CMS Grants TDAPA Reimbursement for Vafseo® (vadadustat) beginning January 1, 2025

Rhea-AI Summary

Akebia Therapeutics (Nasdaq: AKBA) announced that the Center for Medicare & Medicaid Services (CMS) has granted Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement for Vafseo® (vadadustat) starting January 1, 2025. This provides two years of additional reimbursement to dialysis organizations beyond the ESRD bundled rate. Vafseo, approved by the FDA in March 2024 for treating anemia in adults with chronic kidney disease on dialysis for at least three months, is expected to be available in January 2025.

CMS has also assigned a Level II Healthcare Common Procedure Coding System (HCPCS) code to Vafseo to facilitate billing. Akebia's Chief Commercial Officer, Nicholas Grund, highlighted the importance of TDAPA in supporting innovation and new treatments in dialysis practices. The company is actively engaging with dialysis organizations for contracting and plans to interact with healthcare providers at the upcoming American Society of Nephrology conference to drive interest in Vafseo.

Positive

• Vafseo granted TDAPA reimbursement status by CMS, providing additional financial support for dialysis organizations
• HCPCS code assigned to Vafseo, facilitating billing for dialysis organizations
• FDA approval of Vafseo for anemia treatment in chronic kidney disease patients on dialysis
• Active engagement with dialysis organizations for contracting process

Negative

• TDAPA reimbursement to two years, potentially affecting long-term financial outlook
• Vafseo's market availability delayed until January 2025, despite earlier FDA approval

Insights

Pharmaceutical Industry Analyst

The CMS granting TDAPA reimbursement for Vafseo is a significant positive development for Akebia Therapeutics. This decision provides a important two-year window of additional reimbursement, which should facilitate adoption of Vafseo by dialysis centers. The HCPCS code assignment further streamlines the billing process, reducing barriers to use.

From a market perspective, this reimbursement pathway significantly de-risks the commercial launch of Vafseo. It provides financial incentives for dialysis centers to incorporate the drug into their treatment protocols, potentially accelerating market penetration. The timing aligns well with Vafseo's expected market availability in January 2025.

However, investors should note that the long-term success of Vafseo will depend on its clinical performance and cost-effectiveness after the TDAPA period ends. The company's ongoing engagement with dialysis organizations and healthcare providers will be important for building sustained demand beyond the initial two-year reimbursement window.

Healthcare Policy Expert

The TDAPA designation for Vafseo represents a strategic alignment with CMS's goal of promoting innovation in ESRD treatment. This policy mechanism is designed to bridge the gap between drug approval and integration into the ESRD bundled payment system, providing a financial cushion for both manufacturers and providers.

For Akebia, this decision mitigates short-term reimbursement risks and allows time to demonstrate Vafseo's value proposition. However, it's important to recognize that TDAPA is a transitional measure. The company must use this period to generate real-world evidence of Vafseo's clinical and economic benefits to secure its long-term position in the market.

The broader implication is that this decision reinforces the effectiveness of TDAPA as a policy tool to encourage innovation in the ESRD space, potentially influencing future drug development strategies in this therapeutic area.

Designed to help dialysis organizations incorporate new treatments into their practices, TDAPA provides two years of reimbursement in addition to the ESRD bundled rate

A HCPCS code has also been assigned to Vafseo to facilitate reimbursement at dialysis organizations

CAMBRIDGE, Mass., Oct. 10, 2024 /PRNewswire/ -- Akebia Therapeutics^®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that Vafseo^® (vadadustat) meets the criteria for the Transitional Drug Add-On Payment Adjustment (TDAPA) in the anemia management end-stage renal disease (ESRD) prospective payment system functional category, beginning on January 1, 2025. In March 2024, Vafseo was approved by the U.S. Food and Drug Administration for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months, and the product is expected to be available in the market in January 2025. The TDAPA program provides two years of reimbursement for Vafseo in addition to the ESRD bundled rate to dialysis organizations.

Additionally, Akebia received a Level II Healthcare Common Procedure Coding System (HCPCS) code for Vafseo which will be used for billing for the product by dialysis organizations for Medicare enrollees. Within the next several weeks, CMS is expected to issue a Medicare Claims Processing Change Request that will give further billing guidance to dialysis organizations to obtain the separate TDAPA payment for the next two years under Medicare.

"We recognize the important benefit of TDAPA to support dialysis organizations' efforts to bring innovation to patients and incorporate new treatments into their practices," said Nicholas Grund, Chief Commercial Officer of Akebia. "The TDAPA status granted by CMS and issuance of a billing code are the latest milestones marking progress in the Vafseo commercial launch. We continue to actively engage dialysis organizations on the contracting process to facilitate access to Vafseo and look forward to further interacting with nephrologists and healthcare providers at the upcoming American Society of Nephrology conference, as we continue to build interest in Vafseo with a goal to drive usage and demand."

About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

About Vafseo^® (vadadustat) Tablets
Vafseo^® (vadadustat) Tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.

INDICATION
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Limitations of Use

• VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.
• VAFSEO is not indicated for use:
  • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
  • In patients with anemia due to CKD not on dialysis.

IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets

WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS.

VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular  events (MACE).   Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and  arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels.   No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions.

CONTRAINDICATIONS

• Known hypersensitivity to VAFSEO or any of its components
• Uncontrolled hypertension

WARNINGS AND PRECAUTIONS

• Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access
  A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.
• Hepatotoxicity
  Hepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.
• Hypertension
  Worsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.
• Seizures
  Seizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.
• Gastrointestinal (GI) Erosion
  Gastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.
• Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis 
  The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.
• Malignancy
  VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.

ADVERSE REACTIONS

• The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.

DRUG INTERACTIONS

• Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.
• Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.
• BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.
• Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm.
• Lactation: Breastfeeding not recommended until two days after the final dose.
• Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.

Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.

Forward-Looking Statements
Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding:  Akebia's expectations as to the timing of the availability of Vafseo and the receipt and timing of the issuance by CMS of a Medicare Claims Processing Change Request that will give further billing guidance to dialysis organizations to obtain the separate TDAPA payment for the next two years under Medicare; Akebia's belief about the important benefit of TDAPA to support dialysis organizations' efforts to bring innovation to patients and incorporate new treatments into their practices; Akebia's progress in the Vafseo commercial launch, including that Akebia continues to actively engage dialysis organizations on the contracting process to facilitate access to Vafseo and further interact with nephrologists and healthcare providers at the American Society of Nephrology conference; and Akebia's plans to continue to build interest in Vafseo, including its goal to drive usage and demand. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: whether Vafseo will be commercially available when expected; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia^® and Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; the direct or indirect impact of the COVID-19 pandemic on the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

Akebia Therapeutics^® and Vafseo^® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.

Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com

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SOURCE Akebia Therapeutics, Inc.

FAQ

When will Vafseo (vadadustat) be eligible for TDAPA reimbursement?

Vafseo (vadadustat) will be eligible for TDAPA reimbursement beginning January 1, 2025.

What is the duration of TDAPA reimbursement for Vafseo?

The TDAPA program provides two years of reimbursement for Vafseo in addition to the ESRD bundled rate.

When was Vafseo approved by the FDA for anemia treatment in CKD patients?

Vafseo was approved by the U.S. Food and Drug Administration in March 2024 for the treatment of anemia due to chronic kidney disease in adults on dialysis for at least three months.

What is Akebia Therapeutics' stock symbol?

Akebia Therapeutics' stock symbol is AKBA, traded on the Nasdaq.