Ciltacabtagene Autoleucel (Carvykti™)
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 Indication
Carvykti is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
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
Multiple Myeloma
Authorization of 3 months may be granted for treatment of relapsed or refractory multiple myeloma in members 18 years of age and older when all of the following criteria are met:
A. The member has received prior treatment with at least four prior lines of therapy, including at least one drug from each of the following categories:
1. Immunomodulatory agent
2. Proteasome inhibitor
3. Anti-CD38 monoclonal antibody
B. The member has not received previous treatment with the requested medication, another CAR-T therapy directed at any target, or any therapy that is targeted to B-cell maturation antigen (BCMA).
C. The member has an ECOG performance status of 0 to 2.
D. The member has adequate and stable kidney, liver, pulmonary and cardiac function.
E. The member does not have known active or prior history of central nervous system (CNS) involvement, including CNS multiple myeloma.
F. The member does not have clinically significant active infection.
G. The member does not have active graft versus host disease.
H. The member does not have 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. Carvykti [package insert]. Horsham, PA: Janssen Biotech, Inc.; March 2022.
2. Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021 Jul 24;398(10297):314-324.
ORIGINAL EFFECTIVE DATE: 6/1/2022
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.