medical mutual - ohio darbepoetin alfa Prior Auth

Coverage and Medical Necessity Criteria

Renewal Criteria

Renewal criteria — approvals may be renewed when ALL of the following are met

Renewal requirements: Patient continues to meet the universal and indication-specific criteria; previous dose was administered within the past 60 days; documented disease response compared to pretreatment baseline (improvement in anemia); AND absence of unacceptable toxicity (examples: pure red cell aplasia, severe allergic reactions, severe cardiovascular events, uncontrolled hypertension, seizures, severe cutaneous reactions).

Indication-specific Hb/Hct thresholds for renewal: MDS: Hb < 12 g/dL and/or Hct < 36%. MPN (myelofibrosis): Hb < 10 g/dL and/or Hct < 30%. CKD non-ESRD pediatric: Hb < 12 g/dL and/or Hct < 36%; CKD non-ESRD adult: Hb < 11 g/dL and/or Hct < 33%. Chemotherapy: refer to initial criteria and response assessment timelines.

Indication-specific coverage and continuation criteria

Covered when ALL of the following are met for the indicated condition:

Chemotherapy-associated anemia: If after 8 weeks there is no hemoglobin response or RBC transfusions are still required, or following completion of chemotherapy, discontinue therapy.8-week response

Used during palliative chemotherapy with minimum two additional months planned

Coverage contingent on prior approval and documentation

Coverage decisions for J0881 are contingent on prior approval and submission of documentation demonstrating medical necessity.

Prior approval and documentation: Prior approval is required for HCPCS J0881 and will be authorized for a 180-day time period; submitted documentation must meet criteria in the Corporate Medical Policy. Requests meeting criteria may be authorized by a nurse reviewer; requests not meeting criteria will be forwarded to a physician reviewer. The Company may request additional documentation as part of its coverage determination process.180 days

Claims with J0881 will edit with Remark Code M3M or M4M if PA/documentation criteria not met; J0882 for ESRD on dialysis does not require prior authorization.

Coverage for darbepoetin alfa is not provided for members with uncontrolled hypertension. Blood pressure must be controlled before initiating therapy and remain controlled for continued coverage.

If patients do not demonstrate the indicated hematologic response within the policy-specific evaluation periods, treatment should be discontinued or the regimen changed. Examples: for CKD, if hemoglobin rises <1 g/dL after 4 weeks and after dose escalation over a 12-week escalation period there is still no response, discontinuation should be considered; for MDS, consider changing or stopping therapy if there is no ≥1.5 g/dL hemoglobin increase or reduced RBC transfusions by 8 weeks; for MPN, discontinue if no ≥2 g/dL hemoglobin increase or reduced transfusions by 3 months; for chemotherapy-associated anemia, discontinue if no response by 8 weeks or if transfusions are still required or after completion of chemotherapy.

Services, drugs, or uses determined to be investigational, experimental, not medically necessary, or outside the member’s scope of benefits are excluded from reimbursement. The Company may request supporting documentation and reserves the right to deny reimbursement when these conditions apply.

Use of darbepoetin alfa for anemia in patients receiving chemotherapy intended to cure the underlying malignancy (non-palliative intent) is not supported by this policy. Exceptions (for example, patients who refuse transfusions) may be reviewed on a case-by-case basis.

Continued treatment when a patient has failed to meet the response criteria within the specified timeframes is not supported and may lead to denial of ongoing therapy. Providers should discontinue or change therapy when the applicable response thresholds and evaluation periods (see policy response rules) are not met.

When services are determined to be not medically necessary, participating providers are required to write off charges denied for lack of medical necessity. The Company may request additional documentation during review, and appeals are handled by nurse reviewers or escalated to physician reviewers per the policy.

Billing Codes, NDCs, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J0881

Darbepoetin alfa (Aranesp)

HCPCSHCPCSCovered

J0881

Injection, darbepoetin alfa, 1 microgram (non-ESRD use); 1 billable unit = 1 mcg

NDCsNDC

55513-0006-xx	200 mcg/1 mL, Single-dose Vial
55513-0028-xx	200 mcg/1 mL, Single-dose Prefilled Syringe
55513-0111-xx	300 mcg/0.6 mL, Single-dose Prefilled Syringe
55513-0032-xx	500 mcg/1 mL, Single-dose Prefilled Syringe
55513-0002-xx	25 mcg/1 mL, Single-dose Vial
55513-0098-xx	25 mcg/1 mL, Single-dose Prefilled Syringe
55513-0003-xx	40 mcg/1 mL, Single-dose Vial
55513-0057-xx	40 mcg/1 mL, Single-dose Prefilled Syringe
55513-0004-xx	60 mcg/1 mL, Single-dose Vial
55513-0021-xx	60 mcg/1 mL, Single-dose Prefilled Syringe

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Covered ICD-10 Diagnosis CodesICD-10Covered

C93.10	Chronic myelomonocytic leukemia, not having achieved remission.
C94.40	Acute panmyelosis with myelofibrosis not having achieved remission.
C94.41	Acute panmyelosis with myelofibrosis in remission.
C94.42	Acute panmyelosis with myelofibrosis in relapse.
C94.6	Myelodysplastic disease, not classified.
D46.0	Refractory anemia without ring sideroblasts, so stated.
D46.1	Refractory anemia with ring sideroblasts.
D46.20	Refractory anemia with excess of blasts, unspecified.
D46.21	Refractory anemia with excess of blasts 1.
D46.4	Refractory anemia, unspecified.

