Whalatane
1 week ago
Assuming OLC is approved by end of June and immediately enters the TDAPA process
This is how they determine what CMS will pay
The Centers for Medicare & Medicaid Services (CMS) determines the Transitional Drug Add-on Payment Adjustment (TDAPA) pricing for new dialysis drugs based on specific methodologies tied to the drug's pricing data and regulatory criteria. Here is an overview of how CMS establishes TDAPA pricing:
Pricing Basis:
For most drugs, TDAPA payments are set at 100% of the drug’s Average Sales Price (ASP). If ASP is not available, CMS uses the Wholesale Acquisition Cost (WAC). If neither ASP nor WAC is available, the payment is based on the manufacturer's invoice price156.
In some cases, CMS may adjust this formula. For example, calcimimetics were initially reimbursed at ASP + 6%, but this was later reduced to ASP + 0%17.
Eligibility and Duration:
TDAPA applies to new renal dialysis drugs and biological products for at least two years, during which CMS collects utilization and cost data to determine whether adjustments to the ESRD Prospective Payment System (PPS) base rate are necessary15.
Special Adjustments:
For certain categories, such as phosphate binders, CMS has considered additional fixed payments or percentage increases to account for operational costs or acquisition price variations37.
A fixed increase of $36.41 per monthly claim is currently applied for phosphate binders under TDAPA3.
Post-TDAPA Adjustments:
After the TDAPA period ends, CMS may implement a post-TDAPA payment adjustment based on 65% of the estimated expenditure levels from the prior year to ensure continued access to innovative therapies24.
This structured approach ensures that new therapies are temporarily reimbursed outside the bundled payment system while CMS gathers sufficient data to incorporate them into the ESRD PPS framework.
So OLC is expected to cost $1,300 a mth IIRC and CMS will cover all of that for at least the first 2 yrs ....and 65% of that in the following years .
ARDX's XPHOZAH is not currently in the TDAPA process so is receiving nothing from CMS for their Medicare dialysis patients
My take anyway ...feel free to critique
Kiwi
Whalatane
2 weeks ago
So the previous post was about the challenges dialysis patients have with the current phosphate binders.
The question is ...Is OLC more tolerable ( fewer side effects ) than Lanthanum Carbonate ( Fosrenol )
Based on the available data, OLC (oxylanthanum carbonate) appears to be more tolerable than traditional lanthanum carbonate.
The pivotal clinical trial for OLC demonstrated a low rate of discontinuation due to adverse events, with only 5/86 patients (6%) discontinuing from the study1. This compares favorably to the 14% discontinuation rate due to adverse events reported for Fosrenol (lanthanum carbonate) in its FDA-approved Package Insert1.
In the OLC-201 trial, there was only 1 discontinuation due to a treatment-related adverse event in the Evaluable Population (n=71), a rate of 1.4%1. In the full Safety Population, a total of 3 patients discontinued due to treatment-related adverse events, a rate of 3.5%1.
OLC was also well-tolerated in a dose-escalation study with healthy participants. There were no serious adverse events, severe or life-threatening adverse events, deaths, or adverse events leading to discontinuation710.
The most common side effects of OLC were similar to those of lanthanum carbonate, including diarrhea (9%) and vomiting (6%)4. However, the overall safety profile of OLC appears to compare favorably to Fosrenol and other phosphate binders on the market4.
So the issue is ..can UNCY mgt get this FDA approved without having to do a reverse split or raise funds first
They have funds once approved thru the exercising of warrants .
Kiwi
chevelle
1 month ago
Item 8.01 Other Events.
On July 9, 2024, Unicycive Therapeutics, Inc. (the “Company”) received written notice (the “Notice”) from the Nasdaq Stock Market, LLC (“Nasdaq”) indicating that the bid price for the Company’s common stock (the “Common Stock”), for the last 30 consecutive business days, had closed below the minimum $1.00 per share and, as a result, the Company was not in compliance with the $1.00 minimum bid price requirement for the continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2).
In accordance with the Nasdaq Listing Rule 5810(c)(3)(A), the Company had a period of 180 calendar days, or until January 6, 2025, to regain compliance with the minimum bid price requirement.
As of January 6, 2025, the Company has not regained compliance with the minimum bid price requirement. On January 7, 2025, Nasdaq notified the Company that it would have an additional 180 calendar days, or until July 7, 2025, to regain compliance.
The Company intends to actively monitor the closing bid price of its Common Stock and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price under the Nasdaq Listing Rules
Whalatane
2 months ago
In Hellio Nephrology yesterday
Phosphate binder rule is disease-specific discrimination
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In April, CMS issued guidance for the inclusion of oral-only drugs in the end-stage renal disease bundled payment. The directive included Xphozah as a renal dialysis service.
Xphozah, (tenapanor, Ardelyx) is a first-in-class phosphate absorption inhibitor approved to lower serum phosphorus levels for adults on dialysis. CMS intends to include the agent in the ESRD prospective payment system effective Jan. 1, 2025, but unlike calcimimetics and phosphate binders, tenapanor will have its own transitional drug add-on payment adjustment (TDAPA) and be excluded in the calculation for a permanent add-on payment. Under this guidance, tenapanor will be moved from Medicare Part D to Part B, and Part D pharmacies will no longer be allowed to fill prescriptions to Medicare ESRD beneficiaries.
