Whalatane
23 hours ago
Minority groups lining up to support the Kidney Patient Act ...which is good for UNCY when they get OLC approved
The National Minority Quality Forum, a health care research, education and advocacy organization, has joined a lawsuit against CMS to prevent the inclusion of oral phosphate-lowering therapies in the ESRD bundled payment.
The American Association of Kidney Patients (AAKP) is also part of this lawsuit. While not exclusively a minority group, AAKP advocates for all kidney patients, including minority populations who are disproportionately affected by kidney disease.
The Sickle Cell Disease Association of America supports keeping phosphate-lowering drugs out of the ESRD bundle. They note that 1 in 3 adults living with Sickle Cell Disease has chronic kidney disease, and keeping these drugs out of the bundle allows doctors and patients more control over their care regimen.
The National Consumers League, which advocates for patient-centered health care, expresses concern that changes in Medicare coverage will cause kidney patients to lose access to quality care and innovative treatments. This is likely to disproportionately affect minority patients.
Dr. Frita McRae Fisher, a nephrologist, argues that including phosphate-lowering therapies in the bundle would disproportionately affect Black patients, who make up more than 35% of dialysis patients but only 13.2% of the U.S. population.
Kiwi
Whalatane
2 days ago
The dialysis bundle explained and its relevance to UNCY ( and ARDX )
The dialysis bundle in the United States is a comprehensive payment system implemented by Medicare for end-stage renal disease (ESRD) treatment. Here's an explanation of the key aspects:
Purpose and Implementation:
The dialysis bundle, officially known as the End Stage Renal Disease (ESRD) Prospective Payment System (PPS), was implemented on January 1, 2011. Its purpose is to provide a single, bundled payment to dialysis facilities for renal dialysis services provided to Medicare beneficiaries.
What's Included in the Bundle:
The bundled per-treatment payment covers:
Dialysis treatment
Drugs and injectable medications
Laboratory services
Supplies
Capital-related costs
Equipment and supplies used for home dialysis
Oral drugs with injectable equivalents
Payment Structure:
The payment is made on a per-treatment basis and is adjusted for patient-level and facility-level factors. It includes provisions for:
A base rate
Adjustments for patient demographics and comorbidities
Quality incentives through the Medicare Quality Improvement Program (QIP)
Oral-Only Drugs:
Currently, oral-only drugs (those without injectable equivalents) are not included in the bundle. However, CMS plans to incorporate these, specifically phosphate binders, into the bundled payment starting January 1, 2025.
Innovative Treatments:
The system includes provisions for new treatments:
Transitional Drug Add-on Payment Adjustment (TDAPA) for new renal dialysis drugs and biologicals
Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)
Impact on Clinical Care:
The bundled payment system has led to changes in clinical algorithms and quality improvement activities. For example, Fresenius Kidney Care reported optimizing the use of erythropoiesis-stimulating agents (ESAs) and vitamin D treatments while maintaining or improving quality outcomes.
Quality Metrics:
The bundle is tied to quality metrics through the QIP, which examines factors such as dialysis adequacy and management of complications like hypercalcemia.
Drug Designation Process:
CMS uses a drug designation process to determine how new renal dialysis drugs and biological products are incorporated into the bundled payment.
The dialysis bundle aims to incentivize efficient care delivery while maintaining or improving quality outcomes for ESRD patients. It has led to changes in clinical practices and resource allocation within dialysis facilities, with ongoing adjustments to incorporate new treatments and medications into the payment system.
Note high lighted area .
If included in the bundle , price caps would limit any use of OLC ( UNCY ) or Xphazoh (ARDX )
Outside the bundle the MD can get Medicare to cover 75% of the cost and the Co can issue coupons to reduce the copay to the patient
Kiwi
molee
2 weeks ago
Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC)
– Patients preferred OLC more than 4 to 1 over their prior phosphate binder therapy –
– Median daily pill burden reduced by half after switch to OLC –
LOS ALTOS, Calif., July 10, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. The positive top-line results from the oxylanthanum carbonate (OLC) trial in patients with hyperphosphatemia who have chronic kidney disease on dialysis were reported on June 25, 2024.
The patient reported outcomes are being evaluated from a satisfaction questionnaire that was a pre-specified exploratory objective of the study. The questionnaire surveyed patients in the UNI-OLC-201 trial to assess characteristics of their current phosphate binder as compared to OLC after switching medications. The questions included patient satisfaction, ease of use, and preferred therapy and were taken at the start and conclusion of the study. In the survey, OLC consistently outperformed the other phosphate binders in all categories: 79% of patients preferred OLC while 18% preferred their prior therapy, 98% of patients said that OLC was easy to take compared to 55% for their prior therapy, 89% of patients said they were satisfied with OLC while 49% were satisfied with their prior therapy.
