ErnieBilco
2 weeks ago
Editor’s note: This is an automatically generated transcript. Please notify iwaters@healio.com if there are concerns regarding accuracy of the transcription.
Going back to the tenapanor drug, I'm interested in seeing further studies of how we optimally combine this with phosphate binders. It's a twice-a-day drug, which technically doesn't have to be taken with meals, although in the trials, they tended to give it with the meal. The expectation is that we would combine it with phosphate binders. There's a recent publication by a Japanese group doing that, and they lowered the phosphorus substantially in people who were on binders, but not achieving goal. And they increased the proportion of patients getting to a phosphorus of less than, I think they wanted, less than 6 [mg/dL] from 30% with the placebo pill to about 70% of the patients who added the tenapanor to their binder. So that's really exciting. The next is a drug, which just has a code name, EOS789, which is a pan-phosphate inhibitor. It inhibits NaPi2b and two [inorganic phosphate] PiT transporters, which are all phosphate transporters in the gut. This agent, in at least a phase 1 study, did seem to be pretty effective at lowering the proportion of phosphorus absorbed in meals. We're going to need a lot more data on how tolerable it is and how efficient it really is in improving phosphorus in hemo[dialysis] patients going forward.
And then the third agent is a phosphate binder of the lanthanum type. So, we already have lanthanum carbonate. It’s a pretty potent drug. [There are] a lot of problems with the GI side effects, and the pills are extremely hard and have to be chewed thoroughly or crushed in order to be effective. Another company called Unicycive has developed lanthanum dioxycarbonate. And this is a pill, but it's much more potent and doesn't need to be chewed up to be activated. It's kind of microparticles. And at least in preliminary studies, it looks like it's probably about 40% more potent than our most potent binder right now, which is Velphoro (sucroferric oxyhydroxide, Fresenius Medical Care North America). And conceivably, this would lead to 70% to 80% of patients could literally take just one pill with each meal and have adequate phosphorus control, at least less than 5.5 mg/dL. And that's kind of exciting. I think we need more potent phosphate binders.
Whalatane
2 weeks ago
Cosa. There may be a high stakes negotiating game going on here .
ARDX is charging a premium for dialysis patients vs what they charge per gm for their IBCS ( Ibresla ) patients. ....its the same drug Tenapanor ...just different strengths .
The wholesale acquisition cost (WAC) for Ibsrela (tenapanor) is approximately $1,890 for a supply of 60 tablets,
If Xphazoh was priced the same way as Ibresla it would be closer to $2,200 a mth ( not $3,000 a mth ) ...rough calcs
With the launch of Reaptha a PCSK9 CV drug , AMGN wanted close to $14,000 a yr and ran into stiff payor resistance .....finally after 2 yrs they agreed to around $5,000-$6,000 a yr and scripts took off .
Kiwi
Whalatane
3 weeks ago
Minority groups that want Oral pho binders ( Xphazoh ) to remain outside of the dialysis bundle
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
3 weeks ago
If the Kidney Patient Act pass's it benefits the dialysis patients , the companies that make Oral pho binders ( ARDX and UNCY ) and means less stress on the dialysis providers since they don't have to manage securing , storing , dispensing the Oral pho binders.
Politically ... theres a hint of racism here since the majority on dialysis are people of color on Medicare . If Oral pho binders go into the bundle, these patients are likely to be pushed towards the available cheaper generics since the dialysis providers get to keep what ever they save .....between what the govt pays them per dialysis and what they spend per dialysis .
The private dialysis providers financial incentive is to not prescribe the new Oral pho binders ....even tho their patients may do better on them .
Minority groups ( as in black and latino ) are advocating for these new oral pho binders to remain out of the dialysis bundle for at least 2 yrs so that MD's at the private dialysis providers will be free to prescribe as necessary
When freely prescribed , Medicare is billed directly .
Xphazoh is around $3,000 a month .
Medicare will pay about 75 % of that ie $2,250 ...a month
The patients co pay is $750 a month which most of these patients can not afford ...so ARDX will offer coupons so the patient pays little
ARDX makes their $ from the Medicare payment ( $2,250 ) .
Medicare will feel they are being overcharged if X stays outside the bundle ...and ARDX maintains X won't be prescribed if its inside the bundle .
