Pharmacy Prior Authorization Criteria

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)

P & T Revisions

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

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. 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.

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Revision History

• 2024-09-05: 2024 Annual Review
• 2024-03-05: update guideline
• 2023-11-20: New UM PA Criteria

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