytix KidneyIntelX ™ test solution. The savings were realized through more efficient pharmacy management and appropriate referral to a specialist compared to the current standard of care for patients at high risk of disease progression and kidney failure.

Detailed clinical and cost analysis concluded that healthcare systems and insurance plans would realize these significant savings based on slower disease progression (52% savings), delayed or avoided dialysis and transplants. (32% savings) and reduced dialysis accidents (11% savings). Considering the costs associated with the current standard of care, adding a workable biopronostics ™ approach to predict renal function decline in T2DKD patients, steps 1 to 3b resulted in an expected 5-year savings of $ 1.1 billion associated with KidneyIntelX.

“These results are significant and demonstrate once again that predicting the risk of kidney disease in its early stages – when it matters most – is a major benefit for patients, providers and payers,” said the President and CEO of CDPHP, Dr John D. Bennett.

Budget Impact Analysis (BIA) is a key element in ensuring payers coverage in the US market. The BIA is an economic assessment that estimates the financial consequences of adopting a new high-value intervention like KidneyIntelX. The analysis takes the perspective of the payer to assess whether a new intervention is affordable. It uses a short-term time horizon, up to 5 years. The model analyzes the direct costs of specific resources required to implement KidneyIntelX informed care in the PCP office with savings associated with changes in care delivery. This result is multiplied by the number of people affected by the intervention. The results of the analysis provide an understanding of the total budget required to deliver the intervention. The size of the population is explicitly taken into account for this analysis. The goal of a BIA is the direct costs of specific resources needed to implement the intervention, such as testing, pharmacy management, and specialist care. In accordance with best practice, sensitivity analyzes were conducted to assess the impact of basic assumptions related to physician adherence and disease progression.

Renalytix to further expand its economic and health utility evidence with separate business cases evaluating whether intervention with the KidneyIntelX test delivers value, defined as cost versus health outcomes, versus standard current care. These analyzes will be completed in conjunction with three large real-world evidence studies with the Mount Sinai Health System, Wake Forest / Atrium Health and University of Utah Health.

The budget impact model was developed in collaboration with Boston Healthcare Associates (BHA), an external company, in accordance with the best practices of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). BHA researchers assessed the budgetary impact of managing using KidneyIntelX against standard of care over a 5-year horizon in patients with diabetic kidney disease (DKD). The results are detailed in “Payer Budget Impact of an Artificial Intelligence In Vitro Diagnostic to Modify Diabetic Kidney Disease Progression”, published in the Journal of Medical Economics.

About kidney disease
Kidney disease is now recognized as a public health epidemic affecting more than 850 million people worldwide. The Centers for Disease Control and Prevention (CDC) estimates that 15% of American adults, or 37 million people, currently have chronic kidney disease (CKD). Additionally, the CDC reports that 9 in 10 adults with CRF don’t know they have it and that one in two people with very poor kidney function who don’t have dialysis don’t know they have it. with CKD.1 Kidney disease is called a “silent killer” because it often has no symptoms and can go unnoticed until very late. Kidney disease kills more people every year than breast and prostate cancer. Every day, 13 patients in the United States die while waiting for a kidney transplant.
1 https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html

About KidneyIntelX ™
KidneyIntelX, is a one-of-a-kind platform that uses a proprietary artificial intelligence-based algorithm to combine various data inputs, including validated blood biomarkers, inherited genetics, and personalized patient data from patient systems. electronic health record, or EHR, to generate a unique risk score for the patient. This patient risk score can predict the progressive decline of kidney function in chronic kidney disease, or CRD, allowing physicians and healthcare systems to optimize the allocation of treatment and clinical resources to patients most at risk. risk.

About Renalytix
Renalytix (LSE: RENX) (NASDAQ: RNLX) is a developer of artificial intelligence-based clinical in vitro diagnostic solutions for kidney disease, one of the most common and expensive chronic diseases in the world. The company’s flagship product is KidneyIntelX, which has received Breakthrough Designation from the U.S. Food and Drug Administration and is designed to help dramatically improve kidney disease prognosis, transplant management, clinical care, patient stratification for clinical drug trials and drug target. discovery (visit www.kidneyintelx.com). For more information, visit www.renalytix.com.

Forward-looking statements
Statements in this press release regarding matters which are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of such forward-looking statements include statements regarding: the potential benefits, including economic savings, of KidneyIntelX, the potential for KidneyIntelX to receive regulatory approval from the FDA, the business prospects of KidneyIntelX, if approved, including Understood whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, our expectations regarding reimbursement decisions and the ability of KidneyIntelX to reduce the costs of chronic and end-stage renal disease, optimize delivery of care and improve outcomes. patient outcomes. Words such as “anticipates”, “believes”, “believes”, “expects”, “intends”, “plans”, “research” and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. All forward-looking statements are based on the current beliefs and assumptions of management and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on new and rapidly evolving artificial intelligence technologies and that the potential acceptance, utility and clinical practice remain uncertain; we only recently launched KidneyIntelX commercially; and risks related to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described in more detail in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our annual report on Form 20-F filed with the SEC. October 28, 2020, and other documents filed. we do with the SEC from time to time. All information in this press release is as of the date of publication, and we assume no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except if the law requires it.

Media contacts:
United States:
Jennifer moritz
Zer0 to 5ive for Renalytix
(917) 748-4006
[email protected]

Outside the United States:
Walbrook PR Limited
Paul McManus / Lianne Cawthorne
Tel: 020 7933 8780 or [email protected]
Mob: 07980 541 893/07584 391 303


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