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
1. Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
2. Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
3. Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Limitations of use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
B. Compendial Uses
1. Histologic transformation of indolent lymphomas to DLBCL
2. Acquired immunodeficiency syndrome (AIDS)-related B-cell lymphomas (including AIDS-related diffuse large B-cell lymphoma, primary effusion lymphoma, and human herpesvirus 8 (HHV8)-positive diffuse large B-cell lymphoma, not otherwise specific)
3. Monomorphic post-transplant lymphoproliferative disorder (B-cell type)
4. Marginal zone lymphomas:
a. Gastric mucosa associated lymphoid tissue (MALT) lymphoma
b. Nongastric MALT lymphoma
c. Nodal marginal zone lymphoma
d. Splenic marginal zone lymphoma
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
Chart notes, medical record documentation or claims history supporting previous lines of therapy.
III. CRITERIA FOR INITIAL APPROVAL
Adult B-cell lymphomas
Authorization of 3 months may be granted as treatment of B-cell lymphomas in members 18 years of age or older when all of the following criteria are met:
A. Member has received prior treatment with either of the following:
1. Prior treatment with two or more lines of systemic therapy and has any of the following B-cell lymphoma subtypes:
a. Diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma
b. Histologic transformation of indolent lymphomas to DLBCL
c. Diffuse large B-cell lymphoma (DLBCL)
d. Primary mediastinal large B-cell lymphoma
e. High-grade B-cell lymphomas (including high-grade B-cell lymphoma with translocations of MYC and BCL2 and/or BCL6 [double/triple hit lymphoma], high-grade B-cell lymphoma, not otherwise specified)
f. Acquired immunodeficiency syndrome (AIDS)-related B-cell lymphomas (including AIDS-related diffuse large B-cell lymphoma, primary effusion lymphoma, and human herpesvirus 8 (HHV8)-positive diffuse large B-cell lymphoma, not otherwise specific)
g. Monomorphic post-transplant lymphoproliferative disorder (B-cell type)
h. Follicular lymphoma
i. Gastric MALT lymphoma
j. Nongastric MALT lymphoma
k. Nodal marginal zone lymphoma
l. Splenic marginal zone lymphoma
2. Prior treatment with first-line chemoimmunotherapy and has any of the following B-cell lymphoma subtypes:
a. Diffuse large B-cell lymphoma (DLBCL)
b. Primary mediastinal large B-cell lymphoma
c. High-grade B-cell lymphomas (including high-grade B-cell lymphoma with translocations of MYC and BCL2 and/or BCL6 [double/triple hit lymphoma], high-grade B-cell lymphoma, not otherwise specified)
d. Acquired immunodeficiency syndrome (AIDS)-related B-cell lymphomas (including AIDS-related diffuse large B-cell lymphoma, primary effusion lymphoma, and human herpesvirus 8 (HHV8)-positive diffuse large B-cell lymphoma, not otherwise specific)
e. Monomorphic post-transplant lymphoproliferative disorder (B-cell type)
B. The member does not have primary central nervous system lymphoma.
C. The member has not received a previous treatment course of the requested medication or another CD19-directed chimeric antigen receptor (CAR) T-cell therapy.
D. Member has an ECOG performance status 0 to 2 (member is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours).
E. The member has adequate and stable kidney, liver, pulmonary and cardiac function.
F. The member does not have active hepatitis B or hepatitis C or a clinically significant active systemic infection.
G. The member does not an active inflammatory disorder.
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. Yescarta [package insert]. Santa Monica, CA: Kite Pharma; April 2022.
2. The NCCN Drugs & Biologics Compendium®© 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 11, 2022.
3. The NCCN Clinical Practice Guidelines in Oncology® B-Cell Lymphomas (Version 2.2022). © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 11, 2022.
4. Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017;377(26):2531‐2544.
ORIGINAL EFFECTIVE DATE: 12/14/2017
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.
This document has been classified as public information.