CurrentBlue Cross Blue Shield - IowaPolicy 05.04.25

Erythropoiesis-stimulating agents (ESAs) coverage and exception process

Defines preferred and non-preferred ESA products, prior authorization and exception criteria for Mircera, Retacrit, Aranesp, Epogen/Procrit, and coverage rules for members of Wellmark (Blue Cross Blue Shield - Iowa). Applies to prescribers and payers when requesting coverage for these agents.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyErythropoiesis-stimulating agents (ESAs) coverage and exception process

Policy CodePolicy 05.04.25

Change TypeRoutine review — no material changes

Effective DateJan 1, 2024

Next Review DateOct 1, 2024

Key ActionObtain prior authorization and document pretreatment hemoglobin and iron studies (TSAT ≥ 20% or current iron therapy) before approving Mircera.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical approval duration

Retacrit, Aranesppreferred ESA products

TSAT ≥ 20%iron adequacy requirement

10 g/dL / 12 g/dLHb thresholds

Mircera subject

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Coverage Criteria for ESAs (Mircera and others)

Initial Therapy

Covered when ALL of the following are met for initial approval of Mircera in anemia due to CKD:

Initial approval for CKD: Member has pretreatment hemoglobin ≤ 10 g/dL (values due to recent transfusion excluded).Hb ≤ 10 g/dL

Iron assessment: Member has been assessed for iron deficiency and has adequate iron stores (serum transferrin saturation [TSAT] ≥ 20% within the prior 3 months) or is currently receiving iron therapy.TSAT ≥ 20% within prior 3 months

Concomitant ESA use: Member is not using Mircera concomitantly with other erythropoiesis-stimulating agents (ESAs).

Authorization duration note: Authorization of 12 weeks may be granted for the treatment of anemia due to chronic kidney disease.

12-week authorization may be granted

Continuation Therapy

Covered when ALL of the following are met for continuation of Mircera in anemia due to CKD:

Current hemoglobin: Member has a current hemoglobin < 12 g/dL drawn within 30 days of the request.Hb < 12 g/dL (within 30 days)

Demonstrated response: Member has shown a response to therapy with a rise in hemoglobin of ≥ 2 g/dL after at least 12 weeks of ESA therapy.Hb rise ≥ 2 g/dL after ≥ 12 weeks

Iron assessment: Member has been assessed for iron deficiency and has adequate iron stores (TSAT ≥ 20% within the prior 3 months) or is currently receiving iron therapy.TSAT ≥ 20% within prior 3 months

Exception Criteria / Non-preferred coverage

Exception criteria for coverage of non-preferred or targeted products:

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

Exception for Epogen/Procrit: Coverage for Epogen or Procrit is provided when: (1) the member has a documented inadequate response or intolerable adverse event with Aranesp for CKD or chemotherapy-induced anemia, AND (2) the 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.Two-step intolerance/inadequate response

This policy's benefit determinations are governed by the member's contract. Benefits may vary by contract, exclusions or limitations may apply, and individual member benefits must be verified prior to rendering services. The policy may not apply to the Federal Employee Program (FEP); FEP benefit determinations are made by the Federal Employee Program.

Mircera (methoxy polyethylene glycol-epoetin beta) is not medically necessary for continued treatment of anemia due to chronic kidney disease when the member does not meet the continuation criteria specified in this policy. For CKD continuation, those criteria include a current hemoglobin less than 12 g/dL drawn within 30 days and a documented hemoglobin response (rise of ≥ 2 g/dL after at least 12 weeks of ESA therapy); lack of these findings supports a determination of not medically necessary.

Initial Therapy Requirements (Mircera)

Initial therapy (Mircera)

Initial approval requirements for Mircera:

Pretreatment hemoglobin ≤ 10 g/dL (values due to recent transfusion excluded).Hb ≤ 10 g/dL

Iron stores: Assessment for iron deficiency with adequate iron stores (TSAT ≥ 20% within prior 3 months) or current receipt of iron therapy before starting Mircera.TSAT ≥ 20% within prior 3 months

No concomitant ESA: Member may not use Mircera concomitantly with other erythropoiesis-stimulating agents.

