Centene darbepoetin alfa (Aranesp) Policy Update

Coverage Criteria

A. Anemia due to Chronic Kidney Disease (Initial Therapy)

Covered when ALL of the following are met

ALL of the following

1: Diagnosis of anemia of CKD (dialysis and non-dialysis members)
2: Prescribed by or in consultation with a hematologist or nephrologist
3: Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%
4: Pretreatment hemoglobin level < 10 g/dL
5: Step therapy: Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable; if member is unable to use Retacrit, member must use Epogen unless contraindicated (Illinois HIM requests exempt per IL HB 5395)
6: Aranesp is not prescribed concurrently with a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor (e.g., Jesduvroq, Vafseo)

B. Anemia due to Chemotherapy in Patients with Cancer (Initial Therapy)

Covered when ALL of the following are met

ALL of the following

1: Request is for use in solid or non-myeloid malignancies
2: Member is receiving myelosuppressive chemotherapy without curative intent
3: Prescribed by or in consultation with a hematologist or oncologist
4: Age ≥ 18 years

C. Anemia Associated with Myelodysplastic Syndrome (Initial Therapy, off-label)

Covered when ALL of the following are met

ALL of the following

1: Diagnosis of anemia from myelodysplastic syndrome (MDS)
2: Prescribed by or in consultation with a hematologist or oncologist
3: Age ≥ 18 years
4: Either current (within the last 3 months) serum erythropoietin (EPO) ≤ 500 mU/mL OR lower risk (IPSS low/intermediate-1) disease with symptomatic anemia and del(5q)

D. Myelofibrosis-Associated Anemia (Initial Therapy, off-label)

Covered when ALL of the following are met

ALL of the following

1: Diagnosis of anemia associated with myelofibrosis
2: Prescribed by or in consultation with a hematologist or oncologist
3: Age ≥ 18 years
4: Current (within the last 3 months) serum EPO < 500 mU/mL

E. Other diagnoses/indications (Initial Therapy)

Covered when ALL of the following are met

ALL of the following

1: Member meets step therapy: Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable; if member is unable to use Retacrit, member must use Epogen unless contraindicated OR request is for treatment in a state with regulations against oncology step therapy (see Appendix D); Illinois HIM requests exempt per IL HB 5395
2: If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to applicable no-coverage or non-formulary policy depending on formulary/PDL status (policies listed in policy text)

II.A Continued Therapy — Anemia due to Chronic Kidney Disease

Covered when ALL of the following are met

ALL of the following

1: Member currently receiving medication via Centene benefit or member has previously met initial approval criteria OR member is enrolled in a state/product with continuity of care regulations
2: Member is responding positively to therapy
3: Current hemoglobin ≤ 11.5 g/dL
4: Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%

II.B Continued Therapy — Anemia due to Chemotherapy

Covered when ALL of the following are met

ALL of the following

1: Member currently receiving medication via Centene benefit or member has previously met initial approval criteria OR member is enrolled in a state/product with continuity of care regulations
2: Step therapy: Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable; if member is unable to use Retacrit, member must use Epogen unless contraindicated OR request is for treatment in a state with regulations against oncology step therapy (see Appendix D); Illinois HIM requests exempt per IL HB 5395
3: Continuation of ESA therapy is concurrent with myelosuppressive chemotherapy
4:

II.C Continued Therapy — MDS (off-label)

Covered when ALL of the following are met

ALL of the following

1: Member currently receiving medication via Centene benefit or member has previously met initial approval criteria OR member is enrolled in a state/product with continuity of care regulations
2: Step therapy: Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable; if member is unable to use Retacrit, member must use Epogen unless contraindicated OR request is for treatment in a state with regulations against oncology step therapy (see Appendix D); Illinois HIM requests exempt per IL HB 5395
3: If member has received ≥ 8 weeks of ESA therapy, documented response required as evidenced by a rise in hemoglobin > 1.5 g/dL OR a decrease in RBC transfusion requirement

II.D Continued Therapy — Myelofibrosis (off-label)

Covered when ALL of the following are met

ALL of the following

1: Member currently receiving medication via Centene benefit or member has previously met initial approval criteria OR member is enrolled in a state/product with continuity of care regulations
2: Member is responding positively to therapy (examples: for transfusion-independent members with baseline Hgb < 10 g/dL, a ≥ 2 g/dL increase; for previously transfusion-dependent members, becoming transfusion-independent)
3: Step therapy: Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable; if member is unable to use Retacrit, member must use Epogen unless contraindicated OR request is for treatment in a state with regulations against oncology step therapy (see Appendix D); Illinois HIM requests exempt per IL HB 5395

General coverage and approval duration

Covered when specified clinical and administrative criteria are met:

General requirements: 1) Indication aligns with policy-specified covered diagnoses (e.g., anemia due to CKD, chemotherapy, MDS, myelofibrosis); 2) Current hemoglobin threshold met (see thresholds); 3) Adequate iron stores as evidenced by ferritin ≥100 mcg/L or TSAT ≥20% within last 3 months; 4) Step therapy/redirection requirements met unless state/regulatory exception applies.see thresholds

Approval durations vary by line of business.

Approval duration: Medicaid/HIM/ICHRA: 6 months (historical) with update to 12 months for CKD continuation; Commercial: 6 months or to member renewal period, whichever is longer.duration per line of business

See change history for timing of updates.

