CurrentColorado Rocky Mountain Health PlansPolicy IEXD0028.09

Erythropoiesis-Stimulating Agents – Individual Exchange Medical Benefit Drug Policyopen_in_new

Medical benefit drug policy for erythropoiesis-stimulating agents (Aranesp, Epogen, Mircera, Procrit, Retacrit) for Individual Exchange plans (all states except Nevada), defining preferred products, diagnosis-specific medical necessity criteria (CKD with/without dialysis, cancer chemotherapy–related anemia, MDS, myelofibrosis, zidovudine-associated anemia, HCV-associated anemia, perioperative use), authorization durations, and claim submission requirements.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyErythropoiesis-Stimulating Agents – Individual Exchange Medical Benefit Drug Policyopen_in_new

Policy CodePolicy IEXD0028.09

Change TypeRevised/Added/Clarified

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit authorization documentation per diagnosis-specific criteria and include hematocrit within 30 days; for Epogen/Procrit, document prior trial/failure/intolerance to Retacrit or physician attestation.

SourceLink

POLICY UPDATE CHANGES

Removed language indicating the policy does not apply to Massachusetts and New York; clarified applicable states.

Added instruction to refer to UnitedHealthcare Commercial policy version for Nevada.

Preferred Product: added language that Retacrit is the preferred ESA product for Medical Necessity Plans and that Retacrit, Epogen, or Procrit may be approved for Non-Medical Necessity Plans contingent on Diagnosis-Specific Criteria.

Updated References section to reflect current information and archived prior policy version IEXD0028.08.

5ESA products listed

Coverage Summary

This policy defines medical benefit coverage for erythropoiesis‑stimulating agents (ESAs) — specifically Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Mircera (MPG‑epoetin beta), Procrit (epoetin alfa), and the biosimilar Retacrit — for Individual Exchange plans (effective April 1, 2026). It sets diagnosis‑specific medical necessity criteria across multiple indications (CKD on and off dialysis, cancer chemotherapy–related anemia, myelodysplastic syndromes, myelofibrosis, zidovudine‑associated anemia, HCV‑associated anemia, and perioperative use), specifies preferred product rules (Retacrit is the preferred ESA for Medical Necessity Plans with required criteria for continuation of Epogen or Procrit), authorizes typical initial durations (generally up to 12 months, perioperative up to 3 months), and describes claim submission and hematocrit documentation requirements. The policy applies to Individual Exchange plans in all states except Nevada — for Nevada, refer to the UnitedHealthcare Commercial Medical Benefit Drug Policy.

Quick facts & thresholds

Typical initial authorization durationUp to 12 months (perioperative up to 3 months)

Hct required on claimHct value from within 30 days of injection must be submitted

Preferred product (Commercial Medical Necessity Plans)Retacrit designated as preferred ESA; Epogen/Procrit require meeting Preferred Product Criteria for continuation

Key safety signalsIncreased thromboembolic events and increased mortality reported in oncology and some CKD trials

Claim submission noteHct should be submitted on 1500/837P claims; Hct from within 30 days

Counseling / monitoringCounsel patients on ESA risks/benefits prior to each course and monitor for PRCA/thromboembolism

Preferred Product / Substitution Criteria

Preferred Product Criteria

Treatment with Epogen or Procrit is medically necessary for the indications specified in this policy when ONE of the following branches is met. Preserve nested any/all branches showing trial of Retacrit vs history of failure/contraindication/intolerance and physician attestation nodes.

ANY of the following

Trial with Retacrit and physician attestation
- History of a trial of adequate dose and duration of Retacrit, resulting in minimal clinical response
  Document dose, duration, hematocrit/hemoglobin response and objective measures of minimal clinical response
- Physician attests that, in their clinical opinion, the clinical response would be expected to be superior with Epogen or Procrit than experienced with Retacrit
  Attestation should include clinical rationale for expected superior response
Failure/Contraindication/Intolerance to Retacrit with physician attestation

Initial Therapy Criteria (by indication)

Continuation Therapy Criteria (by indication)

Unproven / Not Covered Situations

The policy explicitly states that Mircera is unproven for the treatment of anemia due to cancer chemotherapy and therefore is not supported for that indication in this coverage policy.

