Amivantamab-vmjw (Rybrevant™)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Rybrevant is indicated in combination with lazertinib 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 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Rybrevant is indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
Rybrevant is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
Rybrevant is 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.

Compendial Uses

First-line therapy for recurrent, advanced, or metastatic EGFR exon 20 insertion mutation positive nonsquamous NSCLC
Subsequent therapy for recurrent, advanced, or metastatic EGFR exon 20 insertion mutation positive NSCLC
Subsequent therapy for recurrent, advanced, or metastatic EGFR exon 19 deletion or exon 21 L858R or EGFR S768I, L861Q, and/or G719X mutation positive nonsquamous NSCLC
Recurrent, advanced, or metastatic EGFR exon 19 deletion or exon 21 L858R mutation positive NSCLC in combination with lazertinib

All other indications are considered experimental/investigational and not medically necessary.

DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

Test results showing the presence of EGFR exon 20 insertion mutations, where applicable
Test results showing the presence of EGFR exon 19 deletion or exon 21 L858R or EGFR S768I, L861Q, and/or G719X mutations, where applicable.

COVERAGE CRITERIA

Non-Small Cell Lung Cancer (NSCLC)

Authorization of 12 months may be granted for first-line treatment of advanced, recurrent, or metastatic nonsquamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations when used in combination with carboplatin and pemetrexed.
Authorization of 12 months may be granted for subsequent treatment of advanced, recurrent, or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy, when used as a single agent
Authorization of 12 months may be granted for subsequent treatment of advanced, recurrent, or metastatic nonsquamous NSCLC with EGFR exon 19 deletion or exon 21 L858R or EGFR S768I, L861Q, and/or G719X mutations, whose disease has progressed on Tagrisso (osimertinib), when used in combination with carboplatin and pemetrexed.
Authorization of 12 months may be granted for first-line treatment of recurrent, advanced, or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations when used in combination with lazertinib (Lazcluze).
Authorization of 12 months may be granted for treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor, when used in combination carboplatin and pemetrexed.

CONTINUATION OF THERAPY

Non-Small Cell Lung Cancer (NSCLC)

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for EGFR positive NSCLC when any of the following criteria are met:

There is no evidence of unacceptable toxicity or disease progression while on the current regimen.
The member is requesting the medication in combination with lazertinib (Lazcluze) and there is no evidence of unacceptable toxicity while on the current regimen.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

Rybrevant [package insert]. Horsham, PA: Janssen Biotech, Inc.; September 2024.
The NCCN Drugs & Biologics Compendium^® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed September 10, 2024.

ORIGINAL EFFECTIVE DATE: 8/31/2021

MOST RECENT REVIEW DATE:1/30/2025

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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