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    v1.0.28
    OpenPayerPolicy UpdatesNephrologyCareOregon Erythropoietin Prior Auth Coverage | Op…
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    CurrentcareoregonPolicy N/A

    Erythropoetin Stimulating Agents prior authorization

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    Prior authorization guideline for erythropoietin stimulating agents (e.g., Aranesp, Retacrit) describing initial and reauthorization clinical criteria, approval durations, and required laboratory parameters for members receiving CareOregon coverage.

    Policy Summary
    Payercareoregon
    PolicyErythropoetin Stimulating Agents prior authorization
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and submit required documentation including current therapy status and recent hemoglobin and iron studies to support approval.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3 moinitial approval length
    12 moreauth CKD/HIV
    6 moreauth cancer/chemo
    Hgb <10Hgb threshold
    TSAT >20% / Ferritin >100

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    iron stores

    Coverage Criteria for Erythropoietin Stimulating Agents

    Initial Authorization - CRF or chemotherapy-associated anemia

    Covered when ONE of the following condition groups is met

    Primary eligible conditions: Anemia associated with ONE of the following: Chronic renal failure (CRF) OR solid tumors or multiple myeloma or lymphoma or lymphocytic leukemia who is currently undergoing myelosuppressive chemotherapy

    based on 1.1.1

    Laboratory and iron criteria: Hemoglobin less than 10 g/dL or hematocrit less than 30% AND transferrin saturation greater than 20% AND ferritin greater than 100 ng/mL

    based on 1.1.2 and 1.1.3

    Initial Authorization - HIV/AIDS (zidovudine therapy)

    Covered when ALL of the following are met

    Condition: Anemia associated with HIV/AIDS zidovudine therapy

    based on 1.2.1

    Laboratory and dosing criteria: Hemoglobin less than 10 g/dL or hematocrit less than 30% AND transferrin saturation greater than or equal to 20% AND endogenous erythropoietin less than or equal to 500 IU/L AND zidovudine dose less than or equal to 4200 mg per week

    based on 1.2.2-1.2.5

    Initial Authorization - Pre-operative for patients refusing transfusion

    Covered when ALL of the following are met

    Condition: Anemia is not associated with interferon-ribavirin treatment and request is for pre-operative treatment to raise hemoglobin and hematocrit prior to a scheduled surgical procedure

    based on 1.3.1 and 1.3.2

    Religious refusal: Patient has religious beliefs that preclude blood product transfusions

    based on 1.3.3

    Hemoglobin threshold: Hemoglobin less than 13 g/dL for men OR hemoglobin less than 12 g/dL for women

    based on 1.3.4

    Reauthorization

    Covered when ALL of the following are met

    Current therapy and iron stores: Patient is currently on epoetin or darbepoetin therapy and has maintained adequate iron stores (transferrin saturation greater than 20%).

    based on reauthorization criteria

    Clinical response: Patient has continued to see a response to treatment demonstrated by an increase from baseline hemoglobin/hematocrit or maintenance at target hemoglobin/hematocrit.

    based on reauthorization criteria

    Anemia associated with interferon‑ribavirin treatment (e.g., Pegasys, Peg‑Intron, ribavirin, Ribasphere, Copegus) is explicitly excluded from the pre‑operative eligibility pathway. Requests for pre‑operative erythropoietin stimulating agent therapy for patients with anemia linked to these agents do not meet the pre‑operative criteria.

    Use of erythropoietin stimulating agents is not supported when the laboratory thresholds and iron indices specified in the criteria are not met. Examples include a hemoglobin at or above 10 g/dL (or hematocrit ≥ 30%) and inadequate iron indices such as transferrin saturation ≤ 20% or ferritin ≤ 100 ng/mL. Requests lacking documentation of these required parameters are at risk for denial.

