CurrentCignaPolicy N/A

Nephrology -Jesduvroq Prior Authorization Policy

Prior authorization policy for Jesduvroq (daprodustat tablets) for treatment of anemia due to chronic kidney disease in adults on dialysis, including initial and continuation criteria, not-covered indications, prescribing specialist requirement, and safety considerations.

Policy Summary

PayerCigna

PolicyNephrology -Jesduvroq Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revisionearly annual revisionnew policy

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for Jesduvroq; approvals provided for specified durations (initial: 6 months; continuation: 1 year).

SourceLink

POLICY UPDATE CHANGES

Annual Revision: No criteria changes.

Early Annual Revision added condition not covered: concurrent use with Vafseo (vadadustat).

New Policy created with review date 09/27/2023.

1Covered Indications (on dialysis)

7Not Covered Indications/Scenarios

6 mo / 1 yrApproval Durations

≥4 monthsDialysis duration requirement

Coverage Summary

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Coverage policy for Jesduvroq (daprodustat) addresses treatment of anemia due to chronic kidney disease in adults receiving dialysis for at least 4 consecutive months, with specific initial and continuation criteria, prescriber specialty and safety monitoring requirements. The manufacturer withdrew Jesduvroq from the market for business reasons effective December 19, 2024 (manufacturer states withdrawal not related to safety or efficacy). The product carries a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.

Covered - FDA-Approved Indication

Jesduvroq is covered as medically necessary for the FDA-approved indication when criteria below are met. Approvals provided for specified durations.

ANY of the following

A) Initial Therapy - Approve for 6 months
- i: Patient is ≥ 18 years of age
- ii: Patient has been receiving dialysis for at least 4 consecutive months≥ 4 consecutive months
- iii
  - iii.a: Patient is currently receiving an erythropoiesis-stimulating agent and transitioning to Jesduvroq; AND patient has a hemoglobin level ≤ 12.0 g/dLhemoglobin ≤ 12.0 g/dL
    Examples of ESAs: epoetin alfa, darbepoetin alfa, methoxy polyethylene glycol-epoetin beta
  - iii.b: Patient is NOT currently receiving an erythropoiesis-stimulating agent; AND baseline (prior to initiation) hemoglobin level < 11 g/dLbaseline hemoglobin < 11 g/dL
- iv
  - iv.a: Patient is currently receiving iron therapy
    Administer supplemental iron when ferritin <100 mcg/mL or transferrin saturation <20% per prescribing information
  - iv.b: According to the prescriber, patient has adequate iron stores
- v: Prescriber requirement: medication is prescribed by or in consultation with a nephrologist
B) Continuing Therapy - Approve for 1 year
- i: Patient is ≥ 18 years of age
- ii: Patient has been receiving dialysis for at least 4 consecutive months≥ 4 consecutive months
- iii: Patient has a hemoglobin level ≤ 12.0 g/dLhemoglobin ≤ 12.0 g/dL
  Do not continue if hemoglobin >12.0 g/dL; interrupt treatment if >12 g/dL
- iv
  - iv.a:

Not Medically Necessary / Conditions Not Covered

Jesduvroq is considered not medically necessary for indications and situations listed below.

1: Anemia in a patient with chronic kidney disease who is NOT on dialysis
Jesduvroq is not indicated for CKD patients not on dialysis
2: Anemia associated with cancer
3: Active malignancy (Jesduvroq has not been studied and is not recommended in patients with active malignancies)
4: Anemia due to acute blood loss (not appropriate; not a substitute for transfusion when immediate correction needed)

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Jesduvroq. Approvals are provided for the durations specified in the policy: initial approval is for 6 months and continuation approval is for 1 year.

Documentation Required

Prescriber specialty documentation

Medication must be prescribed by or in consultation with a nephrologist. Document the prescriber specialty or documentation of nephrology consultation with the claim or prior authorization request.

Documentation Required

Hemoglobin and iron status documentation

Document baseline hemoglobin (prior to initiation) and on-therapy hemoglobin levels, and document iron status. Confirm hemoglobin thresholds meet the policy criteria (baseline < 11.0 g/dL if not currently on an ESA; hemoglobin ceiling ≤ 12.0 g/dL for initiation/continuation). Ensure iron therapy or adequate iron stores are documented.

Documentation Required

Treatment response documentation for continuation

For continuation requests, the prescriber must document a response to therapy, such as an increase or stabilization in hemoglobin levels or a reduction/absence of red blood cell transfusions, to support approval for continuation.

Denial Risk

Coverage exclusions

Claims for uses listed as not medically necessary will be denied. Examples include anemia in CKD patients who are not on dialysis, anemia associated with cancer or active malignancy, anemia due to acute blood loss, concurrent use with erythropoiesis-stimulating agents (ESAs), and concurrent use with Vafseo (vadadustat).

Clinical Evidence & Safety

KDIGO (2025) suggests using erythropoiesis-stimulating agents (ESAs) as first-line therapy for anemia in CKD and reserving HIF-PHIs for select patients in whom ESAs are contraindicated or not tolerated; KDIGO also advises against concurrent use of ESAs and HIF-PHIs and recommends suspending HIF-PHIs for cardiovascular/thromboembolic events or new cancer.

The ASCEND-ND trial (daprodustat in non-dialysis CKD) observed increased cardiovascular and other risks with daprodustat versus ESAs, including higher rates of cardiovascular mortality, stroke, thromboembolism, and other serious events.

The boxed warning highlights an increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access, and notes that targeting hemoglobin > 11.0 g/dL or hemoglobin > 12.0 g/dL further increases those risks.

Hemoglobin and Treatment Thresholds

Hemoglobin ceiling for eligibility≤ 12.0 g/dL

Initial therapy baseline hemoglobin (if NOT on ESA)< 11.0 g/dL

Hemoglobin for interruption> 12.0 g/dL (interrupt treatment)

Hemoglobin target limitDo not target hemoglobin > 11.0 g/dL

Dialysis duration requirement≥ 4 consecutive months

Response evaluation timelineDo not continue beyond 24 weeks (6 months) if clinically meaningful increase not achieved

Background & Definitions

Jesduvroq (daprodustat), a HIF-PHI indicated for anemia due to CKD in adults on dialysis for at least 4 months, includes recommendations to evaluate and supplement iron as needed, not to target hemoglobin > 11.0 g/dL, and to interrupt treatment if hemoglobin exceeds 12.0 g/dL. Treatment should not continue beyond 24 weeks (6 months) if a clinically meaningful hemoglobin response is not achieved.

The manufacturer announced withdrawal of all strengths of Jesduvroq from the market for business reasons effective December 19, 2024; the manufacturer stated the voluntary action was not related to the safety or efficacy of Jesduvroq.

Jesduvroq has a Boxed Warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access; no trial has identified a hemoglobin target, dose, or dosing strategy that eliminates these risks, so use the lowest effective dose to reduce RBC transfusion need.

ESA: Erythropoiesis-stimulating agents are agents that stimulate red blood cell production (examples include epoetin alfa products, darbepoetin alfa, and methoxy polyethylene glycol-epoetin beta).

Response to therapy: Increase or stabilization in hemoglobin levels or reduction/absence of red blood cell transfusions as reported by the prescriber (used to document clinical benefit for continuation approvals).

OpenPayer

Nephrology -Jesduvroq Prior Authorization Policy

Coverage Summary

Provider Actions & Authorization

Applicable Codes

Clinical Evidence & Safety

Background & Definitions

Revision History