RYBREVANT (amivantamab-vmjw)

Office-Administration – intravenous (IV) infusion 

Indications for Prior Authorization:
  • First-Line Treatment of NSCLC with EGFRExon 20 Insertion Mutations: Indicated in combination with carboplatin and pemetrexed for the first-line 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.
  • Previously Treated NSCLC with EGFRExon 20 Insertion Mutations: Indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Coverage Criteria:

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

  • Diagnosis of non-small cell lung cancer (NSCLC), AND
  • Disease is one of the following: 
    • Locally advanced 
    • Metastatic, AND 
  • Patient's disease has epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
  • One of the following: 
    • Disease has progressed on or after platinum-based chemotherapy (e.g., carboplatin, cisplatin) 
    • Both of the following:
      • Used as first-line treatment of NSCLC
      • Used in combination with carboplatin and pemetrexed
Reauthorization Criteria:

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

  • Patient does not show evidence of progressive disease while on therapy
Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
Dosing:

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

  • Recommended Dosage for Rybrevant in Combination with Carboplatin and Pemetrexed:
    • Less than 80 kg:
      • 1400 mg weekly (total of 4 doses) from Weeks 1 to 4
        • Week 1 - split infusion on Day 1 and Day 2
        • Weeks 2 to 4 - infusion on Day 1
        • Weeks 5 and 6 – no dose
      • 1750 mg every 3 weeks starting at Week 7 onwards
    • Greater than or equal to 80 kg:
      • 1750 mg weekly (total of 4 doses) for Weeks 1 to 4
        • Week 1 - split infusion on Day 1 and Day 2
        • Weeks 2 to 4 - infusion on Day 1
        • Weeks 5 and 6 – no dose
      • 2100 mg every 3 weeks starting at Week 7 onwards
  • Recommended Dosage Schedule for Rybrevant as a Single Agent:
    • Less than 80 kg:
      • 1050 mg weekly (total of 5 doses) from Weeks 1 to 5
        • Week 1 - split infusion on Day 1 and Day 2
        • Weeks 2 to 5 - infusion on Day 1
        • Week 6 – no dose
      • 1050 mg every 2 weeks starting at Week 7 onwards
    • Greater than or equal to 80 kg:
      • 1400 mg weekly (total of 5 doses) from Weeks 1 to 5
        • Week 1 - split infusion on Day 1 and Day 2
        • Weeks 2 to 5 - infusion on Day 1
        • Week 6 – no dose
      • 1400 mg every 2 weeks starting at Week 7 onwards
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
  • 9/1/2024 (policy effective date)- Abbreviated drug review, added PA criteria for new indication: First-Line Treatment of non-small Cell Lung Cancer (NSCLC).  (P&T 8/20/2024) (P&T Meeting August)
References:
  1. Rybrevant Prescribing Information. Janssen Biotech, Inc. Horsham, PA. March 2024. 

 

 

Last review date: October 19, 2021

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