CurrentCignaPolicy IP0604

Jesduvroq

Clinical coverage policy for use of Jesduvroq (daprodustat) to treat anemia due to chronic kidney disease in adult patients receiving dialysis, describing medical necessity criteria, exclusions, and utilization requirements for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyJesduvroq

Policy CodePolicy IP0604

Change TypeAdded non-covered condition

Effective DateNov 1, 2024

Next Review Date

Key ActionObtain prior authorization and document age ≥18, ≥4 months on dialysis, hemoglobin and iron status, nephrology prescribing/consultation, and response or prior ESA trial as applicable.

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered: Added 'Concurrent Use with Vafseo (vadadustat tablets). The safety and efficacy of concurrent use of Jesduvroq and Vafseo have not been established.'

≥18min age

≥4 momin dialysis duration

6 moinitial approval

1 yrrenewal approval

≤12.0 g/dLHb threshold

Coverage Criteria for Jesduvroq (daprodustat)

Initial and Continuing Therapy Criteria

Jesduvroq is considered medically necessary when the following criteria are met:

Indication groups: Patient meets ONE of the following: A) Initial Therapy OR B) Continuing Therapy

A) Initial Therapy (approve for 6 months): Patient meets ALL of the following:

Initial i: Patient is ≥ 18 years of age

Initial ii: Patient has been receiving dialysis for at least 4 consecutive months

Policy Summary

PayerCigna

PolicyJesduvroq

Policy CodePolicy IP0604

Change TypeAdded non-covered condition

Effective DateNov 1, 2024

Next Review Date

Key ActionObtain prior authorization and document age ≥18, ≥4 months on dialysis, hemoglobin and iron status, nephrology prescribing/consultation, and response or prior ESA trial as applicable.

SourceLink

On This Page

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Initial iii: Patient meets ONE of the following (a or b):

Initial iii a: Patient is currently receiving an erythropoiesis-stimulating agent and transitioning to Jesduvroq AND patient has hemoglobin ≤ 12.0 g/dLHb ≤ 12.0 g/dL

ESA examples: epoetin alfa products, Aranesp, Mircera

Initial iii b: Patient is NOT currently receiving an erythropoiesis-stimulating agent AND baseline (prior to initiation) hemoglobin < 11.0 g/dLbaseline Hb <11.0 g/dL

ESA examples: epoetin alfa products, Aranesp, Mircera

Initial iv: Patient is currently receiving iron therapy OR prescriber documents adequate iron stores

Initial v: Medication prescribed by or in consultation with a nephrologist

Initial vi: Preferred product criteria are met

Refer to product-specific preferred criteria table

B) Continuing Therapy (approve for 1 year): Patient meets ALL of the following:

Continuing i: Patient is ≥ 18 years of age

Continuing ii: Patient has been receiving dialysis for at least 4 consecutive months

Continuing iii: Patient has a hemoglobin level ≤ 12.0 g/dLHb ≤ 12.0 g/dL

Continuing iv: Patient is currently receiving iron therapy OR prescriber documents adequate iron stores

Continuing v: Medication prescribed by or in consultation with a nephrologist

Continuing vi: According to the prescriber, patient has experienced a response to therapy (examples: increase or stabilization in hemoglobin levels or reduction/absence in red blood cell transfusions)

The following clinical contexts and populations are explicitly not covered for Jesduvroq (daprodustat): patients with anemia due to chronic kidney disease who are NOT on dialysis; anemia associated with cancer; patients with active malignancy; anemia due to acute blood loss; concurrent use with erythropoiesis-stimulating agents; concurrent use with Vafseo (vadadustat tablets) (safety and efficacy of concurrent use have not been established); and use to enhance athletic performance.

Any use of Jesduvroq outside the indications and clinical contexts described in this policy is considered experimental, investigational, or unproven. The Conditions Not Covered section lists examples of such uses and will be updated as new published data are available.