Premila Bhat, MD, FASN, AHSCP-CHS, and J. Ganesh Bhat, MD, FASN
Tenapanor in phosphate control
Hyperphosphatemia and metabolic bone disease are the most challenging clinical issues facing nephrologists who treat patients on dialysis. Phosphates are ubiquitous in the diet, and normal kidneys excrete most of the phosphates absorbed from the gut. With the decline of kidney function, phosphates accumulate in the blood, leading to secondary hyperparathyroidism and metabolic bone disease.
Since dialysis became a routine procedure for patients with ESRD, traditional management of elevated phosphorus has been through oral drugs that bind phosphates and prevent absorption. Aluminum hydroxide gel and calcium-containing compounds, such as calcium acetate or citrate, were the mainstay for controlling hyperphosphatemia in dialysis. Aluminum toxicity and concerns about calcium burden led to the introduction of other phosphate binders, such as sevelamer carbonate, sevelamer hydrochloride, lanthanum carbonate and iron-based phosphate binders.
Premila Bhat, MD, FASN, AHSCP-CHS
Premila Bhat
J. Ganesh Bhat, MD, FASN
J. Ganesh Bhat
Dietary restriction and dialysis using currently available dialyzer membranes alone are insufficient to maintain phosphate balance; hence, there is a need to bind phosphate in the gut to prevent absorption. Compliance with conventional phosphate binder therapy is difficult and directly attributable to the “pill burden” and need to take the medication with or soon after meals multiple times a day. Gastrointestinal adverse events and intolerance to the binders further complicate the matter.
Many patients on dialysis cannot maintain a serum phosphorus level between 3.5 mg/dL and 5.5 mg/dL even when using medications to manage the condition. The addition of tenapanor as an add-on therapy for patients who have an inadequate response to phosphate binders or intolerance to any dose of phosphate binder would make these goals easier to achieve and prevent complications due to secondary hyperparathyroidism.
Legal action
In July, Ardelyx started legal action arguing that CMS did not have the authority to include oral-only drugs, such as phosphate binders and phosphate absorption inhibitors, in the bundled payment system. From a mechanism-of-action point of view, Ardelyx argued, these drugs should not be labeled as renal dialysis services because the drugs are not administered either orally or parenterally during dialysis treatment, and a parenteral form of phosphate binder or absorption inhibitor is unlikely to be developed.
The judge dismissed the case on Nov. 8. CMS will move the drug from Medicare Part D to Part B as planned on Jan. 1, 2025. Ardelyx has yet to accede to CMS’s request for it to apply for a Healthcare Common Procedure Coding System code and TDAPA status, leaving dialysis providers with no clear pathway to be reimbursed.
CMS stated that moving phosphate binders from Medicare Part D to Part B improves beneficiary access to these medications. Medicare Part D enrollment among patients with ESRD had increased to almost 80% in 2021, and twice as many patients with ESRD qualify for low-income subsidies as those without ESRD. Medicare seeks to improve access to these drugs to all patients with ESRD under Part B, and moving phosphate binders to Part B from Part D would have a negligible impact on access to these drugs. However, this change would burden dialysis providers to procure the drugs be the gatekeeper, keeping an eye on the cost.
Equity in ESRD
ESRD is one of the clearest examples of racial and ethnic disparity in health care in the United States. Black and Latino patients are affected by ESRD four times and 1.3 times more, respectively, than white patients. Furthermore, poverty, as measured by dual eligibility status and low-income subsidies, makes ESRD the poster child for disparity in health care in the country. Since the introduction of the ESRD bundle, CMS has experimented with ineffective ideas, such as TDAPA and transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) and mandatory ESRD Treatment Choices model, which have an enormous and often negative impact on the lives of patients with ESRD.
Under the current method used by CMS, innovative drugs and technologies are less attractive to innovators and investors, limiting access of patients with ESRD to the advantage of these drugs and technologies in stark contrast to patients who have cancer or heart disease.
For example, Korsuva (difelikefalin, Cara Therapeutics) is a novel anti-pruritic drug that could have treated severe itching for one of six patients on hemodialysis. After the TDAPA period for the drug ended, CMS adopted a 3-year adjustment that spread the cost of it across all Medicare treatments. To recover the cost of providing the drug to a single patient, a facility would have to treat hundreds of patients who do not require it. No facility has a sufficient patient population to make that equation work. Consequently, only a fraction of patients who would have benefited from the drug are now receiving it, and its future availability remains uncertain.
Under the current bundled payment and drug designation process, CMS has reinforced systematic discrimination against patients with ESRD that the administration has indicated it seeks to end. The current system stifles innovation and puts the financial burden on dialysis providers to bear the full cost of providing these expensive drugs and technologies to patients without adequate reimbursement.
Patients with ESRD are discriminated against with regard to access to novel therapeutics, devices and diagnostics compared with their peers without ESRD. Oncology, cardiology, diabetes and patients with other rare diseases enjoy a rich innovation pipeline due to a reimbursement system that rewards companies for innovating in these therapeutic areas. It is time for Congress and other policymakers to revisit how innovation is sustainably paid for in ESRD to ensure brave patients are not left behind.
For more information:
Premila Bhat, MD, FASN, AHSCP-CHS, is CEO of Tidal Home Dialysis LLC, and a partner at NY Kidney Hypertension Medicine in Ridgewood, New York. She can be reached at pbhat@atlanticdialysis.com.
J. Ganesh Bhat, MD, FASN, is a principal at Atlantic Dialysis Management Services LLC, in College Point, New York. He can be reached at jbhat@atlanticdialysis.com.
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Disclosures: The authors report no relevant financial disclosures.
Kiwi
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