Currentblue cross blue shield - tennesseePolicy ID_CHS_2025

Epoetin Alfa Products (Epogen®, Procrit®, Retacrit®)

Medical policy defining covered indications, prior authorization documentation and clinical criteria for initiation and continuation of epoetin alfa products for anemia across specified indications (CKD, chemotherapy-induced, zidovudine-related HIV, perioperative reduction of transfusion, MDS, myelofibrosis, palliative cancer, and patients who will not/cannot receive transfusions). Also states compendial uses considered covered and declares other uses investigational.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyEpoetin Alfa Products (Epogen®, Procrit®, Retacrit®)

Policy CodePolicy ID_CHS_2025

Change TypeReferences updated

Effective DateJun 2, 2026

Next Review Date

Key ActionSubmit chart notes, labs (current hemoglobin within 30 days and TSAT within prior 3 months) and documentation of iron status to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

Policy references and package inserts updated (Epogen Dec 2024; Procrit Apr 2024; Retacrit Jun 2024) and effective date listed as 6/2/2026.

8Covered Indications (listed)

≥1Required lab thresholds

3Referenced products

Coverage Summary & Scope

This policy is a payer-level medical policy for epoetin alfa products (Epogen, Procrit, Retacrit) that defines covered indications, prior authorization documentation, and clinical criteria for initiation and continuation. Covered indications include FDA-approved uses: anemia due to chronic kidney disease (CKD), anemia from myelosuppressive chemotherapy (non-myeloid malignancy), anemia due to zidovudine in HIV-infected patients, and reduction of allogeneic RBC transfusion risk for elective noncardiac, nonvascular surgery. Compendial uses considered covered include symptomatic anemia in myelodysplastic syndromes (MDS), myelofibrosis-associated anemia, anemia in patients who will not/cannot receive transfusions, and anemia in cancer patients undergoing palliative treatment. Other uses not specifically listed under the FDA-approved indications or the listed compendial uses are considered investigational and not medically necessary.

Key clinical thresholds

Pretreatment hemoglobin< 10 g/dL (for most initial therapy indications)

Pretreatment hemoglobin for perioperative reduction>10 to ≤13 g/dL

Continuation hemoglobin< 12 g/dL (for continuation across indications)

Pretreatment serum EPO≤ 500 mU/mL

Transferrin saturation (TSAT)≥ 20% within prior 3 months or receiving iron therapy

Zidovudine dosing≤ 4200 mg per week

Initial Therapy Criteria

Covered Indications - Initial Therapy

Covered when ALL of the following are met for each indication as specified:

ALL of the following

Indication - one of
- Anemia due to chronic kidney disease (CKD)
  - Pretreatment hemoglobin less than 10 g/dL< 10 g/dL
- Anemia due to myelosuppressive chemotherapy (non-myeloid malignancy)
  - Pretreatment hemoglobin less than 10 g/dL< 10 g/dL
    There must be a minimum of two additional months of planned chemotherapy upon initiation
- Anemia due to zidovudine in HIV-infected patients
  - Zidovudine dosing: Currently receiving zidovudine at ≤ 4200 mg per week≤ 4200 mg/week
  - Pretreatment serum EPO: Pretreatment endogenous serum erythropoietin (EPO) level ≤ 500 mU/mL≤ 500 mU/mL
  - Pretreatment hemoglobin less than 10 g/dL< 10 g/dL
- Reduction of allogeneic RBC transfusion for elective, noncardiac, nonvascular surgery
  - Surgical timing: Member scheduled for elective, noncardiac, nonvascular surgery
  - Pretreatment hemoglobin greater than 10 to less than or equal to 13 g/dL>10 to ≤13 g/dL
    Member is at high risk for perioperative blood loss; not indicated if willing to donate autologous blood preoperatively
- Symptomatic anemia in myelodysplastic syndromes (compendial use)
  - Pretreatment hemoglobin less than 10 g/dL< 10 g/dL
- Myelofibrosis-associated anemia (compendial use)
  - Pretreatment serum EPO level less than 500 mU/mL< 500 mU/mL
  - Pretreatment hemoglobin less than 10 g/dL< 10 g/dL
- Anemia in members who will not/cannot receive blood transfusions
  - Pretreatment hemoglobin less than 10 g/dL< 10 g/dL
    Examples: religious beliefs
- Anemia due to cancer in members undergoing palliative treatment (compendial use)
  - Pretreatment hemoglobin less than 10 g/dL< 10 g/dL
Global requirements
- Iron assessment: All members must be assessed for iron deficiency anemia and have adequate iron stores (TSAT ≥ 20% within prior 3 months) or be receiving iron therapy before starting epoetin alfaTSAT ≥ 20% within prior 3 months or receiving iron therapy
- Transfusion exclusion: Values for pretreatment hemoglobin exclude values due to a recent transfusion
- Concomitant therapy exclusion: Members may not use epoetin alfa concomitantly with other erythropoiesis stimulating agents (ESAs) or with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)

Continuation Therapy Criteria

Continuation of Therapy

Continuation is covered when ALL of the following are met as specified per indication:

