CurrentViva HealthPolicy IC-0242

Darbepoetin alfa (non-dialysis)

Defines clinical coverage, initial and renewal criteria, dosing, authorization lengths, maximum billable units, HCPCS/NDC coding and covered ICD-10 diagnoses for darbepoetin alfa (J0881) for non-dialysis indications including chemotherapy-induced anemia, chronic kidney disease (non-dialysis), myelodysplastic syndromes, and myeloproliferative neoplasms (myelofibrosis).

Policy Summary

PayerViva Health

PolicyDarbepoetin alfa (non-dialysis)

Policy CodePolicy IC-0242

Change TypeNo material change

Effective DateOct 17, 2008

Next Review DateN/A

Key ActionDocument lab values within 30 days and evidence of adequate iron stores (ferritin ≥ 100 ng/mL and TSAT ≥ 20%); other causes of anemia must be ruled out.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

4Primary covered indications

45dInitial authorization length

J0881Key HCPCS

MultipleCovered ICD-10 codes listed

Coverage Summary

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This policy addresses coverage for darbepoetin alfa (Aranesp) for non-dialysis indications. Status: CURRENT. Effective date (origin): 10/17/2008; Last review: 02/04/2025. The policy defines clinical eligibility, indication-specific initial and renewal criteria, dosing and maximum billable units, HCPCS/NDC billing guidance, and covered ICD-10 diagnoses for non-dialysis use of darbepoetin alfa (J0881).

Quick reference thresholds and key values

Initial hemoglobin< 10 g/dL (initiation threshold unless otherwise specified)

Initial hematocrit< 30% (initiation threshold unless otherwise specified)

Ferritin (iron stores)≥ 100 ng/mL

TSAT (transferrin saturation)≥ 20%

Serum erythropoietin threshold≤ 500 mU/mL (MDS/MPN relevant; some MDS pathways reference <200 mU/mL)

Primary HCPCS (billable unit)J0881 — Injection, darbepoetin alfa, 1 mcg (1 billable unit = 1 mcg)

Initial authorization length45 days

Primary covered indications count4 (chemotherapy-induced anemia, CKD non-dialysis, MDS, MPN/myelofibrosis)

Coding (HCPCS, NDC, ICD-10)

Primary HCPCS codeHCPCSCovered

J0881

Injection, darbepoetin alfa, 1 microgram (non-ESRD use); 1 billable unit = 1 mcg

NDCs (listed formulations)NDCCovered

55513-0006-xx	200 mcg/1 mL, Single-dose Vial
55513-0028-xx	200 mcg/1 mL, Single-dose Prefilled Syringe
55513-0111-xx	300 mcg/0.6 mL, Single-dose Prefilled Syringe
55513-0032-xx	500 mcg/1 mL, Single-dose Prefilled Syringe
55513-0002-xx	25 mcg/1 mL, Single-dose Vial
55513-0098-xx	25 mcg/1 mL, Single-dose Prefilled Syringe
55513-0003-xx	40 mcg/1 mL, Single-dose Vial
55513-0057-xx	40 mcg/1 mL, Single-dose Prefilled Syringe
55513-0004-xx	60 mcg/1 mL, Single-dose Vial
55513-0021-xx	60 mcg/1 mL, Single-dose Prefilled Syringe

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Covered ICD-10 diagnosis codesICD-10Covered

C93.10	Chronic myelomonocytic leukemia, not having achieved remission
C94.40	Acute panmyelosis with myelofibrosis not having achieved remission
C94.41	Acute panmyelosis with myelofibrosis in remission
C94.42	Acute panmyelosis with myelofibrosis in relapse
C94.6	Myelodysplastic disease, not classified
D46.0	Refractory anemia without ring sideroblasts, so stated
D46.1	Refractory anemia with ring sideroblasts
D46.20	Refractory anemia with excess of blasts, unspecified
D46.21	Refractory anemia with excess of blasts 1
D46.4	Refractory anemia, unspecified

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Provider Actions & Billing Rules

Prior Authorization

Authorization length and renewal

Initial authorization: 45 days. Renewal allowed when renewal criteria are met. For renewal, a previous dose must have been administered within the past 60 days.

Documentation Required

Required labs and iron status documentation

Document labs obtained within 30 days of administration and demonstrate adequate iron stores: serum ferritin ≥ 100 ng/mL AND transferrin saturation (TSAT) ≥ 20% (TSAT/ferritin for renewal may be measured within the previous 3 months as noted). Other causes of anemia must be excluded.

