CurrentEmblemHealthPolicy N/A

Aranesp (darbepoetin alfa) utilization management

Medicare Advantage medical benefit prior authorization and coverage criteria for Aranesp (darbepoetin alfa) for anemia related to CKD, chemotherapy, MDS, myelofibrosis, and other supported indications; applies to Medicare Advantage members and incorporates relevant NCD/LCD guidance.

Policy Summary

PayerEmblemHealth

PolicyAranesp (darbepoetin alfa) utilization management

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Aranesp for most non-dialysis indications and document diagnosis, hemoglobin, and iron status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 yearsCKD on dialysis approval

1 yearCKD not on dialysis approval

6 monthsChemo-related approval

≤500 mcgAdult per-dose max

Hb <10.0 g/dLInitiation Hb threshold

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Anemia in CKD on dialysis (FDA-approved)

Approve for 3 years when ALL criteria met

CKD on dialysis: Patient has anemia in chronic kidney disease and is on dialysis

Approve for 3 years

Anemia in CKD not on dialysis (FDA-approved)

Approve for 1 year when ALL of the following are met (A or B logic preserved)

A or B

A) Initial Therapy: i. Patient meets one of: (a) ≥18 years with hemoglobin < 10.0 g/dL; OR (b) <18 years with hemoglobin ≤ 11.0 g/dL; AND ii. Patient meets one of: (a) currently receiving iron therapy; OR (b) has adequate iron stores according to the prescriber
B) Currently receiving an ESA: i. Patient has hemoglobin ≤ 12.0 g/dL; AND ii. Patient meets one of: (a) currently receiving iron therapy; OR (b) has adequate iron stores according to the prescriber

Operational note: Approve for 1 year when either A or B is satisfied

Anemia due to cancer chemotherapy (FDA-approved)

Approve for 6 months when ALL of the following are met (A or B preserved)

A) Initial Therapy: i. Hemoglobin < 10.0 g/dL (or hematocrit < 30%); AND ii. Patient is currently receiving myelosuppressive chemotherapy AND prescriber states chemotherapy is noncurative; AND iii. Patient is currently receiving iron therapy OR has adequate iron stores according to the prescriberHb < 10.0 g/dL

Approve for 6 months; adult dosing: each dose ≤ 500 mcg no more frequently than weekly; pediatric dosing as specified

B) Currently receiving an ESA: i. Hemoglobin ≤ 12.0 g/dL (or hematocrit < 30%); AND ii. Patient is currently receiving myelosuppressive chemotherapy AND prescriber states chemotherapy is noncurative; AND iii. Patient is currently receiving iron therapy OR has adequate iron stores according to the prescriberHb ≤ 12.0 g/dL

Approve for 6 months; adult dosing: each dose ≤ 500 mcg no more frequently than weekly; pediatric dosing as specified

Anemia associated with Myelodysplastic Syndrome (MDS)

Approve for 1 year when ALL of the following are met (A or B preserved)

A) Initial or B) Continuing: A) Initial: Patient meets one of: hemoglobin < 10.0 g/dL OR serum erythropoietin ≤ 500 mU/mL; AND patient ≥ 18 years of age; AND patient is currently receiving iron therapy OR has adequate iron stores according to the prescriber. OR B) Patient currently receiving an ESA: hemoglobin ≤ 12.0 g/dL; AND patient ≥ 18 years of age; AND patient is currently receiving iron therapy OR has adequate iron stores according to the prescriber.EPO ≤ 500 mU/mL or Hb thresholds

Dosing: each dose ≤ 500 mcg and no more frequently than every 2 weeks

Anemia associated with Myelofibrosis

Approve for specified durations when ALL criteria met (A or B preserved)

A) Initial Therapy: Initial: Patient meets one of: hemoglobin < 10.0 g/dL OR serum erythropoietin ≤ 500 mU/mL; AND patient is currently receiving iron therapy OR has adequate iron stores according to the prescriberHb < 10.0 g/dL or EPO ≤ 500 mU/mL

Initial approval 3 months

B) Continuing ESA: Patient currently receiving an ESA: hemoglobin ≤ 12.0 g/dL; AND patient is currently receiving iron therapy OR has adequate iron stores according to the prescriber; AND prescriber documents response to therapy defined as hemoglobin ≥ 10 g/dL or increase in hemoglobin ≥ 2 g/dLResponse: Hb ≥ 10 g/dL or increase ≥ 2 g/dL

Approve for 1 year

The following uses are considered not indicated or are explicitly excluded from coverage for Aranesp (darbepoetin alfa): anemia in patients with cancer who are not receiving myelosuppressive chemotherapy; anemia associated with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or other myeloid malignancies; anemia in patients receiving radiotherapy alone; use to enhance athletic performance; treatment of anemia due to acute blood loss; and other circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available.

Aranesp is not indicated for cancer patients who are receiving hormonal agents, biologic products, or radiotherapy alone unless those patients are also receiving myelosuppressive chemotherapy. In addition, Aranesp is not indicated when chemotherapy is intended to be curative. Aranesp is not a substitute for immediate red blood cell transfusion.

