CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Mircera (methoxy polyethylene glycol-epoetin beta) for anemia of chronic kidney disease — Coverage Criteria

Covers use of Mircera for treatment of anemia associated with chronic kidney disease for Medicaid members, including adults and pediatric patients converting from other ESAs, when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMircera (methoxy polyethylene glycol-epoetin beta) for anemia of chronic kidney disease — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date9/1/2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation of pretreatment and current hemoglobin, evidence of adequate iron stores or therapy, and trial/failure or contraindication to Retacrit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksauthorization period

< 10 g/dLinitial Hgb threshold

< 12 g/dLcontinuation Hgb threshold

3 months–17 yrspediatric age range

RequiredRetacrit requirement

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMircera (methoxy polyethylene glycol-epoetin beta) for anemia of chronic kidney disease — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date9/1/2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation of pretreatment and current hemoglobin, evidence of adequate iron stores or therapy, and trial/failure or contraindication to Retacrit.

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met for initial approval:

Indication: Anemia due to chronic kidney disease (CKD) in adults (on dialysis or not) or pediatric patients 3 months–17 years converting from another ESA after prior hemoglobin stabilization.

FDA-approved indications only; all other indications are considered experimental/investigational and not medically necessary.

Iron status: Member assessed for iron deficiency and has adequate iron stores or is receiving iron therapy.

Hemoglobin values influenced by recent transfusion should be excluded when assessing eligibility.

Prior therapy: Documentation that member has tried and failed Retacrit or has a documented contraindication to Retacrit.

Members may not use Mircera concomitantly with other erythropoiesis-stimulating agents.

Hemoglobin threshold (initial): Pretreatment hemoglobin < 10 g/dL (documentation provided).< 10 g/dL

Authorization of 12 weeks may be granted for initial treatment.

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Current hemoglobin < 12 g/dL (excluding values due to recent transfusion).< 12 g/dL

Authorization of 12 weeks may be granted for continued treatment.

Response to therapy: Member has shown a response with a rise in hemoglobin of > 1 g/dL after at least 12 weeks of ESA therapy; OR member has not completed 12 weeks of ESA therapy.> 1 g/dL rise

Documentation of hemoglobin response or duration of ESA therapy required.

Concomitant therapy restriction: Member may not use Mircera concomitantly with other erythropoiesis-stimulating agents.

Documentation that no concomitant ESA therapy is being given is required.

All indications for Mircera that are not among the FDA‑approved uses listed in this policy are considered experimental/investigational and are not medically necessary. Coverage is limited to the indications and compendial uses specified in the FDA‑approved labeling.

Use of Mircera for any indication other than treatment of anemia due to chronic kidney disease (including the specified pediatric conversion indication) is considered not medically necessary and will not be covered.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Approvals are typically granted for up to 12 weeks and are based on hemoglobin (Hgb) criteria specific to the indication (see clinical criteria).

Typical approval length: 12 weeks
Approval basis: documented hemoglobin thresholds and ESA response

Denial Risk

Concomitant ESA Use / Retacrit Step Requirement

Concomitant ESA use is not permitted. Members may not use Mircera (or the policy drug) concurrently with other erythropoiesis-stimulating agents. Prior authorization requires documentation that the member has tried and failed Retacrit or has a documented contraindication to Retacrit before approval will be considered.

Concomitant use with other ESAs = denial risk
Documentation required: trial and failure of Retacrit or documented contraindication

OpenPayer

Mircera (methoxy polyethylene glycol-epoetin beta) for anemia of chronic kidney disease — Coverage Criteria

Coverage Criteria for Mircera (methoxy polyethylene glycol-epoetin beta)

Hemoglobin Thresholds and Coding Notes

Provider Requirements, Prior Authorization, and Documentation

Definitions and Special Populations

Background