Medical Policy

Effective Date:01/01/2022 Title:Rybrevant (amivantamab-vmjw)
Revision Date: Document:BI691:00
CPT Code(s):J9061
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Rybrevant (amivantamab-vmjw) requires prior authorization.

2)    Rybrevant is used to treat lung cancer.

3)    Rybrevant is a specialty drug covered under the medical benefit.

Medical Statement

Rybrevant (amivantamab-vmjw) is considered medically necessary for members meeting the following criteria.

 

Non-Small Cell Lung Cancer (NSCLC)

 

1)    Diagnosis of locally advanced or metastatic NSCLC; AND

2)    Prescribed by or in consultation with an oncologist; AND

3)     Age > 18 years; AND

4)    Disease is positive for epidermal growth factor receptor (EGFR) exon 20 insertion mutations; AND

5)    Member has progressed on or after platinum-based therapy; AND

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:

                                          i.    Body weight < 80kg: 1,050mg (3 vials);

                                        ii.    Body weight >80 kg: 1,400mg (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.

 

Codes Used In This BI:

 

J9061 Injection, amivantamab-vmjw, 2mg

Limits
Intentially left empty
Reference

1)    Rybrevant Prescribing Information. Horsham, PA: Janssen Biotech, Inc.; May 2021. Available at: https://www.Rybrevant.com/. Accessed June 8, 2021.

2)    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 8, 2021.

3)    National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. Version 4.2021. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed June 8, 2021

Addendum:

1)    Effective 01-01-2022: New Policy

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.