State and School Employees' Health Insurance Plan - Leukine (sargramostim)

POLICY NUMBER

S.5.01.453

Leukine (sargramostim)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

Leukine (sargramostim) is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) that is produced by recombinant DNA technology in yeast expression system.

Leukine (sargramostim) is indicated for the following:

• To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections or fatal infections following induction chemotherapy in adults 55 years and older with acute myeloid leukemia (AML);

• For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis in adults with cancer undergoing autologous hematopoietic stem cell transplantation;

• For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL), and Hodgkin’s lymphoma (HL);

• For the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogenic bone marrow transplantation from HLA-matched related donors;

• For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older;

• To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).

POLICY

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 

Leukine (sargramostim) may be considered medically necessary when one of the following criteria are met:

1. Individuals 55 years and older with AML following induction chemotherapy to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections; 

2. Adult individuals undergoing mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation; 

3. Individuals 2 years of age or older for the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation; 

4. Individuals 2 years of age or older for the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation; 

5. Individuals 2 years of age or older for treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation; OR

6. Individuals acutely exposed to myelosuppressive doses of radiation in H-ARS to increase survival.

Length of Approval: Duration of treatment

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Participant's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Participant's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Participant, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant's medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/01/2023: New policy added.

10/01/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Leukine (sargramostim). Removed second policy statement and criteria. Revised policy statement to state that Leukine (sargramostim) may be considered medically necessary when one of the listed criteria are met. It previously stated that Leukine (sargramostim) will be approved when one of the criteria are met. Length of approval changed from "Duration of chemo; 1 month for other approvals" to "Duration of treatment." Sources updated.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Leukine (sargramostim). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Revised medically necessary criteria. Sources updated.

SOURCE(S)

Leukine prescribing information. Partner Therapeutics, Inc. December 2024. Last accessed June 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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