CurrentEmblemHealthPolicy MG.MM.PH.402

Jesduvroq (daprodustat) oral tablets

Policy governing medical benefit coverage, authorization, dosing limits, initial and renewal clinical criteria, applicable procedure (J) code, NDCs and ICD-10 diagnoses for Jesduvroq (daprodustat) for treatment of anemia due to chronic kidney disease in adults on dialysis.

Policy Summary

PayerEmblemHealth

PolicyJesduvroq (daprodustat) oral tablets

Policy CodePolicy MG.MM.PH.402

Change TypeAnnual reviewadministrative updatesinitial publication

Effective DateNov 9, 2023

Next Review Date

Key ActionTreating physician must submit clinical evidence to EmblemHealth demonstrating the member meets the criteria (age, dialysis duration, hemoglobin thresholds, iron status, and response for renewals) for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

03/28/2025 Annual Review: No criteria changes.

05/03/2024 Annual Review: Updated definition, added NDC 00173-0897-13, added N18.5 and N18.4, No criteria changes.

10/13/2023 New Policy

1J-code listed

5NDCs listed

5ICD-10 codes listed

24 mgMaximum daily dose

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Coverage Summary

Scope: Policy governing medical benefit coverage, authorization, dosing limits, initial and renewal clinical criteria, applicable procedure (J) code, NDCs and ICD-10 diagnoses for Jesduvroq (daprodustat) for treatment of anemia due to chronic kidney disease in adults on dialysis. Coverage stance: Covered with criteria. Indication: Jesduvroq (daprodustat) for anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. Policy number: MG.MM.PH.402. Effective / origin date: November 9, 2023; Last review: March 28, 2025.

Threshold summary

Age>= 18 years

Dialysis duration>= 4 consecutive months

Hemoglobin (on ESA)<= 12.0 g/dL

Baseline hemoglobin (not on ESA)< 11.0 g/dL

Maximum dosing (medical benefit)24 mg once daily

Initial Therapy Criteria

Initial Therapy

Approve if the patient meets the following (A, B, C, and D):

ALL of the following

A: Patient is ≥ 18 years of age>= 18 years
B: Patient has been receiving dialysis for at least 4 consecutive months>= 4 consecutive months
C: ONE of the following
- i

Continuation (Renewal) Therapy Criteria

Renewal (Continuation) Therapy

Approve if the patient meets the following (A, B, C, D, and E):

ALL of the following

A: Patient is ≥ 18 years of age>= 18 years
B: Patient has been receiving dialysis for at least 4 consecutive months>= 4 consecutive months
C: Patient has a hemoglobin level ≤ 12.0 g/dL≤ 12.0 g/dL

Provider Actions & Billing

Prior Authorization

Preauthorization required with clinical documentation

Treating physician must submit clinical evidence to EmblemHealth demonstrating the member meets the criteria for preauthorization or post-payment review. Required documentation should demonstrate age (≥18 years), duration of dialysis (≥4 consecutive months), hemoglobin thresholds (≤12.0 g/dL for most patients; baseline <11.0 g/dL if not on an ESA), iron status (current iron therapy or documentation of adequate iron stores), and, for renewals, evidence of response to therapy (examples: increased/stabilized hemoglobin or reduced transfusions).

J0889

Documentation Required

Document hemoglobin and iron status

Provider must document baseline and current hemoglobin values and evidence of iron therapy or documentation of adequate iron stores as stated in the initial and renewal criteria.