Is there potential for a compromise ...ala Repatha ( AMGN ) ...time will tell
Kiwi
Whalatane
3 weeks ago
The dialysis bundle explained and its relevance to ARDX and UNCY
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
Whalatane
1 month ago
From X $ARDX Raymond James Note to clients
W e remain STRONG BUY RATED on ARDX and our reducing price target $1 to $15 after today’s announcement they would not be applying to include Xphozah in CMS’ ESRD- PPS TDAPA
What does this mean- Our assumption is that Medicare patients will lose Xphozah coverage indefinitely starting January 2025 unless a development such as the signing law of the Kidney Patient act occurs in the interim -(this is reflected in our model)
While there is much debate amongst investors regarding weather, skipping out on the TDAPA . 1) avoid faster erosion of commercial access to Xphozah (ARDX’s take), or 2) needlessly forfeit potentially two years of Medicare patient revenues (Street’s prevailing take), one thing is clear: there’s already no path to Medicare patient coverage for Xphozah after 2027 outside of legislation or some similar development.
We also point out that ARDX dropped 30% to $5.28 in Tuesday session, which is at a deep discount to our $15 PT and equivalent to ~2X 5-year (2029) consensus Ibsrela net sales (VA, n=3), providing an opportunity to buy the weakness, particularly for investors who think Ibsrela sales could eventually approach or even achieve blockbuster peak sales (we use $748M US Peak sales in our model)
Model Impact - The only changes to our model are inclusion of 50% Kidney Patient Act PoS adjustment to 2025 and 2026 Medicare sales (estimated at 63% of the total US HP market; ARDX estimates to be less conservative at 55%) and removing Medicare sales from 2027 and 2028 (they are already removed from 2029 to 2035). As a result of these changes our price target drops $1 to $15.
Kiwi
Whalatane
1 month ago
Cosa ...along the lines of your argument
Kidney Care Partners Applauds Senate Introduction of Bipartisan Kidney PATIENT Act
June 12, 2024
Delay Will Ensure Continued Access to Innovative Treatments for Individuals Living with Kidney Failure
WASHINGTON – Kidney Care Partners (KCP) – the nation’s leading kidney care multi-stakeholder coalition representing patient advocates, physician organizations, health professional groups, dialysis providers, researchers, and manufacturers – today commends Sens. Ben Ray Luján (D-NM) and Marsha Blackburn (R-TN) for introducing the Kidney Patient Access to Technologically Innovative and Essential Nephrology Treatments (PATIENT) Act (S. 4510), which would delay for two years the inclusion of oral phosphate-binding medication into the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). The Ways & Means and Energy & Commerce Committees have already passed a similar measure in the U.S. House of Representatives.
Oral phosphate-binding medications are necessary to treat hyperphosphatemia, a condition that occurs in nearly all individuals who receive dialysis treatments. If not treated, hyperphosphatemia can increase mortality, vascular calcification, and cardiovascular events
. Currently, patients can access these drugs at their local pharmacy, but as of January 1, 2025, a new policy change from the Centers for Medicare & Medicaid Services (CMS) will instead require dialysis providers to distribute these medications.
KCP is concerned this policy may negatively impact patient access to care, as many dialysis providers lack sufficient infrastructure needed to dispense and administer these drugs.
“We thank Senators Luján and Blackburn for introducing this bill to ensure continued patient access to these vital medications. Without action, CMS’ policy creates yet another challenge for the kidney community to face. Already limited access to innovative treatments and inadequate reimbursement levels are impacting kidney care,” said Colin Roskey, Executive Director of KCP. “To maintain quality, accessible treatment for individuals living with end-stage renal disease, we urge lawmakers to advance this bill without delay.”
I wonder why CMS wants the dialysis providers to manage / store / dispense these oral meds .
Dialysis units usually just want to deal with what they need for the dialysis process ......all additional drugs the patient outside of their point of care ( ie while in the dialysis clinic ) takes is thru the pharmacy
Kiwi
Whalatane
1 month ago
How do dialysis providers save money in the dialysis bundle
Dialysis providers employ several strategies to save money within the bundled payment system for dialysis services:
Reducing use of expensive medications:. my emphasis ...why ARDX wants to delay the TDAPA process and get the Kidney Care act passed .
Providers may decrease the use of costly drugs like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D, substituting them with less expensive alternatives when possible.
Optimizing drug dosing: Facilities carefully manage medication dosing to avoid waste and
unnecessary use while still meeting clinical needs.
Substituting with generics: Where available, providers may switch to generic versions of medications to reduce costs.
Limiting ancillary services: Non-essential services or those not directly related to dialysis may be reduced or eliminated from the bundle.
Shortening treatment times: Some facilities may attempt to reduce dialysis session durations to save on operational costs, though this can be controversial due to potential impacts on quality of care.
Reducing staffing: Facilities may try to operate with minimal staffing levels to cut labor costs.
Shifting care settings: When possible, providers may move certain services to outpatient or home settings which can be less expensive than in-center care.
Improving efficiency: Streamlining processes and optimizing resource utilization can help reduce overall costs.
Careful patient selection: Some facilities may try to select less complex patients who require fewer resources, though this practice is discouraged.
