Lurbinectedin (Zepzelca)

Policy ID: I-228-004

Section: Injections

Effective Date: December 01, 2020

Revised Date: January 15, 2024

Revision Effective Date: March 01, 2024

Last Reviewed: January 16, 2024

Applies To: Commercial and Medicaid Expansion

Description

Lurbinectedin (Zepzelca) is an alkylating agent that binds guanine residues in the minor groove of DNA, resulting in perturbation of the cell cycle and eventual 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.

Lurbinectedin (Zepzelca) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Lurbinectedin (Zepzelca) may be considered medically necessary in individuals 18 years and older for the following:

Small Cell Lung Cancer (SCLC)

As treatment of individuals with metastatic SCLC with disease progression on or after platinum-based chemotherapy; or

Lurbinectedin (Zepzelca) 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

J9223

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

Covered Diagnosis Codes for Procedure Code J9223

C7A.1

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C78.00

C78.01

C78.02

C79.31

C79.51

C79.52

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2020

Adopted new pre-certification policy

Internal Medical Policy Committee 1-19-2021-Effective January 01, 2021

Added new procedure code J9223
Updated diagnosis code from C7A to C7A.1

Internal Medical Policy Committee 1-20-2022

Removed NCCN recommendations; and
Added statement "Lurbinectedin (Zepzelca) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations."

Internal Medical Policy Committee 1-26-2023

Annual Review - no changes in criteria

Internal Medical Policy Committee 1-16-2024 Effective March 01, 2024

Annual review no clinical content change

Links

References (PDF)

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.

Policy ID: I-228-003