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Vafseo is approved for the TDAPA effective January 1, 2025. Learn more

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Vafseo is approved for the TDAPA effective January 1, 2025

The Centers for Medicare & Medicaid Services (CMS) approved Vafseo for the Transitional Drug Add-on Payment Adjustment (TDAPA) under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS).

About the TDAPA

Under the TDAPA, CMS adjusts the bundled payment to providers for dialysis services by adding an amount for the cost of certain new renal dialysis drugs and biological products used in dialysis services
The TDAPA adjustment applies for patients covered under the Medicare ESRD PPS and continues for 2 years until December 31, 2026
The TDAPA helps dialysis organizations integrate innovative therapies into their treatment protocols to allow adoption of these products

Post-TDAPA, Akebia is committed to competitive pricing to ensure access to Vafseo for patients in need.

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Frequently asked questions

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What is Vafseo?

Vafseo is a hypoxia-inducible factor prolyl hydroxylase inhibitor, also known as a HIF-PHI, given once-daily by mouth, for adults with anemia due to CKD who have been receiving dialysis for at least 3 months.¹

Learn more about the Efficacy & Safety of Vafseo >

What is the mechanism of action (MOA) of Vafseo? OR How does Vafseo work?

Vafseo is a hypoxia-inducible factor prolyl hydroxylase inhibitor, also known as a HIF-PHI, that works with the body’s natural response to hypoxia to increase endogenous erythropoietin (EPO) production.^1-4

Learn more about the Vafseo MOA >

Are there any contraindications for Vafseo?

Vafseo is contraindicated in patients with known hypersensitivity to Vafseo or any of its components, and in patients with uncontrolled hypertension.¹

Review the Full Prescribing Information for Vafseo >

What is the boxed warning for Vafseo?

Vafseo has a boxed warning for increased risk of death, myocardial infarction (MI), venous thromboembolism, and thrombosis of vascular access.¹

Review the Full Prescribing Information and the full BOXED WARNING for Vafseo >

How often should Hemoglobin (Hb) be monitored with Vafseo?

Hemoglobin should be monitored every 2 weeks upon initiation of Vafseo and after each dose adjustment until stable, then at least monthly.¹

Learn more about Vafseo dosing >

Can I use Vafseo in my patients who are also taking statins?

Vafseo increases the exposure of certain statins, such as simvastatin and rosuvastatin, when co-administered. If Vafseo is prescribed for a patient who is currently taking a statin: The starting dose of simvastatin should be 5 mg/day and the maximum daily dose should not exceed 20 mg/day. The maximum daily dose of rosuvastatin is not recommended to exceed 5 mg.¹

Learn more about DDIs with Vafseo >

It looks like Hb drops in the initial weeks when transitioning patients on ESAs to Vafseo. Why does this happen?

In the Prevalent Dialysis Trial, the data show an initial transient decrease in mean Hb in the Vafseo arm during the correction/conversion phase. All patients were started on a standardized dose of 300 mg once daily, regardless of prior ESA dosage. In the trial, investigators could only titrate up every 4 weeks and in increments of 150 mg.^1,5,6

Approximately 35% of patients experienced a decrease in Hb levels of 0.5 g/dL or more at week 4 in the Prevalent Dialysis Trial* - especially in those previously maintained on high doses of ESAs (≥300 U/kg/week of IV epoetin equivalent unit).^5,6,†

The mean Hb for the study population began to rise by week 8.^4,^†

By week 12, more than half of patients were taking 450 mg or 600 mg.^6,^†^,‡

It’s important to anticipate a potential dip, which may serve as an opportunity to review dosing and titration, consistent with the Vafseo Prescribing Information.

*Based on descriptive analysis.^5,6

^†Based on a descriptive, subgroup analysis and should be interpreted with caution. Explore this analysis in more detail⁶ >

^‡Excludes patients on 0 mg of Vafseo (eg, dose interrupted due to AE, ESA rescue, elevated Hb) from analysis.⁶

ESA=erythropoiesis-stimulating agent; Hb=hemoglobin; IV=intravenous.

Learn more about the Clinical Trials >

How do I know if Vafseo is covered for my patients?

Vafseo has been approved for the TDAPA January 1, 2025.

Akebia Therapeutics Inc. does not guarantee payment or coverage for any product or service. The provider should contact patients’ payers directly for any revised or additional requirements, information, or guidance. It is always the provider’s responsibility to determine the appropriate healthcare setting and to submit true and correct claims for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.

Learn about access information by visiting AkebiaCares.com >

Can I use Vafseo with erythropoietin stimulating agents (ESAs)?

Vafseo is not approved for use in combination with ESAs. No clinical trials have investigated the efficacy or safety of combining Vafseo with ESAs.^1,4

Review the Full Prescribing Information for Vafseo >

EPO=erythropoietin; ESA=erythropoiesis-stimulating agent; Hb=hemoglobin; HIF-PHI=hypoxia-inducible factor prolyl hydroxylase inhibitor.

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IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets

IMPORTANT SAFETY INFORMATION AND INDICATION

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. A pregnancy exposure registry is available to monitor outcomes in women exposed to VAFSEO during pregnancy. Report pregnancies to 1-844-445-3799.
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.

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.

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

References: 1. Vafseo^® [Package Insert]. Cambridge, MA: Akebia Therapeutics, Inc. 2. Akebia receives FDA approval of Vafseo^® (vadadustat) tablets for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. News release. Akebia Therapeutics, Inc; March 27, 2024. Accessed February 5, 2025. https://ir.akebia.com/news-releases/news-release-details/akebia-receives-fda-approval-vafseor-vadadustat-tablets 3. Gupta N, Wish JB. Hypoxia-inducible factor prolyl hydroxylase inhibitors: a potential new treatment for anemia in patients with CKD. Am J Kidney Dis. 2017;69(6):815-826. doi:10.1053/j.ajkd.2016.12.011 4. Eckardt KU, Agarwal R, Aswad A, et al. Safety and efficacy of vadadustat for anemia in patients undergoing dialysis. N Engl J Med. 2021;384(17):1601-1612. doi:10.1056/NEJMoa2025956 5. Data on file. Akebia Therapeutics, Inc. 6. Chertow GM, Jardine A, Burke S, et al. Safety and efficacy of vadadustat versus darbepoetin alfa in patients with CKD-related anemia on maintenance dialysis by prespecified subgroups of baseline ESA dose. Poster presented at: European Renal Association (ERA) Congress; May 23-26, 2024.