Applicable Codes

Applicable Procedure Codes (Medical Benefit J-code)HCPCSCovered

J0889

Daprodustat, oral, 1 mg, (for ESRD on dialysis)

Applicable NDCsNDCCovered

00173-0914-13	Jesduvroq 8mg Tablet
00173-0911-13	Jesduvroq 6mg Tablet
00173-0906-13	Jesduvroq 4mg Tablet
00173-0903-13	Jesduvroq 2mg Tablet
00173-0897-13	Jesduvroq 1mg Tablet

Applicable ICD-10 DiagnosesICD-10Covered

N18.9	Chronic Kidney Disease, unspecified
N18.6	End stage renal disease (ESRD)
N18.5	Chronic kidney disease, stage 5
N18.4	Chronic kidney disease, stage 4 (severe)
D63.1	Anemia in chronic kidney disease

Clinical Evidence & Definitions

Primary reference: Product Information: JESDUVROQ oral tablets, daprodustat oral tablets. GlaxoSmithKline (per FDA), 2023. The indication in this policy is based on the FDA product information for Jesduvroq for treatment of anemia due to CKD in adults on dialysis.

Definitions: Erythropoiesis-stimulating agent (ESA) examples include epoetin alfa products (Epogen, Procrit, Retacrit), Aranesp (darbepoetin alfa), and Mircera (methoxy polyethylene glycol-epoetin beta) as noted in the policy criteria.

Numeric policy-level thresholds

Maximum daily dose24 mg once daily

Background

Background: Jesduvroq (daprodustat) is indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. EmblemHealth requires the treating physician to submit clinical evidence that the member meets the policy criteria (age, dialysis duration, hemoglobin thresholds, iron status, and response for renewals) to determine medical necessity and coverage under the member's benefit program.

Revision History

10/13/2023New Policy (material)

Initial policy publication establishing criteria and codes. New Policy

05/03/2024Annual Review (administrative)

Administrative updates to definition and coding: added NDC 00173-0897-13 and ICD-10 codes N18.5 and N18.4. No clinical criteria changes.

03/28/2025Annual Review (administrative)Latest

Policy Summary

PayerEmblemHealth

PolicyJesduvroq (daprodustat) oral tablets

Policy CodePolicy MG.MM.PH.402

Change TypeAnnual reviewadministrative updatesinitial publication

Effective DateNov 9, 2023

Next Review Date

SourceLink

On This Page

i.a: Patient is currently receiving an erythropoiesis-stimulating agent AND transitioning to Jesduvroq

Examples: epoetin alfa (Epogen, Procrit, Retacrit), darbepoetin alfa (Aranesp), methoxy polyethylene glycol-epoetin beta (Mircera)

i.b: Patient has a hemoglobin level ≤ 12.0 g/dL≤ 12.0 g/dL

ii.a: Patient is NOT currently receiving an erythropoiesis-stimulating agent
Examples: epoetin alfa (Epogen, Procrit, Retacrit), darbepoetin alfa (Aranesp), methoxy polyethylene glycol-epoetin beta (Mircera)
ii.b: Patient has a baseline (prior to initiation of Jesduvroq) hemoglobin level < 11 g/dL< 11.0 g/dL

D: ONE of the following

D.i: Patient is currently receiving iron therapy
D.ii: According to the prescriber, patient has adequate iron stores

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D: ONE of the following

D.i: Patient is currently receiving iron therapy
D.ii: According to the prescriber, patient has adequate iron stores

E: 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)

Denial Risk

Renewal requires documented response

Claims for renewal may be denied if the prescriber does not document a response to therapy. Examples of evidence to demonstrate response include an increase or stabilization in hemoglobin levels or a reduction or absence in red blood cell transfusions.

Increase or stabilization in hemoglobin levels
Reduction or absence in red blood cell transfusions

Billing Rule

Use J0889 for medical benefit claims

Report daprodustat using HCPCS code J0889 (daprodustat, oral, 1 mg) on medical benefit claims for ESRD on dialysis as applicable.

J0889

Billing Rule

NDC reporting for product identification

Use the applicable National Drug Codes (NDCs) for Jesduvroq tablets to identify product and strength on claims as required.

00173-0914-13
00173-0911-13
00173-0906-13
00173-0903-13
00173-0897-13

Annual Review: No criteria changes.