Medicare Advantage

Medical Policy

Title:

Glofitamab-gxbm (Columvi)

Policy #:

MA08.163d

Policy

In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

GLOFITAMAB-GXBM (COLUMVI)

Glofitamab-gxbm (Columvi) is considered medically necessary and, therefore, covered as a single agent for the treatment of adult individuals for any of the following B-cell lymphomas:

Diffuse Large B-Cell Lymphoma

As National Comprehensive Cancer Network (NCCN) preferred second-line and subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin)

For relapsed disease <12 months after completion of first-line therapy or primary refractory disease in noncandidates for chimeric antigen receptor (CAR) T-cell therapy (includes individuals who do not have access to CAR T-cell therapy)

For relapsed disease >12 months after completion of first-line therapy if no intention to proceed to transplant

As alternative systemic therapy (if not previously used) for relapsed or refractory disease

As National Comprehensive Cancer Network (NCCN) preferred third-line and subsequent therapy (only after at least two lines of systemic therapy) as a single agent for partial response, progressive, relapsed, or refractory disease including individuals with disease progression after transplant or CAR T-cell therapy.

High-Grade B-Cell Lymphomas

As NCCN-preferred second-line and subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin)

For relapsed disease <12 months after completion of first-line therapy or primary refractory disease in non-candidates for transplant (includes individuals who do not have access to CAR T-cell therapy)

For relapsed disease >12 months after completion of first-line therapy if no intention to proceed to transplant

As alternative systemic therapy (if not previously used) for relapsed or refractory disease

As NCCN-preferred third-line and subsequent therapy (only after at least two lines of systemic therapy) for the treatment of individuals with partial response, no response, progressive, relapsed, or refractory disease, including individuals with disease progression after transplant or CAR T-cell therapy.

Histologic Transformation of Indolent Lymphomas to Diffuse Large B-Cell Lymphoma

As a treatment of histologic transformation of follicular or marginal zone lymphoma to diffuse large B-cell lymphoma (only after at least two lines of systemic therapy) for partial response, no response, progressive, or relapsed disease including individuals with disease progression after transplant or CAR T-cell therapy

Human Immunodeficiency Virus (HIV)-Related B-Cell Lymphomas

As a second-line and subsequent therapy for HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and human herpesvirus 8 (HHV8-positive) diffuse large B-cell lymphoma, not otherwise specified, or for HIV-related plasmablastic lymphoma in combination with GemOx (gemcitabine and oxaliplatin)

For relapsed disease <12 months after completion of first-line therapy or primary refractory disease in non-candidates for CAR T-cell therapy (includes individuals who do not have access to CAR T-cell therapy)

For relapsed disease >12 months after completion of first-line therapy if no intention to proceed to transplant

As alternative systemic therapy (if not previously used) for relapsed or refractory disease

As NCCN-preferred third-line and subsequent therapy (only after at least two lines of systemic therapy) for HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified for partial response, no response, relapsed, progressive or refractory disease including individuals with disease progression after transplant or CAR T-cell therapy.

Post-Transplant Lymphoproliferative Disorders (PTLD)

As a second-line and subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin) regimen

For relapsed disease <12 months after completion of initial treatment with chemoimmunotherapy or primary refractory disease in non-candidates for CAR T-cell therapy (includes individuals who do not have access to CAR T-cell therapy)

For relapsed disease >12 months after completion of initial treatment with chemoimmunotherapy if no intention to proceed to transplant

As alternative systemic therapy (if not previously used) for relapsed or refractory disease

As NCCN-preferred third-line and subsequent therapy (only after at least two lines of systemic therapy) for monomorphic PTLD (B-cell type) for partial response, no response, relapsed, progressive or refractory disease including individuals with disease progression after transplant or CAR T-cell therapy.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for glofitamab-gxbm (Columvi) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, glofitamab-gxbm (Columvi) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Glofitamab-gxbm (Columvi) was approved by the US Food and Drug Administration (FDA) on June 15, 2023, for the treatment of individuals with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

This indication was approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

PEDIATRIC USE

The safety and effectiveness of glofitamab-gxbm (Columvi) in pediatric individuals have not been established.

