CurrentCentenePolicy CP.PHAR.238

Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) (PDF)

Defines medical necessity criteria, continuation criteria, exclusions, dosing, and coding implications for Mircera (methoxy polyethylene glycol-epoetin beta) across Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyMethoxy Polyethylene Glycol-Epoetin Beta (Mircera) (PDF)

Policy CodePolicy CP.PHAR.238

Change TypeAnnual reviews and label-driven revisions

Effective Date07.01.16

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

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

Per 2Q 2025, extended continuation approval duration from 6 to 12 months for Medicaid/HIM and revised Retacrit and Epogen redirection language to 'member must use' both unless exceptions apply.

RT4 (06.04.24) updated to expand pediatric use down to 3 months and added pediatric not-on-dialysis use and SC route option.

2Q 2024 annual review added continuation hemoglobin ≤ 12 g/dL requirement and updated dosing to include 1.2 mcg/kg once monthly for adults with CKD not on dialysis.

2Covered populations (adult and pediatric ≥3 months conversion)

1Lines of business (Commercial, HIM/ICHRA, Medicaid)

2Administration routes (SC, IV)

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Dosing interval options (q2w adults, q4w peds)

Coverage Summary

Mircera (methoxy polyethylene glycol-epoetin beta) is covered with criteria for the treatment of anemia of chronic kidney disease (CKD) across Commercial, HIM/ICHRA, and Medicaid lines of business. Coverage applies for adults and for pediatric patients aged ≥ 3 months when converting from another ESA. Excluded indications include anemia due to chemotherapy and use as a substitute for RBC transfusion. ESAs carry boxed warnings for increased risk of death and thrombotic events (including myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression/recurrence). Mircera must be prescribed by or in consultation with a hematologist or nephrologist.

Key numeric thresholds & quick facts

Pretreatment hemoglobin< 10 g/dL

Continuation hemoglobin (current)≤ 11.5 g/dL

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

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

Administration routesSC, IV

Dosing intervalsAdults: once every 2 weeks; Pediatrics: once every 4 weeks

Initial Therapy Criteria — Anemia of Chronic Kidney Disease

Initial Approval Criteria - Anemia of Chronic Kidney Disease

Mircera is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of anemia of chronic kidney disease (CKD)
Age requirement (one of)
- Age ≥ 18 years (dialysis status is irrelevant)
- Age 3 months to ≤ 17 years (dialysis status is irrelevant) AND will be converting from another ESA agent (e.g., epoetin alfa, darbepoetin alfa)
Prescribing specialist requirement:

Initial Therapy — Other Diagnoses / Off‑Label Pathways

Initial Approval Criteria - Other diagnoses/indications

If request does not match labeled CKD criteria or recent label changes, follow one of the pathways below:

Other diagnoses/indications pathways

Label change pathway: If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to formulary/no-coverage or non-formulary policies depending on formulary status: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
Off-label pathway: If requested use is not specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09, HIM.PA.154, CP.PMN.53

Continuation Therapy Criteria — Anemia of Chronic Kidney Disease

Continuation (Renewal) Criteria - Anemia of Chronic Kidney Disease

Continuation is medically necessary when ALL of the following are met:

ALL of the following

Prior receipt
- 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 specific addendums CC.PHARM.03A and CC.PHARM.03B)
Response to therapy: Member is responding positively to therapy

Continuation — Other Diagnoses / Off‑Label Pathways

Continuation - Other diagnoses/indications

Same referral/redirect guidance as initial other indications:

Other continuation pathways

Label change pathway: If label change within 6 months not yet reflected, refer to formulary/non-formulary policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
Off-label pathway: If requested use not listed under section III and above does not apply, refer to off-label use policy: CP.CPA.09, HIM.PA.154, CP.PMN.53

Exclusions / Not Authorized

Diagnoses/Indications NOT authorized

Exclusions

Anemia due to cancer chemotherapy
Non-FDA approved indications not addressed in this policy unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Provider Actions and Prior Authorization

Documentation Required

Support approval with documentation

Submit office chart notes, lab results, or other clinical information that demonstrate the member meets all approval criteria. Key documentation should confirm diagnosis of CKD-related anemia, age/ESA conversion status when pediatric, adequate iron stores, and hemoglobin values per policy.

Office chart notes or progress notes showing diagnosis of anemia of CKD and prescribing specialist (hematologist or nephrologist)
Serum ferritin ≥ 100 mcg/L within the last 3 months
Serum transferrin saturation (TSAT) ≥ 20% within the last 3 months
Pretreatment hemoglobin < 10 g/dL (for initial requests) or current hemoglobin ≤ 11.5 g/dL (for continuation requests)
Documentation of conversion from another ESA for pediatric patients (3 months to ≤17 years) when applicable

Prior Authorization

Prior authorization may be required for Retacrit or Epogen

Applicable Codes

HCPCS codes (informational)HCPCS

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

Background and Clinical Evidence

Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients (on or not on dialysis) and in pediatric patients 3 months to 17 years converting from another ESA. It is not indicated for the treatment of anemia due to cancer chemotherapy or as a substitute for red blood cell transfusion. ESAs have boxed warnings noting increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and potential for tumor progression or recurrence.

