ModifiedmhnPolicy CP.PHAR.236

Clinical Policy: Darbepoetin Alfa (Aranesp)

Defines medical necessity criteria, prior authorization expectations, and approval durations for darbepoetin alfa (Aranesp) for anemia related to CKD, chemotherapy-associated anemia, myelodysplastic syndrome, myelofibrosis, and other indications for members under the payer's commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Darbepoetin Alfa (Aranesp)

Policy CodePolicy CP.PHAR.236

Change TypeMaterial revisions to step therapy/redirection, MDS response timing, hemoglobin thresholds, and continuation durations

Effective DateJul 1, 2016

Next Review Date

Key ActionSubmit prior authorization with diagnosis, prescriber specialty, recent iron studies (ferritin or TSAT), pretreatment and current hemoglobin values, and evidence of step‑therapy trials or exceptions.

SourceLink

POLICY UPDATE CHANGES

For all indications, revised Retacrit and Epogen redirection language from 'failure of' to 'member must use' and revised criteria from 'member meets one of the following' to 'member must meet both of the following'; clarified members must use Epogen if member is unable to use Retacrit.

2Q 2023: for MDS continuation modified response assessment to occur after at least 8 weeks of therapy and added approval pathway for lower risk MDS with del(5q).

2Q 2024: for anemia associated with myelofibrosis added requirement that pretreatment hemoglobin < 10 g/dL for initial requests and current hemoglobin ≤ 12 g/dL for continuation requests; for anemia due to CKD added requirement for continuation requests that current hemoglobin ≤ 12 g/dL.

2Q 2025: extended continuation approval duration from 6 to 12 months for Medicaid/HIM for anemia due to CKD and removed 300 mcg vial from product availability per updated prescribing information.

J0881, J0882HCPCS for darbepoetin alfa

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

<10 g/dLPretreatment Hgb threshold

6 monthsTypical prior approval duration (pre-change)

12 monthsUpdated CKD continuation (Medicaid/HIM)

Ferritin ≥100 or TSAT ≥20%Iron stores required

Coverage Criteria for Darbepoetin alfa (Aranesp)

inv-01: Initial Therapy — CKD

Covered when ALL of the following are met

CKD Initial: 1. Diagnosis of anemia of chronic kidney disease (dialysis or non-dialysis).

CKD Initial: 2. Prescribed by or in consultation with a hematologist or nephrologist.

CKD Initial: 3. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

CKD Initial: 4. Pretreatment hemoglobin level < 10 g/dL.

CKD Initial

a: Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; prior authorization may be required for Retacrit.
b: If member is unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects are experienced; prior authorization may be required for Epogen.

CKD Initial: Note: For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

inv-02: Initial Therapy — Chemotherapy-associated anemia

Covered when ALL of the following are met

Chemo Initial: 1. Request is for use in solid tumors or non-myeloid malignancies.

Chemo Initial: 2. Member is receiving myelosuppressive chemotherapy without curative intent.

Chemo Initial: 3. Prescribed by or in consultation with a hematologist or oncologist.

Chemo Initial: 4. Age ≥ 18 years.

Chemo Initial: 5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

inv-03: Initial Therapy — MDS (off-label)

Covered when ALL of the following are met

MDS Initial: 1. Diagnosis of anemia from myelodysplastic syndrome (MDS).

MDS Initial: 2. Prescribed by or in consultation with a hematologist or oncologist.

MDS Initial: 3. Age ≥ 18 years.

MDS Initial: 4. One of the following: (a) current (within the last 3 months) serum erythropoietin (EPO) ≤ 500 mU/mL; OR (b) lower-risk disease (IPSS low/intermediate-1) with symptomatic anemia and del(5q).

MDS Initial:

inv-04: Initial Therapy — Myelofibrosis (off-label)

Covered when ALL of the following are met

Myelofibrosis Initial: 1. Diagnosis of anemia associated with myelofibrosis.

Myelofibrosis Initial: 2. Prescribed by or in consultation with a hematologist or oncologist.

Myelofibrosis Initial: 3. Age ≥ 18 years.

Myelofibrosis Initial: 4. Current (within the last 3 months) serum erythropoietin (EPO) < 500 mU/mL.

