Levoleucovorin (Fusilev™), Levoleucovorin (Khapzory®), Levoleucovorin
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Levoleucovorin/Fusilev/Khapzory is indicated for rescue after high-dose methotrexate therapy in osteosarcoma.
2. Levoleucovorin/Fusilev/Khapzory is indicated for diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination.
3. Levoleucovorin/Fusilev/Khapzory is indicated for use in combination with fluorouracil for treatment of metastatic colorectal cancer.
B. Compendial Uses
1. Rescue treatment after high-dose methotrexate therapy
2. Combination with fluorouracil-based chemotherapy regimens
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Authorization of 3 months may be granted for any of the settings listed below when leucovorin is not an appropriate/available option at this time:
1. Rescue treatment after high-dose methotrexate therapy
2. Treatment of a folate antagonist overdose or impaired methotrexate elimination
3. Combination therapy with fluorouracil-based chemotherapy regimens
III. CONTINUATION OF THERAPY
All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.
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.
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).
REFERENCES
1. Fusilev [package insert]. East Windsor, NJ: Acrotech Biopharma LLC.; November 2020.
2. Levoleucovorin injection [package insert]. Princeton, NJ: Sandoz Inc.; December 2020.
3. Khapzory [package insert]. East Windsor, NJ: Acrotech Biopharma LLC; March 2020.
4. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org . Accessed July 6, 2023.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 5/14/2024
ID_CHS
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.
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