Erythropoiesis-Stimulating Agents - Policy Number 2026D0028Y

Oct 13, 2026

UnitedHealthcare® Commercial Medical Benefit Drug Policy outlines coverage criteria for erythropoiesis-stimulating agents (ESAs), listing Aranesp, Epogen, Mircera, Procrit, and Retacrit. Retacrit is the preferred ESA, with coverage dependent on diagnosis-specific requirements and therapy response. Epogen or Procrit coverage requires meeting preferred product criteria or documented failure/contraindication/intolerance to Retacrit, with physician attestation. Criteria are detailed for anemia due to chronic kidney disease (dialysis and non-dialysis) and anemia due to cancer chemotherapy, including hematocrit thresholds, contraindications, and authorization duration limits.

LanguageEnglish

CategoryForms

FormatPDF

Pages17

Reading Time6 min

AccessFree to download

Coverage Rationale

Preferred Product

Preferred Product Criteria

Non-Medical Necessity Plans

Diagnosis-Specific Criteria

Anemia Due to Chronic Kidney Disease

Patients Receiving Dialysis

Patients Not Receiving Dialysis

Anemia Due to Cancer Chemotherapy

UnitedHealthcare® Commercial Medical Benefit Drug Policy Erythropoiesis-Stimulating Agents Policy Number: 2026D0028Y Effective Date: April 1, 2026 􀃂 Instructions for Use Table of Contents Page Coverage Rationale ............................................................ 1 Applicable Codes ................................................................ 5 Background......................................................................... 5 Benefit Considerations ........................................................ 6 Clinical Evidence................................................................. 6 U.S. Food and Drug Administration ................................... 13 Centers for Medicare and Medicaid Services ..................... 14 References ....................................................................... 14 Policy History/Revision Information ................................... 16 Instructions for Use ........................................................... 16 | Community Plan Policy | | --- | | • Erythropoiesis-Stimulating Agents | | | | Medicare Advantage Policy | | • Medicare Part B Step Therapy Programs | Coverage Rationale 􀃂 See Benefit Considerations This policy addresses the following erythropoiesis-stimulating agents (ESAs): Aranesp® (darbepoetin alfa) Epogen® (epoetin alfa) Mircera® [methoxy polyethylene glycol-epoetin beta (MPG-epoetin beta)] Procrit® (epoetin alfa) Retacrit ™ (epoetin alfa) Preferred Product Medical Necessity Plans Retacrit is the preferred ESA product. Coverage for Retacrit is contingent on the coverage criteria in the DiagnosisSpecific Criteria section. Prior authorization is not required. Coverage for Epogen or Procrit is contingent on the Preferred Product Criteria in this section and the coverage criteria in the Diagnosis-Specific Criteria section. In order to continue coverage, members already on Epogen or Procrit will be required to change therapy to Retacrit unless they meet the criteria below. Preferred Product Criteria (For Medicare reviews, refer to the CMS section. *) Treatment with Epogen or Procrit is medically necessary for the indications specified in this policy when one the criteria below are met: Both of the following: o History of a trial of adequate dose and duration of Retacrit, resulting in minimal clinical response; and o Physician attests that, in their clinical opinion, the clinical response would be expected to be superior than experienced with Retacrit or Both of the following: o History of failure, contraindication, or intolerance to Retacrit; and o Physician attests that, in their clinical opinion, the same failure, contraindication, or intolerance would not be expected to occur with Epogen or Procrit Non-Medical Necessity Plans Retacrit, Epogen, or Procrit is to be approved contingent on the coverage criteria in the Diagnosis-Specific Criteria section. Diagnosis-Specific Criteria “ESAs” will be used to refer to all erythropoiesis stimulating agents, unless otherwise specified. For the purposes of the Coverage Rationale , all hematocrit (Hct) values are either pretreatment (for the first 4-6 weeks of therapy) or obtained during treatment to assess ongoing titration and safety. Anemia Due to Chronic Kidney Disease Patients Receiving Dialysis ESAs are proven and medically necessary for the treatment of anemia of chronic kidney disease (CKD) when the following criteria are met: For initial therapy, all of the following: o Patient is on dialysis; and o Hematocrit is less than 30% at initiation of therapy; and o Patient does not have evidence of other causes of anemia (e.g. , iron deficiency, hemolysis, vitamin B12 deficiency); and o Initial authorization will be for no more than 12 months For continuation of therapy, all of the following: o If the request is for Epogen or Procrit, patient meets the criteria in the Preferred Product Criteri

FAQs

Which erythropoiesis-stimulating agents (ESAs) are covered under this policy?

The policy addresses Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Mircera (MPG-epoetin beta), Procrit (epoetin alfa), and Retacrit (epoetin alfa).

Why is Retacrit considered the preferred ESA product?

Retacrit is the preferred ESA product, and coverage depends on diagnosis-specific coverage criteria; prior authorization is not required for Retacrit under the stated terms.

What hematocrit thresholds apply for ESA coverage in patients receiving dialysis?

For initial therapy, ESA coverage requires hematocrit less than 30% at initiation; for continuation, hematocrit must remain less than 33%.

Oct 13, 2026

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