Myelofibrosis Initial: 5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

inv-05: Continued Therapy — CKD

Covered when ALL of the following are met

CKD Continued: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

CKD Continued: 2. Member is responding positively to therapy.

CKD Continued

a: Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; prior authorization may be required for Retacrit.
b: If member is unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects are experienced; prior authorization may be required for Epogen.

inv-06: Continued Therapy — Chemotherapy-associated anemia

Covered when ALL of the following are met

Chemo Continued: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Chemo Continued: 2. Continuation of ESA therapy is concurrent with myelosuppressive chemotherapy.

Chemo Continued: 3. If member has received ≥ 8 weeks of ESA therapy, member meets both of the following: (a) documented response to therapy as evidenced by a rise in hemoglobin > 1 g/dL; AND (b) no RBC transfusions are required.

Chemo Continued: 4. Current hemoglobin < 10 g/dL.

inv-07: Continued Therapy — MDS (off-label)

Covered when ALL of the following are met

MDS Continued: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

MDS Continued: 2. If member has received ≥ 8 weeks of ESA therapy, there must be documented response as evidenced by a rise in hemoglobin > 1.5 g/dL OR a decrease in RBC transfusion requirement.

MDS Continued: 3. Current hemoglobin ≤ 12 g/dL.

MDS Continued: 4. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

inv-08: Anemia Associated with Myelodysplastic Syndrome (MDS) — continuation/ongoing therapy

Covered when ALL of the following are met

MDS Continuation: 1. Member is currently receiving medication via Centene benefit or previously met initial approval OR member is in a continuity of care state/product.

MDS Continuation: 2. Step therapy: member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; if unable to use Retacrit, member must use Epogen; state exceptions apply.

MDS Continuation: 3. If member has received ≥ 8 weeks of ESA therapy, there must be documented response (rise in hemoglobin > 1.5 g/dL OR decreased RBC transfusion requirement).

MDS Continuation: 4. Current hemoglobin ≤ 12 g/dL.

inv-09: Myelofibrosis-Associated Anemia — initial and continuation

Covered when ALL of the following are met

Myelofibrosis initial/continued use: 1. Member is currently receiving medication via Centene benefit or previously met initial approval OR member is in a continuity of care state/product.

Myelofibrosis initial/continued use: 2. Member is responding positively to therapy (examples include: for transfusion-independent members with baseline Hgb < 10 g/dL, a ≥ 2 g/dL increase in hemoglobin; or for previously transfusion-dependent members, transitioning to become transfusion-independent).

Myelofibrosis initial/continued use: 3. Step therapy: member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; if unable to use Retacrit, member must use Epogen; state exceptions apply.

Myelofibrosis initial/continued use: 4. Current hemoglobin ≤ 12 g/dL.

inv-10: Other diagnoses/indications (off-label) — adjudication pathway

Covered when ALL of the following are met

Other/Off-label uses: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Other/Off-label uses: 2. Step therapy: member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; if unable to use Retacrit, member must use Epogen; state exceptions apply.

Other/Off-label uses: 3. If the drug label recently changed (within the last 6 months) and the change is not yet reflected in this policy, follow applicable formulary or non-formulary guidance per line of business as specified in the policy.

Other/Off-label uses: 4. If the requested use is not listed under Diagnoses/Indications NOT authorized and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

This policy outlines medical necessity criteria for darbepoetin alfa (Aranesp) and applies to the indications described in the prescribing information and the policy: treatment of anemia due to chronic kidney disease (CKD) (dialysis and non‑dialysis) and treatment of anemia in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy when at least two additional months of planned chemotherapy remain. Coverage of these indications is subject to the specific enrollment, prescriber, laboratory, hemoglobin, iron‑store, and step‑therapy requirements detailed in the criteria sections.

For off‑label hematologic uses addressed in this policy (for example, myelodysplastic syndrome (MDS) and myelofibrosis), coverage is limited to the conditions and documentation requirements explicitly listed in the policy; these off‑label uses are adjudicated under the policy’s stated criteria and referenced guideline sources.

Requests for non‑FDA approved indications that are not specifically addressed in this policy are excluded unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace/HIM, and CP.PMN.53 for Medicaid). Providers should follow those referenced off‑label adjudication pathways when requesting coverage for uses outside the drug’s FDA‑approved indications.