    Clinical Thresholds and Laboratory Parameters

    inv-07: Hemoglobin / Hematocrit — thresholds
    General thresholdHemoglobin (Hgb) less than 10 g/dL OR Hematocrit (Hct) less than 30%.
    Pre-operative (refusal of transfusion) - menHemoglobin less than 13 g/dL.
    Pre-operative (refusal of transfusion) - womenHemoglobin less than 12 g/dL.
    inv-08: Transferrin saturation (TSAT)
    General requirementTransferrin saturation (TSAT) greater than 20%.
    HIV (zidovudine-associated) requirementTransferrin saturation greater than or equal to 20%.
    Reauthorization requirement

    Prior Authorization & Documentation Requirements

    Prior Authorization

    Prior authorization required for Aranesp and Retacrit

    Prior authorization is required for erythropoietin stimulating agents (Aranesp, Retacrit). Initial approvals are documented with the indicated diagnoses and laboratory criteria as specified in the approval criteria.

    Step Therapy

    Reauthorization: current therapy and iron stores required

    Reauthorization requires that the patient is currently on epoetin or darbepoetin therapy and has maintained adequate iron stores, defined as transferrin saturation greater than 20%.

    Documentation Required

    Required clinical documentation

    Background

    Erythropoietin stimulating agents are indicated to treat anemia related to chronic kidney disease, anemia from myelosuppressive chemotherapy for solid tumors or hematologic malignancies, and anemia associated with zidovudine therapy in persons with HIV/AIDS. Treatment eligibility and continuation are guided by measurable hematologic thresholds and iron status to ensure benefit and safety.

    Definitions and Reference Values

    inv-17: Adequate iron stores
    DefinitionAdequate iron stores = Transferrin saturation (TSAT) greater than 20% AND ferritin greater than 100 ng/mL.
    PurposeRequired for initial authorization across most indications and for reauthorization/continuation of epoetin or darbepoetin therapy.
    DocumentationTSAT and ferritin laboratory values must be provided to demonstrate adequate iron stores.
    inv-18: Endogenous erythropoietin level
    Required cutoffEndogenous erythropoietin level must be less than or equal to 500 IU/L for zidovudine-associated anemia criteria.
    ApplicabilitySpecific to the HIV/AIDS (zidovudine therapy) initial authorization pathway.
    Policy Summary
    Payercareoregon
    PolicyErythropoetin Stimulating Agents prior authorization
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and submit required documentation including current therapy status and recent hemoglobin and iron studies to support approval.
    SourceLink
    On This Page
    Coverage Criteria for Erythropoietin Stimulating AgentsClinical Thresholds and Laboratory ParametersPrior Authorization & Documentation RequirementsBackgroundDefinitions and Reference Values
    Maintained adequate iron stores defined as TSAT greater than 20% for continuation approvals.
    inv-09: Ferritin
    Ferritin thresholdFerritin greater than 100 ng/mL.
    Role in adequate iron storesUsed with TSAT >20% to define adequate iron stores required for initial authorization and reauthorization.
    Reauthorization noteFerritin >100 ng/mL is part of the iron indices expected for ongoing therapy evaluations.
    inv-10: Endogenous erythropoietin
    Threshold for endogenous erythropoietinEndogenous erythropoietin less than or equal to 500 IU/L.
    Clinical contextRequired for anemia associated with zidovudine (HIV) prior authorization pathway.
    DocumentationLaboratory measurement must be provided as part of the HIV/zidovudine criteria set.
    inv-11: Zidovudine dosing
    Maximum weekly zidovudine doseZidovudine doses less than or equal to 4200 mg per week (verify with claims history).
    Use in criteriaRequired as part of the HIV/AIDS (zidovudine therapy) initial authorization laboratory and dosing criteria.
    VerificationDosing should be corroborated with claims history documentation.

    Submit documentation demonstrating current therapy status and laboratory evidence of iron stores and hemoglobin/hematocrit values. For specific populations, include zidovudine dosing and endogenous erythropoietin level when applicable.

    • Laboratory values: hemoglobin/hematocrit and transferrin saturation (and ferritin when applicable).
    • For HIV/zidovudine-associated anemia: zidovudine dose (≤4200 mg/week) and endogenous erythropoietin (≤500 IU/L).
    Denial Risk

    Denial risk: clinical thresholds and iron indices not met

    Requests may be denied if hemoglobin or hematocrit thresholds or iron indices do not meet the criteria (e.g., Hgb ≥ 10 g/dL or Hct ≥ 30%, transferrin saturation ≤ 20%, or ferritin ≤ 100 ng/mL).

    Documentation expectationLaboratory result for endogenous erythropoietin should be included in prior authorization submission.