CurrentNeighborhood Health Plan of Rhode IslandPolicy 1619-A

Epoetin alfa (Epogen/Procrit/Retacrit) coverage

Defines medical necessity criteria, authorization durations, and continuation requirements for epoetin alfa products for multiple anemia indications (CKD, chemotherapy-induced, MDS, perioperative reduction of transfusion, zidovudine-related, myelofibrosis, and others) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEpoetin alfa (Epogen/Procrit/Retacrit) coverage

Policy CodePolicy 1619-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with indication-specific pretreatment hemoglobin and document adequate iron stores (TSAT >=20%) before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksstandard initial authorization duration for most indications

12 monthsauthorization duration for zidovudine-related anemia

>=1 g/dLrequired hemoglobin rise for continuation after >=12 weeks

TSAT >=20%adequate iron stores required

<10 g/dL

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common pretreatment hemoglobin threshold

Coverage Criteria for Epoetin Alfa

Anemia Due to CKD (Initial)

Anemia Due to Chronic Kidney Disease — Initial authorization

CKD initial: Authorization of 12 weeks may be granted for treatment of anemia due to chronic kidney diseasepretreatment hemoglobin < 10 g/dL

Exclude hemoglobin values due to recent transfusion; adequate iron stores (TSAT >= 20% within prior 3 months) required; no concomitant ESA use

Anemia Due to CKD (Continuation)

Anemia Due to Chronic Kidney Disease — Continuation

CKD continuation: Authorization of 12 weeks may be granted for continued treatment of anemia due to chronic kidney diseasecurrent hemoglobin < 12 g/dL

Members must have demonstrated hemoglobin response (>= 1 g/dL rise after >= 12 weeks) unless within initial treatment period; exclude hemoglobin values due to recent transfusion; adequate iron stores (TSAT >= 20% within prior 3 months) required

Anemia Due to Myelosuppressive Chemotherapy (Initial)

Anemia Due to Myelosuppressive Chemotherapy — Initial authorization

Chemotherapy initial: Authorization of 12 weeks may be granted for treatment of anemia due to myelosuppressive chemotherapy in members with non-myeloid malignancypretreatment hemoglobin < 10 g/dL and planned ongoing chemotherapy (per FDA/compendia)

Assess and correct iron deficiency (TSAT >= 20% within prior 3 months or receiving iron therapy); no concomitant ESA use

Anemia Due to Myelosuppressive Chemotherapy (Continuation)

Anemia Due to Myelosuppressive Chemotherapy — Continuation

Chemotherapy continuation: Authorization of 12 weeks may be granted for continued treatment of anemia due to myelosuppressive chemotherapycurrent hemoglobin < 12 g/dL

Must meet initial authorization criteria and demonstrate response per general continuation rules (>= 1 g/dL rise after >= 12 weeks) unless within initial treatment period; adequate iron stores required

MDS (Initial)

Myelodysplastic Syndrome (MDS) — Initial authorization

MDS initial: Authorization of 12 weeks may be granted for treatment of anemia in myelodysplastic syndromepretreatment hemoglobin < 10 g/dL

Assess and correct iron deficiency (TSAT >= 20% within prior 3 months or receiving iron therapy); members may not use concomitant ESAs

MDS (Continuation)

Myelodysplastic Syndrome (MDS) — Continuation

MDS continuation: Authorization of 12 weeks may be granted for continued treatment of anemia in myelodysplastic syndromecurrent hemoglobin < 12 g/dL

Must meet initial criteria and demonstrate response per general continuation rules; adequate iron stores required

Perioperative Transfusion Reduction (Initial)

Reduction of Allogeneic RBC Transfusion — Initial authorization

Perioperative initial: Authorization of 8 weeks may be granted for reduction of allogeneic red blood cell transfusion in members scheduled for elective, noncardiac, nonvascular surgerypretreatment hemoglobin <= 13 g/dL (FDA language: >10 to <=13 g/dL for population)