Hemoglobin Thresholds and Clinical Parameters

Hemoglobin thresholds and targets

Baseline hemoglobin for ESA‑naïve patientsBaseline (prior to initiation) hemoglobin < 11.0 g/dL

Hemoglobin for patients transitioning from an ESAHemoglobin ≤ 12.0 g/dL when transitioning from an erythropoiesis‑stimulating agent

Continuing therapy hemoglobin thresholdHemoglobin ≤ 12.0 g/dL required for continuation (approve for 1 year)

Do‑not‑target guidance (prescribing information)Do not target a hemoglobin level greater than 11.0 g/dL; if hemoglobin exceeds 12.0 g/dL, interrupt treatment

Authorization durations tied to thresholdsInitial approval: 6 months when initial criteria (including baseline/transition Hb) are met; continuation approval: 1 year when Hb ≤ 12.0 g/dL and response documented

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required before initiating Jesduvroq (daprodustat). Initial approvals are granted for 6 months; continuation approvals for patients meeting continuation criteria are granted for 1 year. Prescribers must document that the patient meets the medical necessity criteria for either Initial Therapy or Continuing Therapy (see policy medical necessity criteria).

Initial authorization: approve up to 6 months.
Continuation authorization: approve up to 1 year if continuation criteria are met.
Prescriber must be the treating nephrologist or in consultation with a nephrologist.

Step Therapy

Step Therapy for Employer Plans

For employer-sponsored plans, step therapy requires a documented prior trial and inadequate efficacy or significant intolerance to one of the listed erythropoiesis-stimulating agents before Jesduvroq will be authorized, unless contraindicated or not tolerated.

Required prior agents: an epoetin alfa product (examples: Epogen, Procrit, Retacrit) or Aranesp (darbepoetin alfa) or Mircera (methoxy polyethylene glycol-epoetin beta).
Documentation must state inadequate efficacy or significant intolerance to the tried agent.
Receipt of sample product does not satisfy step therapy requirements.

Documentation Required

Required Documentation

Document the clinical information that supports medical necessity. Include patient age, dialysis history, hemoglobin values, iron status, prior ESA use or intolerance, prescriber specialty, and response to therapy for continuation requests.

Age: patient is ≥ 18 years.
Dialysis duration: patient has been receiving dialysis for at least 4 consecutive months.
Hemoglobin: baseline (prior to initiation) and current hemoglobin values (Initial: baseline <11 g/dL if not on ESA; or ≤12.0 g/dL when transitioning or for continuation).
Iron status: documentation of current iron therapy or prescriber statement of adequate iron stores.
Prior therapy: name of prior ESA tried, dates of trial, and reason for discontinuation (inadequate efficacy or intolerance).
Prescriber: note that medication is prescribed by or in consultation with a nephrologist.
For continuation: documentation of clinical response (increase or stabilization in hemoglobin or reduction/absence of transfusions).

Denial Risk

Primary Denial Triggers

Requests will be denied when use is outside of the policy indications or when required clinical criteria or documentation are not met.

Not covered for patients with CKD who are NOT on dialysis.
Not covered for anemia associated with cancer or active malignancy.
Not covered for anemia due to acute blood loss or to substitute for transfusion when immediate correction is required.
Denial for concurrent use with erythropoiesis-stimulating agents.
Denial for concurrent use with Vafseo (vadadustat).
Denial if required prior trial of an ESA (for employer plans) is not documented or if prior therapy did not demonstrate inadequate efficacy/intolerance as specified.

Background on Jesduvroq (daprodustat)

Jesduvroq (daprodustat) is a hypoxia‑inducible factor prolyl hydroxylase inhibitor approved for the treatment of anemia due to chronic kidney disease in adults receiving dialysis. It modifies erythropoiesis by stabilizing hypoxia‑inducible factors, increasing endogenous erythropoietin production. Important safety considerations include a boxed warning for increased risks of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Hemoglobin management recommendations note that clinicians should generally not target hemoglobin > 11.0 g/dL and should interrupt treatment if hemoglobin exceeds 12.0 g/dL.

Definitions and Response Metrics

Definition and examples of clinically meaningful increase in hemoglobin

Operational definitionClinically meaningful increase in hemoglobin is an improvement in hemoglobin level or a reduction/absence of red blood cell transfusions as documented by the prescriber

Example of response — hemoglobin changeIncrease or stabilization in hemoglobin levels compared with baseline as reported by the prescriber

Example of response — transfusion requirementReduction in frequency of red blood cell transfusions or absence of transfusions compared with prior baseline