Erythropoiesis-stimulating agents (ESAs) coverage
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Defines preferred and non-preferred erythropoiesis-stimulating agents, prior authorization exception criteria, and coverage rules for Mircera and other ESAs for Wellmark members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Approval / Exception Criteria
Coverage and exception rules for Mircera and targeted epoetin products.
From Exception Criteria A
From Exception Criteria B
Criteria for Initial Approval
Criteria for Initial Approval pediatric conversion
Continuation Therapy
Continuation criteria for Mircera.
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.
Initial Therapy for Mircera
Initial Therapy for Mircera
Initial approval criteria for Mircera.
Initial Approval
Continuation Therapy for Mircera
Continuation Therapy for Mircera
Continuation criteria for Mircera.
Continuation of Therapy
Procedures, Codes, and Clinical Thresholds
Documentation, Prior Authorization, and Prescribing Requirements
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
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
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 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. |
Biosimilar Preference and Reference Brands
Use Retacrit (preferred) instead of reference epoetin alfa brands
Retacrit is the preferred biosimilar and must be used in place of reference epoetin alfa brands (Epogen/Procrit) when applicable; Retacrit is preferred over reference brands for all indications.
- The biosimilar Retacrit is preferred over reference brands for all indications, not only FDA‑approved indications.
Key Definitions
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.
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