When considering off‑label requests, the Health Plan will apply the policy framework and may require submission of clinical evidence per the off‑label policies; absence of adequate supporting documentation per those policies will result in the request not being authorized.

Coverage determinations made under this clinical policy are subject to the terms, conditions, exclusions, and limitations of the member’s benefit documents (for example, evidence of coverage, certificate of coverage, policy, or contract). This policy is a guide to medical necessity and does not guarantee payment; plan‑level administrative policies, state and federal requirements, and the member’s coverage documents govern final coverage decisions.

Providers remain responsible for documenting medical necessity in the medical record and for complying with any additional requirements in the member’s coverage documents that may affect eligibility or payment.

The drug is not indicated for several cancer settings outside the labeled chemotherapy indication. Specifically, Aranesp 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 when the chemotherapy intent is curative or when the anemia can be managed by transfusion; it is also not a substitute for red blood cell transfusion when immediate correction of anemia is required.

Requests for use in these settings (for example, cancer patients treated with hormonal therapy, biologic agents, or radiotherapy without concurrent myelosuppressive chemotherapy, or when cure is intended) are outside the labeled indications and are not supported by this policy unless the request meets one of the off‑label adjudication pathways described in the policy and supported by referenced off‑label evidence.

Non‑FDA labeled uses that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or other evidence of coverage that permits the use. Use of Aranesp in settings outside the labeled indications and the policy’s specified off‑label criteria (for example, when chemotherapy is given with curative intent or when anemia is readily managed by transfusion) is not supported by this policy and will not be authorized without acceptable off‑label justification.

Providers should include the clinical rationale and supporting evidence when requesting coverage for non‑FDA indications so the request can be evaluated under the referenced off‑label policies.

Coding and Key Clinical Thresholds

No explicit CPT/HCPCS/NDC codes listed in this partmixed

No codes listed

HCPCS Codes referencedHCPCS

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

inv-18: Iron stores — serum ferritin or TSAT thresholds

Minimum iron storesSerum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20% (test within the last 3 months)

CKD initial/continuedFerritin ≥ 100 mcg/L or TSAT ≥ 20% required for both initial and continued therapy in CKD

Chemotherapy-associated anemiaFerritin ≥ 100 mcg/L or TSAT ≥ 20% required (within 3 months) for initial and continued use

MDS and myelofibrosisFerritin ≥ 100 mcg/L or TSAT ≥ 20% required (within 3 months) for initial and continued therapy in MDS and myelofibrosis

inv-19: Pretreatment hemoglobin threshold for initiation

Pretreatment hemoglobin threshold

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must obtain prior authorization and meet step therapy prerequisites before coverage will be considered. For initial and continued therapy requests, submit clinical documentation demonstrating the diagnosis, current and pretreatment hemoglobin values, iron studies (serum ferritin and transferrin saturation within the last 3 months), and evidence of prior therapies or responses as applicable.

Prior authorization may also be required for biosimilars (Retacrit) or comparator agents (Epogen).
Step therapy generally requires trial of Retacrit first, then Epogen if Retacrit is contraindicated, not tolerated, or unavailable due to shortage.
For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
State-specific exceptions may prohibit step therapy for certain oncology indications (see Appendix C/Appendix D and state addenda).

Step Therapy

Step Therapy Redirection — Retacrit First

Dosing and Regimens

Regimen	Indication	Coverage status
Use of erythropoiesis‑stimulating agents (darbepoetin alfa) per policy when criteria met
Anemia in patients with non‑myeloid malignancies where anemia is due to concomitant myelosuppressive chemotherapy and at least two additional months of planned chemotherapy (see coverage criteria for specific requirements)
Covered when all policy criteria are met (prior authorization and step therapy requirements apply as specified)

Dosing option	Administration	Notes
2.25 mcg/kg
Subcutaneous (SC), weekly
Use until completion of chemotherapy course; follow prior authorization and hemoglobin/iron criteria per policy
500 mcg
Subcutaneous (SC), every 3 weeks
Alternative starting dosing option to 2.25 mcg/kg for chemotherapy‑associated anemia; use until completion of chemotherapy course

