ModifiedCentenePolicy CP PHAR.636

Glofitamab-gxbm (Columvi) coverage

Defines medical necessity, prior authorization, and coverage criteria for Columvi (glofitamab-gxbm) for treatment of relapsed or refractory diffuse large B-cell lymphoma and related large B-cell lymphomas for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyGlofitamab-gxbm (Columvi) coverage

Policy CodePolicy CP PHAR.636

Change TypeMaterial updates to indications, prior therapy allowances, and coding

Effective DateSep 1, 2023

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing member meets initial or continued therapy criteria and use HCPCS J9286 on claims where applicable.

SourceLink

POLICY UPDATE CHANGES

Added NCCN Compendium–supported label use for histologic transformation of follicular or marginal zone lymphoma to DLBCL.

Added allowances for partial response, no response, or progressive disease after prior therapy in initial approval logic.

Added NCCN Compendium–supported off-label uses including HIV-related B-cell lymphomas and post-transplant lymphoproliferative disorders, and second-line combination use with GemOx.

Added HCPCS code J9286 for injection, glofitamab-gxbm, 2.5 mg.

Added allowances for continuing therapy after partial response, no response, or progressive disease.

12 cyclesmaximum treatment duration of Columvi

J9286HCPCS code added for glofitamab-gxbm

2+ lines

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Coverage Criteria for Columvi (glofitamab-gxbm)

inv-01: Initial Therapy

Covered when ALL of the following are met for Initial Approval:

Initial Approval - Diagnosis: Diagnosis of DLBCL or LBCL (includes DLBCL, NOS; LBCL arising from follicular lymphoma; histologic transformation of follicular or marginal zone lymphoma to DLBCL; HIV-related B-cell lymphomas; post-transplant lymphoproliferative disorders)

Some off-label uses are NCCN Compendium supported (see document history).

Prescriber: Prescribed by or in consultation with an oncologist

Age: Member is 18 years or older>=18 years

Line of therapy / Prior therapy requirements: For the FDA‑approved indication: disease relapsed or refractory after two or more lines of systemic therapy. For requests other than histologic transformation, prior therapy may include relapsed or refractory disease, relapse ≥12 months after first-line therapy, primary refractory disease, or scenarios where CAR T-cell therapy is not an option. For specified second‑line combination use (e.g., with GemOx) see policy details.after >=2 lines (FDA indication); alternative prior therapy criteria as specified for combination use

Refer to Appendix B and policy history for permitted variations.

Administration regimen: Prescribed as single‑agent Columvi or in combination with GemOx where permitted; obinutuzumab pretreatment is required unless contraindicated with specified step‑up dosing for cycle 1Obinutuzumab pretreatment dosing: 1000 mg IV 7 days before Columvi; step‑up doses Day 8: 2.5 mg, Day 15: 10 mg; maintenance 30 mg every 21 days; maximum of 12 cycles

Prescribed regimen must be FDA‑approved or recommended by NCCN. Prior authorization may be required for obinutuzumab pretreatment.

inv-02: Continuation Therapy

Covered when ALL of the following are met for Continued Therapy:

Current therapy: Member is currently receiving Columvi via Centene benefit or documentation supports current receipt and the member has received Columvi for at least 30 days>=30 days

Response: Member is responding positively to therapy

Positive response required for continued approval

Maximum cycles / Dose increases: Member has not exceeded the maximum treatment duration and dose limits<=30 mg per 21‑day cycle; maximum of 12 cycles

If a dose increase is requested, the new dose must be supported by practice guidelines or peer‑reviewed literature; prescriber must submit supporting evidence for off‑label dose increases

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the request is supported by sufficient documentation of efficacy and safety per the applicable off‑label use policies (for commercial: CP.CPA.09; HIM.PA.154 for Health Insurance Marketplace; CP PMN.53 for Medicaid) or by an established evidence of coverage document.

When a member is covered under a state Medicaid program and a conflict exists between state Medicaid coverage provisions and this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage rules.

Uses of glofitamab‑gxbm for non‑FDA approved indications that lack sufficient supporting documentation as required by the off‑label use policies are considered not authorized for coverage.

