MARGENZA (margetuximab-cmkb)

MARGENZA (margetuximab-cmkb)

Office Administration – Intravenous

Indications for Prior Authorization:

• Indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease

Coverage Criteria:

For diagnosis of metastatic HER2-positive breast cancer:

• Dose does not exceed 15 mg/kg every 3 weeks, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with an oncologist, AND
• Used in combination with chemotherapy (e.g., capecitabine, eribulin, gemcitabine, vinorelbine), AND
• Failure of two anti-HER2-based regimens, at least once of which was for metastatic disease (e.g., pertuzumab + trastuzumab + docetaxel, ado-trastuzumab emtansine, etc.), unless contraindicated or clinically significant adverse effects are experienced

Reauthorization Criteria:

For diagnosis of metastatic HER2-positive breast cancer:

• Dose does not exceed 15 mg/kg every 3 weeks, AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

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 (P&T) Committee.

Additional Information:

• Warnings
  • Left ventricular dysfunction: Margenza may lead to reductions in left ventricular ejection fraction (LVEF).  Evaluate cardiac function prior to and during treatment
  • Embryo-fetal toxicity: exposure to Margenza during pregnancy can cause embryo-fetal harm
  • Infusion-Related Reactions (IRR’s): monitor for signs and symptoms.  If a significant infusion associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies

Policy Updates:

• 06/15/2021 – New policy approved by P&T

References:

• Botticelli A, Mazzuca F, Borro M, et al. FCGRs polymorphisms and response to trastuzumab in patients with HER2-positive breast cancer: Far from predictive value? World J Oncol. 2015;6(5):437-440.
• ClinicalTrials.gov Web site. https://clinicaltrials.gov. Identifiers: NCT02689284, NCT04082364, NCT04425018. Accessed March 23, 2021.
• Food and Drug Administration. Multi-discipline review: Margenza. 2020. FDA Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761150Orig1s000MultidisciplineR.pdf. Accessed March 23, 2021.
• Food and Drug Administration. Press release: FDA approves margetuximab for metastatic HER2-positive breast cancer. December 17, 2020. FDA Web site. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-margetuximab-metastatic-her2-positive-breast-cancer. Accessed March 4, 2021.
• Margenza [package insert], Rockville, MD: MacroGenics, Inc.; December 2020.
• Mayer IA. Systemic treatment for metastatic breast cancer: general principles. UpToDate Web site. Updated November 11, 2020. www.uptodate.com. Accessed March 23, 2021.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Breast cancer, version 3.2021 – March 29, 2021. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed April 7, 2021.
• 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.
• Rugo HS, Im SA, Cardoso F, et al. Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2-positive advanced breast cancer: A Phase 3 randomized clinical trial. Epub ahead of print. JAMA Oncol. 2021 Jan 22:e207932. doi: 10.1001/jamaoncol.2020.7932.
• Schott AF. Systemic treatment for HER2-positive metastatic breast cancer. UpToDate Web site. Updated January 19, 2021. www.uptodate.com. Accessed March 23, 2021.
• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33