To Preserve Patient Access to XPHOZAH®, Ardelyx Chooses Not to File for TDAPA
Ardelyx has decided not to apply for the CMS TDAPA for its phosphate absorption inhibitor, XPHOZAH (tenapanor), to maintain patient access. The company supports bipartisan legislation that aims to extend the exclusion of oral-only medications from the CMS Prospective Payment System. This decision follows Ardelyx's analysis of the CMS policy, determining that including XPHOZAH in the Medicare PPS would significantly restrict its usage and hinder patient access. XPHOZAH, approved by the FDA in October 2023, is the only therapy for patients with inadequate response to phosphate binders, offering a unique mechanism to reduce serum phosphorus in CKD patients on dialysis. A conference call is scheduled for July 2, 2024, at 8:00 AM ET to discuss the announcement.
- XPHOZAH is the only approved therapy for patients with inadequate response to phosphate binders.
- XPHOZAH offers a first-in-class mechanism of action to reduce serum phosphorus.
- The decision supports bipartisan legislation to extend the exclusion of oral-only medications from CMS PPS.
- Including XPHOZAH in the Medicare PPS could significantly restrict its usage and hinder patient access.
- The CMS policy might interfere with the shared decision-making between healthcare professionals and patients.
Ardelyx's decision to forego applying for TDAPA status for XPHOZAH® is significant for investors and stakeholders, given its direct impact on patient access to the drug. TDAPA is a temporary add-on payment adjustment that can influence the reimbursement landscape for new therapies under Medicare. By not pursuing TDAPA, Ardelyx appears to be taking a stance that the CMS implementation could restrict access rather than enhance it.
One critical aspect to understand here is the complexity of the CMS Prospective Payment System (PPS). Inclusion under PPS often leads to bundled payments, where reimbursement for a drug is part of an overall payment for patient care, rather than a separate item. This can sometimes result in reduced financial incentives for healthcare providers to prescribe the medication.
Moreover, the reference to bipartisan legislation underscores the ongoing policy debate about the inclusiveness of oral-only medications under Medicare. If this legislation passes, it could create a more favorable reimbursement environment for XPHOZAH, preserving its market position and accessibility without the constraints of TDAPA.
In the short term, the decision might seem to limit immediate revenue opportunities tied to Medicare reimbursements. However, in the long-term, it could help maintain patient and provider support, which is critical for the drug's sustained market presence. Investors should watch for any legislative progress and potential changes in CMS policies that could alter the reimbursement landscape.
The decision to not pursue TDAPA status for XPHOZAH® has meaningful implications for Ardelyx's market positioning and competitive dynamics within the ESRD treatment space. XPHOZAH is touted as the only therapy for patients inadequately responding to phosphate binders, a significant market segment. By focusing on preserving patient access, Ardelyx is safeguarding its unique value proposition against potential reimbursement challenges.
Understanding the nuances of the ESRD market is crucial. Around
Investors should also note the potential ripple effects of bipartisan legislation on the broader market. If Congress extends the exclusion of oral-only medications from PPS, it could establish a precedent that benefits other similar therapies, fostering an environment where innovative drugs can thrive without restrictive reimbursement policies. This legislative context is vital for understanding the broader market dynamics and Ardelyx's strategic positioning.
Keeping an eye on market reactions, patient uptake data and legislative developments will provide deeper insights into the long-term impact of this decision on Ardelyx's market share and revenue trajectory.
Ardelyx continues support for bipartisan legislation that would extend the exclusion of oral-only medications from entering the CMS Prospective Payment System
Conference call scheduled for 8:00 AM Eastern Time
WALTHAM, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that, in an effort to preserve patient access to its phosphate absorption inhibitor XPHOZAH® (tenapanor), the Company has chosen not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services (CMS) End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Transitional Drug Add-on Payment Adjustment (TDAPA).
Ardelyx’s analysis of the CMS policy to include oral-only medicines in the PPS and the Calendar Year 2025 ESRD PPS Proposed Rule released on June 27, 2024, revealed that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH for all patients, irrespective of insurance coverage, because it interferes with the essential and appropriate shared decision-making between healthcare professionals and their patients.
“At Ardelyx, we recognize that the only way innovative medicines like XPHOZAH can deliver their proven benefits to patients is by ensuring that those prescribed our medicines have access to them. XPHOZAH is the only therapy approved for patients who have an inadequate response to phosphate binder therapy and during the eight months it has been utilized in clinical practice, it is clear that patients are benefitting from and need continued access to this therapeutic option to reduce elevated serum phosphorus,” said Mike Raab, president and CEO of Ardelyx. “We have carefully and thoughtfully considered the potential impact of CMS’s decision to add XPHOZAH into the Medicare PPS and have determined that even during the TDAPA period, the restrictions placed on XPHOZAH would be such that patient access to this novel therapy would be effectively eliminated for all patients. We believe that the proposed bipartisan legislation extending the exclusion of oral-only medications from the Medicare ESRD PPS is the best option to ensure continued patient access, and we call on Congress to pass the bill. Our decision not to apply for TDAPA reflects our steadfast commitment to preserving patients’ access to our medicines and provides the best optionality for us to continue to explore alternatives to protect all patients.”
XPHOZAH was approved by the U.S. Food and Drug Administration in October 2023 to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. Eighty percent of patients with CKD on dialysis require prescription therapy to lower elevated levels of serum phosphorus. Phosphate binders are not sufficient for a majority of patients to achieve and maintain phosphorus levels within target range. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
Conference Call Details
The company will host a conference call today, July 2, 2024, at 8:00 am ET to discuss today's announcement. To participate in the conference call, please dial (844) 481-2838 (domestic) or (412) 317-1858 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, https://ardelyx.com/, and will be available on the website for 30 days following the call.
About XPHOZAH® (tenapanor)
XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full Prescribing Information.
About Hyperphosphatemia
Hyperphosphatemia is a serious condition, defined as resulting in elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL).
IMPORTANT SAFETY INFORMATION (XPHOZAH)
CONTRAINDICATIONS
XPHOZAH is contraindicated in:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONS
Diarrhea
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONS
Diarrhea, which occurred in 43
INDICATION
XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
For additional safety information, please see full Prescribing Information.
About Ardelyx
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the impact of the TDAPA period and the ESRD PPS policy on access to XPHOZAH and our current belief that not applying for TDAPA provides the best optionality to explore options to provide access to all patients. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 2, 2024, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Investor and Media Contacts:
Caitlin Lowie
clowie@ardelyx.com
FAQ
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