CurrentmhnPolicy CP.PHAR.238

Methoxy Polyethylene Glycol‑Epoetin Beta (Mircera) coverage

Defines medical necessity and prior‑authorization criteria for Mircera (methoxy polyethylene glycol‑epoetin beta) for treatment of anemia of chronic kidney disease (CKD) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyMethoxy Polyethylene Glycol‑Epoetin Beta (Mircera) coverage

Policy CodePolicy CP.PHAR.238

Change TypeMultiple material updates (label, age expansion, step therapy, approval duration, dosing)

Effective Date07.01.16

Next Review Date

Key ActionProvider must submit office notes, lab results, or other clinical information demonstrating diagnosis, hemoglobin and iron indices, prescriber specialty, and prior ESA use/conversion status.

SourceLink

POLICY UPDATE CHANGES

Expanded pediatric use down to 3 months of age for patients on dialysis and added use in pediatric patients not on dialysis per updated prescribing information; added SC route option in pediatrics.

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.

Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/HIM.

Added requirement for continuation requests that current hemoglobin ≤ 12 g/dL and updated adult non‑dialysis dosing option to 1.2 mcg/kg once monthly.

<10Required pretreatment hemoglobin for initial approval

≤12Required current hemoglobin for continuation approval

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Medical Necessity Criteria for Mircera (METHOXY POLYETHYLENE GLYCOL‑EPOETIN BETA)

Initial Approval — Anemia of Chronic Kidney Disease

Covered when ALL of the following are met:

ALL of the following

Diagnosis of anemia of CKD.
Age criteria (one required)
- Age ≥ 18 years (dialysis status irrelevant).
- Age 3 months to ≤ 17 years and converting from another ESA after hemoglobin was stabilized with an ESA.
Prescribed by or in consultation with a hematologist or nephrologist.
Adequate iron stores as indicated by current (within last 3 months) serum ferritin ≥ 100 mcg/L OR serum transferrin saturation (TSAT) ≥ 20%.
Pretreatment hemoglobin < 10 g/dL.
Therapeutic redirection (must meet BOTH)
- Member must use Retacrit (epoetin alfa‑epbx), unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage.
  Prior authorization may be required for Retacrit.
- If member is unable to use Retacrit, member must use Epogen (epoetin alfa), unless contraindicated or clinically significant adverse effects are experienced.
  Prior authorization may be required for Epogen.
Dosing interval limit (one required)
- Adults: subcutaneous (SC) or intravenous (IV) once every two weeks (dosing interval must not exceed this).
- Pediatrics: SC or IV once every four weeks (dosing interval must not exceed this).

Initial Approval — Other diagnoses/indications

Covered only when one of the following applies:

ANY of the following

The drug has had a recent label change (within last 6 months) not yet reflected in this policy; follow formulary/no coverage or non‑formulary policies per line of business (see related_policies).
Requested use is not listed under Diagnoses/Indications for which coverage is NOT authorized (section III) and criterion above does not apply; then refer to applicable off‑label use policy (see related_policies).

Continued Therapy — Anemia of Chronic Kidney Disease

Continuation is allowed when ALL of the following are met:

ALL of the following

Continuation eligibility (one required)
- Member currently receiving medication via Centene benefit or member has previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B).
Member is responding positively to therapy (clinical response required).
Current hemoglobin ≤ 12 g/dL.

Diagnoses/Indications NOT authorized

Coverage is NOT authorized for any of the following:

ANY of the following

Anemia due to cancer chemotherapy.
Non‑FDA approved indications not addressed in this policy, unless sufficient documentation justifying off‑label use is provided and reviewed per off‑label use policies.

Key thresholds

Pretreatment hemoglobin< 10 g/dL

Continuation current hemoglobin≤ 12 g/dL

Ferritin≥ 100 mcg/L (within last 3 months)

Transferrin saturation (TSAT)≥ 20% (within last 3 months)

Relevant Billing Codes

HCPCS codes referencedHCPCS

J0887	Injection, epoetin beta, 1 microgram (for ESRD on dialysis)
J0888	Injection, epoetin beta, 1 microgram (for Non‑ESRD use)

What Providers Must Do

Documentation Required

Submit supporting documentation

Provider must submit office chart notes, laboratory results, or other clinical information that demonstrate the diagnosis of anemia of chronic kidney disease, pretreatment and/or current hemoglobin values, and iron indices (serum ferritin and/or transferrin saturation within the last 3 months). Documentation should also identify the prescriber specialty (hematologist or nephrologist) and note prior ESA use or conversion status when applicable.

Prior Authorization

Prior authorization for Mircera and alternatives

Prior authorization may be required for Mircera and for the therapeutic alternatives Retacrit and Epogen; the provider must follow the health plan prior authorization processes and supply the required documentation when submitting a PA request.

Clinical and Safety Context

Mircera (methoxy polyethylene glycol‑epoetin beta) is an erythropoiesis‑stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adults and in pediatrics aged 3 months to 17 years when converting from another ESA after hemoglobin was stabilized with an ESA. The agent is not indicated for the treatment of anemia due to cancer chemotherapy and is not a substitute for red blood cell (RBC) transfusion in patients who require immediate correction of anemia.

Mircera carries boxed warnings noting that ESAs, including Mircera, increase the risk of death, myocardial infarction, stroke, venous thromboembolism (thromboembolism), thrombosis of vascular access, and tumor progression or recurrence. Contraindications include uncontrolled hypertension, pure red cell aplasia that begins after treatment with other erythropoietin protein drugs, and allergic reactions including anaphylaxis.

Defined Terms

Definitions

CKDChronic kidney disease

ESAErythropoiesis‑stimulating agent

RBCRed blood cell

Policy Changes & Materials

2025-03-11Annual review (2Q2025)Latest

Extended continuation approval duration for Medicaid/HIM from 6 to 12 months; revised therapeutic redirection language to require members must use Retacrit then Epogen (clarifying Epogen use if Retacrit cannot be used) and added Illinois HIM step therapy bypass per IL HB 5395.

2024-06-04Regulatory update (RT4)

Updated to reflect expanded FDA‑approved pediatric use down to 3 months for patients on dialysis and new use in pediatric patients not on dialysis, and added subcutaneous (SC) route option in pediatrics.

2024-01-09Annual review (2Q2024)