Line-of-Therapy Positioning

inv-21: second-line

FDA‑approved second‑line indication: Relapsed or refractory DLBCL or LBCL arising from follicular lymphoma after two or more lines of systemic therapyafter >=2 lines

Accelerated approval based on response rate and durability; confirmatory trials pending

inv-22: second-line

Alternative/Off‑label second‑line combination: Use in combination with GemOx as second‑line therapy is permitted per policy additions

NCCN Compendium support noted in document history; specific prior‑therapy criteria may differ from the FDA indication

Regimens and Dosing

Regimen	Indication	Maximum cycles / Dosing details	Coverage status
Obinutuzumab pretreatment (Gazyva) 1,000 mg IV given 7 days before initiation of Columvi; Columvi step‑up dosing: Day 8 (Cycle 1): 2.5 mg IV; Day 15 (Cycle 1): 10 mg IV; thereafter 30 mg IV on Day 1 of a 21‑day cycle
Diffuse large B‑cell lymphoma (DLBCL, NOS) or large B‑cell lymphoma (LBCL) arising from follicular lymphoma
Continue every 21 days up to a maximum of 12 cycles; Cycles 2–12: dose does not exceed 30 mg per 21‑day cycle
Covered when criteria met per policy

Regimen	Example components	Notes	Coverage status
Standard chemoimmunotherapy regimens listed as therapeutic alternatives
R-CHOP; Pola-R-CHP; Dose‑adjusted EPOCH
Listed as alternative regimens in Appendix B; may require prior authorization depending on formulary status
Neutral (therapeutic alternatives) per policy

Regimen	Line of therapy / Indication	Administration notes	Coverage status
Glofitamab-gxbm (Columvi) in combination with GemOx (gemcitabine + oxaliplatin)
Second‑line use for relapsed or refractory disease where specified by policy additions and document history
Prescribed in combination with GemOx; prior authorization and documentation required; regimen must align with policy criteria and supporting NCCN compendium where applicable
Covered when policy criteria for second‑line combination use are met

Coding and Quantity Limits

HCPCS CodesHCPCS

J9286

Injection, glofitamab-gxbm, 2.5 mg

HCPCS CodesHCPCS

J9286

Injection, glofitamab-gxbm, 2.5 mg

inv-08: Maximum cycles

Maximum treatment durationMaximum of 12 cycles

Cycle frequency30 mg every 21 days for maintenance dosing

Cycle 1 step‑up dosingDay 8: 2.5 mg; Day 15: 10 mg (after obinutuzumab pretreatment)

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include clinical documentation supporting that the member meets all applicable approval criteria. Providers must submit office chart notes, relevant lab results, imaging, pathology, and other supporting clinical information with the prior authorization request.

Prior authorization required for initiation and continuation of therapy.
Submit clinical documentation (office notes, labs, pathology, imaging) to demonstrate member meets policy criteria.

Billing Rule

Coding and Claims Submission

Claims for glofitamab-gxbm should use HCPCS code J9286 (injection, glofitamab-gxbm, 2.5 mg). Providers must follow the Health Plan's prior authorization process and current professional coding and billing guidance when submitting claims.

Background

Glofitamab‑gxbm (Columvi) is a bispecific CD20‑directed CD3 T‑cell engager indicated under accelerated approval for adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL, NOS) or large B‑cell lymphoma (LBCL) arising from follicular lymphoma after two or more lines of systemic therapy. Continued approval may be contingent on verification of clinical benefit from confirmatory trials.

Definitions and Abbreviations

inv-18: diffuse large B-cell lymphoma (DLBCL)

TermDiffuse large B-cell lymphoma (DLBCL)

AbbreviationDLBCL: diffuse large B-cell lymphoma

Related regimen notePolicy includes DLBCL, NOS and histologic transformation of follicular or marginal zone lymphoma to DLBCL (NCCN compendium support noted)

inv-19: large B-cell lymphoma (LBCL)

TermLarge B-cell lymphoma (LBCL)

AbbreviationLBCL: large B-cell lymphoma

Coverage context

Policy Revision History

2023-10-27code_addition

Added HCPCS code J9286 (Injection, glofitamab-gxbm, 2.5 mg) to the coding section.

2024-05-06policy_revision

3Q 2024 annual review: added NCCN Compendium–supported label use for histologic transformation of follicular or marginal zone lymphoma to DLBCL and allowed continuing therapy after partial response, no response, or progressive disease following prior therapy.

2025-04-18policy_revisionLatest