Dosing	Frequency	Continuation requirement
150–300 mcg
Subcutaneous (SC), every other week
Continuation of therapy requires documented response after ≥ 8 weeks of ESA therapy (for MDS: rise in hemoglobin >1.5 g/dL or decreased RBC transfusion requirement) and current hemoglobin ≤ 12 g/dL; follow prior authorization and iron criteria

Definitions and Safety Notices

inv-36: Erythropoiesis-stimulating agent (ESA) — darbepoetin alfa (Aranesp) definition

DefinitionDarbepoetin alfa (Aranesp) — an erythropoiesis-stimulating agent (ESA) used to stimulate red blood cell production

Typical dosing (selected)Dosing varies by indication; for chemotherapy starting dose options include 2.25 mcg/kg SC weekly or 500 mcg SC every 3 weeks; for MDS 150–300 mcg SC every other week (per dosing appendix)

Product safety noteRefer to boxed warnings and contraindications for ESA class risks (see Appendix C)

inv-37: erythropoiesis-stimulating agent term reference

TermErythropoiesis-stimulating agent (ESA) — abbreviation and class name used throughout the policy

Acronym keyESA stands for erythropoiesis-stimulating agent (see Appendix A)

Background

Darbepoetin alfa (Aranesp) is an erythropoiesis‑stimulating agent (ESA) indicated to stimulate red blood cell production for treatment of anemia due to chronic kidney disease and for anemia in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy when at least two additional months of chemotherapy are planned. The policy also addresses select off‑label hematologic uses (MDS and myelofibrosis) under defined clinical criteria.

This clinical policy was developed as a guide to medical necessity based on available evidence, product labeling, and clinical guidelines; it does not replace professional judgment and coverage is contingent on the member’s benefit documents and plan‑level administrative policies.

Policy Summary

Payermhn

PolicyClinical Policy: Darbepoetin Alfa (Aranesp)

Policy CodePolicy CP.PHAR.236

Change TypeMaterial revisions to step therapy/redirection, MDS response timing, hemoglobin thresholds, and continuation durations

Effective DateJul 1, 2016

Next Review Date

SourceLink

On This Page

Chemo Initial: 6. Pretreatment hemoglobin < 10 g/dL.

Chemo Initial

a: Both of the following: (i) Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; prior authorization may be required for Retacrit; (ii) If member is unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects are experienced; prior authorization may be required for Epogen.
b: Request is for treatment in a State with regulations against step therapy in certain oncology settings (see Appendix D).

Chemo Initial: Note: For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

MDS Initial: 6. Pretreatment hemoglobin < 10 g/dL.

MDS Initial

a: Both of the following: (i) Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; prior authorization may be required for Retacrit; (ii) If member is unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects are experienced; prior authorization may be required for Epogen.
b: Request is for treatment in a State with regulations against step therapy in certain oncology settings (see Appendix D).

MDS Initial: Note: Off-label indication. Illinois HIM requests are exempt from step therapy per IL HB 5395.

Myelofibrosis Initial: 6. Pretreatment hemoglobin < 10 g/dL.

Myelofibrosis Initial

a: Both of the following: (i) Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage; prior authorization may be required for Retacrit; (ii) If member is unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects are experienced; prior authorization may be required for Epogen.
b: Request is for treatment in a State with regulations against step therapy in certain oncology settings (see Appendix D).

Myelofibrosis Initial: Note: Off-label indication. Illinois HIM requests are exempt from step therapy per IL HB 5395.

CKD Continued: 4. Current hemoglobin ≤ 12 g/dL.

CKD Continued: 5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

CKD Continued: Note: For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Chemo Continued: 5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

Chemo Continued: 6. Step therapy requirements or state exception applies (see policy).

Chemo Continued: Note: For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

MDS Continued: 5. Step therapy requirements or state exception applies (see policy).

MDS Continued: Note: Off-label indication. For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

MDS Continuation: 5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

MDS Continuation: Note: Off-label indication; Illinois HIM requests are exempt from step therapy per IL HB 5395.

Myelofibrosis initial/continued use: 5. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin ≥ 100 mcg/L or transferrin saturation (TSAT) ≥ 20%.

Myelofibrosis initial/continued use: Note: Off-label indication; Illinois HIM requests are exempt from step therapy per IL HB 5395.

