UNCY - Planned Government Move To Expand Access To Drugs For End-Stage Renal Disease Patients Could Shine The Spotlight On Unicycive
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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 providersof dialysis services.
In October, the CMS published its “FinalRule” updating payment rates and policies for the PPS forend-stage renal disease (ESRD), for the calendar year 2023.
The ESRD PPS, oftenreferred to as “the bundle”, is the government-funded program thatpays for renal dialysis services and certain prescription drugs forpatients with late-stage chronic kidney disease (CKD).
A category of drugscalled phosphate binders that dialysis patients need to be able tocontrol a severe complication of their disease known ashyperphosphatemia is currently not covered under the ESRD PPS.
Therefore, dialysispatients currently resort to sourcing their phosphate binders throughprescription drug plans run by for-profit insurance companies, aprocess which is fraught with challenges due to these brandedprescriptions being more expensive and difficult to access.
In the 2023 Final Rule,the CMS commented on its intention to include phosphate binders in thebundle, stating that the addition of phosphate binders would“mitigate the risk of potential access issues for minoritypopulations, which include African-American/Black, Asian, Hispanic,and Other non-white populations, promote health equity for patientsthat lack Medicare Part D coverage or have coverage less generous thanthe Part D standard benefit, and contribute to better clinicaloutcomes by leveling the playing field for all patients withESRD”.
Thischange is slated to be implemented in 2025 through the TDAPA(transitional drug add-on payment adjustment) –- a direct governmentpayment program that takes the reimbursement process out of the handsof private insurance companies. During a minimum 2-year TDAPA periodstarting in 2025, CMS will evaluate the additional cost of addingphosphate binders into the PPS “bundle” and then make the changepermanent.
CMS’sgoal 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 couldbe great news for Unicycive Therapeutics Inc. (NASDAQ: UNCY).The company is developing what they believe to be a best-in-classphosphate binder they hope to get approved by the FDA in 2024.
The company isdeveloping an investigational new drug called RenazorbTM (lanthanumdioxycarbonate that binds and eliminates phosphate in thegastrointestinal tract. Renazorb utilizes a proprietary nanoparticletechnology being developed by Unicycive for the treatment ofhyperphosphatemia in CKD patients on dialysis.
Unicycive says that ithas completed a clinical trial studying Renazorb in 32 healthyvolunteers with encouraging results – as per the study Renazorb wasminimally absorbed into the systemic circulation and was safe andwell-tolerated at doses up to 6000 mg/day. Renazorb was found tosignificantly reduce urine phosphate excretion and significantlyincrease fecal phosphate excretion at doses at and above 3000mg/day.
Thecompany says that Renazorb offers potential advantages over the mostcommonly used phosphate binder – Renvela – because it dramaticallyreduces the number and size of pills that patients are required totake.
Manypeople suffering from CKD are weighed down by a high pill burden dueto their various other comorbidities that require taking multiplepills. This leads to patients neglecting to take their medicationbecause they are overwhelmed by the number and size of the pills theymust take. Unicycle says that the efficiency and smaller size ofRenazorb pills could reduce the pill burden for these patients by 3 to4 fold.
Renazorbalso has an added convenience for patients since it is swallowed withwater 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 patientaccess and reimbursement for newly launched branded drugs can be achallenge” stated Doug Jermasek, Executive Vice President atUnicycive.
“For-profit insurance plans often restrict access to newdrugs or impose very high patient copays. Beginning in 2025, andcoinciding with the expected launch of our promising new medicine,these barriers will be removed for patients and their healthcareproviders. We are excited by the potential to launch RENAZORB intothis new environment of expanded patient access.”
Unicycive is alsodeveloping a drug for the treatment of acute kidney injury – namelyUNI 494 – for which the company is filing to begin Phase 1 humantrials.
Othercompanies developing drugs for the treatment of CKD include ArdelyxInc. (NASDAQ: ARDX), Akebia Therapeutics Inc. (NASDAQ:AKBA), and Cara Therapeutics. ( NASDAQ: CARA).
To learn more aboutUnicycive visit its website .
UnicyciveTherapeutics is a biotechnology company developing novel treatmentsfor kidney diseases. Unicycive’s lead drug, Renazorb, is a novelphosphate binding agent being developed for the treatment ofhyperphosphatemia. UNI-494 is a patent-protected new chemical entityin late preclinical development for the treatment of acute kidneyinjury.
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