ModifiedMass General Brigham Health PlanPolicy N/A

Erythropoiesis Stimulating Agents (ESA) Policy

Defines prior authorization, coverage criteria, continuation and limitations for ESAs (Aranesp, Epogen, Procrit, Mircera, Retacrit) under the pharmacy benefit (specialty designation) for Mass General Brigham Health Plan effective 2025-07-01.

Policy Summary

PayerMass General Brigham Health Plan

PolicyErythropoiesis Stimulating Agents (ESA) Policy

Policy CodePolicy N/A

Change TypeClarified documentation and limitations; material update

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required for ESAs under the pharmacy benefit; document diagnosis, required pretreatment labs and intolerance/response/contraindication to preferred agents, and fill specialty medications at a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

Administrative update clarified documentation requirements and updated Limitations section to indicate Mircera is only approvable for anemia in chronic kidney disease; clarified approval lengths for diagnoses.

Combined all ESA products into one document and updated preferred status historically (noted in prior reviews).

5Listed ESA products

12Covered indications listed

12Approval interval (weeks)

30 daysSurgical transfusion approval length

Coverage Summary & Scope

Scope: This policy defines prior authorization, coverage criteria, continuation and limitations for Erythropoiesis Stimulating Agents (ESAs) — Aranesp, Epogen, Procrit, Mircera, and Retacrit — under the pharmacy benefit with a specialty designation, effective 2025-07-01.

Coverage stance: ESAs are covered with criteria when the diagnosis-specific and general authorization criteria are met (see policy). Preferred agents include Aranesp and Retacrit per historical product placement; some agents are designated preferred vs non-preferred as noted in the policy background. This policy requires specialty pharmacy fulfillment for designated specialty medications.

Key thresholds, continuation criteria, and approval intervals

Pretreatment hemoglobin (general/CKD/MDS/RA/Hep C/Zidovudine/religious objection)< 10 g/dL

Pretreatment hemoglobin (elective noncardiac, nonvascular surgery)< 13 g/dL

Pretreatment hemoglobin (CHF)< 9 g/dL

Pretreatment serum EPO level (MDS / MF / Zidovudine)< 500 mU/mL

Continuation requirement - hemoglobin increase> 1 g/dL after ≥ 12 weeks of ESA treatment

Continuation requirement - current hemoglobin ceiling< 12 g/dL

Approval interval for most diagnoses12 weeks

Approval length for reduction of transfusion for elective noncardiac/nonvascular surgery30 days (no reauthorizations)

Number of listed ESA products5

Initial Therapy Criteria (Diagnosis-specific)

General Authorization Condition

Authorization may be granted when ALL diagnosis-specific criteria are met for the requested indication and treatment with the requested medication (excluding samples or manufacturer assistance):

ALL of the following

Medication is requested for a recognized anemia indication listed in the policy (see diagnosis-specific trees)
Treatment with the requested medication is not obtained as samples or via manufacturer's patient assistance program

Anemia Due to Chronic Kidney Disease (CKD)

Covered when ALL of the following are met:

ALL of the following

Continuation Therapy / Reauthorization Criteria

Operational note (effective 07/01/2025): Administrative updates clarified documentation requirements and the Limitations section, including clarified approval lengths for diagnoses and documentation expectations (material change).

Per the updated limitations, Mircera is only approvable for anemia due to chronic kidney disease; approval lengths for most diagnoses are in 12‑week intervals, with surgical transfusion reduction approvals limited to 30 days.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for erythropoiesis-stimulating agents (ESAs) under the pharmacy benefit. Specialty medications must be filled at a contracted specialty pharmacy; contact phone/fax numbers are provided in the policy.

Specialty fill requirement: medication designated specialty and must be filled at a contracted specialty pharmacy (Medical and Specialty Medications)
Effective date: 07/01/2025

Documentation Required

Documentation of diagnosis and lab values

Providers must document the specific anemia diagnosis and pretreatment hemoglobin. When required by the diagnosis, document pretreatment serum erythropoietin (EPO) level and evidence the member has had an intolerance to, inadequate response to, or a contraindication to Aranesp, Procrit, and Retacrit for requests involving Epogen or Mircera.

Product List / Codes

Product List (no codes provided in document)mixed

Aranesp	darbepoetin alfa
Procrit	epoetin alfa recombinant
Epogen	epoetin alfa recombinant
Mircera	methoxy polyethylene glycol epoetin beta
Retacrit	epoetin alfa recombinant (biosimilar)

Clinical Evidence & References

Prescribing information references: Aranesp (darbepoetin alfa) — December 2024; Epogen (epoetin alfa) — December 2024; Mircera (methoxy polyethylene glycol-epoetin beta) — June 2024; Procrit (epoetin alfa) — April 2024; Retacrit (epoetin alfa-epbx) — June 2024.

Background & Definitions

Background: ESAs stimulate growth and differentiation of stem cells into red blood cell lineages. The policy groups all ESA products together and historically designates certain agents as preferred (Aranesp and Retacrit moved to preferred status in prior updates). The policy applies a specialty pharmacy designation — these medications must be filled at a contracted specialty pharmacy per the specialty fill requirement.

