Amivantamab-vmjw (Rybrevant) Form

Amivantamab-vmjw (Rybrevant ™) is a bispecific epidermal growth factor (EGF) receptor- directed and MET receptor-directed antibody.
FDA Approved Indication(s) Rybrevant is 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, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Policy/Criteria
Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Rybrevant is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Non-Small Cell Lung Cancer (must meet all):

1. Diagnosis of recurrent, locally advanced or metastatic NSCLC;
   
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease is positive for epidermal growth factor receptor (EGFR) exon 20 insertion mutations;

2. Member has progressed on or after platinum-based therapy;

   6. Request meets one of the following (a or b):
      a. Dose does not exceed the appropriate weight-based dose (i or ii) per week for 4 weeks, then every 2 weeks thereafter (see section V for dosing regimen ): i. Body weight < 80 kg: 1,050 mg (3 vials); ii. Body weight ≥ 80 kg: 1,400 mg (4 vials); b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
      Prescribed regimen must be FDA-approved or recommended by NCCN Page 1 of 6

   CLINICAL POLICY Amivantamab-vmjw Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Non-Small Cell Lung Cancer (must meet all):
5. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Rybrevant for NSCLC and has received this medication for at least 30 days;
6. Member is responding positively to therapy;
   3. If request is for a dose increase, request meets one of the following (a or b):
      a. New Dose does not exceed the appropriate weight-based dose (i or ii) every 2 weeks (see section V for dosing regimen): i. Body weight < 80 kg: 1,050 mg (3 vials); ii. Body weight ≥ 80 kg: 1,400 mg (4 vials); b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
      Prescribed regimen must be FDA-approved or recommended by NCCN
      Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 6

   CLINICAL POLICY Amivantamab-vmjw CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration TKI: tyrosine kinase inhibitor MET: mesenchymal-epithelial transition NSCLC: non-small cell lung cancer EGFR: epidermal growth factor receptor Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Platinum-based chemotherapy (e.g., cisplatin, carboplatin) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Varies Maximum Dose Varies Appendix C: Contraindications/Boxed Warnings None reported
   V. Dosage and Administration
   Indication Dosing Regimen NSCLC Weight-based dose IV weekly for 4 weeks, with the Maximum Dose See regimen
   initial dose as a split infusion in Week 1 on Day 1 and Day 2, then every 2 weeks thereafter: Week 1, day 1:
   • Body weight < 80 kg: 350 mg (1 vial) • Body weight ≥ 80 kg: 350 mg (1 vial) Week 1, day 2:
   • Body weight < 80 kg: 700 mg (2 vials) • Body weight ≥ 80 kg: 1050 mg (3 vials) Page 3 of 6

   CLINICAL POLICY Amivantamab-vmjw Indication Dosing Regimen Maximum Dose Week 2 and thereafter:
   • Body weight < 80 kg: 1,050 mg (3 vials) • Body weight ≥ 80 kg: 1,400 mg (4 vials)
   VI. Product Availability
   Solution for injection in a single-dose vial: 350 mg/7 mL (50 mg/mL) VII.