ALL of the following

Indication-specific continuation criteria - one of
- Anemia due to CKD
  - Current hemoglobin less than 12 g/dL< 12 g/dL
- Anemia due to myelosuppressive chemotherapy (non-myeloid malignancy)
  - Current hemoglobin less than 12 g/dL< 12 g/dL
- Anemia in myelodysplastic syndrome (MDS)
  - Current hemoglobin less than 12 g/dL< 12 g/dL
- Reduction of allogeneic RBC transfusion for elective, noncardiac, nonvascular surgery
  - Initial criteria: All members requesting continuation must meet all initial authorization criteria
- Anemia due to zidovudine in HIV-infected patients
  - Receiving zidovudine
  - Current hemoglobin less than 12 g/dL< 12 g/dL
- Anemia in members who will not/cannot receive blood transfusions
  - Current hemoglobin less than 12 g/dL< 12 g/dL
- Myelofibrosis-associated anemia
  - Current hemoglobin less than 12 g/dL< 12 g/dL
- Anemia due to cancer in members undergoing palliative treatment
  - Current hemoglobin less than 12 g/dL< 12 g/dL
Global continuation requirements
- Iron assessment: All members must be assessed for iron deficiency anemia and have adequate iron stores (TSAT ≥ 20% within prior 3 months) or be receiving iron therapy before continuationTSAT ≥ 20% within prior 3 months or receiving iron therapy
- Transfusion exclusion: Values for current hemoglobin exclude values due to a recent transfusion
- Concomitant therapy exclusion: Members may not use epoetin alfa concomitantly with other erythropoiesis stimulating agents (ESAs) or HIF-PHIs

Not Medically Necessary / Investigational

Uses not listed under the FDA-approved indications or the listed compendial uses are considered experimental/investigational and not medically necessary.

ALL of the following

Not listed indications: Any indication not specifically listed under FDA-approved indications or the listed compendial uses (MDS, myelofibrosis, palliative cancer, patients who will not/cannot receive transfusions) is considered investigational/not medically necessary

Operational requirements: the policy excludes concomitant use of epoetin alfa with other erythropoiesis-stimulating agents (ESAs) or with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), and it requires assessment of iron stores prior to initiation or continuation — defined as transferrin saturation (TSAT) ≥ 20% within the prior 3 months or documentation that the member is receiving iron therapy.

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required with documentation

Submission of chart notes, medical records, or laboratory results is required to initiate prior authorization review. Provide current hemoglobin (within the last 30 days) and TSAT measured within the prior 3 months. Note: specific pretreatment endogenous serum erythropoietin (EPO) levels are required for some indications (e.g., zidovudine-related anemia and myelofibrosis require pretreatment serum EPO ≤ 500 mU/mL).

Documentation Required

Iron status documentation

Document serum transferrin saturation (TSAT) ≥ 20% within the prior 3 months, or document that the member is receiving iron therapy, before initiation or continuation of epoetin alfa.

Documentation Required

Exclude post-transfusion lab values

Pretreatment and current hemoglobin values used to determine eligibility must exclude values attributable to a recent blood transfusion.

Billing Rule

Concomitant ESA/HIF-PHI exclusion

Do not authorize concurrent use of epoetin alfa with other erythropoiesis-stimulating agents (ESAs) or with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs); concomitant use is not allowed.

Background & Definitions

Background/indication summary: epoetin alfa is approved for treatment of anemia due to CKD, anemia from myelosuppressive chemotherapy (with at least two additional months of planned chemotherapy at initiation), anemia due to zidovudine in HIV patients (with EPO ≤ 500 mU/mL and zidovudine ≤ 4200 mg/week), and for reduction of perioperative allogeneic RBC transfusion in elective noncardiac, nonvascular surgery for patients with pretreatment hemoglobin >10 to ≤13 g/dL. Compendial uses include MDS, myelofibrosis-associated anemia, patients who will not/cannot receive transfusions, and palliative cancer. The policy-level requirements include assessment of iron stores (TSAT ≥ 20% within prior 3 months or receiving iron therapy) and exclusion of concurrent use with other ESAs or HIF-PHIs.

Term	Definition
Adequate iron stores
Serum transferrin saturation (TSAT) ≥ 20% within the prior 3 months or receiving iron therapy
Pretreatment/current hemoglobin exclusion
Hemoglobin values attributable to a recent transfusion are excluded from consideration

Policy Summary

Payerblue cross blue shield - tennessee

PolicyEpoetin Alfa Products (Epogen®, Procrit®, Retacrit®)

Policy CodePolicy ID_CHS_2025

Change TypeReferences updated

Effective DateJun 2, 2026

Next Review Date

Key ActionSubmit chart notes, labs (current hemoglobin within 30 days and TSAT within prior 3 months) and documentation of iron status to initiate prior authorization review.

SourceLink

On This Page

OpenPayer

Epoetin Alfa Products (Epogen®, Procrit®, Retacrit®)

Coverage Summary & Scope

Initial Therapy Criteria

Continuation Therapy Criteria

Not Medically Necessary / Investigational

Provider Actions & Prior Authorization Requirements

Referenced Drug Products / Codes

Clinical Evidence & References

Background & Definitions

Revision History

Epogen	epoetin alfa (Amgen) - referenced package insert Dec 2024
Procrit	epoetin alfa (Janssen) - referenced package insert Apr 2024
Retacrit	epoetin alfa (Pfizer) - referenced package insert Jun 2024