Step therapy / Redirection for other diagnoses/indications

Redirection requirements for non-CKD indications:

Retacrit/Epogen redirection: Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; if member is unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects occur.N/A

Prior authorization may be required for Retacrit or Epogen; Illinois HIM bypass per IL HB 5395 applies. See Appendix D for states with oncology step therapy protections.

Aranesp (darbepoetin alfa) is not indicated for use in patients with cancer who are receiving hormonal agents, biologic products, or radiotherapy unless they are also receiving concomitant myelosuppressive chemotherapy. Additionally, Aranesp is not indicated for use in patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure, or when the anemia can be managed by transfusion. These labeled limitations should be applied when evaluating coverage for cancer patients receiving the specified agents or radiotherapy.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for marketplace/ICHRA, and CP.PMN.53 for Medicaid) or other evidence-of-coverage documents.

Use of Aranesp in clinical settings described in the labeled limitation(s) of use may be restricted. Specifically, Aranesp should not be used when chemotherapy is administered with curative intent, when anemia can be managed by transfusion, or as a substitute for immediate red blood cell transfusion. Requests for therapy in these settings should be evaluated against the policy exclusions and the FDA limitations of use.

Requests for Aranesp for indications without supportive documentation consistent with off‑label use policies may be considered not medically necessary. Providers should follow the referenced off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) and submit adequate clinical evidence to justify coverage for non‑FDA approved uses.

Coding and Laboratory Thresholds

HCPCS CodesHCPCS

J0881	Injection, darbepoetin alfa, 1 mcg (non-ESRD use)
J0882	Injection, darbepoetin alfa, 1 mcg (for ESRD on dialysis)

Serum ferritin or transferrin saturation

RequirementSerum ferritin ≥ 100 mcg/L OR transferrin saturation (TSAT) ≥ 20% within the last 3 months

Applies toInitial therapy criteria for CKD, chemotherapy, MDS, myelofibrosis, and continued therapy where specified

DocumentationMust submit recent lab results (within 3 months) showing ferritin or TSAT to support prior authorization

Pretreatment hemoglobin (initial)

Pretreatment hemoglobin thresholdHemoglobin < 10 g/dL

Applies toInitial therapy for CKD, chemotherapy, MDS, and myelofibrosis per policy initial criteria

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Billing Codes

Prior authorization is required for requests per the health plan. Providers must document the diagnosis, specialist consultation when required (e.g., hematologist, nephrologist, or oncologist per indication), and relevant laboratory and dosing information to support medical necessity. Failure to submit required documentation may result in denial.

Prior authorization required per health plan for darbepoetin alfa (Aranesp).
HCPCS codes referenced for billing: J0881 (darbepoetin alfa, 1 mcg — non‑ESRD use) and J0882 (darbepoetin alfa, 1 mcg — ESRD on dialysis).
Providers must submit office chart notes, lab results, and any other clinical information supporting the member meets all approval criteria.

Documentation Required

Documentation Requirement

Providers must submit supporting documentation with the prior authorization request. Acceptable documentation includes office chart notes, recent laboratory results, consultation notes from the prescribing specialist, and any other clinical records demonstrating the member meets the specific approval criteria for the requested indication.

Line of Therapy

other

Chemotherapy-associated anemia: Starting dose 2.25 mcg/kg SC weekly or 500 mcg SC every 3 weeks until completion of chemotherapy course; approval requires indication alignment and meeting general criteria (hemoglobin, iron stores).N/A

Dosing examples from dosing section.

Covered Regimens and Dosing

Indication	Regimen / Starting dose	Notes
Anemia due to chemotherapy in patients with cancer
Starting dose: 2.25 mcg/kg subcutaneously (SC) weekly OR 500 mcg SC every 3 weeks
Administer until completion of the chemotherapy course; dosing examples per Dosage and Administration section

Indication	Regimen / Typical dose range	Notes
Anemia associated with myelodysplastic syndromes (MDS)
150–300 mcg SC every other week
Dosing individualized; maximum dose listed as 500 mcg every other week. NCCN referenced for lower‑risk disease pathways (see therapeutic alternatives and compendia).

Definitions and Background

Darbepoetin alfa (Aranesp) is an erythropoiesis‑stimulating agent (ESA) indicated for treatment of anemia due to chronic kidney disease (CKD) and for anemia in patients with non‑myeloid malignancies when related to concomitant myelosuppressive chemotherapy. The FDA‑labeled limitations note Aranesp has not been shown to improve quality of life or fatigue and restricts use in certain cancer treatment settings as described in the policy.

Darbepoetin alfa (Aranesp)

DefinitionDarbepoetin alfa (Aranesp) is an erythropoiesis-stimulating agent (ESA).

Typical useUsed to treat anemia due to CKD and anemia from myelosuppressive chemotherapy; also addressed for certain off-label hematologic conditions

Regulatory safetyESAs carry boxed warnings for increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression/recurrence

ESA

OpenPayer

Darbepoetin Alfa (Aranesp)

Coverage Criteria

Coding and Laboratory Thresholds

Provider Actions and Requirements

Line of Therapy

Covered Regimens and Dosing

Definitions and Background