Applicable Codes

HCPCS/J-codes for ESAs (reference list)mixed

J0881	Injection, darbepoetin alfa, 1 mcg (non-ESRD use)
J0882	Injection, darbepoetin alfa, 1 mcg (for ESRD on dialysis)
J0885	Injection, epoetin alfa, (for non-ESRD use), 1000 units
J0887	Injection, epoetin beta, 1 microgram, (for ESRD on dialysis)
J0888	Injection, epoetin beta, 1 microgram, (for non-ESRD use)
Q4081	Injection, epoetin alfa, 100 units (for ESRD on dialysis)
Q5105	Injection, epoetin alfa-epbx, biosimilar, (Retacrit) (for ESRD on dialysis), 100 units
Q5106	Injection, epoetin alfa-epbx, biosimilar, (Retacrit) (for non-ESRD use), 1000 units

No procedure/drug codes listed in this policy partmixed

No codes listed

Provider Actions / Billing & Documentation

Prior Authorization

Authorization required with duration limits

Authorization is required for initial and reauthorization requests. Initial authorizations are generally limited to no more than 12 months for most indications; perioperative (preoperative) use is authorized for no more than 3 months. Reauthorizations are also limited (typically up to 12 months) per the diagnosis‑specific sections.

Documentation Required

Hematocrit submission on claim

Hematocrit (Hct) must be submitted on the claim (CMS 1500 or 837P electronic claim). The Hct value submitted should be from within 30 days of the injection.

Clinical Evidence & Guideline Summary

Evidence and guideline guidance summarize that ESAs reduce red blood cell transfusion requirements but carry important safety risks: Cochrane and systematic reviews show a reduced transfusion risk (e.g., RR ~ 0.65) and fewer units transfused, while also showing increased thromboembolic risk (e.g., RR ~ 1.52) and signal(s) of increased mortality in some cancer trials (meta‑analyses and individual studies reporting HRs up to ~ 1.17). The TREAT trial in CKD showed fewer transfusions with darbepoetin but an increased risk of stroke (5.0% vs 2.6%).

Background

ESAs (epoetin alfa, darbepoetin alfa, MPG‑epoetin beta and biosimilars) are recombinant or modified erythropoietic proteins that mimic endogenous erythropoietin to stimulate erythroid progenitor proliferation and differentiation. Anemia etiologies include blood loss, decreased marrow production, and increased destruction; treatments range from nutrient repletion and iron to ESAs and transfusion depending on cause and severity. Safety concerns include thromboembolism, hypertension, and rare antibody‑mediated pure red cell aplasia (PRCA), prompting monitoring and evaluation for sudden loss of response and low reticulocyte counts per product labeling and guideline recommendations.

Definitions (compact)

ESAs (term)Erythropoiesis‑stimulating agents including epoetin alfa, darbepoetin alfa, MPG‑epoetin beta, and biosimilars

Initial authorization (term)Authorization for the start of therapy; duration limits specified per indication (commonly up to 12 months)

Biosimilar (term)A biologic highly similar to an FDA‑approved reference product with no clinically meaningful differences in safety or effectiveness

PRCA (term)Pure Red Cell Aplasia — antibody‑mediated severe anemia with rapid Hb decline, low reticulocytes, normal platelets/WBCs; stop ESA if suspected

Revision History

2026-04-01material_revisionLatest

Removed prior exclusions for Massachusetts and New York — policy now applies to Individual Exchange plans in all states except Nevada (Nevada redirected to UnitedHealthcare Commercial policy).

2026-04-01material_revisionLatest

Added instruction for Nevada: refer to the UnitedHealthcare Commercial Medical Benefit Drug Policy for Nevada.

