Coverage Policy Manual
Policy #: 2021040
Category: Pharmacy
Initiated: August 2021
Last Review: August 2023
  Amivantamab-vmjw (e.g., Rybrevant™)
Description:
Amivantamab is an epidermal growth factor (EGF) and mesenchymal epithelial transition (MET) factor bispecific antibody that targets activating and resistant epidermal growth factor receptor (EGFR) exon 20 insertion mutations and MET mutations. Amivantamab is the first available treatment for patients with EGFR exon 20 insertion mutations.
 
Non-small cell lung cancer (NSCLC) attributes to approximately 80-85% of all lung cancer cases; 2-3% of patients with NSCLC have EFGR exon 20 insertion genetic mutations. Tumors with the EGFR exon 20 mutation are more aggressive than other types of EGFR tumor mutations.
 
Regulatory Status
 
Amivantamab (e.g., RybrevantTM) was approved by the U.S. Food and Drug Administration (FDA) on May 21, 2021 for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations 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.
 
Coding
 
See CPT/HCPCS Code section below.
Policy/
Coverage:
Prior Approval is required for Amivantamab-vmjw (e.g., Rybrevant).
 
The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
 
For members of plans that utilize an oncology benefits management program, Prior Approval is required for this service when rendered for oncologic indications and is managed through the oncology benefits management program.
 
Effective August 4, 2022
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
The use of amivantamab meets primary coverage criteria that there be scientific evidence of effectivenss in improving health outcomes for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and ALL of the following criteria are met:
    1. Individual is diagnosed with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation (documentation submitted) [NCCN 2A, FDA 2021] AND  
    2. Individual’s disease has progressed on or after receiving at least one prior platinum-based chemotherapy (FDA 2021) AND  
    3. The drug is used as a single agent (NCCN 2A]
    4. Individual has a current ECOG* performance status of 1 or lower AND
    5. Must be dosed in accordance with the FDA label.
 
*The ECOG or Eastern Cooperative Oncology Group Performance Status is based on the following scale:
    • 0 = Fully active, able to carry on all pre-disease performance without restriction
    • 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light housework, office work
    • 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
    • 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
    • 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
    • 5 = Dead
 
The use of this drug is covered if a FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting all of specified criteria (See policy #2000030).
 
Dosage and Administration
Dosing per FDA Guidelines
 
The recommended dose of amivantamab is based on weight; less than 80kg is 1050mg and greater than or equal to 80kg is 1400mg. Amivantamab is administered weekly for four 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.
 
Amivantamab-vmjw is available as 350 mg/7 mL (50 mg/mL) solution in a single-dose vial.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Amivantamab for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.  
 
For members with contracts without primary coverage criteria, the use of amivantamab for any indication or circumstance other than those described above is considered investigational.
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
The safety and efficacy of amivantamab was evaluated in a phase 1, multicenter, open-label, multi-cohort clinical trial. Inclusion criteria included patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. Patients with untreated brain metastases and patients with a history of interstitial lung disease requiring treatment with prolonged steroids or other immunosuppressive agents within the last 2 years were excluded from the study.
 
Patients received 1050mg (body weight <80kg) or 1400mg (body weight ≥80kg) once weekly for four weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity. 81 patients in the post-platinum cohort were assessed for efficacy. Overall response rate (ORR) for patients receiving amivantamab was 40% [3.7% CR and 36% PR]. The median duration of response (DOR) was 11.1 months, with 63% of patients having a DOR of 6 months or more.
 
The most common adverse effects were rash, infusion related reaction, and paronychia. No treatment related deaths were reported. The incidence of treatment-related adverse effects leading to dose reduction and discontinuation was 15% and 11%, respectively. (Rybrevant, 2021)
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
J9061Injection, amivantamab-vmjw, 2 mg
J9999Not otherwise classified, antineoplastic drugs
References: National Comprehensive Cancer Network(2021) NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 5.2021. June 15, 2021. Accessed August 1, 2021

Rybrevant [package insert] Horsham, PA. Janssen Biotech, Inc., 2021.

Sabari JK, et al.(2021) Amivantamab in post-platinum EGFR exon 20 insertion mutant non-small cell lung cancer. J Thorac Oncol. 2021;16(3 suppl):S108-S109.

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (CHRYSALIS). 2015 November 15 [last updated 2021 May 18; cited 2021 August 2]. In: ClinicalTrials.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine. 2000 - . Available from: https://clinicaltrials.gov/ct2/show/NCT02609776
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.