Population/Indication	Dosing (adults)	Dosing (pediatric)	Approval duration
{"text":"Anemia due to myelosuppressive, noncurative chemotherapy","status":""},{"text":"Each dose ≤ 500 mcg; doses given no more frequently than once every week","status":""},{"text":"Each dose ≤ 2.25 mcg/kg; doses given no more frequently than once every week","status":""},{"text":"Approve for 6 months when criteria are met","status":""}

Billing and Diagnosis Codes

Referenced HCPCS/ICD-10 listsmixed

referenced

Companion articles list specific HCPCS and ICD-10 codes for billing and coding purposes; referenced for provider use

inv-09: Hemoglobin thresholds — Initiation and continuation

Adult initiation thresholdInitiate ESA therapy generally when hemoglobin (Hb) is < 10.0 g/dL for adults (applies across CKD, cancer chemotherapy, MDS, and myelofibrosis criteria)

Pediatric initiation threshold (selected indications)For patients <18 years with CKD not on dialysis, initiate when Hb ≤ 11.0 g/dL as specified in the CKD criteria

Continuing-therapy thresholdPatients currently receiving an ESA may be eligible when Hb ≤ 12.0 g/dL (continuation criteria in CKD not on dialysis, chemotherapy, MDS, and myelofibrosis)

Dose-reduction/hold threshold (CKD on dialysis)If Hb approaches or exceeds 11.0 g/dL in adults with CKD on dialysis, reduce or interrupt Aranesp dose

Therapy goal/upper limits guidanceGenerally avoid maintaining Hb > 11.5 g/dL in adults with CKD per guideline context; use lowest effective dose to reduce transfusion need

Provider Documentation and Prior Authorization

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for medical benefit coverage of Aranesp in patients with conditions other than CKD who are on dialysis. Approvals are provided for the specified durations in the policy; extended approvals may be allowed if the patient continues to meet the Criteria and Dosing. All approvals are provided for the duration noted in the policy (when expressed in months, 1 month = 30 days).

Prior authorization recommended for most non-dialysis indications; exceptions: FDA-approved indication for CKD on dialysis (approve for 3 years).
Approvals provided for specified durations; extended approvals allowed if Criteria and Dosing continue to be met.

Documentation Required

Iron Optimization Required

Documentation of iron status or ongoing iron therapy is required as part of the approval criteria across multiple indications. For initial therapy and continuation therapy criteria, the prescriber must attest that the patient is either currently receiving iron therapy or has adequate iron stores.

Iron optimization required: current iron therapy OR documentation of adequate iron stores per prescriber.
Applies across CKD (not on dialysis), MDS, myelofibrosis, and other supportive-evidence indications where listed.

Documentation Required

Provider Documentation Requirements

Providers must document the diagnosis, relevant hemoglobin and/or hematocrit values, iron status or use of iron therapy, and whether the therapy is for noncurative intent when applicable. For patients already on an ESA, document current hemoglobin (≤ 12.0 g/dL where specified) and age criteria where applicable. Include dosing information to confirm doses meet the policy's dose and frequency limits.

Document diagnosis and indication being treated (e.g., CKD on dialysis, CKD not on dialysis, MDS, myelofibrosis, etc.).
Provide hemoglobin (and hematocrit if available) values supporting initial or continuation therapy criteria (e.g., Hb thresholds such as <10.0 g/dL or ≤12.0 g/dL as specified).
Document iron status: current iron therapy OR prescriber statement of adequate iron stores.
State whether treatment intent is noncurative when applicable and document response to prior ESA therapy (e.g., Hb ≥10 g/dL or increase ≥2 g/dL where required).
Provide dosing details to confirm each dose and dosing interval meet policy limits (e.g., dose ≤500 mcg and frequency no more than every 2 weeks where specified, or ≤0.45 mcg/kg for certain adult dosing).

Prior Authorization

Prior Authorization Note for Dialysis Exceptions

Prior authorization is recommended for medical benefit coverage of Aranesp in patients with conditions other than CKD who are on dialysis; the intent of this policy is to address uses other than anemia in CKD patients on dialysis. Use the policy Criteria and Dosing sections to determine approval duration and requirements.

Prior authorization recommended specifically for non-CKD dialysis patients receiving Aranesp under the medical benefit.
Refer to FDA-approved and other evidence-supported indication sections for specific approval durations (e.g., CKD on dialysis: 3 years; CKD not on dialysis: 1 year initial approvals; MDS: 1 year; myelofibrosis initial: 3 months or continuation: 1 year when criteria met).

Definitions and Terms

inv-15: ESA (erythropoiesis-stimulating agent) — definition and examples

DefinitionErythropoiesis-stimulating agents (ESAs) are a class of medications that stimulate red blood cell production and are used to treat anemia from CKD, chemotherapy, and select hematologic conditions

Agent examplesEpoetin alfa products (e.g., Epogen, Procrit, Retacrit)

Agent examples (continued)Darbepoetin alfa product (Aranesp)

Agent examples (continued)Methoxy polyethylene glycol-epoetin beta product (e.g., Mircera)

inv-16: Noncurative myelosuppressive chemotherapy — policy definition

DefinitionNoncurative myelosuppressive chemotherapy: chemotherapy that is myelosuppressive and, per the prescriber, intended to be noncurative (palliative or disease-control intent); required for ESA eligibility in cancer-related anemia criteria

Documentation requirementPrescriber must indicate that planned myelosuppressive chemotherapy is considered noncurative and typically that ≥2 additional months of chemotherapy are planned at initiation

Applicable indicationRequired for initiation or continuation of ESA therapy in patients with anemia due to cancer chemotherapy per policy criteria

OpenPayer

Aranesp (darbepoetin alfa) utilization management

Coverage Criteria for Aranesp (darbepoetin alfa)

Dosing and Regimens

Billing and Diagnosis Codes

Provider Documentation and Prior Authorization

Laboratory and Biomarker Criteria

Therapy Line and Positioning

Definitions and Terms

Background