ZEPZELCA (lurbinectedin)
OFFICE ADMINISTRATION – INTRAVENOUS (IV)
Indication for Prior Authorization:
Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Coverage Criteria:
For diagnosis of metastatic SCLC:
- Diagnosis of advanced or metastatic SCLC as confirmed by chart note documentation; AND
- Prescribed by or in consultation with an oncologist; AND
- Patient is aged 18 years or older; AND
- Used as subsequent therapy for disease progression on or after platinum-based chemotherapy (i.e., cisplatin, carboplatin); AND
- Dose does not exceed 3.2 mg/m2 every 21 days; AND
- Used as a single agent.
Dosing:
3.2 mg/m2 IV infusion given every 21 days.
Coverage Duration:
6 months.
Authorization is Not Covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee
Additional Information:
- Product Availability: 4 mg single-dose vial (HCPCS Code: J9999)
Review History:
11/17/2020 – New policy.
References:
- ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/home. Identifiers: NCT02566993, NCT04253145. Accessed July 17, 2020.
- Food and Drug Administration. Multi-discipline review: Zepzelca. 2018. FDA Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213702Orig1s000MultidisciplineR.pdf. Accessed July 15, 2020.
- Food and Drug Administration. Press Release: FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer. June 16, 2020. FDA Web site. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer. Accessed July 8, 2020.
- Kelly K. Extensive-stage small cell lung cancer: initial management. UpToDate Web site. Updated June 9, 2020. www.uptodate.com. Accessed July 10, 2020.
- National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Small Cell Lung Cancer, version 1.2021 – August 11, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. Accessed October 12, 2020.
- National Institutes of Health (NIH). National Cancer Institute. Small cell lung cancer treatment (PDQ) health professional version. NIH Web site. Updated March 24, 2020. https://www.cancer.gov/types/lung/hp/small-cell-lung-treatment-pdq#_1. Accessed July 10, 2020.
- Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
- 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;21:645 to 654. Published online March 27, 2020. https://doi.org/10.1016/S1470-2045(20)30068-1.
- Zepzelca [package insert], Palo Alto, CA: Jazz Pharmaceuticals, Inc.; June 2020.