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Prior authorization required HCPCSHCPCSCovered

J0881

Erythropoiesis stimulating agent (document references prior approval required)

No prior authorization HCPCS (ESRD on dialysis)HCPCS

J0882

Erythropoiesis stimulating agent for ESRD on dialysis (no prior authorization required)

inv-17: Iron stores — ferritin and TSAT thresholds

Ferritin thresholdSerum ferritin ≥ 100 ng/mL (mcg/L)

TSAT thresholdTransferrin saturation (TSAT) ≥ 20%

Alternative when iron deficientOR patient is receiving concurrent intravenous iron (satisfies iron requirement)

inv-18: ESA response — definition of response (Hb rise or decreased transfusion need)

Primary response definitionHemoglobin rise ≥ 1.5 g/dL

Alternate response definition

Prior Authorization, Documentation, and Billing Expectations

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial medical benefit requests. Initial approvals are issued for 45 days and may be renewed every 45 days thereafter. Providers must submit requests with the clinical information listed in the policy; approvals are granted when the submitted documentation meets the criteria in the Initial Approval and Renewal sections.

Initial prior authorization duration: 45 days
Renewal interval: every 45 days

Note

What to Expect When Requesting Authorization

When requesting prior authorization, expect a utilization review that evaluates indication, safety, and prior therapy. The company may authorize initial requests for 45 days (see above) and will require documented response to therapy for renewals. Requests that meet criteria may be approved by a nurse reviewer; requests that do not meet criteria will be forwarded to a physician reviewer.

Provider should supply labs, iron studies, prior treatment history, and any other supporting documentation

Dosing Regimens and Dose-Adjustment Rules

Regimen / Indication	Dose and Schedule	Escalation / Stop Rules
Chemotherapy-associated anemia (adult)	2.25 mcg/kg subcutaneously every 7 days — OR — 500 mcg subcutaneously every 21 days	May increase 2.25 mcg/kg → 4.5 mcg/kg q7d for insufficient response; alternative regimens (100 mcg SC q7d may be increased to 200 mcg q7d; 200 mcg SC q14d may be increased to 300 mcg q14d). If no response by 8 weeks (persistent need for RBC transfusions or no Hb rise), discontinue or change regimen.
Chemotherapy-associated anemia (alternative regimens)	100 mcg SC every 7 days (may increase to 200 mcg q7d) — OR — 200 mcg SC every 14 days (may increase to 300 mcg q14d)	Escalate per above for insufficient response; evaluate at 8 weeks and discontinue if no response or ongoing transfusion requirement.

Indication	Weight-based / Fixed Dose (adult & pediatric where specified)	Notes on initiation and adjustments
Chronic Kidney Disease — Non-dialysis (Adult)	0.45 mcg/kg IV or SC every 28 days	Consider 25% dose increases if after 4 weeks Hb increase <1 g/dL and current Hb remains below target; do not increase more often than every 4 weeks; decrease ≥25% if Hb rises >1 g/dL in any 2-week period; discontinue if no response after 12-week escalation.
Chronic Kidney Disease — Non-dialysis (Pediatric)	0.45 mcg/kg IV or SC every 7 days — OR — 0.75 mcg/kg IV or SC every 14 days	Follow same escalation/decrease guidance as adults; pediatric age thresholds apply per indication (policy notes pediatric patients ≥1 month).
Chronic Kidney Disease — Dialysis (Initiation)	Initiate 0.45 mcg/kg IV or SC every 7 days — OR — 0.75 mcg/kg IV or SC every 14 days	Use dialysis dosing schedules for patients on dialysis; adjust per Hb response using 25% increase/decrease rules; monitor per CKD guidance.
Myelodysplastic Syndromes (MDS)	150–300 mcg SC every 14 days. May increase up to 500 mcg every 14 days for insufficient response.	Assess response at 8 weeks (≥1.5 g/dL Hb rise or decreased RBC transfusions). If no response by 8 weeks, consider regimen change or discontinuation.
Myeloproliferative Neoplasms (MPN) — Myelofibrosis	150 mcg SC every 7 days. May increase up to 300 mcg every 7 days for insufficient response.	Assess response at 3 months (≥2 g/dL Hb rise or decreased RBC transfusions). Discontinue if no response by 3 months.