Volume management: Providers may aim to treat a higher volume of patients to spread fixed costs over more treatments.
While these cost-saving measures can improve efficiency, there are concerns that excessive focus on cost reduction could negatively impact quality of care. To counteract this, quality assessment programs and incentive payments have been implemented in some health systems to ensure that cost savings do not come at the expense of patient outcomes.
It's important to note that while these strategies can save money for providers, they must be balanced against maintaining high-quality care and meeting regulatory requirements. Policymakers and healthcare systems continue to work on refining payment models to align financial incentives with optimal patient care.
What are the main cost-saving strategies dialysis providers use within the bundle system
Sources
dialysispatients.org favicon
ncbi.nlm.nih favicon
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Answer
Based on the search results, dialysis providers employ several key strategies to save costs within the bundled payment system:
Reducing use of expensive medications: Providers may decrease the use of costly drugs like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D, substituting them with less expensive alternatives when possible.
Optimizing drug dosing: Facilities carefully manage medication dosing to avoid waste and unnecessary use while still meeting clinical needs.
Shifting care settings: When possible, providers may move certain services to outpatient or home settings which can be less expensive than in-center care.
Shortening treatment times: Some facilities may attempt to reduce dialysis session durations to save on operational costs, though this can be controversial due to potential impacts on quality of care.
Limiting ancillary services: Non-essential services or those not directly related to dialysis may be reduced or eliminated from the bundle.
Implementing fail-first protocols: Some centers require patients to try less expensive treatments first before accessing more costly options, like requiring oral generic drugs before intravenous calcimimetics.
Careful patient selection: Some facilities may try to select less complex patients who require fewer resources, though this practice is discouraged and partially addressed through risk adjustment in the payment system.
Shifting costs outside the bundle: Providers may attempt to move certain services or prescriptions to non-dialysis visits to avoid incurring costs within the bundled payment.
It's important to note that while these strategies can save money for providers, there are concerns that excessive focus on cost reduction could negatively impact quality of care. To counteract this, quality assessment programs and incentive payments have been implemented in some health systems to ensure that cost savings do not come at the expense of patient outcomes.
What are the challenges dialysis providers face when implementing the bundle system
Sources
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ncbi.nlm.nih favicon
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Answer
Dialysis providers face several key challenges when implementing the bundled payment system:
Balancing cost reduction with quality care: Providers must find ways to reduce costs while still maintaining or improving patient outcomes and quality of care. This requires careful management of resources and treatment protocols.
Medication management: The bundle includes previously separately billable medications like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D. Providers need to optimize drug dosing and usage to control costs without compromising patient health.
Adapting to fixed payments: With a set reimbursement rate, providers must carefully manage all aspects of care within the bundle, including medications, laboratory tests, and other dialysis-related services.
Risk of patient selection: While partially addressed through risk adjustment, there's still potential for providers to favor healthier, less complex patients who require fewer resources.
Limited flexibility for complex cases: The bundle may not adequately account for patients with multiple comorbidities or those requiring more intensive care, potentially penalizing providers who treat more complex cases.
Rapid adaptation to treatment changes: As new technologies or treatment methods emerge, providers must quickly adjust their practices within the constraints of the bundle.
Managing outliers: Providers need to develop strategies to address patients who fall outside typical treatment patterns or require additional resources.
Financial risk management: Smaller providers or independent facilities may face challenges in managing financial risks due to their limited ability to pool risks compared to larger organizations.
Aligning incentives with value-based care: While the bundle aims to control costs, providers must also focus on improving overall patient outcomes and moving towards value-based care models.
Potential for undertreatment: There's a risk that the fixed payment structure could incentivize providers to undertreat patients or limit access to necessary but costly treatments.
These challenges require dialysis providers to carefully balance financial considerations with patient care, optimize resource utilization, and continually refine their clinical and operational practices to succeed within the bundled payment system.
What are the biggest obstacles in managing medication costs under the bundle system
Sources
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Answer
Based on the search results, the biggest obstacles dialysis providers face in managing medication costs under the bundle system include:
Balancing cost reduction with quality care: Providers must find ways to reduce medication costs while still maintaining or improving patient outcomes and quality of care.
Optimizing drug dosing and usage: With medications like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D now included in the bundle, providers need to carefully manage dosing to control costs without compromising patient health.
Adapting to fixed payments: The bundled system provides a set reimbursement rate, requiring providers to carefully manage all aspects of care, including medications, within the bundle constraints.
Managing complex cases: The bundle may not adequately account for patients with multiple comorbidities or those requiring more intensive care and medication regimens.
Rapid adaptation to treatment changes: As new medications or treatment methods emerge, providers must quickly adjust their practices within the constraints of the bundle.
