CurrentBlue Cross Blue Shield - IowaPolicy 05.04.93

Jesduvroq (daprodustat) — Coverage Criteria for Anemia of CKD in Dialysis Patients

This policy governs prior authorization, coverage criteria, and continuation requirements for Jesduvroq (daprodustat) for treatment of anemia due to chronic kidney disease in adult members receiving dialysis; it applies to Wellmark Blue Cross and Blue Shield members in North Carolina as stated.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyJesduvroq (daprodustat) — Coverage Criteria for Anemia of CKD in Dialysis Patients

Policy CodePolicy 05.04.93

Change TypeNo material change

Effective DateDec 19, 2025

Next Review DateOct 1, 2025

Key ActionObtain prior authorization for initial therapy; initial approvals may be granted for 12 weeks when all initial approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥ 4 monthsMinimum dialysis duration

<11 g/dLPretreatment Hgb threshold

24 mg/dayMax daily dose

≥1 g/dLHemoglobin increase for continuation

J0889Covered HCPCS code

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Coverage Criteria for Jesduvroq (daprodustat)

Initial Therapy

Covered when ALL of the following are met for initial approval (12 weeks):

Initial Approval: A. Member is 18 years of age or older; B. Member has been receiving dialysis for ≥ 4 months; C. Member has a diagnosis of anemia due to CKD; D. Member has been assessed for iron deficiency anemia and has adequate iron stores OR is receiving iron supplementation prior to starting Jesduvroq; E. Member has a pretreatment hemoglobin level < 11 g/dL (excluding values reflecting recent transfusion); F. Member is hyporesponsive to erythropoiesis-stimulating agents (ESA) when one of the following is met: (1) requiring >300 IU/kg per week of epoetin alfa OR (2) requiring at least 1.5 mcg/kg per week of darbepoetin alfa; G. Member does NOT meet any of the following contraindication criteria: (1) cardiovascular abnormalities (MI, acute coronary syndrome, stroke, TIA) within four weeks of initiation; (2) history of NYHA Class IV heart failure, uncontrolled hypertension, OR liver disease (e.g., ALT >2x ULN, bilirubin >1.5x ULN, current unstable liver or biliary disease); (3) history of malignancy within two years of initiation, current cancer treatment, or history of complex kidney cyst; (4) planned receipt of a living kidney transplant; H. Member will not use Jesduvroq concomitantly with an ESA.

Initial authorization duration: 12 weeks.

Continuation Therapy

Covered when ALL of the following continuation criteria are met for a 12-week authorization:

Continuation Approval: Pathway 1: Member has achieved or maintained a clinically meaningful increase in hemoglobin of ≥ 1 g/dL AND member's hemoglobin is ≤ 11 g/dL. OR Pathway 2: Member has NOT achieved/maintained ≥ 1 g/dL increase AND ALL of: (a) dose will be increased as tolerated to a maximum of 24 mg per day; (b) member has NOT received 24 mg per day for > 12 weeks without achieving a ≥ 1 g/dL increase; (c) member's hemoglobin is ≤ 11 g/dL.≥ 1 g/dL hemoglobin increase; Hgb ≤ 11 g/dL; max dose 24 mg/day

Continuation authorization duration: 12 weeks. Hemoglobin values reflecting recent transfusion are excluded from consideration.

Additional Continuation Requirements: B. Member has been assessed for iron deficiency anemia and has adequate iron stores OR is receiving iron supplementation before continuing therapy with Jesduvroq; C. Member will not use Jesduvroq concomitantly with an ESA.

Coverage of Jesduvroq (daprodustat) is limited to adult members on dialysis and is not indicated for patients who are not receiving dialysis. It is not a substitute for transfusion when immediate correction of anemia is required. The drug has not been shown to improve quality of life, fatigue, or patient well‑being, and these limitations should be considered when evaluating appropriateness of therapy. Coverage requires documented assessment of iron status with either adequate iron stores or active iron supplementation prior to initiation or continuation of therapy, and members must meet specified dialysis duration and hemoglobin thresholds for approval.

Jesduvroq is considered not medically necessary for members who do not meet the specified initial or continuation criteria. Specifically, requests that fail to demonstrate the required pretreatment hemoglobin, dialysis duration, iron repletion or supplementation, ESA hyporesponsiveness (when required), absence of listed contraindications, or that propose concomitant use with an ESA will be deemed not medically necessary.

Coding and Key Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J0889

daprodustat, oral, 1 mg, (for esrd on dialysis)

inv-06: Pretreatment hemoglobin

Pretreatment hemoglobin threshold< 11 g/dL (pretreatment hemoglobin level; values reflecting recent transfusion excluded)

Context for thresholdRequired for initial approval of Jesduvroq for dialysis patients (part of initial criteria set)

Assessment requirementHemoglobin values reflecting recent transfusion are excluded from consideration

inv-07: Minimum dialysis duration

Minimum dialysis duration≥ 4 months (member has been receiving dialysis for ≥ 4 months)

ApplicabilityCriterion for initial 12‑week authorization for Jesduvroq in CKD-related anemia

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required for initial therapy

Prior authorization is required. Initial authorization may be granted for 12 weeks when all initial approval criteria are met, including age ≥18, ≥4 months on dialysis, diagnosis of anemia due to CKD, assessment/adequate iron stores or on iron supplementation, pretreatment hemoglobin <11 g/dL (excluding recent transfusion), ESA hyporesponsiveness per dosing thresholds, absence of listed contraindications, and no concurrent ESA use.

Initial authorization duration: 12 weeks
Covered HCPCS code: J0889

Step Therapy

Positioning vs ESAs — hyporesponsiveness required

Jesduvroq is positioned as an alternative for patients who are hyporesponsive or intolerant to erythropoiesis‑stimulating agents (ESAs). Coverage requires demonstration of ESA hyporesponsiveness using the specified dosing thresholds (e.g., >300 IU/kg/week epoetin alfa or ≥1.5 mcg/kg/week darbepoetin alfa).

Jesduvroq is an alternative when patients are ESA hyporesponsive or intolerant

Background

Anemia of chronic kidney disease (CKD) is most often a normocytic anemia caused by inadequate endogenous erythropoietin production and becomes more common as CKD progresses. It is associated with increased cardiovascular risk, higher hospitalization rates, impaired cognition, reduced quality of life, and mortality. Jesduvroq (daprodustat) is an oral hypoxia‑inducible factor prolyl hydroxylase inhibitor approved for treatment of anemia due to CKD in adults on dialysis ≥ 4 months; clinical trial data (ASCEND‑D) demonstrated noninferiority to erythropoiesis‑stimulating agents for efficacy and major adverse cardiovascular events, but the agent carries risks for thrombotic and bleeding events that should be weighed when considering therapy.

Definitions

inv-14: NYHA Class IV heart failure

Definition (NYHA Class IV)Unable to carry on any physical activity without discomfort; symptoms of heart failure at rest; any physical activity increases discomfort.

Role in policyHistory of NYHA Class IV heart failure is listed as a contraindication for initiation of Jesduvroq

ReferenceSee Appendix: New York Heart Association (NYHA) Functional Classification for full context