BlueCross BlueShield of Tennessee Medical Policy Manual

Gemcitabine in Sodium Chloride Injection

NDC CODE(S)

62756-0073-XX Infugem 1200-0.9 MG/120ML-% SOLN (SUN PHARMACEUTICALS)

62756-0008-XX Infugem 1300-0.9 MG/130ML-% SOLN (SUN PHARMACEUTICALS)

62756-0102-XX Infugem 1400-0.9 MG/140ML-% SOLN (SUN PHARMACEUTICALS)

62756-0219-XX Infugem 1500-0.9 MG/150ML-% SOLN (SUN PHARMACEUTICALS)

62756-0321-XX Infugem 1600-0.9 MG/160ML-% SOLN (SUN PHARMACEUTICALS)

62756-0438-XX Infugem 1700-0.9 MG/170ML-% SOLN (SUN PHARMACEUTICALS)

62756-0533-XX Infugem 1800-0.9 MG/180ML-% SOLN (SUN PHARMACEUTICALS)

62756-0614-XX Infugem 1900-0.9 MG/190ML-% SOLN (SUN PHARMACEUTICALS)

62756-0746-XX Infugem 2000-0.9 MG/200ML-% SOLN (SUN PHARMACEUTICALS)

62756-0974-XX Infugem 2200-0.9 MG/220ML-% SOLN (SUN PHARMACEUTICALS)

DESCRIPTION

Gemcitabine, synthetic pyrimidine nucleoside, is a nucleoside metabolic inhibitor or antimetabolite antineoplastic agent.  It kills cells undergoing DNA synthesis and blocks cell progression through the G1/S-phase boundary. 

Gemcitabine in sodium chloride injection is a single-dose, premixed intravenous infusion bag (10 mg/mL) for intravenous use and does not require any further preparation.  Each 100 mL contains 1000 mg of gemcitabine (equivalent to 1138 mg of gemcitabine hydrochloride, USP), 900 mg of sodium chloride, and water for injection. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

AIDS-Related Kaposi Sarcoma

1000 mg every 2 weeks

 

All Other Indications

1000 mg/m2 every 7 days. May give 2-4 times a month depending on regimen

OR

1250 mg/m2 days 1 and 8; repeat cycle every 21 days

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

Lexicomp Online. (2019, February). AHFS DI. Gemcitabine. Retrieved May 15, 2019 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, April). Gemcitabine. Retrieved May 13, 2019 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Gemcitabine. Retrieved May 13, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, July). Center for Drug Evaluation and Research. INFUGEM (gemcitabine in sodium chloride injection), for intravenous use.Retrieved May 13, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208313Orig1s000lbl.pdf.

ORIGINAL EFFECTIVE DATE: 9/30/2019

MOST RECENT REVIEW DATE:  9/30/2019

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; 1 billable unit = TBD

DIAGNOSIS

MAXIMUM UNITS

All indications

2600 units every 7 days