Effective with date of service June 27, 2023, NC Medicaid Direct and NC Medicaid Managed Care cover glofitamab-gxbm injection, for intravenous use (Columvi) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs.
Strength/Package Sizes: Injection: 2.5 mg/2.5 mL (1 mg/mL) in a single-dose vial, 10 mg/10 mL (1 mg/mL) in a single-dose vial
Glofitamab-gxbm injection is indicated for the treatment of adult patients 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.
Recommended Dose: Treatment cycle = 21 days. Cycle 1 Day 8: 2.5mg (step-up dose 1), Day 15: 10mg (step-up dose 2). Cycle 2 through 12, Day 1: 30mg.
Patients should be hospitalized for the 2.5 mg step-up dose and for subsequent infusions as recommended.
See full prescribing information for further detail.
For Medicaid Billing:
- The ICD-10-CM diagnosis codes required for billing are:
- C83.31 - Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck;
- C83.32 - Diffuse large B-cell lymphoma, intrathoracic lymph nodes;
- C83.33 - Diffuse large B-cell lymphoma, intra-abdominal lymph nodes;
- C83.34 - Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb;
- C83.35 - Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb;
- C83.36 - Diffuse large B-cell lymphoma, intrapelvic lymph nodes;
- C83.37 - Diffuse large B-cell lymphoma, spleen;
- C83.38 - Diffuse large B-cell lymphoma, lymph nodes of multiple sites;
- C83.39 - Diffuse large B-cell lymphoma, extranodal and solid organ sites
- Providers must bill with HCPCS code: J9999 - Not otherwise classified, antineoplastic drugs
- One Medicaid unit of coverage is: 1 mg
- The maximum reimbursement rate per unit is: $1,103.64840
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 50242-0125-01, 50242-0127-01
- The NDC units should be reported as "UN1"
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
- For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on NC Medicaid's website.
- Providers shall bill their usual and customary charge for non-340B drugs.
- PADP reimburses for drugs billed for Medicaid beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is their actual acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
- The fee schedule for the PADP is available on the NC Medicaid Fee Schedule & Covered Code portal.
ICD-10-CM Manual. American Medical Association, 2023 manual.
*Information current as of Sept. 26, 2023, and is not a substitute for professional judgment. For full prescribing information, please refer to current package insert or other appropriate sources prior to making clinical judgments.
Contact
NCTracks Call Center: 800-688-6696