Ferritin ≥ 100 ng/mL
TSAT ≥ 20%
Labs obtained within 30 days of administration
Rule out other causes of anemia (e.g., hemolysis, bleeding, vitamin deficiency)

Billing Rule

HCPCS/NDC billing

Bill HCPCS J0881 per 1 microgram (1 billable unit = 1 mcg). Use the listed NDCs for product identification as applicable.

HCPCS: J0881 — Injection, darbepoetin alfa, 1 microgram (1 billable unit = 1 mcg)
Use listed NDCs (see policy Appendix/NDC list) for product identification

Billing Rule

Dual coding for CKD non-dialysis

For anemia due to CKD (non-dialysis), submit both diagnosis code D63.1 and one of the specified CKD diagnosis codes on the claim.

Must bill D63.1 AND one of: I12.9, I13.0, I13.10, N18.30, N18.31, N18.32, N18.4, N18.5

Documentation Required

Response monitoring and discontinuation guidance

Document treatment response versus pretreatment baseline. “No response” is defined as lack of ≥1.5 g/dL rise in hemoglobin OR lack of a decrease in RBC transfusion requirement (within 6–8 weeks for ESAs or within 3–6 months for luspatercept). Monitoring and discontinuation timing: for ESAs, assess at indicated intervals below and consider changing regimen or discontinuing if no response.

No response definition: lack of ≥1.5 g/dL Hb rise OR no reduction in RBC transfusion requirement (6–8 weeks for ESAs; 3–6 months for luspatercept)
ESA response assessment timing: MDS — evaluate after 8 weeks; if no response, change regimen or discontinue
MPN — evaluate after 3 months; if no response (≥2 g/dL Hb rise or reduced transfusions not achieved), discontinue
CKD — consider dose adjustments per CKD guidance; discontinue if no response over the indication-specific timeframe (see CKD dosing and 12-week escalation note)

Billing Rule

Max units / frequency limits

Adhere to maximum billable units and frequency by indication when billing J0881.

MDS: up to 500 units every 14 days
MPN (myelofibrosis): up to 300 units every 7 days
CKD (non-dialysis): up to 600 units every 28 days
Chemotherapy-induced anemia: up to 600 units every 21 days

Background & Evidence

Background: This policy governs use of darbepoetin alfa (Aranesp) for non-dialysis indications and references the FDA-approved indications and product labeling, the NCCN Drugs & Biologics Compendium and related NCCN guideline compendia, and KDIGO guidance for anemia in chronic kidney disease. The document includes the Aranesp package insert (Amgen) as the primary product reference and cites NCCN compendia and KDIGO among guideline sources.

Clinical emphasis: Before initiating or renewing therapy, patients should have documented adequate iron repletion and other causes of anemia excluded (e.g., hemolysis, bleeding, vitamin deficiencies). Required iron parameters are serum ferritin ≥ 100 ng/mL and transferrin saturation (TSAT) ≥ 20% (measured within the previous 3 months for renewal). Laboratory values used for decision-making should be obtained within 30 days of administration.

Serum erythropoietin thresholds: The policy requires a serum erythropoietin level of ≤ 500 mU/mL for MDS and MPN contexts (with additional pathways referencing a < 200 mU/mL threshold for some MDS scenarios).

Evidence: Primary reference is the Aranesp package insert (Amgen), April 2024 (accessed January 2025). Guideline and compendium sources include the NCCN Drugs & Biologics Compendium (2025) (darbepoetin alfa and related hematopoietic growth factor entries) and the KDIGO clinical practice guideline for anemia in chronic kidney disease (2012). Additional supporting trials and reviews cited in the policy include randomized and observational studies and systematic reviews of darbepoetin alfa in chemotherapy-induced anemia, MDS, CKD, and pediatric CKD.

Defined term(s)

No response (term)No response

No response (definition)Lack of ≥1.5 g/dL rise in hemoglobin OR lack of a decrease in RBC transfusion requirement (within 6-8 weeks when treated with ESAs or within 3-6 months when treated with luspatercept).

Name	Number	Effective Date	Type
Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions	110.21	2007-07-30	NCD

Policy Summary

PayerViva Health

PolicyDarbepoetin alfa (non-dialysis)

Policy CodePolicy IC-0242

Change TypeNo material change

Effective DateOct 17, 2008

Next Review DateN/A

Key ActionDocument lab values within 30 days and evidence of adequate iron stores (ferritin ≥ 100 ng/mL and TSAT ≥ 20%); other causes of anemia must be ruled out.

SourceLink

On This Page

OpenPayer

Darbepoetin alfa (non-dialysis)

Coverage Summary

Medical Necessity Criteria (Initial and Renewal)

Coding (HCPCS, NDC, ICD-10)

Provider Actions & Billing Rules

Background & Evidence

Medicare Determinations

Revision History