00024-5843-XX Leukine 250 MCG SOLR (SANOFI PHARMACEUTICALS)
Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rGM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. Like endogenous GM-CSF, rGM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells in the granulocyte-macrophage pathways which include neutrophils, monocytes/macrophages and myeloid-derived dendritic cells. It is also capable of activating mature granulocytes and macrophages. Various cellular responses such as division, maturation and activation are induced by GM-CSF binding to specific receptors expressed on the cell surface of target cells.
Sargramostim for the treatment of the following is considered medically necessary:
Acute myelogenous leukemia following induction or consolidation chemotherapy
Bone Marrow Transplantation (BMT) failure or Engraftment Delay
Individuals acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome [H-ARS])
Myeloid reconstitution after autologous or allogeneic bone marrow transplant (BMT)
Peripheral Blood Progenitor Cell (PBPC) mobilization and transplant
Sargramostim for the treatment of chemotherapy-induced febrile neutropenia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Sargramostim for the treatment of other conditions/diseases is considered investigational.
Sargramostim is considered medically appropriate if ALL of the following:
Used for the treatment of chemotherapy induced febrile neutropenia in individuals who have not received prophylactic therapy with a granulocyte colony stimulating factor
Individual has ANY ONE of the following risk factors for developing infection-related complications:
Absolute neutrophil count [ANC] <100/mcL
Duration of neutropenia expected to be greater than 10 days
Pneumonia or other clinically documented infections
Invasive fungal infection
Hospitalization at the time of fever
Prior episode of febrile neutropenia
Sargramostim is considered medically appropriate for renewal if ALL of the following:
Initial appropriateness criteria are met
Absence of toxicity or adverse reactions, including serious allergic or anaphylactic reaction to recombinant protein.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Acute Exposure to Myelosuppressive Doses of Radiation||
|All other indications||250 mcg/m2 daily for up to 14 days|
LENGTH OF AUTHORIZATION
Coverage will be provided for four months and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of sargramostim for the treatment or prevention of other conditions or diseases.
Lexi-Comp Online. (2018). AHFS Dl. Sargramostim. Retrieved May 31, 2018 from Lexi Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, May) Sargramostim. Retrieved May 31, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Sargramostim. Retrieved May 31, 2018 from the National Comprehensive Cancer Network.U. S. Food and Drug Administration. (2018, March). Center for Drug Evaluation and Research. Leukine®(sargramostim). Retrieved May 31, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5237lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 8/14/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit