Permanent J-code available for COLUMVI™ (glofitamab-gxbm)

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The Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code for COLUMVI.

J-code

J9286: Injection, glofitamab-gxbm, 2.5 mg

Effective date

January 1, 2024

Billable units

2.5 mg=1 billable unit

HCPCS modifier*

JZ: Zero drug amount discarded/not administered to any patient

10-digit NDCs

50242-125-01: 2.5 mg/2.5 mL single-dose vial

50242-127-01: 10 mg/10 mL single-dose vial

11-digit NDCs

50242-0125-01: 2.5 mg/2.5 mL single-dose vial

50242-0127-01: 10 mg/10 mL single-dose vial

Check with your payer to determine appropriate coding for dates of service prior to January 1, 2024.

For a list of sample codes, visit
Genentech-Access.com/COLUMVI.

These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any item or service.

HCPCS=Healthcare Common Procedure Coding System; NDC=National Drug Code.

As of July 1, 2023, CMS requires the use of the JZ modifier to indicate there were no units of a drug discarded. For more information, visit CMS.gov.

For billing and coding questions, or to request live support from Genentech Access Solutions, call (866) 4ACCESS/(866) 422-2377.

Indication

COLUMVI (glofitamab-gxbm) is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL), or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

This indication is 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(s).

Important Safety Information

BOXED WARNING: Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity.

Warnings and Precautions

•

Neurologic Toxicity: Can cause serious neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Monitor for neurologic toxicity; withhold or permanently discontinue based on severity.

Continued below.

Important Safety Information (cont)

Warnings and Precautions (cont)

•

Serious Infections: Can cause serious or fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately.

•

Tumor Flare: Can cause serious tumor flare reactions. Monitor patients at risk for complications of tumor flare.

•

Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

Most Common Adverse Reactions

The most common (≥ 20%), adverse reactions, excluding laboratory abnormalities, are cytokine release syndrome, musculoskeletal pain, rash, and fatigue. The most common (≥ 20%) Grade 3 to 4 laboratory abnormalities are lymphocyte count decreased, phosphate decreased, neutrophil count decreased, uric acid increased, and fibrinogen decreased.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see the COLUMVI full Prescribing Information for additional Important Safety Information, including BOXED WARNING.

For Colorado Prescribers: In accordance with Colorado Law, please access Wholesale Acquisition Cost (WAC) https://www.drugpricinglaw.com/co.html.
For Connecticut Prescribers and Pharmacists: In accordance with Connecticut Law, please access the list price (i.e., Wholesale Acquisition Cost (WAC)) information here: https://www.drugpricinglaw.com/ct.html.