Pretreatment hemoglobin < 10 g/dL is required for initiation (CKD, chemotherapy-associated anemia, MDS, myelofibrosis)

Chemotherapy initiationPretreatment Hgb < 10 g/dL required for initial darbepoetin alfa use with chemotherapy

MDS and myelofibrosis initiationPretreatment Hgb < 10 g/dL required for initial requests in MDS and myelofibrosis

inv-20: Continued therapy hemoglobin ceiling (CKD/MDS)

Continued therapy hemoglobin ceilingCurrent hemoglobin ≤ 12 g/dL required for continuation of therapy in CKD and MDS

Myelofibrosis continuationCurrent hemoglobin ≤ 12 g/dL required for continued therapy in myelofibrosis

Chemotherapy continuation distinctionChemotherapy continuation criteria use specific continuation Hgb thresholds within the chemotherapy section (see policy), but CKD/MDS ceiling is ≤ 12 g/dL

inv-21: ESA response after ≥8 weeks (chemotherapy/MDS)

ESA response after ≥8 weeksDocumented response after ≥8 weeks of ESA therapy: for chemotherapy-associated anemia a rise in hemoglobin > 1 g/dL and no RBC transfusions required; for MDS a rise in hemoglobin > 1.5 g/dL or decreased RBC transfusion requirement

Documentation timingResponse must be documented after at least 8 weeks of ESA therapy before continuation approval

Transfusion metric for MDSDecrease in RBC transfusion requirement is acceptable evidence of response for MDS continuation

inv-20: Hemoglobin — current and pretreatment thresholds across indications

Current hemoglobin ceiling for continuationCurrent hemoglobin ≤ 12 g/dL for continuation across CKD, MDS, and myelofibrosis indications

Pretreatment hemoglobin for initiationPretreatment hemoglobin < 10 g/dL for initial requests (including myelofibrosis)

Chemotherapy continuation Hgb requirementFor chemotherapy-associated anemia continuation, if member has received ≥ 8 weeks of ESA therapy, requirement includes documented rise in Hgb > 1 g/dL and no RBC transfusions; pretreatment Hgb <10 g/dL applies to initiation

When step therapy redirection applies, members must generally use Retacrit first unless there is documented contraindication, clinically significant adverse effects, or documented unavailability due to shortage. If the member is unable to use Retacrit, Epogen should be used next unless contraindicated or not tolerated. Prior authorization may be required for Retacrit or Epogen. For requests in states with prohibitions against step therapy in certain oncology settings, those state rules supersede redirection requirements.

Retacrit → Epogen redirection applies to initial and continued therapy sections unless state law prohibits step therapy (examples include multiple states listed in Appendix C).
Document reason for inability to use Retacrit (e.g., contraindication, adverse event, shortage) to support redirection to Epogen.

Documentation Required

Provider Documentation and Responsibility

Providers are responsible for submitting all supporting documentation required to adjudicate the prior authorization and step therapy requirements. Failure to submit requested documentation (office notes, lab results, prior treatment history, prescriber specialty consultation notes) may result in denial. This policy is a guide to medical necessity to assist coverage decisions and does not guarantee payment; providers must exercise professional judgment in patient care.

Required documentation includes office chart notes, current labs (hemoglobin, ferritin, transferrin saturation, and EPO where applicable), and documentation of prior biologic/ESA trials and responses.
Prescriptions should be from or in consultation with the appropriate specialist (hematologist, nephrologist, or oncologist) as specified in the clinical criteria.
Coverage remains subject to the member's benefit contract, exclusions, limitations, and applicable state and federal requirements.

Class examplesExamples of ESAs referenced in policy include darbepoetin alfa (Aranesp) and epoetin products (Retacrit, Epogen)

inv-38: ESA boxed warnings — major safety risks

Major boxed warningsESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence

ContraindicationsContraindications include uncontrolled hypertension, pure red cell aplasia that begins after treatment with Aranesp or other erythropoietin protein drugs, and serious allergic reactions

Clinical implicationUse ESAs only when benefits outweigh risks and per labeled indications and policy criteria

inv-39: 'Health Plan' definition

Health Plan definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

Policy useThe clinical policy is a guide to medical necessity used to assist in making coverage decisions and administering benefits; it is not a contract or guarantee of payment

Contractual precedenceCoverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law