Centene sargramostim Coverage Update

Coverage Criteria

Initial Therapy - Acute Myelogenous Leukemia (AML)

Covered when ALL of the following are met

AML post-induction criteria: 1. Diagnosis of acute myelogenous leukemia (AML); 2. Prescribed for use following induction therapy for AML; 3. Age ≥ 55 years; 4. Member meets one of the following: a) request is for treatment associated with cancer for a state with regulations against oncology step therapy (see Appendix E), or b) failure of Zarxio® unless contraindicated or clinically significant adverse effects are experienced; 5. Leukine will not be prescribed concurrently with other colony stimulating factors (e.g., filgrastim, pegfilgrastim) within any chemotherapy cycle; 6. Dose does not exceed 250 mcg/m2 IV daily.

Initial Therapy - PBPC collection and transplantation

Covered when ALL of the following are met

PBPC mobilization / post-PBPC transplant: 1. Prescribed for one of the following: a) mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation; or b) following autologous peripheral blood progenitor cell (PBPC) transplantation in members with NHL, ALL, or HL to accelerate myeloid reconstitution; 2. Age ≥ 2 years; 3. Member meets one of the following: a) request is for treatment associated with cancer for a state with regulations against oncology step therapy (see Appendix E), or b) failure of Zarxio® unless contraindicated or clinically significant adverse effects are experienced; 4. Leukine will not be prescribed concurrently with other colony stimulating factors (e.g., filgrastim, pegfilgrastim) within any chemotherapy cycle; 5. Dose does not exceed 250 mcg/m2 IV or SC daily.

Initial Therapy - Bone Marrow Transplantation

Covered when ALL of the following are met

Bone marrow transplantation: 1. Prescribed for use in one of the following settings: a) following autologous bone marrow transplantation (BMT) in members with NHL, ALL, or HL to accelerate myeloid reconstitution; b) following allogeneic BMT to accelerate myeloid reconstitution; or c) following BMT where engraftment is delayed or has failed; 2. Age ≥ 2 years; 3. Leukine will not be prescribed concurrently with other colony stimulating factors (e.g., filgrastim, pegfilgrastim) within any chemotherapy cycle; 4. Member meets one of the following: a) request is for treatment associated with cancer for a state with regulations against oncology step therapy (see Appendix E), or b) failure of Zarxio® unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 500 mcg/m2 IV daily.

Initial Therapy - Acute Radiation Syndrome (H-ARS)

Covered when ALL of the following are met

Acute Radiation Syndrome: 1. Prescribed following suspected or confirmed acute exposure to myelosuppressive doses of radiation (H-ARS); 2. Member meets one of the following: a) request is for treatment associated with cancer for a state with regulations against oncology step therapy (see Appendix E), or b) failure of Zarxio® unless contraindicated or clinically significant adverse effects are experienced; 3. Leukine will not be prescribed concurrently with other colony stimulating factors (e.g., filgrastim, pegfilgrastim) within any chemotherapy cycle; 4. Documentation of member's current weight in kg is provided; 5. Dose does not exceed: a) weight < 15 kg: 12 mcg/kg SC daily; b) weight 15–40 kg: 10 mcg/kg SC daily; c) weight > 40 kg: 7 mcg/kg SC daily.

Initial Therapy - Neuroblastoma (off-label)

Covered when ALL of the following are met

Neuroblastoma (off-label): 1. Diagnosis of high-risk neuroblastoma; 2. Prescribed by or in consultation with an oncologist; 3. Prescribed in combination with one of the following regimens: a) Danyelza® plus temozolomide and irinotecan; or b) Unituxin® combined with temozolomide and irinotecan, or with isotretinoin; 4. Request meets one of the following: a) dose does not exceed both of the following for each treatment cycle: i) 250 mcg/m2 SC daily for 5 doses prior to day 1 of Danyelza administration; and ii) 500 mcg/m2 SC daily for 5 doses in combination with Danyelza; or b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Initial Therapy - Febrile Neutropenia (off-label)

Covered when ALL of the following are met

Chemotherapy-induced febrile neutropenia (off-label): 1. Prescribed for the treatment of chemotherapy-induced febrile neutropenia; 2. Prescribed by or in consultation with an oncologist; 3. Member has not received prophylactic granulocyte colony-stimulating factors (e.g., filgrastim, pegfilgrastim); 4. Member has at least one risk factor for infection-related complications (e.g., sepsis syndrome, age > 65 years, ANC < 100/mcL, neutropenia expected > 10 days, pneumonia or other documented infection, invasive fungal infection, hospitalization at time of fever, prior febrile neutropenia); 5. Member meets one of the following: a) request is for treatment associated with cancer for a state with regulations against oncology step therapy (see Appendix E), or b) failure of Zarxio® unless contraindicated or clinically significant adverse effects are experienced; 6. Leukine will not be prescribed concurrently with other colony stimulating factors within any chemotherapy cycle; 7. Dose does not exceed 250 mcg/m2 IV daily or dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Initial Therapy - Other indications

