CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aranesp (darbepoetin alfa) — Coverage Criteria

Policy governs authorization criteria for Aranesp (darbepoetin alfa) to treat anemia from chronic kidney disease, chemotherapy-induced anemia, myelodysplastic syndromes, certain myelofibrosis conditions, and for patients who refuse transfusions; applies to plan members of Neighborhood Health Plan of Rhode Island under the payer's medical benefit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAranesp (darbepoetin alfa) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of pretreatment hemoglobin, iron status (TSAT ≥ 20% or evidence of iron therapy), and relevant EPO level when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weekstypical authorization period

<10 g/dLinitial Hgb threshold

>1 g/dLcontinuation response

TSAT ≥20%adequate iron stores

<500 mU/mLEPO threshold (MDS/MF)

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Coverage Criteria for Aranesp (darbepoetin alfa)

Initial Therapy

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

General prerequisites: Member has no exclusions to therapy; pretreatment hemoglobin values exclude results due to a recent transfusion; adequate iron stores (TSAT >= 20% within the prior 3 months) or member is receiving iron therapy; member is not using Aranesp concomitantly with other erythropoiesis-stimulating agents.

Applicable to all indications.

Indication-specific initial criteria

CKD initial: Anemia due to chronic kidney disease (including dialysis and nondialysis patients) AND pretreatment hemoglobin < 10 g/dL.Hgb < 10 g/dL
Chemotherapy-induced initial: Anemia due to myelosuppressive chemotherapy in patients with non-myeloid malignancy AND pretreatment hemoglobin < 10 g/dL AND at initiation there are at least two additional months of planned chemotherapy.Hgb < 10 g/dL
MDS initial: Symptomatic anemia in myelodysplastic syndrome AND pretreatment hemoglobin < 10 g/dL AND pretreatment serum erythropoietin (EPO) level < 500 mU/mL.Hgb < 10 g/dL; EPO < 500 mU/mL
Religious refusal of transfusion initial: Member's religious beliefs forbid blood transfusions AND pretreatment hemoglobin < 10 g/dL.Hgb < 10 g/dL
Myelofibrosis initial: Anemia in primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis AND pretreatment hemoglobin < 10 g/dL AND pretreatment serum EPO level < 500 mU/mL.Hgb < 10 g/dL; EPO < 500 mU/mL
Palliative cancer initial: Anemia due to cancer in members who are undergoing palliative treatment.

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

General continuation prerequisites: Pretreatment hemoglobin values exclude results due to a recent transfusion; adequate iron stores (TSAT >= 20% within the prior 3 months) or member is receiving iron therapy; member is not using Aranesp concomitantly with other erythropoiesis-stimulating agents.

Applies to all continuation indications.

Response requirement: Member has completed at least 12 weeks of ESA treatment and demonstrates a rise in hemoglobin of > 1 g/dL. Members who completed less than 12 weeks and have not yet responded may be granted up to 12 additional weeks to demonstrate response.>1 g/dL increase

Continuation is contingent on response after >=12 weeks; limited extension allowed for early therapy.

Indication-specific continuation criteria

CKD continuation:

All indications for Aranesp (darbepoetin alfa) that are not listed in this policy’s FDA‑approved indications or the enumerated compendial uses are considered experimental/investigational and not medically necessary for coverage.

Use of Aranesp outside of its FDA‑approved indications and the specific compendial uses enumerated in this policy is considered not medically necessary and therefore experimental/investigational for purposes of coverage decisions.

Clinical Thresholds and Definitions (Key Values)

Hemoglobin thresholds — initial Hgb, continuation Hgb, continuation response criteria

Initial Hgb thresholdPretreatment hemoglobin < 10 g/dL required for initial approval

Continuation Hgb thresholdCurrent hemoglobin < 12 g/dL required for continuation of therapy

Continuation response criteriaAfter ≥12 weeks of ESA treatment, member must demonstrate a rise in hemoglobin of > 1 g/dL (members with <12 weeks may be granted up to 12 additional weeks to respond)

EPO threshold — Pretreatment serum EPO < 500 mU/mL required for MDS and specified myelofibrosis indications

EPO pretreatment thresholdPretreatment serum erythropoietin (EPO) < 500 mU/mL is required for initial approval in myelodysplastic syndrome (MDS) and specified myelofibrosis indications

Myelofibrosis criteria

Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required — typical 12‑week approvals

Prior authorization is required for Aranesp (darbepoetin alfa). Typical approvals are issued in 12‑week increments; initial and continuation authorizations follow the criteria in the policy. Request sufficient duration to cover the planned treatment interval (commonly 12 weeks).

