CurrentmhnPolicy CP.PHAR.238

Methoxy Polyethylene Glycol-Epoetin Beta (Mircera)

Defines medical necessity criteria, approvals, contraindications, dosing, and billing HCPCS codes for Mircera (methoxy polyethylene glycol-epoetin beta) for anemia of chronic kidney disease across Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyMethoxy Polyethylene Glycol-Epoetin Beta (Mircera)

Policy CodePolicy CP.PHAR.238

Change TypeRevised / Clarified (annual reviews 2024–2026)

Effective DateJul 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes and labs) showing member meets all approval criteria and provide recent ferritin, TSAT, and hemoglobin results for authorization.

SourceLink

POLICY UPDATE CHANGES

2Q 2026 annual review: modified continuation hemoglobin requirement from ≤ 12 g/dL to ≤ 11.5 g/dL; added requirement that requested product is not prescribed concurrently with a HIF PH inhibitor; added ICHRA line of business.

Per March SDC (2Q 2025): revised Retacrit and Epogen redirection language from 'failure of' to 'member must use' and changed criteria to require both Retacrit and Epogen redirection steps.

2Q 2024 annual review: added continuation hemoglobin requirement ≤ 12 g/dL and updated dosing to include 1.2 mcg/kg once monthly for adults with CKD not on dialysis; added pediatric expansion to 3 months in 2024 RT4 update.

RT4 (06.04.24): expanded uses down to 3 months of age for pediatric patients on dialysis and added new use in pediatric patients not on dialysis; added SC route option in pediatrics.

1Covered Primary Indication (CKD anemia)

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Coverage Summary

Policy CP.PHAR.238 covers Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic kidney disease (CKD) under defined medical necessity criteria. Coverage is subject to specific requirements (age, prescriber specialty, iron stores, hemoglobin thresholds, dosing intervals, and step therapy with preferred ESAs). Mircera is not indicated for anemia due to cancer chemotherapy and is not a substitute for immediate red blood cell (RBC) transfusion. ESAs, including Mircera, carry boxed warnings for increased risks of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.

Key thresholds and scope

Serum ferritin≥ 100 mcg/L (within last 3 months)

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

Pretreatment hemoglobin (initial)< 10 g/dL

Current/continuation hemoglobin≤ 11.5 g/dL

ScopeMedical necessity criteria for Mircera (CKD-related anemia) across Commercial, HIM/ICHRA, and Medicaid; includes approvals, contraindications, dosing intervals, and HCPCS codes

Coverage stanceCovered with criteria (requires iron thresholds, hemoglobin thresholds, prescriber specialty, step therapy with Retacrit→Epogen, and no concurrent HIF PH inhibitor)

Initial Therapy Criteria - Anemia of Chronic Kidney Disease

Initial Approval Criteria - Other diagnoses/indications

Must meet one of the following:

Other diagnoses/indications guidance: If drug label has changed within last 6 months that is not reflected in this policy, follow no-coverage or non-formulary policy references depending on formulary status; if requested use is not listed and criterion 1 does not apply, refer to off-label use policy for the relevant line of business

References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53

Continuation (Renewal) Criteria - Anemia of Chronic Kidney Disease

Diagnoses / Indications Not Authorized

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization and documentation

Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) to support that the member meets all approval criteria. Prior authorization may be required for Retacrit and Epogen.

Documentation Required

Iron status and hemoglobin documentation

Provide current (within the last 3 months) serum ferritin and transferrin saturation (TSAT) results demonstrating ferritin ≥ 100 mcg/L or TSAT ≥ 20%, and hemoglobin values showing pretreatment hemoglobin < 10 g/dL for initial requests and current hemoglobin ≤ 11.5 g/dL for continuation requests.

Applicable Codes

HCPCS CodesHCPCS

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

Clinical Evidence & References

Key evidence and guidance cited in this policy include the Mircera FDA Prescribing Information (Mircera PI, updated June 2024) and KDIGO clinical practice guidelines (KDIGO 2012 and KDIGO 2026). The policy notes that KDIGO states there is no evidence any ESA brand is superior to another, and the policy also highlights boxed warnings for ESAs regarding increased cardiovascular, thrombotic, and other risks.

Background & Definitions

Mircera is an erythropoiesis-stimulating agent indicated for treatment of anemia associated with chronic kidney disease in adults and in pediatric patients (3 months to 17 years) converting from another ESA when applicable. Limitations explicitly state Mircera is not indicated for anemia due to cancer chemotherapy and should not be used as a substitute for immediate RBC transfusion. ESAs, including Mircera, carry boxed warnings that they increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and may promote tumor progression or recurrence.

Definitions:

CKD: Chronic kidney disease — a condition referenced throughout this policy as the indication for Mircera.

ESA: Erythropoiesis-stimulating agent — class of drugs that includes Mircera used to stimulate red blood cell production.

HIF PH inhibitor: Hypoxia-inducible factor prolyl hydroxylase inhibitor (examples: Jesduvroq, Vafseo) — agents that should not be prescribed concurrently with Mircera per the policy.

Revision History

2Q 2026 (P&T Approval Date 05.26.26)annual_review (material)Latest

Modified continuation hemoglobin requirement from ≤ 12 g/dL to ≤ 11.5 g/dL; added requirement that Mircera is not prescribed concurrently with a HIF PH inhibitor; added ICHRA/ICHRA line of business.

2Q 2025 (March SDC 03.11.25; P&T Approval Date 05.25)clarification (material)

Clarified step therapy: revised Retacrit and Epogen redirection language from 'failure of' to 'member must use' and changed criteria so member must meet both Retacrit then Epogen steps; clarified members must use Epogen if unable to use Retacrit.