Potential for undertreatment: There's a risk that the fixed payment structure could incentivize providers to undertreat patients or limit access to necessary but costly medications.
Shifting costs outside the bundle: Some providers may attempt to move certain services or prescriptions to non-dialysis visits to avoid incurring costs within the bundled payment, which can lead to fragmented care.
Managing multiple pharmacy sources: With the inclusion of dialysis-specific oral medications in the bundle, patients may receive prescriptions from multiple pharmacies, complicating medication management.
Limited flexibility: The bundle system may restrict providers' ability to use more expensive, potentially higher-quality treatment options or newer medications.
Implementing cost-effective medication management services: Providers need to develop efficient systems for medication reconciliation and therapy management within the constraints of the bundle, which can be challenging and resource-intensive.
These obstacles require dialysis providers to carefully balance financial considerations with patient care, optimize resource utilization, and continually refine their clinical and operational practices to succeed within the bundled payment system.
How does the bundle system affect the availability of medications for dialysis patients
Sources
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Answer
The bundled payment system for dialysis care has significantly impacted the availability and utilization of medications for dialysis patients in several ways:
Reduced use of expensive medications: Providers have decreased the use of costly drugs like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D to control costs, while still maintaining or improving patient outcomes.
Optimization of drug dosing: Facilities carefully manage medication dosing to avoid waste and unnecessary use while meeting clinical needs.
Substitution with generics: Where available, providers may switch to generic versions of medications to reduce costs.
Potential undertreatment: There is a risk that the fixed payment structure could incentivize providers to undertreat patients or limit access to necessary but costly treatments.
Challenges with new medications: The bundle system may restrict providers' ability to use more expensive, potentially higher-quality treatment options or newer medications. For example, the anti-itching drug difelikefalin faced uncertainty about long-term funding, discouraging nephrologists from prescribing it, resulting in fewer than 1% of dialysis patients receiving it.
Expansion of home dialysis: Following the introduction of bundling, there was a slight uptick in patients starting renal-replacement therapy on home dialysis, especially peritoneal dialysis (PD), as providers sought more cost-effective options.
Increased focus on value-based care: The bundle has encouraged dialysis providers to focus on how they can achieve the best patient outcomes while restraining costs, leading to a greater emphasis on value-based care models.
In summary, while the bundle system aims to control costs, it has also created challenges in ensuring dialysis patients have access to necessary medications, particularly newer or more expensive treatments. Providers must carefully balance cost-saving measures with maintaining high-quality care and meeting patients' needs.
AI generated
Kiwi
Whalatane
1 month ago
How does the TDAPA process limit use of a new drug
The Transitional Drug Add-on Payment Adjustment (TDAPA) process does not directly limit the use of new drugs, but it does impact how new drugs are paid for under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). Here are the key points about how TDAPA works:
TDAPA provides a temporary payment adjustment for certain new renal dialysis drugs and biological products for a limited time period.
For drugs that fall into an existing ESRD PPS functional category, TDAPA is paid for 2 years.
For drugs that do not fall into an existing functional category, TDAPA is paid for at least 2 years until sufficient claims data is available for rate setting analysis.
During the TDAPA period, the new drug is paid at 100% of its Average Sales Price (ASP). If ASP is unavailable, payment is based on Wholesale Acquisition Cost (WAC) or manufacturer's invoice.
After the TDAPA period ends, the drug is incorporated into the ESRD PPS bundled payment.
For drugs in existing functional categories, the bundled payment rate is not automatically adjusted after TDAPA ends to reflect the new drug's costs.
TDAPA is not available for certain generic drugs and drugs approved under specific FDA application types.
While TDAPA does not directly restrict drug use, the payment structure may indirectly impact utilization:
The temporary nature of the add-on payment could influence facilities' decisions about adopting new, potentially more expensive therapies.
Once TDAPA ends and the drug is incorporated into the bundle without a rate adjustment, facilities may have financial incentives to limit use of costlier new drugs.....my emphasis
The exclusion of certain drug types from TDAPA eligibility may affect their uptake in ESRD care.
Overall, TDAPA aims to balance supporting innovation and access to new therapies with maintaining the bundled payment structure of the ESRD PPS.
The time-limited nature of the adjustment and the eventual incorporation into the bundle without guaranteed rate increases could indirectly influence drug utilization patterns.
AI generated from Gov and legal sources .
Once a drug is in the dialysis bundle theres pressure on prescribers to use less expensive generic drugs whenever possible as any savings is kept by the dialysis provider .
If the Kidney Care act is passed and Xphazoh stays out of the bundle for 2 yrs ...then another 2 yrs from the Tdapa process ...they have 4 yrs without MD's facing pressure to prescribe less expensive drugs ...just my take
Kiwi
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