CurrentMass General Brigham Health PlanPolicy N/A

Erythropoiesis Stimulating Agents

Prior authorization and coverage criteria for erythropoiesis stimulating agents (Aranesp/darbepoetin alfa; Epogen/epoetin alfa; Procrit/epoetin alfa; Retacrit/epoetin alfa-epbx) when provided via the medical benefit to Mass General Brigham Health Plan members, including approved diagnoses, initial and continuation criteria, limitations and authorization durations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyErythropoiesis Stimulating Agents

Policy CodePolicy N/A

Change TypeRevised; clarified; annual review

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization required for ESAs under the medical benefit; provide recent hemoglobin values and supporting documentation as specified.

SourceLink

POLICY UPDATE CHANGES

Policy updated to better reflect agents with prior authorization on medical benefit and Mircera removed as it was available on medical benefit without prior authorization.

Performed annual medical criteria review and updated agents requiring prior authorization on medical benefit.

Clarified criteria for members with CRF who were stable on an ESA previously (not a new member and no previous approval on file) with higher Hb levels must meet initial criteria.

Separated Rx vs medical benefit policies and removed preferred product requirement for requests under medical benefit.

8Approved Indications

60dHb documentation window (typical)

various

Typical initial auth durations

Coverage Summary

Prior authorization and coverage criteria for erythropoiesis stimulating agents (ESAs) — Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa), and Retacrit (epoetin alfa-epbx) when provided via the medical benefit to Mass General Brigham Health Plan members. The policy applies to the medical benefit (contact information and billing instructions provided) and aligns with the MassHealth UPPL. Covered diagnoses include: anemia of chronic renal failure, anemia post-renal transplant, anemia due to chemotherapy for cancer, anemia due to myelosuppressive HIV regimens (e.g., zidovudine), anemia due to myelosuppressive hepatitis C regimens, decreasing need for blood transfusions in surgery patients, and idiopathic sideroblastic anemia / myelodysplastic syndrome (MDS). The policy specifies initial and continuation criteria with documentation requirements (including hemoglobin values within specified windows, GFR calculations using the National Kidney Foundation calculator, and prescriber attestation when applicable), limitations on authorizations by indication (duration varies by diagnosis), and operational notes for hemodialysis billing and members new to the plan. Status: CURRENT, coverage stance: covered_with_criteria.

Quick facts & thresholds

Typical Hb documentation window60 days

Surgery Hb documentation window30 days (surgery indication)

Number of approved indications8

GFR cutoffs for CRF criteriaGFR < 30 mL/min OR GFR 30-60 mL/min with other causes of anemia ruled out

Continuation Hb thresholdHemoglobin < 12 g/dL (dated within the last 60 days)

General Authorization / New-to-Plan

Authorization may be granted for members when ALL the following criteria are met; and documentation is provided:

ALL of the following

Member is new to Mass General Brigham Health Plan or member is currently receiving treatment with the requested ESA (authorization for members currently receiving treatment may be reviewed case-by-case; excludes products obtained as samples or via manufacturer patient assistance programs).
Appropriate diagnosis consistent with an approved indication (e.g., anemia of chronic renal failure, post-renal transplant anemia, anemia due to chemotherapy for cancer, anemia due to myelosuppressive regimen for HIV or Hepatitis C, idiopathic sideroblastic anemia/myelodysplastic syndrome, decrease need for blood transfusions for planned surgery).
ONE of the following (Hemoglobin criteria)
- Hemoglobin (Hb) measurement with value and date provided

Initial Therapy Criteria (by indication)

Anemia due to Chronic Renal Failure (CRF) - Initial Authorization

Authorization when ALL of the following are met; documentation required:

ALL of the following

ONE of the following
- Hemoglobin (Hb) < 10 g/dL (dated within the last 60 days)Hb < 10 g/dL
- Member is noted to be stable on one of the ESA agents previously and Hb < 12 g/dL (dated within the last 60 days)Hb < 12 g/dL
  For members stable on ESA previously
- Member is a child and is noted to be symptomatic with a Hb < 11 g/dL

Continuation Therapy Criteria

Continuation of Therapy - Chronic Renal Failure, Post-Renal Transplant, Idiopathic Sideroblastic Anemia/MDS

Authorization for continuation when ONE of the following is met:

ONE of the following

Hemoglobin level < 12 g/dL (dated within the last 60 days)Hb < 12 g/dL
Hemoglobin level > 12 g/dL (dated within the last 60 days) and request addresses if erythropoietin dose is to be held or reduced to remain within appropriate targetHb > 12 g/dL
Requires documentation about dose hold/reduction

Continuation of Therapy - Chemotherapy or HIV myelosuppressive regimen

Authorization for continuation when ALL of the following are met:

Applicable Codes

Medical benefit J-codes / HCPCS (implied: medical benefit administration/billing guidance)HCPCS

No codes listed

Pharmacy benefit referencemixed

No codes listed

Clinical Evidence & Background

Erythropoiesis Stimulating Agents (ESAs) promote the growth and differentiation of stem cells into specific blood cell lineages. This policy aligns coverage with the MassHealth UPPL and specifies clinical thresholds and documentation requirements for use across indications including renal failure, post-renal transplant, chemotherapy-induced anemia, HIV zidovudine-associated anemia, hepatitis C regimen–related anemia, surgery-related transfusion avoidance, and myelodysplastic syndrome/sideroblastic anemia.

