Toripalimab-tpzi (Loqtorzi)
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.
FDA-Approved Indications
A. Loqtorzi is indicated, in combination with cisplatin and gemcitabine, for first-line treatment
of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC).
B. Loqtorzi is indicated, as a single agent, for the treatment of adults with recurrent unresectable
or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
All other indications are considered experimental/investigational and not medically necessary.
II. EXCLUSIONS
Coverage will not be provided for members who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy.
III. CRITERIA FOR INITIAL APPROVAL
Nasopharyngeal carcinoma (NPC)
Authorization of 6 months may be granted when either of the following criteria are met:
A. The requested medication will be used in combination with cisplatin and gemcitabine for the first-line treatment of metastatic or recurrent locally advanced NPC.
B. The requested medication will be used as a single agent for treatment of recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
IV. CONTINUATION OF THERAPY
Authorization of 6 months (for up to 24 months total when being used as first line therapy) may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
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. Loqtorzi [package insert]. Redwood City, CA: Coherus BioSciences, Inc; October 2023.
ORIGINAL EFFECTIVE DATE: 3/1/2024
MOST RECENT REVIEW DATE: 3/1/2024
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.
This document has been classified as public information.