CurrentBlue Cross Blue Shield - IowaPolicy 05.04.25

Erythropoiesis-stimulating agents (ESAs) coverage

Defines preferred and non-preferred erythropoiesis-stimulating agents, prior authorization exception criteria, and coverage rules for Mircera and other ESAs for Wellmark members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyErythropoiesis-stimulating agents (ESAs) coverage

Policy CodePolicy 05.04.25

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review DateJan 1, 2026

Key ActionObtain prior authorization and document TSAT ≥ 20% (or ongoing iron therapy) and required hemoglobin values when requesting Mircera.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

TSAT ≥ 20%minimum TSAT

< 10 g/dLinitial Hgb (CKD)

< 12 g/dLcontinuation Hgb (CKD)

Preferredbiosimilar preference

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Initial Approval / Exception Criteria

Coverage and exception rules for Mircera and targeted epoetin products.

Mircera Exception: Coverage for non-preferred Mircera is provided when the member has a documented inadequate response or intolerable adverse event with BOTH preferred products (Aranesp and Retacrit).

From Exception Criteria A

Targeted product (Epogen/Procrit) Exception: Coverage for Epogen or Procrit is provided when BOTH: (1) member has a documented inadequate response or intolerable adverse event with the preferred product Aranesp when prescribed for anemia due to CKD or for chemotherapy-induced anemia, AND (2) member has a documented intolerable adverse event with Retacrit that was NOT an expected adverse event attributed to the active ingredient per the prescribing information.

From Exception Criteria B

Initial approval for Mircera in adult CKD: Authorization up to 12 months may be granted for adults with pretreatment hemoglobin < 10 g/dL. Must assess for iron deficiency and have TSAT ≥ 20% within prior 3 months or be receiving iron therapy. No concomitant use with other ESAs or HIF-PHIs.Hgb < 10 g/dL; TSAT ≥ 20%

Criteria for Initial Approval

Pediatric conversion to Mircera: Authorization up to 12 months may be granted for pediatric members (3 months to 17 years) converting from another ESA after hemoglobin was stabilized (e.g., Hgb 10-12 g/dL).Hgb 10-12 g/dL stabilization

Criteria for Initial Approval pediatric conversion

Continuation Therapy

Continuation criteria for Mircera.

Continuation for CKD: Authorization up to 12 months may be granted for continued treatment when current hemoglobin is less than 12 g/dL. Must have adequate iron stores (TSAT ≥ 20% within prior 3 months) or be receiving iron therapy. No concomitant use with other ESAs or HIF-PHIs.Hgb < 12 g/dL; TSAT ≥ 20%

Continuation of Therapy criteria

This policy may not apply to members covered under the Federal Employee Program (FEP). Benefit determinations are based on the applicable contract language in effect at the time services were rendered; exclusions, limitations, or exceptions may apply and individual member benefits must be verified. Wellmark will determine medical necessity only when the benefit exists and no contract exclusions are applicable. For FEP members, benefits are determined by the Federal Employee Program.

When a patient does not meet the listed Mircera initial or continuation criteria, Mircera (methoxy polyethylene glycol-epoetin beta) is considered not medically necessary. Coverage for continued treatment is contingent on meeting the continuation criteria (for example, current hemoglobin thresholds); if those criteria are not satisfied, coverage will be denied as not medically necessary.

Procedures, Codes, and Clinical Thresholds

Procedures/Billing codesHCPCS

J0885	Injection, epoetin alfa, (for non-esrd use), 1000 units
Q4081	Injection, epoetin alfa, 100 units (for esrd on dialysis)
J0887	Injection, epoetin beta, 1 microgram, (for esrd on dialysis)
J0888	Injection, epoetin beta, 1 microgram, (for non esrd use)

Hemoglobin thresholds — initial and continuation Hgb thresholds and pediatric conversion guidance

Adult initial pretreatment hemoglobinPretreatment Hgb < 10 g/dL (values due to a recent transfusion excluded).

Pediatric conversion hemoglobinPediatric members (3 months to 17 years) converting from another ESA must have stabilized Hgb (e.g., 10–12 g/dL).

Continuation hemoglobin thresholdCurrent Hgb < 12 g/dL for continued treatment (authorization up to 12 months).

