vp-0607
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Rybrevant™ (amivantamab-vmjw) (Intravenous)

Policy Number: VP-0607

Last Review Date: 06/01/2021

Date of Origin: 06/01/2021

Dates Reviewed: 06/2021

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization

Coverage will be provided for six months and may be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Rybrevant 350 mg/7 mL solution SDV: 4 vials per 7 days initially for 4 weeks, then 4 vials every 14 days thereafter
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 1400 mg every 7 days for 4 weeks followed by 1400 mg every 14 days thereafter

III. Initial Approval Criteria1

Coverage is provided in the following conditions:

  • Patient must be at least 18 years old; AND
  • Patient has been instructed/counseled on limiting sun exposure and the use of protective clothing and/or broad-spectrum UVA/UVB sunscreen; AND

Universal Criteria

  • Patient does not have untreated brain metastases (clinically stable asymptomatic brain metastases are allowed); AND

Non-Small Cell Lung Cancer (NSCLC) 1,2,3,4

  • Patient has locally advanced or metastatic disease; AND
  • Patient disease has epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved or CLIA compliant testv; AND
  • Patient has disease progression on or subsequent to platinum-based chemotherapy

v If confirmed using an immunotherapy assay-http://www.fda.gov/companiondiagnostics

FDA Approved Indication(s) ; Compendia recommended indication(s); Ф Orphan Drug

IV. Renewal Criteria1

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy),  performance status, etc. identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion-related reactions, interstitial lung disease, pneumonitis, dermatologic reactions (e.g., acneiform dermatitis and toxic epidermal necrolysis), ocular toxicity, etc.

V. Dosage/Administration1

Indication

Dose

NSCLC

  • Administer weekly for 4 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.
  • Administer premedications before each infusion as recommended.
  • The recommended dose of Rybrevant is based on baseline body weight:
  • Less than 80 kg: 1050 mg (3 vials)
  • Greater than or equal to 80 kg: 1400 mg (4 vials)

Note: Dose adjustments not required for subsequent body weight changes.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9999 – Not otherwise classified, antineoplastic drugs
  • C9399 – Unclassified drugs or biologicals(for hospital outpatient use ONLY)

NDC:

  • Rybrevant 350 mg/7 mL (50 mg/mL) solution as a SDV: 57894-0501-xx

VII. References

  1. Rybrevant [package insert]. Horsham, PA; Janssen Biotech, Inc.; May 2021. Accessed May 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for amivantamab. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed May 2021.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-Small Cell Lung Cancer, Version 4.2021. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed May 2021.
  4. Cho, BC; Lee, KH; Cho, EK; et al.  Amivantamab (JNJ-61186372), an anti-EGFR-MET bispecific antibody, in patients with EGFR exon 20 insertion (exon20ins)-mutated non-small cell lung cancer (NSCLC). DOI: 10.1200/JCO.2020.38.15_suppl.9512 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 9512-9512.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC