Loncastuximab tesirine-lpyl (Zynlonta)

Policy ID: I-240-001

Section: Injections

Effective Date: April 01, 2022

Last Reviewed: March 23, 2022

Applies To: Commercial and Medicaid Expansion

Description

Loncastuximab tesirine (Zynlonta(R)) is a CD19-directed antibody-drug conjugate (ADC), consisting of 3 components including the humanized IgG1-kappa monoclonal antibody for CD19; the pyrrolobenzodiazepine dimer cytotoxic alkylating agent, SG3199; and a protease-cleavable valine-alanine linker. The component of SG3199 attached to the linker is known as SG3249 or tesirine. The anticancer activity of loncastuximab tesirine is due to the binding of ADC to CD19 followed by the internalization of the ADC-CD19 complex and the subsequent release of SG3199. The SG3199 binds to DNA causing DNA interstrand crosslinks and subsequent cell death.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Compendia Sources

Loncastuximab tesirine-lpyl (Zynlonta) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Loncastuximab tesirine-lpyl (Zynlonta) may be considered medically necessary in individuals 18 years and older for the following:

Large B-Cell Lymphoma

As treatment of individuals with relapsed or refractory large B-cell lymphoma (e.g., diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma arising from low grade lymphoma, high-grade-B-cell lymphoma) with disease progression on or after two (2) or more different lines of chemotherapy.

Loncastuximab tesirine-lpyl (Zynlonta) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9359

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

Diagnosis Code B20 covered when billed with ANY ONE of the following diagnosis codes

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.80

C83.81

C83.82

C83.83

C83.84

C83.85

C83.86

C83.87

C83.88

C83.89

C85.80

C85.81

C85.82

C85.83

C85.84

C85.85

C85.86

C85.87

C85.88

C85.89

Professional Statements and Societal Positions Guidelines

Not applicable

ND Committee Review

Internal Medical Policy Committee 3-23-2022 Adopted new precertification drug policy effective April 1, 2022

Links

References

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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Fargo, North Dakota 58121

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