Concomitant therapy restrictionNo concomitant use of Mircera with other ESAs or HIF-PHI agents when initiating or continuing therapy.

Transfusion exclusion notePretreatment and documented Hgb values exclude values due to a recent transfusion.

Documentation, Prior Authorization, and Prescribing Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — prior authorization is required for non-preferred erythropoiesis-stimulating agents (ESAs) and for Mircera when requested. The prior authorization process documents clinical rationale and confirms whether coverage criteria and exception requirements are met.

Non-preferred ESAs and Mircera require prior authorization
Exception process documented in coverage review

Step Therapy

Preferred-first Requirement

Preferred-first requirement — use of preferred products is required before coverage of non-preferred or targeted products. Documentation of prior inadequate response or intolerable adverse events to preferred agents is required to approve non-preferred ESAs or Mircera.

Retacrit (biosimilar) and Aranesp are preferred products
Coverage for Epogen or Procrit requires documented inadequate response or intolerable adverse event to Aranesp
Coverage for Mircera requires documented inadequate response or intolerable adverse events to both preferred products

Documentation Required

Required Laboratory and Hemoglobin Documentation

Required laboratory and hemoglobin documentation — members must have iron stores assessed and documented before initiating or continuing Mircera. TSAT must be ≥ 20% within the prior 3 months or the member must be receiving iron therapy. Pretreatment hemoglobin requirements exclude values due to a recent transfusion. For continuation of therapy in CKD-related anemia, authorization may be granted for 12 months when current hemoglobin is < 12 g/dL.

Document serum transferrin saturation (TSAT) ≥ 20% within the prior 3 months OR documentation the member is receiving iron therapy
Document pretreatment hemoglobin (exclude values due to recent transfusion)
For CKD-related anemia continuation: current hemoglobin < 12 g/dL supports 12-month authorization

Denial Risk

Denial for Not Meeting Mircera Criteria

Denial Risk — Mircera is not medically necessary and will be denied if the member does not meet both the Mircera exception criteria and the applicable initial/continuation criteria.

Mircera requires meeting BOTH the Exception Criteria for Mircera and the Criteria for Initial Approval/Continuation when applicable
If criteria are not met, Mircera is considered not medically necessary

Step Therapy Requirements

Requirement	Details
Step therapy requirement	Trials of preferred agents (Aranesp and Retacrit) are required before coverage of non-preferred targeted products unless exception criteria are met; coverage for non-preferred Mircera is allowed when the member has a documented inadequate response or intolerable adverse event with BOTH preferred products.
Exception pathway for Epogen/Procrit	Coverage for Epogen or Procrit is allowed when: (1) the member has a documented inadequate response or intolerable adverse event with the preferred product Aranesp for CKD- or chemotherapy-related anemia, AND (2) the member has a documented intolerable adverse event with Retacrit that was not an expected active-ingredient adverse event per prescribing information.
Prior authorization	Prior authorization is required to document trials of preferred agents or to apply an exception; approvals are granted following review of the exception criteria.

Background and Clinical Context

Erythropoiesis-stimulating agents (ESAs) are used to treat anemia associated with chronic kidney disease and other causes. This policy defines preferred ESAs and an exception process for non-preferred products, and it establishes clinical thresholds and documentation requirements to support prior authorization decisions. For anemia due to chronic kidney disease, Mircera may be authorized for up to 12 months when continuation criteria are met (for example, current hemoglobin < 12 g/dL and adequate iron stores). Providers should verify member benefits and any contract-specific exclusions before requesting ESA therapy, as this policy may not apply to FEP where benefits are determined by the Federal Employee Program.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyErythropoiesis-stimulating agents (ESAs) coverage

Policy CodePolicy 05.04.25

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review DateJan 1, 2026

Key ActionObtain prior authorization and document TSAT ≥ 20% (or ongoing iron therapy) and required hemoglobin values when requesting Mircera.

SourceLink

On This Page

OpenPayer

Erythropoiesis-stimulating agents (ESAs) coverage

Coverage and Medical Necessity Criteria

Initial Therapy for Mircera

Continuation Therapy for Mircera

Procedures, Codes, and Clinical Thresholds

Documentation, Prior Authorization, and Prescribing Requirements

Step Therapy Requirements

Biosimilar Preference and Reference Brands

Key Definitions

Background and Clinical Context