CurrentNeighborhood Health Plan of Rhode IslandPolicy 1618-A

Mircera (methoxy polyethylene glycol-epoetin beta) coverage

Defines coverage criteria and authorization requirements for Mircera for treatment of anemia due to chronic kidney disease (CKD) for adult and pediatric members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMircera (methoxy polyethylene glycol-epoetin beta) coverage

Policy CodePolicy 1618-A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Mircera; initial and continuation authorizations are generally granted for 12 weeks.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksauthorization duration

Hgb <10 g/dLinitiation Hgb threshold

Hgb <12 g/dLcontinuation Hgb threshold

≥1 g/dL riserequired response

TSAT ≥20%iron stores

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Initial therapy — adults

Covered when ALL of the following are met

Adult CKD initiation: Member has anemia due to chronic kidney disease (CKD) and is an adult (on dialysis or not on dialysis); pretreatment hemoglobin is less than 10 g/dL (excluding values due to a recent transfusion); adequate iron stores defined as TSAT ≥20% within the prior 3 months or member is receiving iron therapy; member is not using Mircera concomitantly with other erythropoiesis-stimulating agents.pretreatment Hgb < 10 g/dL; TSAT ≥20% (within prior 3 months)

Authorization of 12 weeks may be granted.

Initial therapy — pediatric conversion

Covered when ALL of the following are met

Pediatric conversion: Patient is 3 months to 17 years of age and converting from another erythropoiesis-stimulating agent (ESA) after hemoglobin was stabilized on that ESA (e.g., Hgb ~10–12 g/dL); adequate iron stores defined as TSAT ≥20% within the prior 3 months or receiving iron therapy; not using Mircera concomitantly with other ESAs.stable Hgb ~10–12 g/dL prior to conversion; TSAT ≥20% (within prior 3 months)

Authorization of 12 weeks may be granted.

Continuation of therapy

Covered when ALL of the following are met

Response after ≥12 weeks: Member has received at least 12 weeks of Mircera therapy and demonstrates a hemoglobin rise ≥1 g/dL (values due to recent transfusion excluded).≥1 g/dL

Members with <12 weeks of therapy and no response may receive up to 12 additional weeks of authorization to assess response.

Continuation hemoglobin threshold: Current hemoglobin is less than 12 g/dL (excluding values due to a recent transfusion); adequate iron stores (TSAT ≥20% within prior 3 months) or receiving iron therapy; member is not using Mircera concomitantly with other ESAs.Current Hgb < 12 g/dL; TSAT ≥20% (within prior 3 months)

Authorization of 12 weeks may be granted for continued treatment.

Coverage of Mircera (methoxy polyethylene glycol-epoetin beta) is limited to the treatment of anemia associated with chronic kidney disease (CKD) when the member meets the specific clinical criteria in this policy. This includes initiation and continuation criteria for adult members with CKD and defined criteria for pediatric patients converting from another erythropoiesis-stimulating agent. Authorization durations and response requirements described elsewhere in this policy apply to covered uses.

Use of Mircera for indications other than the FDA‑approved indication for anemia due to chronic kidney disease (CKD) — including any adult or pediatric use not described in this policy — is considered experimental/investigational and is not medically necessary.

Documentation, Prior Authorization, and Provider Requirements

Denial Risk

Concomitant ESA use — do not co-administer

Members may not use Mircera concomitantly with other erythropoiesis-stimulating agents (ESAs). Concomitant use is a denial risk and will be reviewed; submit documentation showing Mircera is the only ESA being administered.

Affected therapies: epoetin alfa, darbepoetin alfa, other ESAs

Documentation Required

Iron status and hemoglobin documentation required

All members must be assessed for iron deficiency anemia and have adequate iron stores before initiating or continuing Mircera. Adequate iron stores are defined as a serum transferrin saturation (TSAT) ≥ 20% within the prior 3 months, or documentation the member is receiving ongoing iron therapy.

Required lab: TSAT ≥ 20% within prior 3 months
Or documentation of current iron therapy

Prior Authorization

Pediatric conversion requirement

Pediatric members (3 months to 17 years) converting to Mircera must have prior stabilization on another ESA. Provide documentation of prior hemoglobin stabilization (for example, Hgb 10–12 g/dL) while on the previous ESA before authorization will be considered.

Age range: 3 months–17 years
Documentation: prior ESA regimen and hemoglobin values showing stabilization (e.g., Hgb 10–12 g/dL)

Prior Authorization

Prior authorization duration — typical 12-week authorizations

Initial and continuation authorizations are generally granted for 12 weeks for eligible members; ensure documentation supports the applicable initial or continuation criteria (including hemoglobin response for continuation).

Initial authorization: up to 12 weeks for adults with pretreatment Hgb <10 g/dL
Pediatric conversion: up to 12 weeks per conversion criteria
Continuation: up to 12 weeks; continuation requires Hgb rise ≥1 g/dL after ≥12 weeks or may grant up to 12 weeks to allow response

Key Definitions

Adequate iron stores

TSAT thresholdSerum transferrin saturation (TSAT) ≥20% within the prior 3 months.

Alternate evidenceDocumentation that the member is receiving iron therapy when TSAT is not documented.

Timing of assessmentIron stores must be assessed prior to initiation and again for continuation of therapy as noted in policy.

Pediatric conversion

Age range for pediatric conversionPatients 3 months to 17 years of age.

Conversion requirementConverting patients must have been stabilized on another ESA prior to switching to Mircera.

Example stabilized hemoglobinStabilized hemoglobin example provided in policy: Hgb ~10–12 g/dL prior to conversion.

OpenPayer

Mircera (methoxy polyethylene glycol-epoetin beta) coverage

Mircera Coverage Criteria

Coding and Authorization Details

Documentation, Prior Authorization, and Provider Requirements

Key Definitions

Background