CurrentCignaPolicy N/A

Nephrology - Jesduvroq Prior Authorization Policy • Jesduvroq (daprodustat tablets)

Cigna prior authorization policy for Jesduvroq (daprodustat tablets) governing medical necessity, initial and continuation criteria, excluded indications, prescribing specialty requirement, approval durations, and related safety/monitoring recommendations for members whose plans follow this policy.

Policy Summary

PayerCigna

PolicyNephrology - Jesduvroq Prior Authorization Policy • Jesduvroq (daprodustat tablets)

Policy CodePolicy N/A

Change TypeAnnual Revision (no criteria changes)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approvals given for 6 months (initial) or 1 year (continuation) and the medication must be prescribed by or in consultation with a nephrologist with documentation of iron status and, for continuation, response to therapy.

POLICY UPDATE CHANGES

Annual Revision, Review Date = 07/23/2025 (no criteria changes).

1Covered Indications (on dialysis)

7Enumerated Not Covered Uses

6mInitial Approval Duration

1yContinuation Approval Duration

Coverage Summary

This policy covers Jesduvroq (daprodustat) for treatment of anemia due to chronic kidney disease in adults on dialysis with coverage status: covered_with_criteria. The policy is CURRENT and specifies medical necessity criteria for initial and continuing use. Jesduvroq carries a Boxed Warning for an increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. The manufacturer voluntarily withdrew Jesduvroq from the market effective 2024-12-19 for business reasons; the FDA determined the withdrawal was not for reasons of safety or effectiveness.

Continuation Criteria and Exclusions

Continuing Therapy - Anemia in a Patient with Chronic Kidney Disease who is on Dialysis

Continuing Therapy branch and requirements for ongoing approval (approve 1 year):

B) Continuing Therapy (approve 1 year)

Patient is ≥ 18 years of age≥ 18 years
Patient has been receiving dialysis for at least 4 consecutive months≥ 4 consecutive months
Hemoglobin threshold: Patient has a hemoglobin level ≤ 12.0 g/dLHgb ≤ 12.0 g/dL
Interrupt treatment if Hgb > 12.0 g/dL per prescriber guidance
Iron status: Patient is currently receiving iron therapy OR according to the prescriber, patient has adequate iron stores
Document iron therapy or adequate iron stores
Response to therapy: According to the prescriber, patient has experienced a response to therapy
Examples: increase or stabilization in hemoglobin levels or a reduction or absence in red blood cell transfusions
Prescriber specialty: The medication is prescribed by or in consultation with a nephrologist

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Jesduvroq. Approvals are provided for the durations specified in the policy: initial therapy approvals are for 6 months; continuation (maintenance) approvals are for 1 year.

Documentation Required

Prescriber specialty and iron status documentation

Prescriptions must be written by or in consultation with a nephrologist. The prescriber must document that the patient is receiving iron therapy or has adequate iron stores. For continuation of therapy, the prescriber must document a response to treatment (for example, an increase or stabilization in hemoglobin or reduced/absent red blood cell transfusions).

Denial Risk

Exclusion risk for non-dialysis or other indications

Claims for uses listed under Conditions Not Covered are considered not medically necessary and may be denied. Examples of excluded uses include: anemia in CKD patients who are NOT on dialysis, anemia associated with cancer, active malignancy, anemia due to acute blood loss, concurrent use with erythropoiesis-stimulating agents, concurrent use with Vafseo (vadadustat), and use to enhance athletic performance.

Documentation Required

Hemoglobin monitoring and dosing actions

Monitor hemoglobin during therapy. Interrupt treatment if hemoglobin exceeds 12.0 g/dL and do not target hemoglobin above 11.0 g/dL. Do not continue Jesduvroq beyond 24 weeks (approximately 6 months) without a clinically meaningful increase in hemoglobin.

Key Clinical Thresholds & Approval Durations

Key Thresholds and Approval Durations

Age≥ 18 years

Dialysis duration≥ 4 consecutive months

Initial therapy Hgb — transitioning from ESA≤ 12.0 g/dL

Initial therapy baseline Hgb — not on ESA< 11 g/dL

Continuation therapy Hgb≤ 12.0 g/dL

Hemoglobin safety actionsIf Hgb > 12.0 g/dL, interrupt treatment; do not target Hgb > 11.0 g/dL

Treatment trial durationDo not continue beyond 24 weeks without a clinically meaningful Hgb increase

Approval durationsInitial: 6 months; Continuation: 1 year

Clinical Evidence & Guidance

Key evidence and guideline findings: KDIGO (2025) recommends addressing correctable causes of anemia first and suggests using erythropoiesis-stimulating agents (ESAs) as first-line therapy, reserving HIF-PHIs for select patients in whom ESAs are contraindicated or not tolerated; KDIGO also advises that ESAs and HIF-PHIs should not be used concurrently. The ASCEND-ND trial (daprodustat in non-dialysis patients) observed an increased risk of cardiovascular and other serious events with daprodustat compared with ESA therapy.

Background

Background: Jesduvroq (daprodustat) is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) indicated for anemia due to chronic kidney disease in adults who have been receiving dialysis for at least 4 consecutive months. The drug carries a Boxed Warning for an increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access, and guidance states targeting hemoglobin > 11.0 g/dL increases these risks and that treatment should be interrupted if hemoglobin exceeds 12.0 g/dL. The manufacturer withdrew all strengths from the market effective December 19, 2024 for business reasons; FDA documentation states the withdrawal was not related to safety or efficacy.

Definitions:

- ESA (erythropoiesis-stimulating agent): agents that stimulate red blood cell production; examples include epoetin alfa products (e.g., Epogen, Procrit, Retacrit), darbepoetin alfa (Aranesp), and methoxy polyethylene glycol-epoetin beta (Mircera).

Revision History

07/24/2024revision

Early Annual Revision: Conditions Not Covered — concurrent use of Jesduvroq with Vafseo (vadadustat) was added.

07/23/2025annual_reviewLatest