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Asset Publisher
Zepzelca™ (lurbinectedin) (Intravenous)
Policy Number: VP-0550
Intravenous
Last Review Date: 03/05/2024
Date of Origin: 07/01/2020
Dates Reviewed: 07/2020, 09/2020, 01/2021, 03/2021, 03/2022, 03/2023, 03/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Coverage will be provided for 6 months and may be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- 4 mg single-dose vial for injection: 2 vials every 21 days
- Max Units (per dose and over time) [HCPCS Unit]:
- 80 billable units every 21 days
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is at least 18 years of age; AND
Universal Criteria 1
- Used as a single agent; AND
Small Cell Lung Cancer † ‡ Ф 1-4
- Used for metastatic disease after disease progression on or after platinum-based chemotherapy (i.e., cisplatin, carboplatin) †; OR
- Used as subsequent therapy for relapsed or primary progressive disease ‡
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1
Coverage may be renewed based on the following criteria:
- Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: myelosuppression (e.g., neutropenia, thrombocytopenia, anemia, etc.), hepatotoxicity, extravasation resulting in tissue necrosis, rhabdomyolysis, etc.
- Dosage/Administration 1
Indication |
Dose |
Small Cell Lung Cancer |
Administer 3.2 mg/m2 by intravenous infusion every 21 days until disease progression or unacceptable toxicity. |
- Billing Code/Availability Information
HCPCS Code:
- J9223 – Injection, lurbinectedin, 0.1 mg; 1 billable unit = 0.1 mg
NDC:
- Zepzelca 4 mg single-dose vial for injection: 68727-0712-xx
- References
- Zepzelca [package insert]. Palo Alto, CA; Jazz Pharmaceuticals, Inc.; July 2023. Accessed January 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) lurbinectedin. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2024.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Cell Lung Cancer Version 2.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed January 2024.
- Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C33 |
Malignant neoplasm of trachea |
C34.00 |
Malignant neoplasm of unspecified main bronchus |
C34.01 |
Malignant neoplasm of right main bronchus |
C34.02 |
Malignant neoplasm of left main bronchus |
C34.10 |
Malignant neoplasm of upper lobe, unspecified bronchus or lung |
C34.11 |
Malignant neoplasm of upper lobe, right bronchus or lung |
C34.12 |
Malignant neoplasm of upper lobe, left bronchus or lung |
C34.2 |
Malignant neoplasm of middle lobe, bronchus or lung |
C34.30 |
Malignant neoplasm of lower lobe, unspecified bronchus or lung |
C34.31 |
Malignant neoplasm of lower lobe, right bronchus or lung |
C34.32 |
Malignant neoplasm of lower lobe, left bronchus or lung |
C34.80 |
Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
C34.81 |
Malignant neoplasm of overlapping sites of right bronchus and lung |
C34.82 |
Malignant neoplasm of overlapping sites of left bronchus and lung |
C34.90 |
Malignant neoplasm of unspecified part of unspecified bronchus or lung |
C34.91 |
Malignant neoplasm of unspecified part of right bronchus or lung |
C34.92 |
Malignant neoplasm of unspecified part of left bronchus or lung |
C7A.1 |
Malignant poorly differentiated neuroendocrine tumors |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH
|
CGS Administrators, LLC |