Neighborhood Health Plan RI Aranesp Coverage | OpenPayer

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Neighborhood Health Plan RI Aranesp Coverage | OpenPayer

Coverage Criteria for Aranesp (darbepoetin alfa)

Initial approval — Anemia due to Chronic Kidney Disease (CKD)

Covered when ALL of the following are met:

CKD initial: Pretreatment hemoglobin < 10 g/dL; assessed for iron deficiency and have adequate iron stores (serum TSAT >= 20% within prior 3 months) or receiving iron therapy; not receiving another erythropoiesis-stimulating agent concurrently.see text

Authorization of up to 12 weeks may be granted for initial treatment.

Initial approval — Anemia due to Myelosuppressive Chemotherapy

Covered when ALL of the following are met:

Chemotherapy-related anemia initial: Member has nonmyeloid malignancy receiving myelosuppressive chemotherapy with at least two additional months of planned chemotherapy; pretreatment hemoglobin <= 10 g/dL; assessed for iron deficiency and have adequate iron stores (serum TSAT >= 20% within prior 3 months) or receiving iron therapy; not receiving another erythropoiesis-stimulating agent concurrently.see text

Authorization of up to 12 weeks may be granted for initial treatment.

Initial approval — Myelodysplastic Syndrome (MDS)

Covered when ALL of the following are met:

MDS initial: Pretreatment hemoglobin < 10 g/dL; pretreatment serum erythropoietin (EPO) level <= 500 mU/mL; assessed for iron deficiency and have adequate iron stores (serum TSAT >= 20% within prior 3 months) or receiving iron therapy; not receiving another erythropoiesis-stimulating agent concurrently.see text

Authorization of up to 12 weeks may be granted for initial treatment.

Initial approval — Religious refusal of transfusion

Covered when ALL of the following are met:

Religious refusal initial: Member's religious beliefs forbid blood transfusions; pretreatment hemoglobin < 10 g/dL; assessed for iron deficiency and have adequate iron stores (serum TSAT >= 20% within prior 3 months) or receiving iron therapy; not receiving another erythropoiesis-stimulating agent concurrently.see text

Authorization of up to 12 weeks may be granted for initial treatment.

Initial approval — Primary Myelofibrosis or Post-PV/ET Myelofibrosis

Covered when ALL of the following are met:

Myelofibrosis initial: Pretreatment hemoglobin < 10 g/dL; pretreatment serum erythropoietin (EPO) level < 500 mU/mL; assessed for iron deficiency and have adequate iron stores (serum TSAT >= 20% within prior 3 months) or receiving iron therapy; not receiving another erythropoiesis-stimulating agent concurrently.see text

Authorization of up to 12 weeks may be granted for initial treatment.

Initial approval — Anemia due to Cancer (palliative)

Covered when ALL of the following are met:

Cancer palliative initial: Member has cancer and is undergoing palliative treatment; assessed for iron deficiency and have adequate iron stores (serum TSAT >= 20% within prior 3 months) or receiving iron therapy; not receiving another erythropoiesis-stimulating agent concurrently.see text

Authorization of up to 12 weeks may be granted for initial treatment.

Continuation of therapy

Covered when ALL of the following are met:

General continuation: Member has been on erythropoiesis-stimulating agent treatment for at least 12 weeks and demonstrates response defined as a rise in hemoglobin of >= 2 g/dL; assessed for iron deficiency and have adequate iron stores (serum TSAT >= 20% within prior 3 months) or receiving iron therapy; not receiving another erythropoiesis-stimulating agent concurrently.>=2 g/dL rise

Members who completed less than 12 weeks of ESA treatment and have not yet responded may be granted up to 12 additional weeks to demonstrate response.

Indication-specific current hemoglobin: Continuation authorization may also require indication-specific current hemoglobin thresholds (examples: for myelosuppressive chemotherapy current hemoglobin < 12 g/dL; for religious refusal and myelofibrosis continued treatment when current hemoglobin < 12 g/dL).see individual indication text

Authorization of up to 12 weeks may be granted for continued treatment.

Indications for Aranesp (darbepoetin alfa) that are not specifically listed in this policy — beyond FDA‑approved and compendial uses such as treatment of anemia related to chronic kidney disease, chemotherapy, myelodysplastic syndromes, myelofibrosis, and anemia when religious beliefs forbid transfusion — are considered experimental/investigational and not medically necessary.

All other clinical uses of Aranesp that are not described in the coverage criteria above are considered experimental/investigational and therefore not medically necessary for coverage purposes.

Clinical Thresholds and Coding-related Values

Hemoglobin response for continuation

Hemoglobin response required for continuationRise in hemoglobin of >= 2 g/dL after at least 12 weeks of ESA treatment; members with <12 weeks of treatment may be granted up to 12 additional weeks to demonstrate response.

Timing for assessmentResponse must be demonstrated after at least 12 weeks of ESA therapy for continuation requests.

Exclusion of recent transfusionPretreatment and response hemoglobin requirements exclude values due to a recent transfusion.

Transferrin saturation (TSAT)

Required TSAT level>= 20% within the prior 3 months

Alternative to TSATActive receipt of iron therapy qualifies if recent TSAT not available.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 12 weeks may be granted for initial treatment when indication-specific pretreatment criteria are met (see indication-specific sections for hemoglobin and EPO thresholds). Members who completed less than 12 weeks of ESA treatment and have not yet met response criteria may be granted authorization of up to 12 weeks to allow sufficient time to demonstrate a response.

Authorization of up to 12 weeks may be granted for initial therapy for CKD, myelosuppressive chemotherapy, myelodysplastic syndrome, primary/post-polycythemia vera/post-essential thrombocythemia myelofibrosis, anemia in members whose religious beliefs forbid transfusion, and anemia due to cancer undergoing palliative treatment when specific pretreatment hemoglobin and EPO criteria are met.
Members who completed <12 weeks of ESA treatment and have not yet responded (rise in hemoglobin <2 g/dL) may be granted up to 12 additional weeks.

Documentation Required

Documentation Required: Iron Stores and Hemoglobin

All members must be assessed for iron deficiency and have adequate iron stores before initiation or continuation of therapy. Adequate iron stores are defined as a serum transferrin saturation (TSAT) >= 20% within the prior 3 months, or documentation of active iron therapy.

Background on Darbepoetin alfa (Aranesp)

Darbepoetin alfa (Aranesp) is an erythropoiesis‑stimulating agent referenced in this policy for treatment of symptomatic anemia in several settings, including chronic kidney disease, myelodysplastic syndromes, myelofibrosis, cancer patients receiving palliative care, and for patients whose religious beliefs forbid blood transfusion. Uses outside these FDA‑approved and compendial indications are considered experimental/investigational.

Definitions and Laboratory Thresholds

Adequate iron stores

DefinitionSerum transferrin saturation (TSAT) >= 20% within the prior 3 months or active receipt of iron therapy.

When requiredMust be documented before initiating Aranesp and before continuation of therapy.

PurposeEnsures adequate iron stores prior to erythropoiesis-stimulating agent use.

Pretreatment serum EPO level requirement

EPO threshold for MDSPretreatment serum erythropoietin (EPO) level <= 500 mU/mL is specified for myelodysplastic syndrome criteria.

EPO threshold for myelofibrosisPretreatment serum EPO level < 500 mU/mL is specified for primary myelofibrosis and post-PV/ET myelofibrosis.