Epcoritamab-bysp (Epkinly™)
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 Indication
Epkinly is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapy.
B. Compendial Uses
B-Cell Lymphomas:
1. Diffuse Large B-Cell Lymphomas
2. High Grade B-Cell Lymphomas
3. Histologic Transformation of Indolent Lymphomas to Diffuse Large B-Cell Lymphoma
4. Human Immunodeficiency Virus (HIV)- Related B-Cell Lymphomas
a. HIV-related diffuse large B-cell lymphoma
b. Primary effusion lymphoma
c. Human Herpes Virus Type 8 (HHV8)-positive diffuse large B-cell lymphoma, not otherwise specified
5. Monomorphic Post-Transplant Lymphoproliferative Disorders
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
B-Cell Lymphomas
Authorization of 12 months may be granted for treatment of B-cell lymphoma after at least 2 prior lines of systemic therapy when the member has partial response, no response, progressive, relapsed or refractory disease with any of the following subtypes:
A. Diffuse Large B-Cell Lymphoma (DLBCL)
B. High Grade B- Cell Lymphoma
C. Histologic Transformation of Indolent Lymphoma to DLBCL
D. HIV-Related B- Cell Lymphoma including HIV-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL, not otherwise specified when the requested medication is used as a single agent
E. Monomorphic Post-Transplant Lymphoproliferative Disorder when the requested medication is used as a single agent
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section II 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. Epkinly [package insert]. Plainsboro, NJ: Genmab US, Inc.; May 2023.
2. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed June 5, 2023.
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 1/1/2024
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.
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