CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aranesp 1616 A Sgm P2023

Defines coverage and prior authorization criteria for Aranesp (darbepoetin alfa) for FDA-approved indications and specified compendial uses, including requirements for initial and continuation approvals, hemoglobin and iron parameters, and treatment durations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAranesp 1616 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization of 12 weeks may be granted for initial and continued treatment when criteria met; document TSAT ≥ 20% within prior 3 months and required hemoglobin values and treatment plans.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in this update.

6Covered Indications Listed

12 wksAuth duration (standard)

≥1 g/dLRequired Hb response

≥20%Iron threshold (TSAT)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines coverage and prior authorization criteria for Aranesp (darbepoetin alfa) for FDA-approved indications and specified compendial uses, including requirements for initial and continuation approvals, hemoglobin and iron parameters, and treatment durations.

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Covered indications (when all approval criteria are met and no exclusions apply): Anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis; Anemia due to chemotherapy in patients with non-myeloid malignancies when anemia is from concomitant myelosuppressive chemotherapy and there are at least two additional months of planned chemotherapy; Symptomatic anemia in myelodysplastic syndromes (MDS); Anemia in patients whose religious beliefs forbid blood transfusions; Symptomatic anemia in primary myelofibrosis, post-polycythemia vera MF, or post-essential thrombocythemia MF; and Anemia in cancer patients undergoing palliative treatment.

Initial Therapy Criteria

Covered indications (FDA-approved and compendial) are considered a benefit when ALL criteria below are met. Note: Pretreatment hemoglobin values exclude readings due to a recent transfusion. All members must be assessed for iron deficiency anemia and have adequate iron stores (serum transferrin saturation [TSAT] ≥ 20% within the prior 3 months) or be receiving iron therapy before initiation of Aranesp. Members may not use Aranesp concomitantly with other erythropoiesis-stimulating agents.

ALL of the following

- Anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
- Anemia due to myelosuppressive chemotherapy in patients with non-myeloid malignancies when at least two additional months of planned chemotherapy remain.
- Symptomatic anemia in patients with myelodysplastic syndromes (MDS).
- Anemia in patients whose religious beliefs forbid blood transfusions.
- Symptomatic anemia in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
- Cancer patients who are undergoing palliative treatment.
Indication-specific
- Anemia Due to Chronic Kidney Disease (CKD)
  - Pretreatment hemoglobin < 10 g/dL< 10 g/dL
  - Authorization duration: 12 weeks
    May grant initial authorization for 12 weeks.
- Anemia Due to Myelosuppressive Chemotherapy
  - Non-myeloid malignancy with at least two additional months of planned chemotherapy
    Anemia must be due to effect of concomitant myelosuppressive chemotherapy.
  - Pretreatment hemoglobin < 10 g/dL< 10 g/dL
All members must have adequate iron stores (TSAT ≥ 20% within prior 3 months) or be receiving iron therapy before starting Aranesp.
TSAT requirement applies to all indications and excludes values affected by recent transfusion.
Members may not use Aranesp concomitantly with other erythropoiesis-stimulating agents.

Provider Actions and Authorization

Prior Authorization

Authorization required and duration

Authorization of 12 weeks may be granted for initial and continued treatment when criteria are met. Specific indications have pretreatment or current hemoglobin thresholds and other laboratory requirements that must be documented to support approval.

Documentation Required

Iron status documentation

Document adequate iron stores before initiation or continuation: serum transferrin saturation (TSAT) ≥ 20% within the prior 3 months or evidence the patient is receiving iron therapy.

Documentation Required

Hemoglobin documentation and transfusion exclusion

Document pretreatment and current hemoglobin values and ensure values exclude results due to a recent transfusion. For initial approval, document pretreatment Hb (generally < 10 g/dL for listed indications); for continuation, document current Hb and hemoglobin response (rise in Hb ≥ 1 g/dL after ≥ 12 weeks of ESA; current Hb thresholds vary by indication, commonly < 12 g/dL).

Denial Risk

Concurrent ESA use

Do not use Aranesp concomitantly with other erythropoiesis-stimulating agents. Concurrent ESA use is prohibited and may lead to denial of authorization.

Documentation Required

Chemotherapy plan for cancer indication

For chemotherapy-induced anemia, document the patient has a non-myeloid malignancy and that at initiation there are at least two additional months of planned myelosuppressive chemotherapy to support use of Aranesp.

Clinical Evidence and Guidelines

Evidence: Package insert: Aranesp [package insert], Amgen Inc.; January 2019 (reference 1).

Guideline and compendia citations: NCCN Drugs & Biologics Compendium (accessed September 7, 2023) and KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease (KDIGO Anemia guideline; referenced/accessed September 7, 2023).

Additional references listed include NCCN guideline PDFs for myeloproliferative neoplasms and myelodysplastic syndromes (accessed September 7, 2023) as supporting compendial guidance.

Background

Background: Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating agent indicated for treatment of anemia in CKD, chemotherapy-induced anemia, and certain compendial hematologic conditions. Patients must have appropriate iron stores (defined as TSAT ≥ 20% within the prior 3 months or be receiving iron therapy) before initiation or continuation. ESA therapy should not be used concomitantly with other erythropoiesis-stimulating agents.

Adequate iron storesSerum transferrin saturation (TSAT) ≥ 20% within the prior 3 months or patient is receiving iron therapy

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAranesp 1616 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Aranesp 1616 A Sgm P2023

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Not Covered / Investigational

Provider Actions and Authorization

Applicable Codes

Clinical Evidence and Guidelines

Background

Revision History