Member must be at high risk for perioperative blood loss; epoetin alfa is intended for this perioperative population and not for autologous blood donation

Perioperative Transfusion Reduction (Continuation)

Reduction of Allogeneic RBC Transfusion — Continuation

Perioperative continuation: All members requesting continuation must meet all initial authorization criteriaN/A

Continuation only if initial perioperative criteria remain met

Zidovudine-related Anemia (Initial)

Anemia Due to Zidovudine in HIV-infected Patients — Initial authorization

Zidovudine initial: Authorization of 12 months may be granted for treatment of anemia due to zidovudine in HIV-infected members currently receiving zidovudinepretreatment hemoglobin < 10 g/dL and pretreatment serum EPO <= 500 mU/mL

Assess and correct iron deficiency (TSAT >= 20% within prior 3 months or receiving iron therapy); duration differs from other indications

Zidovudine-related Anemia (Continuation)

Anemia Due to Zidovudine in HIV-infected Patients — Continuation

Zidovudine continuation: Authorization of 12 months may be granted for continued treatment of anemia due to zidovudinecurrent hemoglobin < 12 g/dL

Member must be receiving zidovudine; assess iron stores (TSAT >= 20% within prior 3 months or receiving iron therapy)

Anemia When Transfusions Not Acceptable

Anemia in Members Who Will Not/Cannot Receive Blood Transfusions

No-transfusion initial: Authorization of 12 weeks may be granted for treatment in members who will not/cannot receive blood transfusions (e.g., religious beliefs)pretreatment hemoglobin < 10 g/dL

Assess and correct iron deficiency (TSAT >= 20% within prior 3 months or receiving iron therapy); no concomitant ESA use

Myelofibrosis-associated Anemia

Myelofibrosis: Authorization of 12 weeks may be granted for treatment of myelofibrosis-associated anemiapretreatment hemoglobin < 10 g/dL AND pretreatment serum EPO <= 500 mU/mL

Assess and correct iron deficiency (TSAT >= 20% within prior 3 months or receiving iron therapy); no concomitant ESA use

Cancer-related Anemia (Palliative)

Anemia Due to Cancer (Palliative)

Cancer palliative: Authorization of 12 weeks may be granted for treatment of anemia due to cancer in members who have cancer and are undergoing palliative treatmentN/A

Assess and correct iron deficiency (TSAT >= 20% within prior 3 months or receiving iron therapy); intended for palliative setting per compendial uses

Continuation Criteria (General)

Continuation of Therapy — General

Continuation general: For all indications (excluding zidovudine-related), members requesting continuation after at least 12 weeks of ESA treatment must show a hemoglobin rise >= 1 g/dL; members treated <12 weeks without response may be granted up to 12 more weeks to demonstrate response>=1 g/dL rise after >=12 weeks; continuation hemoglobin thresholds vary by indication (generally <12 g/dL)

Exclude hemoglobin values due to recent transfusion; assess and ensure adequate iron stores (TSAT >= 20% within prior 3 months) before continuation; no concomitant ESA use

Continuation authorization criteria

Covered when the continuation request meets the initial authorization criteria and the specific indication criteria below.

General continuation requirement: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

Continuation requests must meet initial authorization criteria

Zidovudine-associated anemia continuation: Member is HIV-infected receiving zidovudine; current hemoglobin < 12 g/dL; authorization duration: 12 months.current hemoglobin < 12 g/dL

Member must be receiving zidovudine; assess iron stores

Anemia when transfusion refused/unavailable continuation: Member will not/cannot receive blood transfusions (e.g., religious beliefs); current hemoglobin < 12 g/dL; authorization duration: 12 weeks.current hemoglobin < 12 g/dL

Uses of epoetin alfa (Epogen/Procrit/Retacrit) that are not among the FDA-approved indications or listed compendial uses are considered experimental/investigational and are not medically necessary.

Requests to continue therapy must demonstrate that the member meets the same criteria required for initial authorization; all continuation requests (including for new members) must meet the applicable initial authorization criteria before a continuation approval will be granted.

