RYBREVANT (amivantamab-vmjw)

RYBREVANT (amivantamab-vmjw)

Office-Administration

Indications for Prior Authorization:

• Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.

Coverage Criteria:

For diagnosis of non-small cell lung cancer (NSCLC)

• Dose does not exceed weight-based dosing, AND
• Prescribed by or in consultation with an oncologist, AND
• Disease is locally advanced or metastatic, AND
• Patient’s disease has epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Disease has progressed on or after platinum-based chemotherapy (e.g., carboplatin, cisplatin)

Reauthorization Criteria:

For diagnosis of non-small cell lung cancer (NSCLC)

• Dose does not exceed weight-based dosing, and
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Dosing:

• Recommended dosage of Rybrevant is based on baseline body weight:
  • Less than 80 kg: 1050 mg (3 vials of 350 mg/7mL)
  • Greater than or equal to 80 kg: 1400 mg (4 vials of 350 mg/7mL)
• Administer Rybrevant weekly for 4 weeks, with the initial dose as a split infusion in week 1 on day 1 and day 2, then administer every 2 weeks thereafter until disease progression or unacceptable toxicity

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 and precautions
  • Infusion-Related Reactions (IRR): Interrupt infusion at the first sign of IRRs. Reduce infusion rate or permanently discontinue RYBREVANT based on severity
  • Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening symptoms indicative of ILD. Immediately withhold RYBREVANT in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed
  • Dermatologic Adverse Reactions: May cause rash including acneiform dermatitis and toxic epidermal necrolysis. Withhold, dose reduce or permanently discontinue RYBREVANT based on severity
  • Ocular Toxicity: Promptly refer patients with worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT based on severity
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception

Policy Updates:

• 10/19/2021 – New policy approved by P&T

References:

• Baraibar I, Mezquita L, Gil-Bazo I, Planchard D. Novel drugs targeting EGFR and HER2 exon 20 mutations in metastatic NSCLC. Crit Rev Oncol Hematol. 2020;148:102906. doi: 10.1016/j.critrevonc.2020.102906.
• ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/home. Identifiers: NCT04538664, NCT04487080, NCT04606381, NCT04945733. Accessed July 8, 2021.
• Food and Drug Administration. Multi-discipline review: Rybrevant. 2021. FDA Web site. 761210Orig1s000MultidisciplineR.pdf (fda.gov). Accessed July 7, 2021.
• Food and Drug Administration. Premarket Approval (PMA): Guardant360 CDx. Premarket Approval (PMA) (fda.gov). June 14, 2021. Accessed June 17, 2021.
• Food and Drug Administration. Press Release: FDA approves first targeted therapy for subset of non-small cell lung cancer. May 21, 2021. FDA Web site. FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer | FDA. Accessed July 7, 2021.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: Non-small cell lung cancer. Version 5.2021 – June 15, 2021. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 6, 2021.
• Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
• Remon J, Hendriks LEL, Cardona AF, Besse B. EGFR exon 20 insertions in advanced non-small cell lung cancer: a new history begins. Cancer Treat Rev. 2020;90:102105.
• Rybrevant [dossier], Titusville, NJ: Janssen Biotech, Inc.; June 2021.
• Rybrevant [package insert], Horsham, PA: Janssen Biotech, Inc.; May 2021.
• Sequist LV, Neal JW. Personalized, genotype-directed therapy for advanced non-small cell lung cancer. UpToDate Web site. Updated June 2, 2021. http://www.uptodate.com. Accessed July 7, 2021.
• Surveillance, Epidemiology, and End Results program (SEER) Cancer Stat Facts: Lung and Bronchus Cancer. SEER Web site. Lung and Bronchus Cancer — Cancer Stat Facts. Accessed July 7, 2021.
• Takeda M, Sakai K, Hayashi H, et al. Clinical characteristics of non-small cell lung cancer harboring mutations in exon 20 of EGFR or HER2. Oncotarget. 2018;9(30):21132-21140. doi: 10.1016/j.ctrv.2020.102105.
• Vyse, S., Huang, P.H. Targeting EGFR exon 20 insertion mutations in non-small cell lung cancer. Sig Transduct Target Ther 4,5. 2019. doi.org/10.1038/s41392-019-0038-9.