Description

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL). DLBCL is one of the most frequent subtypes of aggressive lymphomas, which can become transformed lymphoma that mostly develops from other types of lymphoma. Individuals with DLBCL who are treated with first-line therapy can become refractory to therapy or relapse after initially responding to therapy. Individuals who become refractory to therapy, or relapse or progress after therapy, often have a poor prognosis.

Glofitamab-gxbm (Columvi) is a bispecific antibody that binds to CD20 expressed on the surface of B cells, and to CD3 receptor expressed on the surface of T cells. Glofitamab-gxbm causes T-cell activation and proliferation, secretion of cytokines, and the lysis of CD20-expressing B cells. Glofitamab-gxbm showed anti-tumor activity in vivo in mouse models of DLBCL.

The efficacy of glofitamab-gxbm (Columvi) was evaluated in an open-label, multicenter, multicohort, single-arm clinical trial (NCT03075696), that included individuals with relapsed or refractory LBCL after two or more lines of systemic therapy. Individuals received pretreatment with obinutuzumab on cycle one day one. After obinutuzumab, individuals received glofitamab-gxbm (Columvi) by intravenous infusion, starting with a 2.5-mg step-up dose on cycle one day eight, followed by a 10-mg step-up dose on cycle one day 15, then 30 mg on cycle two day one and on day one of each subsequent cycle. The cycle length was 21 days. Glofitamab-gxbm (Columvi) was administered for up to 12 cycles unless individuals experienced progressive disease or unacceptable toxicity. The efficacy population consists of 132 individuals with de novo DLBCL, NOS (80%) or LBCL arising from follicular lymphoma (20%) who received at least one dose of glofitamab-gxbm (Columvi). The median age was 67 years (range, 21–90 years), 64% were male, 77% were White, 4.5% were Asian, 0.8% were Black or African American, 5% were Hispanic or Latino. The median number of prior lines of systemic therapy was three. Most individuals (83%) had refractory disease to the last therapy, 55% had primary refractory disease, 30% had received chimeric antigen receptor (CAR) T-cell therapy, and 19% had received autologous hematopoietic stem cell transplant (HSCT). Efficacy was based on objective response rate (ORR) and duration of response (DOR). After a median follow-up of 2.8 months, across all efficacy-evaluable individuals (n=32), the ORR and complete metabolic response (CMR) rate was 62.5% and 40.6%, respectively. For individuals with aggressive Non-Hodgkin lymphoma (aNHL) (n=24), the ORR was 50.0% with complete molecular remission (CMR) rates of 29.2%. As of the data cut-off date, 17 individuals with aNHL (70.8%) had reached the first response assessment only (C3) and remain on treatment; four individuals (16.7%) had reached the second response assessment (C6). For individuals with indolent Non-Hodgkin lymphoma (iNHL) (n=8), the ORR was 100.0% with 75.0% of individuals achieving CMR. The most common adverse events (AEs) were cytokine release syndrome (CRS) (57.9%), pyrexia (31.6%), neutropenia, thrombocytopenia, and hypophosphatemia (28.9% each). No AEs led to treatment discontinuation.

OFF-LABEL INDICATIONS
There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

American Hospital Formulary Service (AHFS). Drug Information. 2024. Glofitamab-gxbm. [LexiDrugs website]. 06/20/2024. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 15, 2024.

Elsevier Gold Standard’s Clinical Pharmacology Compendium. Glofitamab-gxbm. [Clinical Pharmacology website]. 09/29/2023. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. [via subscription only]. Accessed July 15, 2024.

Genentech, Inc., South San Francisco, CA. Glofitamab-gxbm (Columvi). labeling.06/2023. Available at: columvi_prescribing.pdf (gene.com). Accessed July 15, 2024.

