Columvi (glofitamab-gxbm) — HCPCS J9286
CareCost Estimate · Billing Cheat Sheet
Genentech (Roche)
2.5 mg/2.5 mL & 10 mg/10 mL single-dose vials
IV infusion q21 days × 12 cycles
Reviewed: May 2, 2026
ASP: Q2 2026
HCPCS
J9286
1 unit = 2.5 mg
Route
IV
Not SC. q3wk infusion.
Maint dose
12 units
30 mg IV q3wk (C3+)
Admin CPT
96413
+ 96415 (each addl hr)
Medicare ASP+6%
$2,840.677
/unit (per 2.5 mg) · $1,136.27/mg
BILLER ERROR TRAP — 1 unit = 2.5 mg. Most J-codes use 1 mg = 1 unit. J9286 uses 2.5 mg per unit. A 30 mg dose = 12 units, NOT 30 units (a 2.5x overbill). Verify against HCPCS descriptor on every claim.
Codes & vials
| HCPCS | J9286 — "Inj, glofitamab-gxbm, 2.5 mg" · permanent |
|---|
| Vials | 2.5 mg / 2.5 mL single-dose · 10 mg / 10 mL single-dose |
|---|
| Pretreatment | J9301 Gazyva (obinutuzumab) 1,000 mg IV Day -7 = 100 units (10 mg per unit) |
|---|
| NDC | Pull carton-level NDC from Genentech access materials at billing time. N4 + NDC + ML. |
|---|
| Benefit | Medical (provider buy-and-bill); not specialty pharmacy |
|---|
Step-up + Gazyva pretreatment
| Day | Drug / dose | HCPCS | Units |
|---|
| Day -7 | Gazyva 1,000 mg IV | J9301 | 100 |
| C1 D8 | Columvi 2.5 mg IV (step-up 1) | J9286 | 1 |
| C1 D15 | Columvi 10 mg IV (step-up 2) | J9286 | 4 |
| C2 D1 | Columvi 30 mg IV (first full dose) | J9286 | 12 |
| C3-C12 | Columvi 30 mg IV q21 days | J9286 | 12 ea |
Day -7 Gazyva = separate same-day claim with own admin codes. Mandatory per FDA label — depletes CD20+ B-cells to mitigate CRS. Skipping is a label deviation + PA denial.
Fixed duration — 12 cycles MAX
- 12 cycles total — treatment stops, regardless of response
- Cycle length 21 days · total ~9 months from C1 D1
- NOT response-extended (unlike Lunsumio's CR/PR split)
- NOT indefinite (unlike MM bispecifics Tecvayli/Elrexfio/Talvey)
- After C12: surveillance imaging + clinical follow-up; J9286 charges stop
Course total: 137 J9286 units (1+4+11×12) ≈ ~$389K Columvi drug cost + ~$8.5–9.5K Day -7 Gazyva ≈ ~$398K total course (Q2 2026 ASP+6%).
Administration & modifiers
| Code | When |
|---|
96413 | Chemo IV, initial hour (every Columvi infusion + Day -7 Gazyva) |
96415 | Each addl hr — first step-up ~4 hr = 96413 + 96415 × 3 |
96365 | NOT appropriate — Columvi bills under chemo admin |
JZ | Required — single-dose vial, no waste at standard label doses |
JW | Only if partial-vial waste (rare; one of JZ/JW required) |
ICD-10 — DLBCL family
| Code | For |
|---|
C83.30 | DLBCL, unspecified site (most common) |
C83.31–C83.39 | DLBCL, by anatomic site (head/neck, intrathoracic, intra-abdominal, axilla, inguinal, intrapelvic, spleen, multiple sites, extranodal) |
C82.x | FL family — use when LBCL arose from prior FL (transformation); document histologic transformation |
Required PA docs: DLBCL/LBCL Dx (IHC), ≥2 prior systemic therapies (R-CHOP + salvage), Gazyva pretreatment plan. Top denial reason = missing prior-therapy detail.
Payer requirements (May 2026)
| Payer | PA | Notes |
|---|
| UnitedHealthcare | Yes | Aggressive site-of-care UM; prefers extended-OP infusion |
| Aetna | Yes | Separate Site-of-Care policy for oncology bispecifics |
| Cigna | Yes | Aligned with FDA label + NCCN; eviCore on some plans |
| BCBS plans | Yes | Plan-specific; NCCN-aligned |
| Medicare Part B | No | MAC LCDs cover label indication |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% per unit | $2,840.677 (per 2.5 mg) |
| Per-mg equivalent | $1,136.27/mg |
| 2.5 mg dose (1 unit) | $2,840.68 |
| 10 mg dose (4 units) | $11,362.71 |
| 30 mg dose (12 units) | $34,088.12 |
| 12-cycle course total | ~$389,173 (137 units) |
Site of care
| Setting | POS | Notes |
|---|
| OP cancer center (extended obs) | 22/11 | Increasingly common for C1 step-up |
| Hospital outpatient | 22 | Common for step-up; UB-04 / 837I |
| Hospital inpatient observation | 21 | Sometimes used for first step-up |
| Physician office / AIC | 11/49 | Acceptable C3+ maint w/ CRS protocols |
| Patient home | 12 | Not appropriate — CRS-capable site needed |
Patient assistance — Genentech
- Phone: 1-866-422-2377 (Genentech Access Solutions)
- Commercial copay: Genentech Oncology Co-pay Assistance — up to $25,000/year ($0 for eligible commercial)
- Patient Foundation: free product for uninsured/underinsured
- Foundations: PAN, HealthWell, CancerCare, LLS Co-Pay Assistance (Medicare patients; verify open lymphoma funds quarterly)
- Web: genentech-access.com/hcp/brands/columvi.html
BOXED WARNING — CRS: Cytokine Release Syndrome, including life-threatening or fatal reactions (~70% incidence; Gr 3+ ~4%). Tocilizumab (Actemra) on hand before any dose. 24-hr observation after each step-up (C1 D8, D15). Day -7 Gazyva pretreatment substantially mitigates CRS — do not skip.