RYBREVANT (amivantamab-vmjw)

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.