CurrentNeighborhood Health Plan of Rhode IslandPolicy 1618-A

Mircera (methoxy polyethylene glycol-epoetin beta)

Defines coverage and authorization criteria for Mircera (methoxy polyethylene glycol-epoetin beta) for treatment of anemia associated with chronic kidney disease (CKD) including adult and pediatric patients, plus continuation criteria and requirements for iron status and non-concomitant ESA use.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMircera (methoxy polyethylene glycol-epoetin beta)

Policy CodePolicy 1618-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization of up to 12 weeks is required for initial and continuation treatment per the listed clinical criteria; providers must request authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

2Covered populations (adult, pediatric 3 months-17y converting from ESA)

12 weeksStandard authorization duration

>=1 g/dLRequired hemoglobin response for continuation

Coverage Summary

Coverage stance: covered_with_criteria for Mircera (methoxy polyethylene glycol-epoetin beta). Scope: Defines coverage and authorization criteria for Mircera for treatment of anemia associated with chronic kidney disease (CKD) including adult and pediatric patients (3 months–17 years converting from another ESA), with requirements for iron status and non-concomitant ESA use. Standard authorization duration: 12 weeks. Members must have adequate iron stores (TSAT >= 20% within prior 3 months or be receiving iron therapy) prior to therapy and may not receive concurrent erythropoiesis-stimulating agents (ESAs).

Initial Therapy Criteria

Initial Authorization - Anemia due to CKD (Adults)

Authorization of 12 weeks may be granted when ALL of the following are met:

ALL of the following

Diagnosis of anemia associated with chronic kidney disease (CKD)
Patient is an adult (on dialysis or not on dialysis)
Pretreatment hemoglobin less than 10 g/dLPretreatment Hgb < 10 g/dL
Pretreatment hemoglobin value excludes values due to a recent transfusion
Member has adequate iron stores OR is receiving iron therapy prior to starting MirceraTSAT >= 20% within prior 3 months
Member is not using Mircera concomitantly with other erythropoiesis-stimulating agents (ESAs)

Initial Authorization - Anemia due to CKD (Pediatrics converting from another ESA)

Authorization of 12 weeks may be granted when ALL of the following are met:

ALL of the following

Diagnosis of anemia associated with CKD
Patient is pediatric, age 3 months to 17 years
Converting from another erythropoiesis-stimulating agent (ESA)
Hemoglobin level was stabilized with an ESA prior to conversion (example: Hgb 10 to 12 g/dL)
Member has adequate iron stores OR is receiving iron therapy prior to starting MirceraTSAT >= 20% within prior 3 months

Continuation Therapy Criteria

Continuation of Therapy - General Requirements

All members requesting continuation after at least 12 weeks must meet ALL of the following:

ALL of the following

Member has been treated with Mircera for at least 12 weeks
Member shows a response with a rise in hemoglobin >= 1 g/dL>= 1 g/dL increase from baseline
Current hemoglobin excludes values due to a recent transfusion
Member has adequate iron stores OR is receiving iron therapyTSAT >= 20% within prior 3 months
Member is not using Mircera concomitantly with other erythropoiesis-stimulating agents (ESAs)

Exception when <12 weeks of therapy

Members who have completed less than 12 weeks of Mircera treatment and have not yet responded (rise in Hgb >= 1 g/dL) may be granted an authorization of up to 12 weeks to allow time to demonstrate a response

Continuation Authorization - Anemia due to CKD (Adults)

Authorization of 12 weeks may be granted for continued treatment when ALL of the following are met:

ALL of the following

Diagnosis of anemia due to CKD
Current hemoglobin less than 12 g/dLCurrent Hgb < 12 g/dL
Current Hgb excludes values due to a recent transfusion
Member has adequate iron stores OR is receiving iron therapyTSAT >= 20% within prior 3 months
Member is not using Mircera concomitantly with other erythropoiesis-stimulating agents (ESAs)

Provider Actions / Authorization

Prior Authorization

Authorization required

Authorization of up to 12 weeks is required for initial and continuation treatment per the listed clinical criteria; providers must request authorization.

Authorization duration: up to 12 weeks for initial or continuation requests per criteria
Applies to adults and pediatric patients converting from another ESA as specified in criteria

Documentation Required

Document hemoglobin and iron status

Document pretreatment and current hemoglobin values (excluding values due to a recent transfusion) and evidence of adequate iron stores: TSAT ≥ 20% within the prior 3 months or documentation that the member is receiving iron therapy.

Pretreatment and current Hgb: exclude values due to recent transfusion
TSAT ≥ 20% within prior 3 months OR documentation of iron therapy

Denial Risk

Concomitant ESA use prohibited

Claims may be denied if Mircera is used concomitantly with other erythropoiesis-stimulating agents (ESAs).

Clinical Evidence & References

Evidence: Mircera [package insert], Vifor (International) Inc.; April 2024. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease, Kidney Int. 2012; Suppl 2:279-335. Mircera is an erythropoiesis-stimulating agent indicated for anemia associated with chronic kidney disease in adults and pediatric patients 3 months to 17 years converting from another ESA.

Background & Definitions

Background: Mircera is indicated for the 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 of age who are converting from another erythropoiesis-stimulating agent (ESA) after hemoglobin was stabilized with an ESA. Members must have adequate iron stores (defined as TSAT >= 20% within the prior 3 months or be receiving iron therapy) prior to initiation or continuation. Members may not use Mircera concomitantly with other ESAs.

Definitions

Adequate iron stores (definition)Serum TSAT >= 20% within the prior 3 months or receiving iron therapy

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMircera (methoxy polyethylene glycol-epoetin beta)

Policy CodePolicy 1618-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization of up to 12 weeks is required for initial and continuation treatment per the listed clinical criteria; providers must request authorization.

SourceLink

On This Page

OpenPayer

Mircera (methoxy polyethylene glycol-epoetin beta)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Exclusions / Concomitant Use

Applicable Codes

Provider Actions / Authorization

Clinical Evidence & References

Background & Definitions

Revision History