WHA

JESDUVROQ (daprodustat)

Self-Administration – Oral

Diagnosis considered for coverage: 

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.

Coverage Criteria: 

For diagnosis of Anemia Due to Chronic Kidney Disease:

  • Diagnosis of chronic kidney disease (CKD) AND
  • Patient has been on dialysis for at least 4 months AND
  • Prescribed by or in consultation with either a hematologist or nephrologist AND
  • Hemoglobin levels less than 11 g/dL AND
  • Adequate iron stores confirmed by both of the following: 
    • Patient’s ferritin level is greater than 100mcg/L AND
    • Patient’s transferrin saturation (TSAT) is greater than 20% AND
  • Trial and failure, contraindication or intolerance to one of the following: 
    • Retacrit
    • Procrit
    • Aranesp
Reauthorization Criteria: 

For diagnosis of Anemia Due to Chronic Kidney Disease:

  • Patient demonstrates positive clinical response to therapy (e.g., increase in hemoglobin)
  • Hemoglobin level does not exceed 12g/dL
  • Patient is not on concurrent treatment with an erythropoietin stimulating agent (ESA) (e.g., Aranesp, Epogen, Procrit)
  • Adequate iron stores confirmed by both of the following: 
    • Patient’s ferritin level is greater than 100 mcg/L
    • Patient’s transferrin saturation (TSAT) is greater than 20%
Coverage Duration: 
  • Initial: 6 months
  • Reauthorization: 12 months
Dosing:

For diagnosis of Anemia Due to Chronic Kidney Disease:

  • Take once a day with or without food
  • Patients not being treated with ESA, after initiating therapy and each dose adjustment 
    • Pre-Treatment Hb Level (g/dL) Starting Dosage of Daprodustat
      Less than 9 4 mg orally once daily
      9 to 10 2 mg orally once daily
      Greater than 10 1 mg orally once daily
  • Monitor every 2 weeks for the first month and then every 4 weeks thereafter
  • Do not target hB higher than 11g/dL. Adjust dosage no more than once every 4 weeks.
  • Increase or decrease by 1 dose level if dose needs adjustment, 
  • If Hb exceeds 12 g/dL, interrupt therapy; when Hb is within target range, restart therapy at 1 dose level lower
  • Do not continue beyond 24 weeks of therapy if a clinically meaningful increase in Hb level is not achieved
    • Daily Dose Levels of Daprodustat
      1 mg
      2 mg
      4 mg
      6 mg
      8 mg
      12 mg
      16 mg
      24 mg
      ^, MAX recommended once daily dose
 
Authorization is not covered for the following: 

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 
Additional Information:  
  • The goals of anemia treatment for most patients on dialysis are to alleviate symptoms and to reduce the need for blood transfusions
  • Current treatment options for anemia of CKD include iron supplementation, erythropoiesis-stimulating agents (ESAs), and red blood cell (RBC) transfusion. Jesduvroq (daprodustat) is a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in February 2023 for the treatment of anemia due to CKD. The selection of therapy depends on the presence of iron deficiency and on the severity of anemia
  • Daprodustat is the first HIF-PHI, and the first oral treatment, to receive FDA approval for this indication. It was approved via standard review on February 1, 2023
  • Daprodustat has a boxed warning highlighting an increased risk of death, MI, stroke, venous thromboembolism, and thrombosis of vascular access. Additional warnings and precautions include risk for heart failure, hypertension, gastrointestinal (GI) erosion, serious adverse events (AEs) in patients with anemia due to CKD not on dialysis, and malignancy.
  • Daprodustat is contraindicated in patients who are receiving a strong cytochrome P450 2C8 (CYP2C8) inhibitor such as gemfibrozil and in patients with uncontrolled hypertension.
Policy Updates: 
  • 6/1/2024 (policy effective date)- New Jesduvroq Criteria (P&T 5/21/2024) (P&T meeting May)
References:
  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. Daprodustat. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed Feb 1, 2024. http://www.micromedexsolutions.com.

Last review date: June 1, 2024