CurrentHealth NetPolicy CP PHAR.238

Clinical Policy: Methoxy Polyethylene Glycol-Epoetin Beta (Mircera)

Defines medical necessity criteria, prior authorization expectations, dosing, exclusions, and coding implications for Mircera (methoxy polyethylene glycol-epoetin beta) for treatment of anemia of chronic kidney disease across commercial, HIM and Medicaid lines of business, including pediatric use and step therapy redirection to alternative ESAs.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Methoxy Polyethylene Glycol-Epoetin Beta (Mircera)

Policy CodePolicy CP PHAR.238

Change TypeMultiple material updates (pediatric expansion, dosing, continuation duration, step therapy language)

Effective DateJul 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, other clinical information) supporting that member meets all approval criteria.

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.

Added requirement for continuation requests that current hemoglobin < 12 g/dL and updated adult dosing to include 1.2 mcg/kg once monthly for CKD not on dialysis.

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

Revised Retacrit and Epogen redirection language from 'failure of' to 'member must use' and clarified members must use Epogen if unable to use Retacrit; added step therapy bypass for IL HIM per IL HB 5395.

Added Appendix D referencing KDIGO guidelines that do not indicate preference for any ESA.

Covered indication (CKD anemia)

2Pediatric age groups covered (>=3 months to <17 years)

2Required iron parameters (ferritin, TSAT)

3Step therapy sequence (Retacrit -> Epogen -> Mircera)

Coverage Summary

Scope: This policy defines medical necessity criteria, prior authorization expectations, dosing, exclusions, and coding implications for Mircera (methoxy polyethylene glycol-epoetin beta) for treatment of anemia of chronic kidney disease (CKD) across commercial, HIM and Medicaid lines of business, including pediatric use and step therapy redirection to alternative ESAs. Coverage stance: covered_with_criteria. Indication summary: Mircera is an ESA indicated for anemia associated with CKD in adults and certain pediatric patients; it is not indicated for anemia due to cancer chemotherapy or as a substitute for red blood cell (RBC) transfusions.

Key clinical thresholds

Serum ferritin>= 100 mcg/L

Transferrin saturation (TSAT)>= 20%

Pretreatment hemoglobin (initial)<= 10 g/dL

Current hemoglobin (continuation)< 12 g/dL

Initial Therapy Criteria

Initial Approval Criteria

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

ALL of the following

Diagnosis of CKD anemia: Diagnosis of anemia of chronic kidney disease (CKD)
Age / Indication options
- Adult patients (>= 18 years), dialysis status irrelevant
- Pediatric conversion: Pediatric patients 3 months to < 17 years who are converting from another ESA after their hemoglobin level was stabilized with an ESA
  Expanded pediatric use down to 3 months for dialysis and added non-dialysis use

Continuation Therapy Criteria

Continued Therapy (Renewal) Criteria

Covered when ALL of the following are met for continuation:

ALL of the following

Continuation eligibility: Member currently receiving medication via Centene benefit OR member has previously met initial approval criteria OR member is enrolled in a state/product with continuity of care regulations
Refer to state-specific addendums CC.PHARM.03A and CC.PHARM.03B
Positive response: Member is responding positively to therapy
Step therapy / formulary redirection (must meet both)
- Retacrit first:

Other Diagnoses / Exclusions

Other diagnoses/indications and Diagnoses/Indications Not Authorized

Requests that do not meet the above must meet one of the following:

Other pathways (must meet one): For drugs on the formulary/PDL follow the no-coverage policy for the relevant line of business; for drugs not on formulary follow the non-formulary policy; if use is not listed under Diagnoses/Indications Not Authorized and initial criteria do not apply, refer to off-label use policy

Policies referenced: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid); non-formulary: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid); off-label: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Diagnoses/Indications Not Authorized: Anemia due to cancer chemotherapy (not indicated) OR Non-FDA approved indications unless sufficient documentation per off-label policies

Mircera is not indicated for anemia due to cancer chemotherapy and non-FDA indications require off-label policy review

Applicable Codes

HCPCS codes (informational)HCPCS

J0887
J0888	Injection epoetin beta - microgram for Non ESRD use

Provider Actions / Billing

Prior Authorization

Prior authorization required

Prior authorization may be required for Mircera and for redirected agents Retacrit and Epogen; providers should obtain prior authorization as applicable to the line of business.