“We are gratified by the encouraging patient reported findings from our pivotal trial that mirror the better-than-expected topline clinical results that we reported last month,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “In the design of our pivotal clinical trial for OLC, we believed that it was important to consider the patient perspective and the personal challenges that they face in managing their hyperphosphatemia. Importantly, the results showed that patients preferred OLC greater than 4 to 1 over their prior phosphate binder therapy. Our focus is now directed toward filing our New Drug Application and making OLC available to patients who may benefit from its potential best-in-class profile, if approved.”
Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial, commented, “In this clinical study, our patients stated a clear preference for OLC over their prior phosphate lowering therapies. This positive patient reported experience with OLC is encouraging because hyperphosphatemia outcomes are often negatively impacted by non-adherence to phosphate lowering prescriptions due to side effects and high pill burden. At the end of the study, several of my patients asked not to be put back on their prior phosphate binder.”
Background
Patients screened to enter the trial were taking the following phosphate binder therapies (n=128): 52% Renvela® (sevelamer carbonate), 19% PhosLo® (calcium acetate, 15% Auryxia® (ferric citrate), 13% Velphoro® (sucroferric oxyhydroxide, and 1% Other. Once patients were enrolled into the trial, they went through a washout period for two weeks to clear their current phosphate binder from the body.
Key Findings
Preferred Therapy: In response to the question: Based on your experience in this clinical trial, do you prefer your current phosphate binder or OLC, 79% preferred OLC, 18% preferred their prior phosphate binder, and 3% preferred neither.
https://ml.globenewswire.com/Resource/Download/9a233ce4-0844-4e63-b22e-650fa9d140b6/image3.png
Ease of Use: In the trial, the median patient pill burden on OLC was reduced by half compared to their prior phosphate binder therapy. The pill burden on prior therapy at screening was a median of 6 (mean 6.5) pills per day. On OLC, the pill burden at the end of the study was a median of 3 (mean 3.9) pills per day.
In response to the question: My current phosphate binding medication is easy to take, 55% of patients agreed, 41% disagreed, and 4% neither agreed nor disagreed. In response to the question: Oxylanthanum carbonate (OLC) is easy to take, 98% of patients agreed, 1% disagreed, and 1% neither agreed nor disagreed.
https://ml.globenewswire.com/Resource/Download/39ea3031-e96f-488a-9212-331b53aa376f/image4.png
Patient Satisfaction: At screening, less than half of the patients in the study agreed with the statement, I am satisfied with my current phosphate binder medication. At the end of the study and after switching to OLC, 89% of patients agreed with the statement, I am satisfied with oxylanthanum carbonate. Only 6% expressed dissatisfaction with OLC.
https://ml.globenewswire.com/Resource/Download/1f4d052e-09f9-4043-bc89-b34cdc87ddcc/image5.png
The initial findings from the Oxylanthanum carbonate (OLC) pivotal trial satisfaction questionnaire are preliminary and subject to change based on further detailed analysis. Full survey results are expected to be presented at a future medical conference.
molee
4 weeks ago
Since you mentioned it , I checked :
"Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On June 20, 2024, stockholders of Unicycive Therapeutics, Inc. (the “Company”) approved an increase to the number of authorized shares of the Company’s common stock from 200,000,000 shares to 400,000,000 shares as set forth in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2024. On June 21, 2024, the Company filed a Certificate of Amendment (the “Amendment”) to its Amended and Restated Certificate of Incorporation with the Delaware Secretary of State to increase its authorized shares of common stock from 200,000,000 shares to 400,000,000 shares."
https://www.otcmarkets.com/filing/html?id=17645573&guid=jXO-knJPBAGaJth
rosemountbomber
4 weeks ago
Saw this on another board so can’t vouch for accuracy but no reason to not believe:
“Maxim Group analyst Jason McCarthy maintained a Buy rating on Unicycive Therapeutics) yesterday and set a price target of $4.00.
Jason McCarthy has given his Buy rating due to a combination of factors surrounding the performance and potential of Unicycive Therapeutics’ oxylanthanum carbonate (OLC). The positive results from the UNI-OLC-201 pivotal trial, demonstrating the safety and tolerability in patients with chronic kidney disease (CKD), exceeded expectations. Despite a recent drop in UNCY shares, which McCarthy attributes to profit-taking, the impressive trial outcomes suggest a strong case for FDA approval and subsequent filing in the third quarter of 2024. These developments, along with the drug’s potential to become a leading phosphate binder, provide a solid foundation for the Buy rating. Moreover, McCarthy’s optimism is bolstered by OLC’s performance in studies, notably outperforming fosrenol with a lower discontinuation rate due to adverse events. With approximately 90% phosphate control achieved in trial participants, OLC’s efficacy is evident. Additionally, the drug’s formulation as easy-to-swallow tablets positions it competitively in the market, potentially enabling it to capture significant market share from current treatments. McCarthy’s analysis suggests that OLC’s approval could disrupt the phosphate binder landscape, which underpins the positive outlook for Unicycive Therapeutics’ stock.”
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ErnieBilco
2 weeks ago