Evidence and references include manufacturer prescribing information for Epogen, Procrit, Retacrit, and Aranesp (2024–2025) and guideline sources such as KDIGO/KDOQI, NCCN, and ASCO/ASH.

Definitions

GFR (definition)Glomerular filtration rate; for calculations use National Kidney Foundation calculator

Hb (definition)Hemoglobin

ESA (definition)Erythropoiesis Stimulating Agent

Thresholds & Quick Reference

Named thresholds (quick reference)

Adult CRF — initial HbHb < 10 g/dL (dated within the last 60 days)

Adult stable on ESAHb < 12 g/dL (dated within the last 60 days)

Pediatric symptomaticChild symptomatic with Hb < 11 g/dL

Surgery patientsHb < 13 g/dL (dated within the last 30 days) — surgery planned within 3 months

Hepatitis C (severe)Hb < 8.5 g/dL (dated within the last 60 days)

Continuation thresholdHemoglobin < 12 g/dL (dated within the last 60 days)

GFR cutoffs

Revision History

2025-06-01policy_updateLatest

Effective 06/01/2025: Policy updated to better reflect agents with prior authorization on the medical benefit; Mircera removed because it was available on the medical benefit without prior authorization; formatting and references updated.

2023-10-02clarification

Effective 10/02/2023: Clarified criteria for members with chronic renal failure who were stable on an ESA previously (not new to plan and no previous approval on file) — higher hemoglobin levels must meet initial criteria; formatting updates.

2023-06-05policy_update

Policy Summary

PayerMass General Brigham Health Plan

PolicyErythropoiesis Stimulating Agents

Policy CodePolicy N/A

Change TypeRevised; clarified; annual review

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization required for ESAs under the medical benefit; provide recent hemoglobin values and supporting documentation as specified.

SourceLink

On This Page

Hb result must be dated within the last 60 days unless otherwise specified by indication; for surgery indication Hb must be dated within the last 30 days.

Member is noted to be stable on one of the ESA agents previously and Hb < 12 g/dL

Hb dated within the last 60 days

Member is a child who is symptomatic with Hb < 11 g/dL

Hb dated within the last 60 days

Member is noted to be stable on one of the ESA agents previously and Hb > 12 g/dL with prescriber attestation that erythropoietin dose will be held or reduced to remain within appropriate target

Hb dated within the last 60 days

ONE of the following (Renal function for CRF)

Glomerular filtration rate (GFR) < 30 mL/min
For all GFR calculations, use the National Kidney Foundation calculator.
Glomerular filtration rate (GFR) 30-60 mL/min with documentation that other causes of anemia have been ruled out (iron, vitamin B12, folate deficiency, and hemolysis)
For all GFR calculations, use the National Kidney Foundation calculator.

Documentation of relevant supportive information as applicable (e.g., paid claims or physician documentation that member continues to receive the causative myelosuppressive agent for chemotherapy/HIV/Hepatitis C indications; prescriber attestation and plan for dose adjustment if Hb above target; planned surgery date for transfusion-sparing use).

Prior Authorization

Prior authorization required

Prior authorization is required for medical benefit coverage of Aranesp, Epogen, Procrit, and Retacrit. Authorization for members new to Mass General Brigham Health Plan who are currently receiving treatment with the requested ESA may be reviewed case-by-case (this does not apply when the product was obtained as samples or via manufacturer patient assistance programs). Providers must document the most recent hemoglobin (Hb) value and the date of the test in the authorization request (Hb must generally be dated within the last 60 days unless otherwise specified by indication; for preoperative/surgery indications Hb must be within the last 30 days).

Products: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa), Retacrit (epoetin alfa-epbx)
Documentation required: most recent Hb value and date (within 60 days unless otherwise specified); indication-specific labs or attestation (e.g., GFR calculation, documentation of continued causative agent, planned surgery date)
Case-by-case review: applies for members new to plan who are currently receiving treatment (excludes samples and manufacturer patient assistance program-supplied products)

Pediatric symptomatic threshold

Member is noted to be stable on one of the ESA agents previously and Hb > 12 g/dL (dated within the last 60 days) with prescriber attestation that erythropoietin dose will be held or reduced to remain within appropriate targetHb > 12 g/dL

Requires prescriber attestation

ONE of the following GFR conditions

Glomerular filtration rate (GFR) < 30 mL/minGFR < 30 mL/min
Glomerular filtration rate (GFR) 30-60 mL/min and other causes of anemia have been ruled out (iron, vitamin B12, folate deficiency and hemolysis)GFR 30-60 mL/min
Requires documentation ruling out other causes

Member is NOT receiving hemodialysis

If member is receiving hemodialysis, prescriber must contact dialysis clinic for proper billing procedure as medication is provided by the clinic.

Anemia post-renal transplant - Initial Authorization