Lexi-Drugs Compendium. Glofitamab-gxbm (Columvi). 04/25/2024. [Lexicomp Online Website]. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/3509801 [via subscription only]. Accessed July 15, 2024.

Lymphoma Research Foundation [website]. Diffuse Large B-Cell Lymphoma. Revised 2024. Available at: http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300143. Accessed July 15, 2024.

Hutchings M, Carlo-Stella C, Bachy E. Glofitamab step-up dosing induces high response rates in patients with hard-to-treat refractory or relapsed non-Hodgkin lymphoma. Blood. 2020;136(Supplement 1):46-48.

Micromedex® Healthcare Series [Internet database]. Glofitamab-gxbm. Greenwood Village, CO: Thomson Micromedex. 06/26/2024. Available at: http://www.micromedexsolutions.com/micromedex2/librarian. Accessed July 15, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - B-Cell Lymphomas. V2.2024. [NCCN Web site]. 04/30/2024. Available at: http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf [via subscription only]. Accessed July 15, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Drugs and Biologics Compendium. Glofitamab-gxbm. [NCCN Web site]. Available at: http://www.nccn.org/index.asp [via subscription only]. Accessed July 15, 2024.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @FDA. Prescribing Information. Columvi (glofitamab-gxbm). [FDA website]. 06/15/2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf. Accessed July 15, 2024.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

HCPCS Level II Code Number(s)

J9286 Injection, glofitamab-gxbm, 2.5 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA08.163d:

07/28/2025

This version of the policy will become effective 07/28/2025.

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling and National Comprehensive Cancer Network (NCCN) compendia.

The following criteria have been updated in this policy:

NCCN guidelines with new recommendations for glofitamab-gxbm (Columvi) for:

Diffuse large B-cell lymphoma, large B-cell lymphoma (LBCL)
Histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma
Human immunodeficiency virus (HIV)-related B-cell lymphomas
Post-transplant lymphoproliferative disorders (PTLD)

The following criteria have been updated in this policy:

High-grade B-cell lymphomas

All of the ICD-10 CM codes have been removed from this policy, since they are informational. Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

Revisions From MA08.163c:

10/01/2024

This version of the policy will become effective 10/01/2024.
Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following ICD-10 codes have been added to this policy:
C83.390 Primary central nervous system lymphoma
C83.398 Diffuse large B-cell lymphoma of other extranodal and solid organ sites

The following ICD-10 code has been removed from this policy:
C83.39 Diffuse large B-cell lymphoma, extranodal and solid organ sites

Revisions From MA08.163b:

09/09/2024

This version of the policy will become effective 09/09/2024.

NCCN guidelines with new recommendations for glofitamab-gxbm (Columvi) for

Diffuse Large B-Cell Lymphoma, Large B-cell lymphoma (LBCL)
Histologic Transformation of Indolent Lymphomas to Diffuse Large B-Cell Lymphoma
High-Grade B-Cell Lymphomas
Human Immunodeficiency Virus (HIV)-Related B-Cell Lymphomas
Post-Transplant Lymphoproliferative Disorders (PTLD)

Revisions From MA08.163a:

01/02/2024

This version of the policy will become effective 01/02/2024.

The following NOC codes have been removed from this policy and were replaced by the following HCPS codes:

REMOVED: C9399 Unclassified drugs or biologics AND J3590 Unclassified biologics

REPLACED WITH: J9286 Injection, glofitamab-gxbm, 2.5 mg

New Policy MA08.163:

01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
10/23/2023	This version of the policy will become effective 10/04/2023 This new policy has been issued to communicate the Company’s coverage position and criteria for glofitamab-gxbm (Columvi).

Version Effective Date:

7/28/2025

Version Issued Date:

7/28/2025

Version Reissued Date:

Medicare Advantage

Medical Policy

Notification

Policy

Guidelines

Description

References

Coding

CPT Procedure Code Number(s)

ICD - 10 Procedure Code Number(s)

ICD - 10 Diagnosis Code Number(s)

HCPCS Level II Code Number(s)

Revenue Code Number(s)

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History