2026-04-01material_revision

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyErythropoiesis-Stimulating Agents – Individual Exchange Medical Benefit Drug Policyopen_in_new

Policy CodePolicy IEXD0028.09

Change TypeRevised/Added/Clarified

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

History of failure, contraindication, or intolerance to Retacrit
Provide documentation of adverse events, laboratory evidence, or other clinical data supporting failure/contraindication/intolerance
Physician attests that, in their clinical opinion, the same failure, contraindication, or intolerance would not be expected to occur with Epogen or Procrit
Attestation should include clinical rationale explaining why Epogen or Procrit are expected to be tolerated or effective

KDIGO and Professional Society Recommendations (Summary of coverage-relevant criteria)

Follow KDIGO and relevant professional society guidance on ESA use in CKD, including individualized hemoglobin/hematocrit targets and minimizing transfusion risk
Policy aligns coverage with recommendations to use ESAs when benefits outweigh risks and to monitor cardiovascular and thromboembolic risks
Cover ESA therapy when evidence-based indications are met (e.g., CKD with Hct/Hb thresholds, chemotherapy-induced anemia where not curative intent, MDS criteria, zidovudine-associated anemia) and alternative causes of anemia have been evaluated and addressed
See Diagnosis-Specific Criteria for condition-specific thresholds and requirements
Require shared decision-making and documentation of risks/benefits consistent with professional guidance before initiating or continuing ESA therapy
Documentation should reflect discussion of thromboembolic risk, hypertension, tumor progression risk (where applicable), and transfusion avoidance goals

Prior Authorization

Preferred product and continuation criteria (policy revision)

Counsel on risks and benefits: Document that the patient was counseled on the risks and benefits of ESAs, including thromboembolic events, hypertension, potential impact on tumor outcomes (when applicable), and the intended therapeutic goal (e.g., reduce transfusion risk).

Prior authorization applies for Epogen/Procrit when used instead of preferred product Retacrit in Medical Necessity Plans per the criteria above (effective 2026-04-01).
For Medical Necessity Plans: Retacrit is the preferred ESA product; Epogen or Procrit may be approved only if Preferred Product Criteria are met (trial of Retacrit with inadequate response and physician attestation, or documented failure/contraindication/intolerance to Retacrit with physician attestation).
For Non-Medical Necessity Plans: Retacrit, Epogen, or Procrit will be approved contingent on meeting the Diagnosis-Specific Criteria in this policy (no step therapy to Retacrit required).
Providers must include clinical documentation of Retacrit trial (dose, duration, response) or documentation of failure/contraindication/intolerance, and a physician attestation explaining rationale for switching to Epogen or Procrit when applicable.

Documentation Required

Clinical documentation for preferred product exceptions

Requests for Epogen or Procrit must include documentation that the patient met the Preferred Product Criteria: either a prior trial of adequate dose and duration of Retacrit with minimal clinical response plus physician attestation that Epogen/Procrit would be expected to be superior, or documentation of failure, contraindication, or intolerance to Retacrit plus physician attestation that the same issue would not be expected with Epogen/Procrit.

Denial Risk

Claims may be denied if thresholds not met

Claims or prescriptions that do not meet the policy thresholds (hematocrit/serum erythropoietin levels) or other diagnosis‑specific criteria may be considered unproven and not medically necessary and may be denied. Examples include failure to meet Hct initiation or continuation thresholds specified in the diagnosis sections.

Documentation Required

Evaluate for PRCA

Evaluate for possible antibody‑mediated pure red cell aplasia (PRCA) when a patient on ESA >8 weeks develops a sudden rapid hemoglobin decline (about 0.5–1.0 g/dL per week), normal platelets and WBC, and an absolute reticulocyte count <10,000/µl. If antibody‑mediated PRCA is suspected, stop ESA therapy and pursue antibody testing per prescribing information and KDIGO guidance.

Clarified preferred product and continuation rules: for Medical Necessity Plans Retacrit is designated the preferred ESA; for Non‑Medical Necessity Plans Retacrit, Epogen, or Procrit may be approved contingent on Diagnosis‑Specific Criteria; continuation of Epogen or Procrit requires meeting the Preferred Product Criteria (members on Epogen/Procrit must change to Retacrit unless criteria met).