Definitions:

ESA: Erythropoiesis Stimulating Agent.

EPO: Serum erythropoietin level.

Revision History

2025-07-01material_changeLatest

2022-11-16non-material_revision

Prior updates moved Procrit to preferred status (effective 01/01/2023).

2020-11-18non-material_revision

Combined all ESA products into one document and moved Aranesp and Retacrit to preferred status per rebate strategy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyErythropoiesis Stimulating Agents (ESA) Policy

Policy CodePolicy N/A

Change TypeClarified documentation and limitations; material update

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Documented diagnosis of anemia due to CKD

Documentation of pretreatment hemoglobin < 10 g/dL< 10 g/dL

For Epogen and Mircera only

Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Anemia in Members with Malignancy

Covered when ALL of the following are met:

ALL of the following

Documented diagnosis of anemia in malignancy
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Anemia in Myelodysplastic Syndrome (MDS)

Covered when ALL of the following are met:

ALL of the following

Documented diagnosis of anemia in MDS
Documentation of pretreatment hemoglobin 10 g/dL and pretreatment serum erythropoietin (EPO) level < 500 mU/mLHgb 10 g/dL; EPO < 500 mU/mL
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Reduction of Allogeneic RBC Transfusion for Elective, Noncardiac, Nonvascular Surgery

Covered when ALL of the following are met:

ALL of the following

Documentation member is using requested medication for reduction of allogeneic red blood cell transfusion in members scheduled to have an elective, noncardiac, nonvascular surgery
Documentation of pretreatment hemoglobin < 13 g/dL< 13 g/dL
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Anemia in Congestive Heart Failure (CHF)

Covered when ALL of the following are met:

ALL of the following

Documentation member has a diagnosis of anemia in congestive heart failure
Documentation of pretreatment hemoglobin < 9 g/dL< 9 g/dL
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Anemia in Rheumatoid Arthritis (RA)

Covered when ALL of the following are met:

ALL of the following

Documentation member has a diagnosis of anemia in RA
Documentation of pretreatment hemoglobin < 10 g/dL< 10 g/dL
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Anemia Due to Hepatitis C Treatment

Covered when ALL of the following are met:

ALL of the following

Documentation member has a diagnosis of anemia due to Hepatitis C treatment
Documentation of pretreatment hemoglobin < 10 g/dL for those receiving ribavirin with interferon alfa or peginterferon alfa< 10 g/dL
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Anemia Due to Zidovudine in HIV-infected Patients

Covered when ALL of the following are met:

ALL of the following

Documentation member has a diagnosis of anemia due to zidovudine in HIV-infected patients
Documentation of pretreatment hemoglobin < 10 g/dL and pretreatment serum EPO level is 500 mU/mL< 10 g/dL; EPO 500 mU/mL
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Anemia in Members Whose Religious Beliefs Forbid Blood Transfusions

Covered when ALL of the following are met:

ALL of the following

Documentation of diagnosis of anemia in member whose religious beliefs forbid blood transfusions
Documentation of pretreatment hemoglobin < 10 g/dL< 10 g/dL
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Anemia in Primary Myelofibrosis (MF), Post-PV MF, or Post-ET MF

Covered when ALL of the following are met:

ALL of the following

Documentation the member has a diagnosis of anemia in primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
Laboratory requirements
- Pretreatment hemoglobin < 10 g/dL< 10 g/dL
- Pretreatment serum EPO level < 500 mU/mL< 500 mU/mL
For Epogen only
- Documentation the member has had an intolerance to Aranesp, Procrit, and Retacrit
- Documentation the member has had an inadequate response to Aranesp, Procrit, and Retacrit
- Documentation the member has a contraindication to Aranesp, Procrit, and Retacrit

Diagnoses that require a pretreatment serum EPO level: MDS (pretreatment EPO < 500 mU/mL), Zidovudine-related anemia (EPO 500 mU/mL), Primary Myelofibrosis/post-PV/post-ET MF (pretreatment EPO < 500 mU/mL)

Billing Rule

Specialty fill requirement

This medication has been designated specialty and must be filled at a contracted specialty pharmacy. The specialty fill requirement applies to Medical and Specialty Medications as specified in the policy; contact information for the specialty pharmacy is provided.

Applies to Medical and Specialty Medications
Contact Phone: 877-519-1908; Fax: 855-540-3693

Documentation Required

Reauthorization evidence

For reauthorization, provide documentation that the member's hemoglobin has increased by more than 1 g/dL after at least 12 weeks of ESA treatment and that the member's current hemoglobin is less than 12 g/dL. Submit current hemoglobin results and treatment timeline to support continuation.

Required for reauthorization: hemoglobin increase > 1 g/dL after ≥ 12 weeks
Required for reauthorization: current hemoglobin < 12 g/dL
Submit: current hemoglobin lab results and documentation of treatment duration (≥12 weeks)