Medical Policy

Effective Date:01/01/2024 Title:Columvi
Revision Date: Document:BI729:00
CPT Code(s):
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)    Columvi (glofitamab-gxbm) requires prior authorization.

2)    Columvi is used to treat diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL).

3)    Columvi is covered under the medical benefit.

Medical Statement

Columvi is considered medically necessary when meeting the following criteria:

 

Initial Approval Criteria

I.             Diffuse Large B-Cell Lymphoma or Large B-Cell Lymphoma (must meet all):

a.    Diagnosis of one of the following (a or b):

                                          i.    DLBCL

                                        ii.    LBCL arising from follicular lymphoma;

b.    Prescribed by or in consultation with an oncologist;

c.    Age > 18 years;

d.    Disease is refractory to or has relapsed after > 2 line of system therapy;

e.    Member is prescribed Obinutuzumab (Gazyva) as pretreatment, unless contraindicated or clinically significant adverse effects are experienced;

f.     Dosing is consistent with FDA-labeling

 

Approval Duration: 6 months

 

Continuing Therapy Criteria

1.    Member is responding positively to therapy;

2.    Member has received < 12 cycles of Columvi

3.    Dosing is consistent with FDA-labeling

 

Continuing Therapy Approval Duration: 6 months

Limits
Intentially left empty
Reference

1. Columvi Prescribing Information. South San Francisco, CA: Genentech, Inc.; June 2023. Available at: https://www.gene.com/download/pdf/columvi_prescribing.pdf. Accessed June 27, 2023.

2. National Comprehensive Cancer Network Guidelines. B-Cell Lymphomas Version 4.2023. Available at https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed June 27, 2023.

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.