Any indication outside the FDA-approved and compendial uses listed in this policy is considered not medically necessary (i.e., experimental/investigational) and will not be covered.

Clinical Thresholds and Coding-related Key Values

inv-19: Hemoglobin thresholds — key Hb thresholds for initial and continuation authorizations and response criteria

Initial authorization (most indications)Pretreatment hemoglobin < 10 g/dL; standard authorization duration: 12 weeks.

Perioperative transfusion reduction (initial)Pretreatment hemoglobin <= 13 g/dL (FDA language: >10 to <=13 g/dL); authorization duration: 8 weeks.

Continuation hemoglobin thresholdCurrent hemoglobin < 12 g/dL required for continuation for most indications; authorization duration generally 12 weeks.

Continuation response requirementFor continuation after >=12 weeks of ESA treatment, member must demonstrate a hemoglobin rise >= 1 g/dL to continue (except where different durations/requirements apply).

inv-20: Hemoglobin — continuation Hb < 12 g/dL (single-value emphasis)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for initiation of Epogen/Procrit/Retacrit. Pretreatment hemoglobin and indication-specific durations must be documented with the initial request.

Pretreatment hemoglobin according to indication (see individual indication criteria).
Authorization durations vary by indication (e.g., 8–12 weeks or 12 months for zidovudine-associated anemia).

Documentation Required

Required Clinical Documentation (Initial and Continuation)

All requests (initial and continuation) must include documentation of pretreatment hemoglobin and iron status. For continuation requests, provide indication-specific documentation demonstrating treatment response and current hemoglobin as specified below.

Pretreatment hemoglobin value (exclude recent transfusion values).

Definitions and Population Descriptions

inv-32: BACKGROUND — brief background fallback block (low importance) for epoetin alfa indications and role

Epoetin alfa classEpoetin alfa products (Epogen/Procrit/Retacrit) are erythropoiesis-stimulating agents used to treat anemia from multiple causes, including CKD, zidovudine-related HIV anemia, chemotherapy-induced anemia, and to reduce perioperative RBC transfusion in certain elective surgeries.

Indication nuancePerioperative indication applies to elective, noncardiac, nonvascular surgery in patients at high risk for blood loss; not indicated for patients willing to donate autologous blood.

Iron assessment roleMembers must be assessed for iron deficiency and have adequate iron stores or be receiving iron therapy prior to initiation and continuation.

inv-33: Adequate iron stores — TSAT >=20% or receiving iron therapy definition

Definition of adequate iron storesSerum transferrin saturation (TSAT) >= 20% within the prior 3 months, or the member is receiving iron therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEpoetin alfa (Epogen/Procrit/Retacrit) coverage

Policy CodePolicy 1619-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with indication-specific pretreatment hemoglobin and document adequate iron stores (TSAT >=20%) before initiating therapy.

SourceLink

On This Page

Myelofibrosis-associated anemia continuation: Member has myelofibrosis-associated anemia; current hemoglobin < 12 g/dL; authorization duration: 12 weeks.current hemoglobin < 12 g/dL

Assess iron stores

Cancer-related palliative anemia continuation: Member has cancer and is undergoing palliative treatment; authorization duration: 12 weeks.

Assess iron stores

Single-value continuation threshold

Current hemoglobin < 12 g/dL is required for continuation authorization across multiple indications.

Applies to CKD continuationAuthorization of 12 weeks may be granted for continued treatment of anemia due to CKD in members with current hemoglobin < 12 g/dL.

Applies to zidovudine continuationAuthorization of 12 months may be granted for continued treatment of zidovudine-associated anemia when current hemoglobin < 12 g/dL.

Applies to transfusion-refusal and myelofibrosisAuthorization of 12 weeks may be granted for continued treatment in members who will not/cannot receive transfusions or with myelofibrosis when current hemoglobin < 12 g/dL.

