CurrentBlue Cross Blue Shield - IowaPolicy 05.04.93

Jesduvroq (daprodustat) for anemia due to chronic kidney disease in dialysis-dependent adults

Defines prior authorization criteria, required documentation, dosing/quantity limits, prescriber specialty, and continuation criteria for Jesduvroq (daprodustat) for adults with anemia due to CKD who have been on dialysis ≥4 months.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyJesduvroq (daprodustat) for anemia due to chronic kidney disease in dialysis-dependent adults

Policy CodePolicy 05.04.93

Change TypeClarified coverage criteria and dosing limits

Effective DateDec 19, 2025

Next Review Date

Key ActionSubmit prior authorization with chart notes, medical records, and lab values (hemoglobin, ferritin, transferrin saturation) documenting diagnosis, dialysis duration, prior ESA treatment and responses, and recent hemoglobin values excluding post-transfusion values.

POLICY UPDATE CHANGES

Policy reflects coverage consistent with product labeling and specifies initial and continuation criteria tied to hemoglobin thresholds, ESA hyporesponsiveness, iron assessment, and dialysis duration.

1Covered HCPCS drug code listed

24 mg/dayMaximum daily dose limit

>=4 moDialysis duration requirement

<11 g/dLPretreatment hemoglobin threshold

Coverage Summary

Coverage stance: covered_with_criteria for Jesduvroq (daprodustat) for treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for ≥ 4 months. The policy (Policy #05.04.93) defines prior authorization criteria, required documentation, dosing/quantity limits, prescriber specialty, and continuation criteria for use in this population.

Key Thresholds

Pretreatment hemoglobin< 11 g/dL

Clinically meaningful hemoglobin increase (continuation)>= 1 g/dL

ESA hyporesponsiveness — epoetin alfa> 300 IU/kg per week

ESA hyporesponsiveness — darbepoetin alfa>= 1.5 mcg/kg per week

Maximum daily dose24 mg/day

Dialysis duration prior to initiation>= 4 months

Continuation Therapy Criteria

Continuation of Therapy

Authorization of 12 weeks may be granted when criteria below are met:

Hemoglobin response

Option A (response)
- Member has achieved or maintained a clinically meaningful increase in hemoglobin of ≥ 1 g/dL>= 1 g/dL
- Member's hemoglobin level is ≤ 11 g/dL<= 11 g/dL
Option B (no response but meeting conditions)
- Member has not achieved nor maintained a clinically meaningful increase in hemoglobin of ≥ 1 g/dL>= 1 g/dL
- The dose will be increased as tolerated to a maximum of 24 mg per daymax 24 mg/day
- The member has NOT received 24 mg per day for > 12 weeks without achieving a clinically meaningful increase in hemoglobin of ≥ 1 g/dL24 mg/day > 12 weeks
- Member's hemoglobin is ≤ 11 g/dL<= 11 g/dL

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required with documentation

Submit chart notes, medical records, and laboratory values (hemoglobin, ferritin, transferrin saturation) demonstrating diagnosis of anemia due to CKD, duration of dialysis (≥4 months), prior ESA treatment details (dose, frequency, duration) and responses. For continuation requests include recent hemoglobin values excluding values reflecting recent transfusion.

J0889

Documentation Required

Prescriber specialty requirement

Medication must be prescribed by or in consultation with a nephrologist or hematologist.

Billing Rule

Quantity limit

Quantities are limited to the FDA-approved maximum of 24 mg per day; the policy sets a maximum dose of 24 mg/day in accordance with labeling and dosing limits.

J0889
HCPCS listing effective 10/1/23

Denial Risk

Exclusionary clinical conditions

Claims may be denied for members with exclusionary clinical conditions, including a cardiovascular event (myocardial infarction, acute coronary syndrome, stroke, transient ischemic attack) within four weeks of initiation, history of NYHA Class IV heart failure, uncontrolled hypertension, specified liver disease (e.g., ALT >2x ULN, bilirubin >1.5x ULN, current unstable liver or biliary disease), history of malignancy within two years if currently receiving cancer treatment, planned receipt of a living kidney transplant, or concurrent use of an ESA.

Clinical Evidence

HR 0.93 (95% CI 0.81-1.07)MACE proportion ASCEND-D

Evidence summary: In the ASCEND-D trial Jesduvroq was shown to be noninferior to erythropoiesis-stimulating agents (ESAs) for the primary efficacy outcome (mean hemoglobin change week 28–52) and met noninferiority for MACE. However, Jesduvroq carries boxed warnings for increased risk of thrombotic vascular events and other serious safety signals (e.g., heart failure hospitalization, increased blood pressure, gastrointestinal bleeding). ESAs remain the standard of care; Jesduvroq is presented as an alternative option for patients who are hyporesponsive or intolerant to ESAs.

Background & Definitions

Background: Jesduvroq (daprodustat) is an FDA-approved hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor indicated for anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. In ASCEND-D (a phase 3 randomized trial) Jesduvroq was noninferior to ESAs for hemoglobin response and for MACE. Due to observed adverse effects, the drug label includes a Boxed Warning for increased risk of thrombotic vascular events (including death, myocardial infarction, stroke, and venous thromboembolism) and additional warnings for heart failure hospitalization, worsening hypertension, and gastrointestinal bleeding. ESAs remain the current standard of care, and Jesduvroq is an alternative therapy for ESA-hyporesponsive or ESA-intolerant dialysis-dependent patients. The policy lists HCPCS code J0889 for daprodustat (oral, 1 mg, effective 10/1/23) and limits quantity to the FDA-approved maximum of 24 mg per day.

Term	Definition
{"text":"NYHA Class IV","status":""},{"text":"Unable to carry on any physical activity without discomfort; symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.","status":""}
{"text":"ESA hyporesponsiveness","status":""},{"text":"Requirement of >300 IU/kg/week epoetin alfa or 1.5 mcg/kg/week darbepoetin alfa.","status":""}

Revision History

2025-12-19effective

Policy effective date per document metadata.

2025-10-01last_review

Policy last reviewed on this date per document metadata.

clarified

Policy lists J0889 HCPCS effective 10/1/23 and sets maximum dose 24 mg/day.