WHA

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)

  • Guideline ID
    GL-150949

  • Formulary
    premium

  • Effective date
    Oct 1, 2024

  • P&T approval date
    Sep 18, 2024

P & T Revisions

2024-09-06

  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.
  1. Efficacy in each study was based on the difference in mean change of Hb from baseline to the primary evaluation period (Weeks 24 to 36). [1]
  2. In both the INNO2VATE-1 and INNO2VATE-2 trials, Vafseo was non-inferior to darbepoetin alfa in correcting and maintaining Hb levels. Recommended Starting Dose of Vafseo: Adults Not Being Treated with an ESA: The recommended starting dose is 300 mg orally once daily. Adults Being Switched from an ESA: When converting from an ESA to Vafseo, the recommended starting dose is 300 mg orally once daily. [1]
  3. If the Hb level exceeds 11 g/dL, interrupt the dose of Vafseo until Hb is less than or equal to 11 g/dL then resume with a dose that is 150 mg less than the dose prior to interruption. [1]
  4. Evaluate iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of therapy. [1]
  • 2024-09-06: New UM PA Program