Authorization period commonly issued in 12‑week increments
Prior authorization required before initiating therapy

Denial Risk

Concurrent ESA Use Prohibited

Members may not receive Aranesp concurrently with any other erythropoiesis‑stimulating agent (ESA). Concurrent ESA use is prohibited and may result in denial of the authorization request.

Concurrent administration with other ESAs (e.g., epoetin alfa) is not allowed

Background

Darbepoetin alfa (Aranesp) is an erythropoiesis‑stimulating agent used to treat symptomatic anemia in several settings described in this policy, including myelodysplastic syndromes (MDS), anemia in patients whose religious beliefs forbid blood transfusions, symptomatic anemia in specified myelofibrosis subtypes, and for certain patients with cancer receiving palliative treatment.

Key Definitions

Adequate iron stores — TSAT ≥ 20% within prior 3 months or documentation of receiving iron therapy

Adequate iron stores definitionTSAT ≥ 20% within the prior 3 months, or documentation that the member is receiving iron therapy

Assessment requirementAll members must be assessed for iron deficiency anemia prior to initiating or continuing Aranesp

Documentation acceptedEither lab evidence of TSAT ≥ 20% within 3 months or documented iron therapy is acceptable for authorization

Response to ESA — increase in hemoglobin > 1 g/dL after at least 12 weeks of ESA treatment

Response definitionIncrease in hemoglobin of > 1 g/dL after at least 12 weeks of ESA treatment is required to demonstrate response for continuation

Timing allowanceMembers with <12 weeks of ESA treatment who have not yet responded may be granted up to 12 additional weeks to demonstrate a >1 g/dL hemoglobin rise

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAranesp (darbepoetin alfa) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of pretreatment hemoglobin, iron status (TSAT ≥ 20% or evidence of iron therapy), and relevant EPO level when required.

SourceLink

On This Page

Anemia due to chronic kidney disease AND current hemoglobin < 12 g/dL.

Chemotherapy continuation: Anemia due to myelosuppressive chemotherapy in patients with non-myeloid malignancy AND current hemoglobin < 12 g/dL.Hgb < 12 g/dL

MDS continuation: Anemia in myelodysplastic syndrome AND current hemoglobin < 12 g/dL.Hgb < 12 g/dL

Religious refusal continuation: Member's religious beliefs forbid blood transfusions AND current hemoglobin < 12 g/dL.Hgb < 12 g/dL

Myelofibrosis continuation: Anemia in primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis AND current hemoglobin < 12 g/dL.Hgb < 12 g/dL

Palliative cancer continuation: Anemia due to cancer in members who are undergoing palliative treatment.

For primary MF, post‑polycythemia vera MF, or post‑essential thrombocythemia MF, pretreatment EPO < 500 mU/mL plus pretreatment Hgb < 10 g/dL are required for initial approval

Documentation notePretreatment EPO level must be provided when applying for MDS or specified myelofibrosis indications

Iron stores — TSAT ≥ 20% within prior 3 months

TSAT thresholdSerum transferrin saturation (TSAT) ≥ 20% within the prior 3 months required to demonstrate adequate iron stores

Timing of testTSAT must be measured within the 3 months before initiation or continuation of Aranesp

Alternative to TSATDocumentation of receiving iron therapy may substitute for TSAT ≥ 20%

Document absence of concurrent ESA therapy on the request

Documentation Required

Required Clinical Data for Authorization

Documentation submitted with the authorization request must include pretreatment hemoglobin and iron status. For continuation requests after at least 12 weeks of ESA therapy, provide evidence of response (rise in hemoglobin > 1 g/dL). If less than 12 weeks of prior ESA therapy, document current duration and a plan for up to 12 additional weeks to assess response.

Pretreatment hemoglobin (exclude values due to recent transfusion)
Evidence of response for continuation: hemoglobin rise > 1 g/dL after ≥12 weeks of ESA therapy
If <12 weeks of prior ESA therapy, document duration and request up to 12 weeks to assess response

Documentation Required

Iron Repletion Requirement — assess and document adequate iron stores

All members must be assessed for iron deficiency and have adequate iron stores prior to initiation or continuation of Aranesp. Adequate iron stores are defined as transferrin saturation (TSAT) ≥ 20% within the prior 3 months, or the member must be receiving iron therapy. Document recent TSAT (within 3 months) or active iron therapy on the request.

TSAT ≥ 20% within the prior 3 months OR documentation of ongoing iron therapy
Assessment and documentation of iron status required before starting or continuing Aranesp

Continuation requirementAll members requesting continuation after ≥12 weeks must show the >1 g/dL hemoglobin rise to be eligible for further authorization