Covered when ALL of the following are met

Continued Therapy — All indications (continuation node 1)

Covered when ALL of the following are met

Continued therapy: 1. Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; or b) enrolled in continuity of care regulations where applicable; 2. Member is responding positively to therapy; 3. Leukine will not be prescribed concurrently with other colony stimulating factors (e.g., filgrastim, pegfilgrastim) within any chemotherapy cycle; 4. If request is for a dose increase, the new dose meets one of the following: a) does not exceed the FDA‑approved maximum recommended dose for the relevant indication in Section V; b) for neuroblastoma, does not exceed both cycle-specific limits (i.e., 250 mcg/m2 SC daily x5 prior to Danyelza and 500 mcg/m2 SC daily x5 in combination with Danyelza); or c) is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Continued Therapy — All indications (continuation node 2)

Covered when ALL of the following are met

Continued therapy for other indications: 1. Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; or b) enrolled in continuity of care regulations where applicable; 2. Member is responding positively to therapy; 3. Leukine will not be prescribed concurrently with other colony stimulating factors within any chemotherapy cycle; 4. For other diagnoses/indications, member must try Zarxio® unless contraindicated or experiences clinically significant adverse effects, unless redirection is prohibited by state regulations; 5. If the drug recently had a label change not yet reflected in this policy, follow the referenced formulary/no‑coverage or non‑formulary policies; 6. Off‑label uses not listed require following off‑label use policies for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Other diagnoses/indications

Covered when ALL of the following are met

Other diagnoses/indications: 1. Member meets one of the following: a) member must use Zarxio® unless contraindicated or clinically significant adverse effects are experienced; or b) request is for treatment associated with cancer for a state with regulations against oncology step therapy (see Appendix E); 2. If the drug label recently changed and the change is not yet reflected in this policy, follow the referenced formulary/no‑coverage or non‑formulary policies for the applicable line of business; 3. If the requested use is not specifically listed under Section III and criterion 2 above does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid).

Leukine (sargramostim) must not be prescribed concurrently with other colony stimulating factors such as filgrastim or pegfilgrastim within the same chemotherapy cycle. This restriction applies across the covered indications including acute myelogenous leukemia, peripheral blood progenitor cell mobilization/transplantation, bone marrow transplantation, acute radiation syndrome, chemotherapy‑induced febrile neutropenia, and other listed oncology uses, and is required for both initial and continued therapy determinations.

Requests that include concurrent use of multiple colony stimulating factors within a single chemotherapy cycle will not meet coverage criteria and should be denied unless specific, policy‑supported exceptions are documented.

Non‑FDA approved (off‑label) indications that are not explicitly addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. For commercial lines of business, follow CP.CPA.09; for Health Insurance Marketplace (HIM) follow HIM.PA.154; for Medicaid follow CP.PMN.53.

When submitting requests for off‑label indications not listed in this policy, providers must include supporting evidence (for example, peer‑reviewed literature or recognized practice guidelines) as required by the referenced off‑label policies to allow medical necessity review.

Uses that lack sufficient documentation of efficacy and safety per the applicable off‑label use policies are considered not medically necessary and will be denied. The policy requires submission of evidence demonstrating that the off‑label use is supported by clinical literature or recognized guidelines consistent with CP.CPA.09, HIM.PA.154, or CP.PMN.53.

Providers requesting coverage for off‑label indications must ensure all required documentation is included; failure to provide adequate evidence will support a determination of not medically necessary.

Covered Regimens and Dosing

Indication	Regimen / Dosing	Coverage status
Neuroblastoma (high-risk) — combination with Danyelza, temozolomide, and irinotecan
250 mcg/m2 SC once daily for 5 doses prior to Day 1 of Danyelza administration OR 500 mcg/m2 SC once daily for 5 doses when given in combination with Danyelza; alternatively, dose supported by practice guidelines or peer-reviewed literature with submitted evidence
Prescribed by or in consultation with an oncologist; regimen must be FDA‑approved or recommended by NCCN; prior authorization may be required

Indication	Regimen / Dosing	Coverage status
Acute Myelogenous Leukemia (post‑induction)
250 mcg/m2 per day IV administered over approximately a 4‑hour period, given approximately on day 11 or four days following completion of induction chemotherapy
Dose maximum: 250 mcg/m2 IV daily per policy limits; prior authorization required and step‑therapy criteria apply where defined

Indication	Regimen / Dosing	Coverage status
Peripheral blood progenitor cell (PBPC) mobilization and post‑PBPC transplantation
250 mcg/m2 per day administered IV over 24 hours OR given subcutaneously once daily (250 mcg/m2 IV or SC daily)
Age ≥ 2 years for PBPC indications; prior authorization required

