BlueCross BlueShield of Tennessee Medical Policy Manual

Sargramostim

NDC CODE(S)

Leukine 250 MCG SOLR – 00024-5843-xx (SANOFI PHARMACEUTICALS)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications 250 mcg/m2 daily for up to 14 days

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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 of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016, March). AHFS Dl. Sargramostim. Retrieved June 28, 2016 from Lexi­ Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, March). Sargramostim. Retrieved June 28, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Sargramostim. Retrieved June 28, 2016 from the National Comprehensive Cancer Network.

Sanofi-Aventis US, LLC. (2013). Genzyme Corp. Leukine®(sargramostim). Retrieved June 28, 2016 from http://products.sanofi.us/Leukine/Leukine.html.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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.

Pharmaceutical Decision Support Tree

Sargramostim (Leukine®)

  1. Is this the initial request for this agent for this individual?

If yes, go to question #2

If no, go to question #8

  1. Does the individual have a diagnosis of bone marrow transplant failure/engraftment delay?

If yes, go to question #7

If no, go to question #3

  1. Does the individual have a diagnosis of acute myelogenous leukemia following ANY ONE of the following?

If yes, go to question #7

If no, go to question #4

  1. Did the individual experience a neutropenic complication from a prior cycle of the same chemotherapy?

If yes, go to question #7

If no, go to question #5

  1. Does the individual have a need for mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis following autologous bone marrow transplantation?

If yes, go to question #7

If no, go to question #6

  1. Is there a need for acceleration of myeloid reconstitution after autologous or allogeneic bone marrow transplant (BMT)?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 10 or less billable units per day (1 billable unit = 50 mcg) for dosage of 250 mcg/m2 daily for up to 14 days for an authorization period of four months?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the request continue to meet the initial criteria in numbers 2 through 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there an absence of toxicity/adverse reactions to the agent with prior use, e.g., pericardial effusion, severe edema, dyspnea, arrhythmias?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.