Example Indication	Typical Starting Dose(s)	Escalation guidance and evaluation timing
Chemotherapy-associated anemia	2.25 mcg/kg SC q7d — OR — 500 mcg SC q21d (alternatives: 100 mcg SC q7d or 200 mcg SC q14d)	Increase dose for insufficient response (e.g., 2.25 → 4.5 mcg/kg q7d; 100 → 200 mcg q7d; 200 → 300 mcg q14d). Evaluate at 8 weeks; discontinue or change regimen if no Hb response or ongoing transfusion requirement.
Myelodysplastic syndromes (MDS)	150–300 mcg SC q14d (may increase to 500 mcg q14d)	Assess at 8 weeks for ≥1.5 g/dL Hb rise or reduced transfusion needs; if no response, consider discontinuation or regimen change.
Myeloproliferative neoplasms (MPN)	150 mcg SC q7d (may increase to 300 mcg q7d)	Assess at 3 months for ≥2 g/dL Hb rise or reduced transfusions; discontinue if no response by 3 months.
Chronic Kidney Disease (CKD) — weight-based	Adult: 0.45 mcg/kg IV/SC q28d. Pediatric: 0.45 mcg/kg IV/SC q7d or 0.75 mcg/kg IV/SC q14d. Dialysis initiation: 0.45 mcg/kg IV/SC q7d or 0.75 mcg/kg IV/SC q14d.	For CKD, consider 25% dose increases if after 4 weeks Hb rise <1 g/dL and current Hb below target; avoid increases more frequently than every 4 weeks; decrease ≥25% for rapid Hb rises (>1 g/dL in 2 weeks); if no response over 12-week escalation, discontinue.

Laboratory and Biomarker Conditions

inv-38: Serum erythropoietin threshold — numeric threshold used in some branches (<= 500 mU/mL; some specify <200 mU/mL for MDS)

General serum EPO thresholdSerum erythropoietin ≤ 500 mU/mL

Lower EPO threshold for some MDS branchesSome MDS pathways specify serum erythropoietin < 200 mU/mL

Use contextRequired for MDS and MPN indication pathways per the policy criteria

inv-39: Ring sideroblasts / SF3B1 mutation — criteria referencing % ring sideroblasts and SF3B1 status

Ring sideroblasts criteria (general)Patient has ring sideroblasts < 15% (or < 5% with an SF3B1 mutation)

Alternate ring sideroblasts clauseSome branches allow use when ring sideroblasts ≥ 15% (or ≥ 5% with SF3B1) with prior luspatercept failure as specified

Therapy Line and Supportive Use

not_specified

Chemotherapy-induced anemia line: Use during palliative (non-curative) chemotherapy when at least two additional months of planned chemotherapy remain.

Patients refusing transfusions may be considered case-by-case

supportive

Use in chemotherapy-associated anemia: Use during active chemotherapy to manage anemia with evaluation at 8 weeks; discontinue after completion of chemotherapy or if transfusions are still required after 8 weeks.8-week response

This is supportive (given alongside ongoing chemotherapy)

Key Definitions and Response Criteria

inv-34: No response — definition for lack of response thresholds and relevant timeframes

Definition of no response (ESA)Lack of ≥ 1.5 g/dL rise in hemoglobin OR lack of a decrease in RBC transfusion requirement

ESA evaluation interval contextNo response assessed within 6–8 weeks for ESAs (policy note)

Longer evaluation for other agentsFor agents like luspatercept, lack of response assessed within 3–6 months

inv-35: Response — condition-specific response thresholds (MDS, MPN, CKD)

MDS response ruleAfter 8 weeks, response defined as ≥ 1.5 g/dL Hb increase or decreased RBC transfusions; if no response consider regimen change or discontinuation

MPN response ruleAfter 3 months, response defined as ≥ 2 g/dL Hb increase or decreased RBC transfusions; if no response consider discontinuation

Clinical Background

Darbepoetin alfa (Aranesp) is an erythropoiesis-stimulating agent indicated for treatment of anemia from multiple causes including chemotherapy-induced anemia, anemia due to chronic kidney disease (dialysis and non-dialysis), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN). Monitoring for efficacy and safety includes hemoglobin/hematocrit and iron studies; adequate iron stores are required (ferritin ≥ 100 ng/mL and TSAT ≥ 20%) and response definitions vary by indication (e.g., ≥1.5 g/dL Hb rise by 8 weeks for MDS).

OpenPayer

Erythropoiesis stimulating agent - Darbepoetin alfa (Aranesp)

Coverage and Medical Necessity Criteria

Billing Codes, NDCs, and Diagnosis Codes

Prior Authorization, Documentation, and Billing Expectations

Dosing Regimens and Dose-Adjustment Rules

Laboratory and Biomarker Conditions

Therapy Line and Supportive Use

Key Definitions and Response Criteria

Clinical Background