WHA

Jesduvroq (daprodustat) - PA, NF

Indications for Prior Authorization

Jesduvroq (daprodustat)
  • For diagnosis of Anemia Due to Chronic Kidney Disease
    Indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months.

Criteria

Jesduvroq

Prior Authorization (Initial Authorization)

Length of Approval: 6 months [D, 1]

  • Diagnosis of chronic kidney disease (CKD)
    • AND
  • Patient has been on dialysis for at least 4 months
    • AND
  • Adequate iron stores confirmed by both of the following: [A-B, 1, 4]
    • 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 [E-G, 1,3,9]
    • AND
  • Trial and failure, contraindication or intolerance to one 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)
Jesduvroq

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 12g/dL [H, 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)
Jesduvroq

Non Formulary (Initial Authorization)

Length of Approval: 6 months [D, 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 4 months
    • AND
  • Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following: [A-B, 1, 4]
    • 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 [E-G, 1,3,9]
    • 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: [I, 10-12]
      • 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)
Jesduvroq

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 12g/dL [H, 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: [I, 10-12]
      • 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-154477

  • Formulary
    premium

  • Effective date
    Dec 1, 2024

  • P&T approval date
    Nov 16, 2023

P & T Revisions

2024-09-05, 2024-03-05, 2023-11-20

  1. Jesduvroq Prescribing Information. GlaxoSmithKline. Durham, NC. February 2023.
  2. Singh, A., Carroll, K., et al. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2113379?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. Accessed October 16, 2023.
  3. Singh, A., Blackorby, A., et al. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Available at: https://academic.oup.com/ndt/article/37/5/960/6179323?login=true. Accessed October 16, 2023.
  4. ClinicalTrials.gov. Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D). Available at: https://www.clinicaltrials.gov/study/NCT02879305?term=NCT02879305&rank=1. Accessed October 16, 2023.
  5. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney inter., Suppl. 2012; 2: 279-335. Available at: https://kdigo.org/wp-content/uploads/2016/10/KDIGO-2012-Anemia-Guideline-English.pdf. Accessed October 16, 2023.
  6. Kliger, A., Foley, R., et al. KDOQI US Commentary on the 2012 KDIGO Clinical Practice Guideline for Anemia in CKD. Available at: https://www.ajkd.org/article/S0272-6386(13)00978-5/fulltext. Accessed October 16, 2023.
  7. UptoDate. Treatment of anemia in patients on dialysis. Available at: https://www.uptodate.com/contents/treatment-of-anemia-in-patients-on-dialysis?search=anemia%20in%20chronic%20kidney%20disease&source=search_result&selectedTitle=4~150&usage_type=default&display_rank=4#. Accessed Ocober 16, 2023.
  8. UptoDate. Diagnosis of iron deficiency in chronic kidney disease. Available at: https://www.uptodate.com/contents/diagnosis-of-iron-deficiency-in-chronic-kidney-disease?search=anemia%20in%20chronic%20kidney%20disease&topicRef=1953&source=see_link. Accessed October 16, 2023.
  9. FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-modified-dosing-recommendations-improve-safe-use-erythropoiesis. Accessed November 8, 2023.
  10. Retacrit Prescribing Information. Hospira, Inc. Lake Forest, IL. April 2023.
  11. Procrit Prescribing Information. Amgen Inc. Thousand Oaks, CA. July 2018.
  12. Aranesp Prescribing Information. Amgen Inc. Thousand Oaks, CA. January 2019.
  1. Evaluate the iron status in all patients before and during treatment with Jesduvroq. Administer supplemental iron therapy when serum ferritin is less than 100 ng/ml or when serum transferrin saturation is less than 20%. [1]
  2. Clinical Trials Exclusion criteria: Ferritin less than or equal to 100mcg/L and transferrin saturation (TSAT) less than or equal to 20% at screening [4]
  3. In this randomized, open-label, phase 3 trial, we assigned patients with CKD who were undergoing dialysis and who had a hemoglobin level of 8.0 to 11.5 g per deciliter to receive an oral HIF-PHI (daprodustat) or an injectable ESA (epoetin alfa if they were receiving hemodialysis or darbepoetin alfa if they were receiving peritoneal dialysis). [2]
  4. The efficacy and safety of Jesduvroq were evaluated as co-primary endpoints: the mean change in hemoglobin from baseline to the Evaluation Period (Weeks 28 to 52) [1]
  5. Ascend-D trial the target hemoglobin range was 10-11g/dL [3]
  6. Do not target a hemoglobin higher than 11 g/dL [1]
  7. Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular events and has not been shown to provide additional patient benefit [9]
  8. If hemoglobin exceeds 12 g/dL, interrupt treatment with Jesduvroq [1]
  9. Do not increase the dose more frequently than once every 4 weeks. For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. For patients who do not respond adequately over a 12-week escalation period, increasing the Retacrit dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Retacrit if responsiveness does not improve. [10-12]
  • 2024-09-05: 2024 Annual Review
  • 2024-03-05: update guideline
  • 2023-11-20: New UM PA Criteria