CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Epogen-Procrit-Retacrit Non-Oncology

Defines coverage and authorization criteria for epoetin alfa (Epogen, Procrit, Retacrit) for non-oncology indications (FDA-approved and compendial) for Medicaid members, including initial and continuation criteria, limits of use, and requirement to try/contraindicate Retacrit before Epogen or Procrit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEpogen-Procrit-Retacrit Non-Oncology

Policy CodePolicy N/A

Change TypeClarified; Revised

Effective DateJan 1, 2019

Next Review DateN/A

Key ActionProviders must obtain prior authorization and document pretreatment/current hemoglobin and trial/failure or contraindication to Retacrit when requesting Epogen or Procrit.

SourceLink

POLICY UPDATE CHANGES

Policy requires trial of Retacrit or documentation of contraindication before Epogen or Procrit.

Continuation criteria standardized: response defined as rise in hemoglobin > 1 g/dL after ≥ 12 weeks; members who completed < 12 weeks may receive up to 12 weeks to demonstrate response.

6Covered Indications (listed)

7Reviewed Dates Count

12wTypical Authorization Duration

Defines coverage and authorization criteria for epoetin alfa (Epogen, Procrit, Retacrit) for non-oncology FDA-approved and compendial uses for Medicaid members, including initial and continuation criteria, limits of use, and requirement to try or document a contraindication to the biosimilar Retacrit before prescribing Epogen or Procrit. Authorization is typically for up to 12 weeks for initial and many continuation situations. Effective date: 2019-01-01; Last review: 2025-04-01.

Limitations of Use (Not Indicated)

Denial Risk

Denial risk for non-indicated uses

Claims may be denied for uses listed as not indicated (for example certain cancer scenarios, cardiac/vascular surgery, immediate correction of anemia, or patients willing to donate autologous blood) or when required hemoglobin thresholds are not met. Denials may also occur if the member has not tried and failed Retacrit or does not have a documented contraindication to Retacrit, or if pretreatment/current hemoglobin values are not documented or are excluded because they were due to a recent transfusion.

Continuation Therapy Criteria

Continuation of Therapy

For continuation after at least 12 weeks of ESA treatment members must demonstrate response; otherwise limited authorizations may be granted to allow response time:

ALL of the following

Response to therapy: All members requesting continuation after ≥ 12 weeks must show a rise in hemoglobin of > 1 g/dLrise in hemoglobin of > 1 g/dL after ≥ 12 weeks
Members who completed < 12 weeks and have not yet responded may be granted up to 12 weeks to demonstrate a response

Continuation Criteria by Indication

Anemia due to CKD: current hemoglobin < 12 g/dLcurrent hemoglobin < 12 g/dL
Authorization of 12 weeks may be granted
Anemia in CHF or RA: current hemoglobin < 12 g/dLcurrent hemoglobin < 12 g/dL
Authorization of 12 weeks may be granted
Anemia due to hepatitis C treatment: member is receiving ribavirin + interferon/peginterferon AND current hemoglobin < 12 g/dLcurrent hemoglobin < 12 g/dL
Authorization of 12 weeks may be granted
Anemia due to zidovudine in HIV-infected patients: current hemoglobin < 12 g/dLcurrent hemoglobin < 12 g/dL
Authorization of 12 weeks may be granted
Anemia in members whose religious beliefs forbid blood transfusions: current hemoglobin < 12 g/dLcurrent hemoglobin < 12 g/dL
Authorization of 12 weeks may be granted

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization required with indication-specific criteria

Prior authorization is required. Authorization of up to 12 weeks may be granted when indication-specific pretreatment hemoglobin thresholds and other criteria are met, including documentation that the member has tried and failed or has a contraindication to Retacrit for Epogen and Procrit requests. Note that pretreatment hemoglobin values due to a recent transfusion are excluded.

Documentation Required

Document hemoglobin and transfusion status

Document pretreatment and current hemoglobin values (excluding values due to a recent transfusion). When applicable, include evidence of a trial and failure of Retacrit or documentation of a contraindication to Retacrit. For the zidovudine indication, document zidovudine dosing and endogenous serum erythropoietin level as specified.

Background

Epoetin alfa (Epogen, Procrit, Retacrit) is an erythropoiesis-stimulating agent indicated for specific anemias such as anemia due to chronic kidney disease, anemia due to zidovudine in HIV-infected patients meeting dosing and erythropoietin criteria, and to reduce allogeneic RBC transfusions in selected perioperative patients. This policy governs non-oncology FDA-approved and compendial uses for Medicaid members and specifies covered indications, authorization criteria, and limits of use. The policy also notes limitations where ESAs are not indicated, including several cancer-related situations, cardiac/vascular surgery, and as a substitute for immediate transfusion; it also states that epoetin alfa has not been shown to improve quality of life or fatigue.

Pretreatment hemoglobin: Hemoglobin value prior to initiation of ESA therapy; values due to recent transfusion are excluded.

Response to therapy: Rise in hemoglobin of > 1 g/dL after at least 12 weeks of ESA treatment.

Revision History

2019-01-01policy_effective

Policy effective date published (scope: Medicaid).

2024-06material_changeLatest

Requirement to try biosimilar Retacrit before Epogen or Procrit clarified as a coverage prerequisite for Epogen/Procrit requests; documentation of trial/failure or contraindication to Retacrit required for approval of Epogen or Procrit requests within the policy criteria and prior authorization process.

2024-04 to 2025-04material_changeLatest

Continuation criteria standardized: response defined as a rise in hemoglobin of > 1 g/dL after at least 12 weeks of ESA treatment; members who completed < 12 weeks may be granted up to 12 weeks to demonstrate response.