CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aranesp (darbepoetin alfa) — coverage criteria

Defines medical necessity and prior authorization criteria for Aranesp (darbepoetin alfa) to treat various types of anemia (including CKD, chemotherapy-related, MDS, myelofibrosis, and religious transfusion refusal) for Neighborhood Health Plan of Rhode Island members when approval criteria are met.

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 ActionObtain prior authorization and document pretreatment hemoglobin and TSAT (>=20%) or evidence of iron therapy before initiating or continuing Aranesp.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksauthorization interval

< 10 g/dLpretreatment Hb threshold

>= 20%minimum TSAT

>= 2 g/dLresponse Hb rise

Coverage Criteria for Aranesp (darbepoetin alfa)

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Initial Therapy

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

General prerequisites: Member has an appropriate indication (FDA-approved or compendial use); pretreatment hemoglobin not attributable to a recent transfusion; adequate iron stores (TSAT >= 20% within the prior 3 months) or is receiving iron therapy; and member is not using another erythropoiesis-stimulating agent concomitantly.

See indication-specific hemoglobin thresholds below; authorization of up to 12 weeks may be granted for initial treatment.

Indication-specific hemoglobin criteria

Chronic kidney disease (CKD): Pretreatment hemoglobin < 10 g/dL for anemia due to CKD (including dialysis and non-dialysis).< 10 g/dL
Authorization of 12 weeks may be granted for initial treatment.
Myelosuppressive chemotherapy (non-myeloid malignancy): Pretreatment hemoglobin < 10 g/dL and there are at least two additional months of planned chemotherapy.< 10 g/dL
Authorization of 12 weeks may be granted for initial treatment.
Myelodysplastic syndromes (MDS): Pretreatment hemoglobin < 10 g/dL for symptomatic anemia in MDS.< 10 g/dL
Authorization of 12 weeks may be granted for initial treatment.
Religious refusal of transfusion: Pretreatment hemoglobin < 10 g/dL in patients whose religious beliefs forbid blood transfusions.< 10 g/dL
Authorization of 12 weeks may be granted for initial treatment.
Primary or post‑myeloproliferative myelofibrosis: Pretreatment hemoglobin < 10 g/dL AND pretreatment serum erythropoietin (EPO) level < 500 mU/mL.< 10 g/dL; EPO < 500 mU/mL
Authorization of 12 weeks may be granted for initial treatment.
Anemia due to cancer (palliative): Members with cancer undergoing palliative treatment meet indication criteria as specified for anemia due to cancer.
Authorization of 12 weeks may be granted for initial treatment.

Continuation Therapy

Covered when ALL of the following are met for continuation:

General continuation prerequisites: Member has been assessed for iron deficiency and has adequate iron stores (TSAT >= 20% within the prior 3 months) or is receiving iron therapy, and is not using another erythropoiesis-stimulating agent concomitantly.

Response requirement: For members who have received >= 12 weeks of ESA therapy, there must be a documented hemoglobin response with an increase of 2 g/dL to continue therapy. Members who have completed < 12 weeks of ESA treatment and have not yet responded may be granted up to 12 additional weeks to demonstrate response.Hb rise >= 2 g/dL after >= 12 weeks

Authorization of 12 weeks may be granted for continued treatment.

Indication-specific continuation hemoglobin criteria

Myelosuppressive chemotherapy (non-myeloid malignancy): Current hemoglobin < 12 g/dL for continued treatment in chemotherapy-related anemia.< 12 g/dL
Religious refusal of transfusion: Current hemoglobin < 12 g/dL for continued treatment in members whose religious beliefs forbid blood transfusions.< 12 g/dL
Primary or post‑myeloproliferative myelofibrosis: Current hemoglobin < 12 g/dL for continued treatment in primary or post‑myeloproliferative myelofibrosis.< 12 g/dL
Chronic kidney disease (CKD) and MDS: Authorization of 12 weeks may be granted for continued treatment of anemia due to CKD or MDS as specified in the policy (current hemoglobin thresholds where noted).

Covered Indications

Covered indications include the following FDA-approved and compendial uses:

FDA-approved indications: 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 at least two additional months of planned chemotherapy exist.

Compendial uses: Anemia in patients whose religious beliefs forbid blood transfusions; symptomatic anemia in myelodysplastic syndromes (MDS); symptomatic anemia in primary or post‑myeloproliferative myelofibrosis (including post‑polycythemia vera and post‑essential thrombocythemia MF); and cancer patients undergoing palliative treatment.