Indication	Regimen / Dosing	Coverage status
Bone marrow transplantation — myeloid reconstitution after autologous or allogeneic BMT; treatment of engraftment delay or failure
250 mcg/m2 per day IV over a 2‑hour period beginning 2–4 hours after bone marrow infusion (and not less than 24 hours after last chemotherapy/radiotherapy dose); dosing up to 500 mcg/m2 IV daily is noted as a maximum in some settings (e.g., BMT failure/engraftment delay)
Age ≥ 2 years for BMT indications; prior authorization required

Weight tier	Dosing (SC once daily)	Coverage status / Notes
< 15 kg
12 mcg/kg SC once daily
Documentation of current weight in kg is required to confirm appropriate weight‑based dosing

Coding

Policy identifiermixed

CP.PHAR.295

Clinical Policy reference number

HCPCS Codes referencedHCPCS

J2820

Injection, sargramostim (GM-CSF), 50 mcg

Weight tiers for Acute Radiation Syndrome (ARS) dosing

Weight <15 kg12 mcg/kg SC once daily

Weight 15–40 kg10 mcg/kg SC once daily

>40 kg7 mcg/kg SC once daily

Examples of common maximum doses across indications

AML post‑induction typical dose250 mcg/m2 IV daily (approximately on day 11 or 4 days after completion of induction chemotherapy)

PBPC collection / transplantation typical dose250 mcg/m2 IV over 24 hours or SC once daily

Myeloid reconstitution after BMT typical and maximum

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation demonstrating the member meets the specific indication criteria and any applicable step therapy or redirection requirements prior to approval.

Prior authorization may be required for Zarxio per indication notes
For Illinois HIM requests, step therapy/redirection requirements do not apply as of 1/1/2026 per IL HB 5395

Documentation Required

Documentation Requirement

Providers must submit clinical documentation (e.g., office chart notes, relevant laboratory results, consult notes, prior treatment history) to support that the member meets all approval criteria. Failure to provide required documentation may result in denial or delay of the request.

Examples: chart notes, labs, imaging, prior authorization records showing prior agents tried/failed

Line of Therapy

first-line

first-line: Use following induction therapy in adults ≥ 55 years to shorten neutrophil recovery and reduce severe infections.

post-transplant

post-transplant: Used to accelerate myeloid recovery following autologous PBPC or bone marrow transplant and following allogeneic BMT.

salvage

Neuroblastoma combination: Coverage includes sargramostim in combination with Danyelza; 2025 update removed requirement for relapse/refractory and clarified combination should also include temozolomide.

Definitions

Sargramostim (Leukine) — definition

Drug identitySargramostim (Leukine) is recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF).

Primary actionsShortens time to neutrophil recovery, mobilizes hematopoietic progenitor cells, and accelerates myeloid reconstitution after transplantation.

Pediatric/ARS indicationIndicated to increase survival in patients (birth to 17 years) acutely exposed to myelosuppressive doses of radiation (H-ARS).

H-ARS — definition

DefinitionH-ARS (Hematopoietic Syndrome of Acute Radiation Syndrome) — acute myelosuppressive radiation exposure where sargramostim may increase survival.

Clinical contextOccurs following suspected or confirmed exposure to myelosuppressive doses of radiation and requires weight-documented, weight-based dosing per policy.

Background

Sargramostim (Leukine) is a recombinant human granulocyte‑macrophage colony stimulating factor (GM‑CSF) indicated and used to stimulate recovery of neutrophils and myeloid cells in several clinical contexts. It is employed to shorten time to neutrophil recovery after induction chemotherapy for acute myelogenous leukemia (AML), to mobilize hematopoietic progenitor cells for peripheral blood collection, and to accelerate myeloid reconstitution following autologous or allogeneic bone marrow transplantation.

In addition to the above FDA‑approved and transplant‑related uses, sargramostim is included in this policy for management of delayed engraftment or graft failure and for specific off‑label oncology uses (for example, select neuroblastoma regimens and chemotherapy‑induced febrile neutropenia) when supported by practice guidelines or peer‑reviewed literature. Sargramostim is also indicated in the acute setting to increase survival following hematopoietic syndrome of acute radiation exposure (H‑ARS).

Per policy, coverage determinations require adherence to indication‑specific criteria (age limits, dosing ceilings, prior authorization, and step‑therapy requirements where applicable) and off‑label uses require sufficient documentation of efficacy and safety consistent with Centene’s off‑label use policies.

OpenPayer

Sargramostim (Leukine) coverage

Coverage Criteria

Covered Regimens and Dosing

Coding

Provider Actions and Requirements

Line of Therapy

Definitions

Background