Evidence sources referenced in this policy include the Genentech Mircera Prescribing Information, June 2024 (Prescribing information) and the KDIGO Clinical Practice Guideline for Anemia in CKD (2012) with the KDIGO 2026 guideline also referenced.

Definitions

ESA: erythropoiesis-stimulating agent — a class of agents that stimulate red blood cell production (Mircera is an ESA).

CKD: chronic kidney disease — the condition for which Mircera is FDA‑approved to treat associated anemia.

Revision History

04.23.26 (P&T Approval Date 05.26)annual review (material)Latest

03.11.25 (P&T Approval Date 05.25)annual review (material)

Per 2Q 2025, extended continuation approval duration from 6 to 12 months for Medicaid/HIM and revised Retacrit and Epogen redirection language to 'member must use' both unless exceptions apply.

06.04.24

Policy Summary

PayerCentene

PolicyMethoxy Polyethylene Glycol-Epoetin Beta (Mircera) (PDF)

Policy CodePolicy CP.PHAR.238

Change TypeAnnual reviews and label-driven revisions

Effective Date07.01.16

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Prescribed by or in consultation with a hematologist or nephrologist

Adequate iron stores (one of)

Serum ferritin ≥ 100 mcg/L (within last 3 months)
Serum transferrin saturation ≥ 20% (within last 3 months)

Pretreatment hemoglobin < 10 g/dL< 10 g/dL

Retacrit/Epogen step requirements (both required unless exceptions apply): Member must use Retacrit (epoetin alfa-epbx) unless contraindicated, clinically significant adverse effects occur, or Retacrit is unavailable due to shortage; if member is unable to use Retacrit, member must use Epogen (epoetin alfa) unless contraindicated or clinically significant adverse effects are experienced

For Illinois HIM requests, these step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Concurrent HIF PH inhibitor prohibition: Mircera is not prescribed concurrently with a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor (e.g., Jesduvroq, Vafseo)

Dosing interval (one of)

Adults: SC or IV once every two weeksq2w
Pediatrics (converting from another ESA): SC or IV once every four weeksq4w

Retacrit/Epogen step requirements (both required unless exceptions apply): Member must use Retacrit unless contraindicated, clinically significant adverse effects, or unavailable due to shortage; if member is unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects

For Illinois HIM requests, these step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Current hemoglobin ≤ 11.5 g/dL≤ 11.5 g/dL

Adequate iron stores (one of)

Serum ferritin ≥ 100 mcg/L (within last 3 months)
Serum transferrin saturation ≥ 20% (within last 3 months)

Concurrent HIF PH inhibitor prohibition: Mircera is not prescribed concurrently with a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor (e.g., Jesduvroq, Vafseo)

Dosing interval (one of)

Adults: SC or IV once every two weeksq2w
Pediatrics: SC or IV once every four weeksq4w

Retacrit (epoetin alfa-epbx) and Epogen (epoetin alfa) are required step therapy alternatives per policy and may require prior authorization when used before Mircera. Providers should be aware that members must use Retacrit unless contraindicated or unavailable, and if unable to use Retacrit, must use Epogen unless contraindicated.

Member must use Retacrit unless contraindicated, clinically significant adverse effects occur, or unavailable due to shortage
If unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects occur
For Illinois HIM requests, these step requirements do not apply as of 1/1/2026

Denial Risk

Concurrent HIF PH inhibitor use

Requests will be denied if Mircera is prescribed concurrently with a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor. Examples of HIF PH inhibitors included in the policy are Jesduvroq and Vafseo.

Concurrent use with HIF PH inhibitors (e.g., Jesduvroq, Vafseo) is not allowed and will result in denial

Billing Rule

Prescribing specialist requirement

Mircera must be prescribed by, or in consultation with, a hematologist or nephrologist. Ensure the prescriber or consultation is documented in records submitted for authorization; this requirement is part of the medical necessity criteria and may affect coverage decisions and billing/authorization.

Documenting the prescribing specialist (hematologist or nephrologist) or consultation supports approval and claim adjudication

RT4 update (material)

RT4 (06.04.24) updated to expand pediatric use down to 3 months and added pediatric not-on-dialysis use and SC route option.

01.09.24 (P&T Approval Date 05.24)annual review (material)

2Q 2024 annual review added continuation hemoglobin ≤ 12 g/dL requirement and updated dosing to include 1.2 mcg/kg once monthly for adults with CKD not on dialysis.