CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Mircera (methoxy polyethylene glycol-epoetin beta) coverage for anemia of chronic kidney disease

Defines medical necessity criteria, initial and continuation authorization rules, and requirements for Mircera for treatment of anemia associated with chronic kidney disease (CKD) including pediatric conversion use. Applies to coverage decisions when approval criteria are met and no member exclusions exist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMircera (methoxy polyethylene glycol-epoetin beta) coverage for anemia of chronic kidney disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionProviders must obtain authorization (typically for 12 weeks) demonstrating that hemoglobin and iron parameters meet the specified thresholds and that member is not receiving concomitant ESAs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weekstypical authorization duration (initial and continuation)

<10pretreatment hemoglobin threshold for initial approval

<12current hemoglobin threshold for continuation approval

>=20%minimum TSAT required within prior 3 months

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Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients both on dialysis and not on dialysis, and in pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after hemoglobin stabilization with that ESA.

Indications / Covered Uses

Mircera is covered for FDA-approved indications when approval criteria below are met:

Covered indications (any of the following)

Anemia associated with chronic kidney disease (CKD) in adult patients on dialysis
Anemia associated with CKD in adult patients not on dialysis
Pediatric patients 5 to 17 years of age on hemodialysis converting from another erythropoiesis-stimulating agent (ESA) after hemoglobin was stabilized with an ESA

General coverage condition

Member meets one of the covered indications above
Member has no exclusions to the prescribed therapy
All approval criteria (detailed below) are met

Initial Approval — Anemia due to CKD

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

ALL of the following

Pretreatment hemoglobin is < 10 g/dL
Hemoglobin values due to recent transfusion are excluded from consideration
Member has been assessed for iron deficiency anemia and has adequate iron stores OR is receiving iron therapy
Adequate iron stores defined as TSAT >= 20% within prior 3 months
Member will not use Mircera concomitantly with other erythropoiesis-stimulating agents (ESAs)

Continuation of Therapy — Anemia due to CKD

Authorization for continued treatment may be granted under the following conditions:

ANY of the following

If member has completed >= 12 weeks of ESA therapy
- Current hemoglobin is < 12 g/dL
  Hemoglobin values due to recent transfusion are excluded
- Member has shown response to therapy defined as rise in hemoglobin of > 1 g/dL after at least 12 weeks of ESA therapy
- Member has adequate iron stores (TSAT >= 20% within prior 3 months) or is receiving iron therapy
- Member is not using Mircera concomitantly with other ESAs
If member has not completed 12 weeks of ESA therapy

Not Covered / Experimental

Uses not listed as FDA-approved indications are considered not medically necessary

ALL of the following

Any indication other than the FDA-approved and compendial uses listed above
These are considered experimental/investigational and not medically necessary

Approval Thresholds

Pretreatment hemoglobin for initial approval< 10 g/dL

Current hemoglobin for continuation approval< 12 g/dL

Hemoglobin response to ESA> 1 g/dL rise after >= 12 weeks of ESA therapy

Iron stores requirement (TSAT)>= 20% within prior 3 months

What Providers Must Do

Prior Authorization

Authorization required meeting criteria

Authorization (typically for 12 weeks) is required and will be granted only when hemoglobin and iron parameters meet the policy thresholds and the member is not receiving concomitant erythropoiesis-stimulating agents (ESAs).

authorization duration: 12 weeks
pretreatment hemoglobin < 10 g/dL for initial approval; current hemoglobin < 12 g/dL for continuation (with response criteria)
adequate iron stores defined as TSAT >= 20% within prior 3 months or receiving iron therapy
no concomitant use of other ESAs

Documentation Required

Iron assessment and hemoglobin documentation

Document assessment for iron deficiency with TSAT >= 20% within the prior 3 months or documentation that the member is receiving iron therapy, and document baseline and follow-up hemoglobin values; hemoglobin measurements due to recent transfusion must be excluded from consideration.

Required labs: serum transferrin saturation (TSAT) >= 20% within prior 3 months or evidence of ongoing iron therapy
Document baseline and follow-up hemoglobin values; exclude hemoglobin values due to recent transfusion

Clinical Background

This policy defines medical necessity criteria for Mircera use in CKD-related anemia, including initial and continuation authorization rules and documentation requirements. Authorization may be granted for 12 weeks when specified thresholds are met: for initial approval pretreatment hemoglobin must be < 10 g/dL, members must have been assessed for iron deficiency and have adequate iron stores (TSAT >= 20% within the prior 3 months) or be receiving iron therapy, and members must not receive Mircera concomitantly with other ESAs. For continuation, authorization may be granted when current hemoglobin is < 12 g/dL and the member has shown response to therapy (a rise in hemoglobin of > 1 g/dL after at least 12 weeks of ESA therapy); members who have not completed 12 weeks of ESA therapy may receive authorization for up to 12 weeks. Hemoglobin values due to recent transfusion are excluded from consideration.

OpenPayer

Mircera (methoxy polyethylene glycol-epoetin beta) coverage for anemia of chronic kidney disease

Medical Necessity Criteria for Mircera

What Providers Must Do

Coding / Billing Notes

Defined Terms

At-a-Glance Authorization Metrics

Clinical Background