Pharmacy Prior Authorization Criteria

Vafseo (vadadustat) - PA, NF

Indications for Prior Authorization

Vafseo (vadadustat)

• For diagnosis of Anemia Due to Chronic Kidney Disease
  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:Not been shown to improve quality of life, fatigue, or patient well-being. Not indicated for use as a substitute for transfusion in patients requiring immediate correction of anemia or in patients with anemia due to CKD not on dialysis.

Criteria

Vafseo

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A, 1]

• Diagnosis of chronic kidney disease (CKD)
AND
• Patient has been on dialysis for at least 3 months
AND
• Adequate iron stores confirmed by both of the following: [D, 1]
• Patient's ferritin level is greater than 100mcg/L
• Patient's transferrin saturation (TSAT) is greater than 20%
AND
• Hemoglobin level less than 11 g/dL
AND
• Trial and failure, contraindication or intolerance to one of the following: [B, 1]
• Retacrit
• Procrit
• Aranesp
AND
• Prescribed by or in consultation with one of the following:
• hematologist
• nephrologist
AND
• Patient is not on concurrent treatment with an erythropoeitin stimulating agent [ESA] (e.g., Aranesp, Epogen, Procrit)

Vafseo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., increase in hemoglobin)
AND
• Hemoglobin level does not exceed 11g/dL [C, 1]
AND
• Adequate iron stores confirmed by both of the following:
• Patient's ferritin level is greater than 100mcg/L
• Patient's transferrin saturation (TSAT) is greater than 20%
AND
• Trial and failure, contraindication or intolerance to one of the following:
• Retacrit
• Procrit
• Aranesp
AND
• Patient is not on concurrent treatment with an erythropoeitin stimulating agent [ESA] (e.g., Aranesp, Epogen, Procrit)

Vafseo

Non Formulary (Initial Authorization)

Length of Approval: 6 Months [A, 1]

• Diagnosis of chronic kidney disease (CKD)
AND
• Submission of medical records (e.g., chart notes) confirming patient has been on dialysis for at least 3 months
AND
• Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following: [D, 1]
• Patient's ferritin level is greater than 100mcg/L
• Patient's transferrin saturation (TSAT) is greater than 20%
AND
• Submission of medical records (e.g., chart notes) confirming hemoglobin level less than 11 g/dL
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming a minimum 12 -week trial and failure, to one of the following: [B, 1]
• Retacrit
• Procrit
• Aranesp
OR
• Submission of medical records (e.g., chart notes) confirming contraindication or intolerance to ALL of the following:
• Retacrit
• Procrit
• Aranesp
AND
• Prescribed by or in consultation with one of the following:
• hematologist
• nephrologist
AND
• Patient is not on concurrent treatment with an erythropoeitin stimulating agent [ESA] (e.g., Aranesp, Epogen, Procrit)

Vafseo

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., increase in hemoglobin)
AND
• Submission of medical records (e.g., chart notes) confirming hemoglobin level does not exceed 11g/dL [C, 1]
AND
• Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following:
• Patient's ferritin level is greater than 100mcg/L
• Patient's transferrin saturation (TSAT) is greater than 20%
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming a minimum 12 -week trial and failure, to one of the following:
• Retacrit
• Procrit
• Aranesp
OR
• Submission of medical records (e.g., chart notes) confirming contraindication or intolerance to ALL of the following:
• Retacrit
• Procrit
• Aranesp
AND
• Patient is not on concurrent treatment with an erythropoeitin stimulating agent [ESA] (e.g., Aranesp, Epogen, Procrit)

P & T Revisions

2024-09-06

References

1. Vafseo Prescribing Information. Akebia Therapeutics, Inc. Cambridge, MA. March 2024.
2. ClinicalTrials.gov. Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD) [NCT02865850]. Available at: https://www.clinicaltrials.gov/study/NCT02865850?cond=NCT02865850&rank=1#participation-criteria. Accessed August 5, 2024.
3. ClinicalTrials.gov. Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD). Available at : https://www.clinicaltrials.gov/study/NCT02892149?cond=NCT02892149&rank=1#participation-criteria. Accessed August 5, 2024.
4. Executive Summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: Known Knowns AND Known Unknowns. Available at : https://kdigo.org/wp-content/uploads/2017/02/KDIGO-2024-CKD-Guideline-Executive-Summary.pdf. Accessed August 5, 2024.
5. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Available at: https://kdigo.org/wp-content/uploads/2016/10/KDIGO-2012-Anemia-Guideline-English.pdf. Accessed August 5, 2024.

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Revision History

• 2024-09-06: New UM PA Program

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