BlueCross BlueShield of Tennessee Medical Policy Manual

Emapalumab-lzsg

NDC CODE(S)

72171-0501-XX Gamifant 10 mg/2 mL SOLN (Novimmune SA)

 

72171-0501-XX Gamifant 10 mg/2 mL SOLN (Novimmune SA)

DESCRIPTION

Emapalumab-lzsg is an interferon gamma (IFNγ) blocking monoclonal antibody that binds to and neutralizes interferon gamma (IFNγ). Nonclinical data suggest that IFNγ plays a pivotal role in the pathogenesis of hemophagocytic lymphohistiocytosis (HLH) by being hypersecreted. Emapalumab-lzsg reduces the plasma concentrations of CXCL9, a chemokine induced by IFNγ.  Emapalumab-lzsg is produced in Chinese Hamster Ovary cells by recombinant DNA technology. 

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

 

RENEWAL CRITERIA

*Patients should be evaluated for HSCT when a high-risk of relapse and a high-risk of mortality exists (e.g., homozygous or compound heterozygous HLH mutations exists, lack of response to initial HLH therapy, central nervous system involvement, and incurable hematologic malignancy).

 

INDICATION(S)

DOSAGE & ADMINISTRATION

HLH

Administer initial doses of 1 mg/kg, intravenously over one hour, twice weekly. Titrate

doses up to 10 mg/kg as follows:

·         On day 3, if an unsatisfactory improvement in clinical condition is assessed by the healthcare provider, increase to 3 mg/kg

·         From day 6 through 8, if an unsatisfactory improvement in clinical condition is assessed by the healthcare provider on the 3 mg/kg dose, increase to 6 mg/kg

·         From day 9 and onwards, if an unsatisfactory improvement in clinical condition is assessed by the healthcare provider on the 6 mg/kg dose, increase to 10 mg/kg

·         Used in combination with dexamethasone at a daily dose of at least 5-10 mg/m2 starting the day before Gamifant treatment begins

·         Administer until hematopoietic stem cell transplantation (HSCT) is performed or unacceptable toxicity.

·         Discontinue when a patient no longer requires therapy for the treatment of HLH

LENGTH OF AUTHORIZATION

Coverage will be provided for six 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.

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).

SOURCES

Jordan M, Allen C, Weitzman S, et al. How I treat hemophagocytic lymphohistiocytosis. Blood. 2011;118(15):4041. Epub 2011 Aug 9.

Henter, Jan-Inge MD, PhD,  Horne, AnnaCarin MD, Arico, Maurizio MD, et al.  REVIEW: HLH-2004: Diagnostic and Therapeutic Guidelines for Hemophagocytic Lymphohistiocytosis Pediatric Blood & Cancer 2007;48: 24–131 2006 Wiley-Liss, Inc. DOI 10.1002/pbc

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, September). Emapalumab-lzsg. Retrieved December 13, 2018 from MICROMEDEX Healthcare Series. 

U. S. Food and Drug Administration. (2018, November). Center for Drug Evaluation and Research. Gamifant™(emapalumab-lzsg) injection, for intravenous use.  Retrieved  December 13, 2018 from   https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761107s000lbl.pdf

ORIGINAL EFFECTIVE DATE: 4/30/2019

MOST RECENT REVIEW DATE:  4/30/2019

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.

This document has been classified as public information.

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

MAXIMUM UNITS

Hemophagocytic Lymphohistiocytosis (HLH)

2300 mg weekly