In the U.S., reimbursement of dialysis expenses by the Centers for Medicare & Medicaid Services (CMS) is done using a prospective payment system (PPS) which enables the payout of a predetermined amount to providers of dialysis services.

In October, the CMS published its updating payment rates and policies for the PPS for end-stage renal disease (ESRD), for the calendar year 2023.

The ESRD PPS, often referred to as “the bundle”, is the government-funded program that pays for renal dialysis services and certain prescription drugs for patients with late-stage chronic kidney disease (CKD).

A category of drugs called phosphate binders that dialysis patients need to be able to control a severe complication of their disease known as hyperphosphatemia is currently not covered under the ESRD PPS.

Therefore, dialysis patients currently resort to sourcing their phosphate binders through prescription drug plans run by for-profit insurance companies, a process which is fraught with challenges due to these branded prescriptions being more expensive and difficult to access.

In the 2023 Final Rule, the CMS commented on its intention to include phosphate binders in the bundle, stating that the addition of phosphate binders would “mitigate the risk of potential access issues for minority populations, which include African-American/Black, Asian, Hispanic, and Other non-white populations, promote health equity for patients that lack Medicare Part D coverage or have coverage less generous than the Part D standard benefit, and contribute to better clinical outcomes by leveling the playing field for all patients with ESRD”.

This change is slated to be implemented in 2025 through the TDAPA (transitional drug add-on payment adjustment) –- a direct government payment program that takes the reimbursement process out of the hands of private insurance companies. During a minimum 2-year TDAPA period starting in 2025, CMS will evaluate the additional cost of adding phosphate binders into the PPS “bundle” and then make the change permanent.

CMS’s goal in this planned change to phosphate binder reimbursement is to “result in better drug therapy management for the ESRD beneficiary, and to improve their access to these medications”.

This development could be great news for Unicycive Therapeutics Inc. (NASDAQ: UNCY). The company is developing what they believe to be a best-in-class phosphate binder they hope to get approved by the FDA in 2024.

The company is developing an investigational new drug called RenazorbTM (lanthanum dioxycarbonate that binds and eliminates phosphate in the gastrointestinal tract. Renazorb utilizes a proprietary nanoparticle technology being developed by Unicycive for the treatment of hyperphosphatemia in CKD patients on dialysis.

Unicycive says that it has completed a clinical trial studying Renazorb in 32 healthy volunteers with encouraging results – as per the study Renazorb was minimally absorbed into the systemic circulation and was safe and well-tolerated at doses up to 6000 mg/day. Renazorb was found to significantly reduce urine phosphate excretion and significantly increase fecal phosphate excretion at doses at and above 3000 mg/day.

The company says that Renazorb offers potential advantages over the most commonly used phosphate binder – Renvela – because it dramatically reduces the number and size of pills that patients are required to take.

Many people suffering from CKD are weighed down by a high pill burden due to their various other comorbidities that require taking multiple pills. This leads to patients neglecting to take their medication because they are overwhelmed by the number and size of the pills they must take. Unicycle says that the efficiency and smaller size of Renazorb pills could reduce the pill burden for these patients by 3 to 4 fold.

Renazorb also has an added convenience for patients since it is swallowed with water instead of having to be chewed.

Renazorb is protected by patents in the U.S. and other countries outside the U.S. including Canada, Europe, Japan, China, and Australia, with validity until 2031.

“Gaining early patient access and reimbursement for newly launched branded drugs can be a challenge” stated Doug Jermasek, Executive Vice President at Unicycive.

“For-profit insurance plans often restrict access to new drugs or impose very high patient copays. Beginning in 2025, and coinciding with the expected launch of our promising new medicine, these barriers will be removed for patients and their healthcare providers. We are excited by the potential to launch RENAZORB into this new environment of expanded patient access.”

Unicycive is also developing a drug for the treatment of acute kidney injury – namely UNI 494 – for which the company is filing to begin Phase 1 human trials.

Other companies developing drugs for the treatment of CKD include Ardelyx Inc. (NASDAQ: ARDX), Akebia Therapeutics Inc. (NASDAQ: AKBA), and Cara Therapeutics. (NASDAQ: CARA).

To learn more about Unicycive visit its .

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.

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Anne Marie Fields - Stern Investor Relations