Serum transferrin saturation (TSAT) ≥20% within the prior 3 months or documentation that the member is receiving ongoing iron therapy.

For continuation: documentation of hemoglobin response (≥1 g/dL rise after ≥12 weeks of ESA treatment) for all indications except zidovudine-associated anemia. If treatment <12 weeks and no response yet, authorization may be granted for up to 12 additional weeks to evaluate response.

Prior Authorization

Zidovudine-associated Anemia — Specific Prior Authorization Requirements

Zidovudine-associated anemia has distinct pretreatment and continuation requirements. Initial requests must document pretreatment hemoglobin <10 g/dL and pretreatment serum EPO ≤500 mU/mL. Continued treatment may be authorized for up to 12 months with current hemoglobin <12 g/dL.

Initial: pretreatment hemoglobin <10 g/dL and pretreatment serum EPO ≤500 mU/mL.
Continuation: current hemoglobin <12 g/dL; authorization up to 12 months.

Prior Authorization

Indication-specific Authorization Durations and Continuation Requirements

For indications with 12-week authorizations (CKD, chemotherapy-related, MDS, transfusion-refusal, myelofibrosis, cancer-related palliative anemia), initial authorization may be granted for 12 weeks (reduction of allogeneic RBC transfusion: 8 weeks). Continuation requests must demonstrate the required response/current hemoglobin to qualify for additional 12-week authorizations.

CKD, chemotherapy-related, MDS, transfusion-refusal, myelofibrosis, cancer (palliative): initial authorization up to 12 weeks; reduction of allogeneic transfusion: up to 8 weeks.
Continuation: current hemoglobin thresholds generally <12 g/dL and documentation of response as required per indication.

Denial Risk

Concomitant ESA Use Prohibited

Concomitant use of Epogen/Procrit/Retacrit with other erythropoiesis-stimulating agents is not permitted. Requests indicating concurrent ESA therapy will be denied.

Members may not use Epogen/Procrit/Retacrit concomitantly with other ESAs.

Denial Risk

Continuation Requires Meeting Initial Criteria — Denial Risk

Continuation requests will be denied if initial authorization criteria are not met. All members requesting continuation must meet the initial authorization criteria for the respective indication.

All continuation requests (including new members) must meet initial criteria.
Failure to provide required documentation (pretreatment hemoglobin, TSAT or iron therapy, and response/current hemoglobin) may result in denial.

Required timing for TSATTSAT should be documented within the prior 3 months before initiating epoetin alfa.

Action if iron deficientAssess and correct iron deficiency (provide iron therapy) before initiating epoetin alfa.

inv-34: Perioperative transfusion reduction population — definition of perioperative population (preop Hb >10 to <=13 g/dL etc.)

Perioperative population hemoglobin rangePatients with preoperative hemoglobin > 10 to <= 13 g/dL (FDA language) scheduled for elective, noncardiac, nonvascular surgery who are at high risk for perioperative blood loss.

Authorization duration (initial)Authorization of 8 weeks may be granted for reduction of allogeneic RBC transfusion in this population.

Exclusion for autologous donorsEpoetin alfa is not indicated for patients who are willing to donate autologous blood preoperatively.

inv-35: Continuation authorization — definition and examples of time-limited continuation approvals

DefinitionA continuation authorization is a time-limited approval to continue ESA therapy for a specific anemia indication (examples: 12 months for zidovudine-associated anemia; 12 weeks for transfusion-refusal, myelofibrosis-associated, and certain cancer-related palliative anemias).

Documentation requirementContinuation requests must meet all initial authorization criteria and document current hemoglobin values per indication (e.g., < 12 g/dL where specified).

Response criteriaFor continuation after >=12 weeks of ESA treatment, members must generally demonstrate a hemoglobin rise >= 1 g/dL unless still within the initial trial period.

Examples of durationsZidovudine-associated anemia: 12 months; most other continuations (transfusion-refusal, myelofibrosis, palliative cancer): 12 weeks.