Documentation Required

Submit supporting documentation

Submit office notes, laboratory results, and other clinical information that support the member meets all approval criteria.

office notes
labs
other clinical information

Clinical Evidence & Guidance

Evidence: FDA prescribing information for Mircera (label accessed 2025-01-17) is cited for indications, dosing, and safety. The KDIGO 2012 guideline notes there is no evidence that any ESA brand is superior and recommends choosing an ESA based on pharmacodynamics, safety, clinical outcome data, costs, and availability. Boxed warnings (ESAs): ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism (VTE), thrombosis of vascular access, and tumor progression/recurrence (see Clinical Evidence/Appendix C for details).

Background

Background: Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA) indicated for treatment of anemia associated with chronic kidney disease (CKD) in adult patients (on dialysis and not on dialysis) and in pediatric patients 3 months to 17 years who are converting from another ESA after hemoglobin stabilization. Mircera is not indicated for anemia due to cancer chemotherapy and is not a substitute for RBC transfusions. ESAs carry boxed warnings for serious risks including increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression/recurrence (refer to the Clinical Evidence/Appendix C section for boxed warning details).

Definitions

CKDChronic kidney disease

ESAErythropoiesis-stimulating agent

RBCRed blood cell

Revision History

06.04.24added

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.

01.09.24 (P&T 05.24)revised

Added requirement for continuation requests that current hemoglobin < 12 g/dL and updated adult dosing to include 1.2 mcg/kg once monthly for CKD not on dialysis.

03.11.25 (P&T 05.25)revisedLatest

Policy Summary

PayerHealth Net

PolicyClinical Policy: Methoxy Polyethylene Glycol-Epoetin Beta (Mircera)

Policy CodePolicy CP PHAR.238

Change TypeMultiple material updates (pediatric expansion, dosing, continuation duration, step therapy language)

Effective DateJul 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, other clinical information) supporting that member meets all approval criteria.

On This Page

Prescriber requirement:

Prescribed by or in consultation with a hematologist or nephrologist

Iron stores: Adequate iron stores within the last 3 months as indicated by serum ferritin >= 100 mcg/L or transferrin saturation (TSAT) >= 20%ferritin >= 100 mcg/L; TSAT >= 20%

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

Policy states 'Pretreatment hemoglobin 10 g/dL' interpreted as <= 10 g/dL for initiation

Step therapy / formulary redirection (must meet both)

Retacrit first: 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
Then Epogen: 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 (must not exceed one of the following)

Adults dosing interval: Adults: SC or IV once every two weeksq2w
Also adult option per dosing guidance: 1.2 mcg/kg once monthly for CKD not on dialysis
Pediatrics dosing interval: Pediatrics: SC or IV once every four weeksq4w
Maintain same route as prior ESA in patients <6 years when switching

Member must use Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage

Prior authorization may be required for Retacrit

Then Epogen: If member is unable to use Retacrit, member must use Epogen unless contraindicated or clinically significant adverse effects are experienced

Prior authorization may be required for Epogen

Iron stores: Adequate iron stores within the last 3 months as indicated by serum ferritin >= 100 mcg/L or TSAT >= 20%ferritin >= 100 mcg/L; TSAT >= 20%

Current hemoglobin < 12 g/dL< 12 g/dL

Added requirement for continuation in 2Q 2024 annual review

Dosing interval (must not exceed one of the following)

Adults dosing interval: Adults: SC or IV once every two weeksq2w
Also adult option per dosing guidance: 1.2 mcg/kg once monthly for CKD not on dialysis
Pediatrics dosing interval: Pediatrics: SC or IV once every four weeksq4w

Step Therapy

Step therapy redirection to Retacrit then Epogen

Member must use Retacrit unless contraindicated, clinically significant adverse effects occur, or Retacrit is unavailable; if the member is unable to use Retacrit, the member must use Epogen unless contraindicated or clinically significant adverse effects occur.

Illinois HIM requests: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Billing Rule

Refer to coding guidance

HCPCS codes J0887 and J0888 are listed for informational purposes; inclusion or exclusion does not guarantee coverage. Providers should reference current coding guidance when submitting claims.

J0887
J0888

Denial Risk

Denial risk if ineffective or lab criteria not met

Continuation requests may be denied if the member is not responding to therapy, the current hemoglobin is greater than or equal to 12 g/dL, or adequate iron stores criteria are not met.

Extended continuation therapy approval duration from 6 to 12 months for Medicaid/HIM; revised Retacrit and Epogen redirection language from 'failure of' to 'member must use' and clarified members must use Epogen if unable to use Retacrit; added step therapy bypass for IL HIM per IL HB 5395.

06.30.20added

Added Appendix D referencing KDIGO guidelines that do not indicate preference for any ESA.