All other indications are considered experimental/investigational and not medically necessary.

Key Clinical Thresholds and Definitions

Pretreatment hemoglobin threshold — < 10 g/dL

Pretreatment hemoglobin threshold< 10 g/dL

Applies toCKD, myelosuppressive chemotherapy (non-myeloid), MDS, religious transfusion refusal, primary/post‑myelofibrosis

Authorization noteAuthorization of up to 12 weeks may be granted when criteria met

Current hemoglobin threshold for continuation (some indications) — < 12 g/dL

Current hemoglobin threshold for continuation< 12 g/dL

Applies toSome indications including chemotherapy-related anemia and religious transfusion refusal; myelofibrosis continuation

Authorization noteAuthorization of 12 weeks may be granted for continued treatment when current Hb criteria met

Transferrin saturation (TSAT)

TSAT requirement>= 20% within prior 3 months

AlternativeOr documented receipt of iron therapy

TimingTSAT must be within the prior 3 months before initiation or continuation

Response threshold for continuation — Hb rise >= 2 g/dL after >= 12 weeks

Response threshold for continuationHemoglobin rise >= 2 g/dL after >= 12 weeks of ESA treatment

Shorter treatment allowanceMembers with <12 weeks of ESA treatment may be granted up to 12 additional weeks to demonstrate response

DocumentationResponse must be documented to approve continuation

Pretreatment serum EPO in myelofibrosis — < 500 mU/mL

Pretreatment serum EPO (myelofibrosis)< 500 mU/mL

Applies toPrimary or post‑myeloproliferative myelofibrosis indications

Paired requirementAlso requires pretreatment hemoglobin < 10 g/dL for initial approval

Adequate iron stores definition

Definition of adequate iron storesSerum TSAT >= 20% within the prior 3 months

Alternate pathwayOr member is receiving iron therapy

Requirement timingMust be assessed before initiating or continuing Aranesp

Response to ESA therapy definition

Definition of response to ESA therapyA rise in hemoglobin of 2 g/dL after at least 12 weeks of ESA treatment

Continuation implicationDocumented response required to continue therapy after >=12 weeks

Insufficient durationMembers with <12 weeks who have not yet responded may receive up to 12 additional weeks to demonstrate response

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required for Initial Therapy

Prior authorization is required for initial Aranesp (darbepoetin alfa) therapy. Authorization of up to 12 weeks may be granted for initial treatment when the member meets the indication-specific pretreatment hemoglobin criteria (for example, pretreatment hemoglobin < 10 g/dL for CKD, myelodysplastic syndrome, myelosuppressive chemotherapy, religious transfusion refusal, or primary/post‑myelofibrosis indications) and other specified pretreatment requirements are met.

Authorization of up to 12 weeks may be granted for initial treatment when indication-specific pretreatment criteria are met (e.g., pretreatment hemoglobin < 10 g/dL for many indications).
Assess and correct iron deficiency and confirm adequate iron stores (TSAT ≥ 20% within prior 3 months) or document that the member is receiving iron therapy prior to initial treatment.
Document pretreatment hemoglobin (not due to recent transfusion) and other required labs as applicable; for primary/post‑myelofibrosis document pretreatment serum erythropoietin (EPO) level < 500 mU/mL where applicable.

Denial Risk

Concurrent ESA Use Not Permitted

Members may not use Aranesp concomitantly with other erythropoiesis stimulating agents. Concurrent use of Aranesp with another ESA is not permitted and may result in denial of the request.

Note

Not Medically Necessary for Unlisted Indications

Use of Aranesp for indications not listed in the policy (other than FDA‑approved or compendial uses) is considered experimental/investigational and is not medically necessary.

Compendial/covered uses include: anemia in patients whose religious beliefs forbid transfusions; symptomatic anemia in MDS; symptomatic anemia in primary or post‑myeloproliferative myelofibrosis; and anemia in cancer patients undergoing palliative treatment.
All other indications are considered experimental/investigational and not medically necessary.

Background

Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating agent indicated for treatment of anemia in multiple contexts, including anemia due to chronic kidney disease, anemia due to myelosuppressive chemotherapy in non‑myeloid malignancies, symptomatic anemia in myelodysplastic syndromes (MDS), symptomatic anemia in primary or post‑myeloproliferative myelofibrosis, anemia in patients who refuse blood transfusions for religious reasons, and cancer patients receiving palliative care. Adequate iron stores and adherence to indication‑specific criteria are required for authorization.