Authorization note:

Continuation Criteria (Mircera)

Mircera continuation

Continuation criteria for Mircera in CKD anemia:

Current hemoglobin < 12 g/dL within 30 days of the request.Hb < 12 g/dL (within 30 days)

Hemoglobin response: Documented hemoglobin rise of ≥ 2 g/dL after at least 12 weeks of ESA therapy (authorization of up to 12 weeks may be granted for those who have not completed 12 weeks).Hb rise ≥ 2 g/dL after ≥ 12 weeks

Iron stores: Assessment for iron deficiency with adequate iron stores (TSAT ≥ 20% within prior 3 months) or current receipt of iron therapy.TSAT ≥ 20% within prior 3 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mircera and other targeted erythropoiesis-stimulating agents per the exception criteria. Approvals are typically granted for 12 weeks (initial or continuation as specified) or up to 12 months when clinically appropriate and supported by documentation.

Prior authorization required for Mircera (methoxy polyethylene glycol-epoetin beta).
Typical authorization length: 12 weeks for initial or continued treatment; may be adjusted per policy-specific criteria.

Step Therapy

Try Preferred Products First

Preferred products (Retacrit and Aranesp) must be tried before coverage of non-preferred products. Coverage for Mircera or other non-preferred products is provided only when there is documented inadequate response or an intolerable adverse event to the preferred products.

Member must have documented inadequate response or intolerable adverse event with both preferred products (Retacrit and Aranesp) before Mircera is covered.

Procedures, Codes, and Hemoglobin Thresholds

Procedures and billing codesHCPCS

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

Hemoglobin thresholds

Initial (pretreatment)Pretreatment hemoglobin ≤ 10 g/dL (values due to recent transfusion excluded). Authorization of 12 weeks may be granted for CKD.

Continuation — current HbCurrent hemoglobin < 12 g/dL drawn within 30 days of the request.

Continuation — documented responseDocumented hemoglobin increase ≥ 2 g/dL after at least 12 weeks of ESA therapy.

Definitions and Laboratory Requirements

Adequate iron stores defined

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

Alternative to TSATCurrent receipt of iron therapy (documented) satisfies the adequate iron stores requirement.

Timing of assessmentIron studies demonstrating adequate stores must be performed prior to starting Mircera (within prior 3 months for TSAT).

Background

Erythropoiesis-stimulating agents (ESAs) such as Mircera are used to treat anemia associated with chronic kidney disease. Prior to initiating or continuing ESA therapy, the policy requires objective laboratory documentation of anemia and adequacy of response, and directs verification of member benefits because benefits may vary by contract and the policy may not apply to FEP. For continuation decisions in CKD, the policy specifies a current hemoglobin threshold of < 12 g/dL (drawn within 30 days) and evidence of response as a hemoglobin increase of ≥ 2 g/dL after ≥ 12 weeks of ESA therapy; these clinical thresholds are used to guide prior authorization and medical necessity determinations.

Step Therapy Requirements

Step	Requirement	Failure criteria / exception	Coverage status
1	Member must trial preferred products (Retacrit and Aranesp) prior to coverage of non-preferred/targeted products	Documented inadequate response or intolerable adverse event to both preferred products	Coverage contingent on meeting exception criteria
Notes	Retacrit is preferred over reference brands for all indications; exception process as defined in policy applies	For Epogen/Procrit, additional requirement: inadequate response or intolerable adverse event to Aranesp AND intolerable adverse event to Retacrit that was not an expected adverse event attributed to the active ingredient	Coverage allowed when exception demonstrated

Biosimilar Preference

Billing Rule

Use Retacrit (preferred over Epogen/Procrit)

Retacrit (epoetin alfa biosimilar) is preferred over reference brands Epogen/Procrit for all indications; use Retacrit as the preferred epoetin formulation when clinically appropriate.

Policy states Retacrit will be preferred over the reference brands for all indications, not limited to FDA-approved indications.