BlueCross BlueShield of Tennessee Medical Policy Manual

Levoleucovorin

NDC CODE(S)

68152-0101-XX Fusilev 50 MG SOLR (Spectrum)

DESCRIPTION

Levoleucovorin is the levo isomeric form of racemic d,l-leucovorin, present as the calcium salt.  It is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid.  Administration of levoleucovorin can counteract the therapeutic and toxic effects of folic acid antagonists such as methotrexate which act by inhibiting dihydrofolate reductase.  It can enhance the therapeutic and toxic effects of fluoropyrimidines used in cancer therapy such as 5-fluorouracil or 5-FU.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
In combination with high dose methotrexate

7.5 mg (approximately 5 mg/m2) IV every 6 hours for 10 doses starting 24 hours after beginning of methotrexate infusion. Dosing is based on a methotrexate dose of 12 grams/m2 administered by intravenous infusion over 4 hours. Continue until methotrexate levels are less than 5 x 108 M (0.05 micromolar)

Reduction of toxicity due to impaired elimination or inadvertent overdose with folic acid antagonists

Methotrexate overdosage: 7.5 mg (approximately 5 mg/m2) IV every 6 hours until methotrexate levels are less than 108 M (0.01 micromolar)

In combination with 5-FU

100 mg/m2 administered by slow intravenous injection over a minimum of 3 minutes, followed by 5-FU at 370 mg/m2 by intravenous injection.

OR

10 mg/m2 administered by intravenous injection followed by 5-FU at 425 mg/m2 by intravenous injection.

Treatment is repeated daily for five days. This five-day treatment course may be repeated at 4-week (28-day) intervals, for 2 courses and then repeated at 4 to 5 week (28 to 35 day) intervals provided that the patient has completely recovered from the toxic effects of the prior treatment course.

Alternate Dosing Regimen

200 mg/m2 administered by intravenous injection DAY 1 followed by 5-FU 400 mg/m2 bolus on DAY 1, then 5-FU 1200 mg/m2 /day x 2 days IV continuous infusion; repeat every 14 days

NOTE: Levoleucovorin is dosed at one-half the usual dose of racemic d, l-leucovorin

LENGTH OF AUTHORIZATION

Coverage will be provided ninety days and may be renewed

Click here to view DOSAGE LIMITS

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 levoleucovorin for the treatment or prevention of other conditions or diseases.

SOURCES

Lexicomp Online. (2018). AHFS DI. Levoleucovorin calcium. Retrieved February 19, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, August). Levoleucovorin. Retrieved February 19, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Levoleucovorin. Retrieved February 19, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2011, April). Center for Drug Evaluation and Research. Fusilev® (levoleucovorin) for injection, powder, lyophilized, for solution for intravenous use. Retrieved February 19, 2018 from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020140.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  5/8/2018

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; 0.5 mg = 1 billable unit

DIAGNOSIS

MAXIMUM UNITS

In combination with methotrexate or for inadvertent overdosage

1,200 billable units every 28 days

In combination with fluorouracil

2,500 billable units every 28 days