Lunsumio (mosunetuzumab-axgb) — HCPCS J9350
CareCost Estimate · Billing Cheat Sheet
Genentech (Roche)
1 mg/mL & 30 mg/30 mL single-dose vials
IV infusion (NOT SC)
R/R FL after ≥2 prior systemic therapies
Reviewed: May 2, 2026
ASP: Q2 2026
Maint. dose
30 units
30 mg q3wk (C3+)
Modifier
JZ
Single-dose vial · JW for waste
Admin CPT
96413
+ 96415 each addl hr
Medicare ASP+6%
$654.542
/mg · $19,636.26/30 mg
BOXED WARNING — Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS may occur,
especially during cycle 1 step-up. Tocilizumab (Actemra) on hand. 24-hr observation after each
step-up dose (C1 D1, D8, D15) and first full dose (C2 D1). Premedicate with corticosteroid + antihistamine + antipyretic 60 min prior.
Step-up dosing schedule (mandatory C1)
| When | Dose | Units |
|---|
| C1 Day 1 | 1 mg IV (step-up 1) | 1 |
| C1 Day 8 | 2 mg IV (step-up 2) | 2 |
| C1 Day 15 | 60 mg IV (1st full dose) | 60 |
| C2 Day 1 | 60 mg IV | 60 |
| C3+ Day 1 (q21d) | 30 mg IV maintenance | 30 |
24-hr post-dose observation required after each step-up + first full dose. Premed required for these doses; may discontinue from C3 if no Gr 2+ CRS.
Fixed-duration vs indefinite-duration therapy
| Drug class | Duration |
|---|
| Lunsumio (CD20×CD3, FL) | FIXED: 8 cycles (CR) or up to 17 cycles (PR) |
| Columvi (CD20×CD3, DLBCL) | FIXED: 12 cycles |
| Epkinly (CD20×CD3, DLBCL) | Until progression |
| Tecvayli / Elrexfio / Talvey (BCMA, MM) | Until progression |
CR responder course total: 303 units over 8 cycles ≈ $198,326 drug cost (Medicare ASP+6%). PR up to 17 cycles adds ~270 units.
NDC, vials, codes
| HCPCS | J9350 — "Inj, mosunetuzumab-axgb, 1 mg" (permanent) |
|---|
| Vial 1 | 1 mg / 1 mL single-dose (for C1 D1 + D8 step-up) |
|---|
| Vial 2 | 30 mg / 30 mL single-dose (60 mg = 2 vials; 30 mg = 1) |
|---|
| BLA | 761263 — accelerated approval Dec 22, 2022 |
|---|
| Benefit | Medical (provider buy-and-bill) |
|---|
| NDC | Pull carton-level NDC from Genentech access materials at billing time; N4 + ML qualifier |
|---|
Administration & modifiers
| Code | When |
|---|
96413 | IV chemo admin, 1st hour (every infusion) |
96415 | Each additional hour — 60 mg ≈ 4 hr → ×3; 30 mg ≈ 2 hr → ×1 |
96365 | NOT appropriate — chemo admin codes apply for bispecific mAb |
96401 | NOT applicable — Lunsumio is IV, not SC |
JZ | Required on virtually every claim (single-dose vial, no waste) |
JW | Only if partial-vial waste (rare at label doses) |
No REMS — but CRS-capable site required
- No formal FDA REMS (unlike Tecvayli/Elrexfio/Talvey for MM)
- Tocilizumab (Actemra J3262) on hand — minimum 2 doses
- Premed: dex 20 mg IV + diphenhydramine 50–100 mg + acetaminophen 500–1000 mg, 60 min prior
- 24-hr observation after each step-up + first full dose
- CRS grading per ASTCT consensus criteria; intervene at Gr 2+
- ICANS reported but NOT in Boxed Warning
IV vs SC bispecific contrast
| Drug | HCPCS | Route | Indication |
|---|
| Lunsumio | J9350 | IV | R/R FL |
| Columvi | J9286 | IV | R/R DLBCL |
| Epkinly | J9321 | SC | R/R DLBCL |
| Tecvayli | J9380 | SC | R/R MM (BCMA) |
| Elrexfio | varies | SC | R/R MM (BCMA) |
| Talvey | varies | SC | R/R MM (GPRC5D) |
Common error: billing J9286 (Columvi) or J9321 (Epkinly) for an FL patient. Lunsumio = J9350 only.
ICD-10 — Follicular Lymphoma (C82)
| Code family | Description |
|---|
C82.00–C82.09 | FL grade 1, by site |
C82.10–C82.19 | FL grade 2, by site |
C82.20–C82.29 | FL grade 3, by site |
C82.30–C82.39 | FL grade 3a, by site |
C82.40–C82.49 | FL grade 3b, by site |
C82.50–C82.59 | Diffuse follicle center lymphoma |
C82.60–C82.69 | Cutaneous follicle center lymphoma |
Required documentation: FL Dx by IHC + ≥2 prior systemic therapies (anti-CD20 mAb + chemoimmuno like R-CHOP/BR).
Payer requirements (May 2026)
| Payer | PA | Step / Documentation |
|---|
| UnitedHealthcare | Yes | FL IHC + ≥2 prior lines + line-of-therapy detail |
| Aetna | Yes | FL Dx + prior therapies + Site-of-Care UM applies |
| Cigna | Yes | NCCN-aligned; eviCore review on some plans |
| BCBS | Yes | NCCN-aligned + plan-specific UM |
| Medicare Part B | No | Covered for label indication via MAC LCDs |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $654.542 / mg (effective 4/1 – 6/30/2026) |
| 1 mg step-up (C1 D1) | $654.54 |
| 2 mg step-up (C1 D8) | $1,309.08 |
| 30 mg maintenance (C3+) | $19,636.26 |
| 60 mg dose (C1 D15 / C2 D1) | $39,272.52 |
| 8-cycle CR course (303 units) | ~$198,326 drug cost |
Among highest per-mg drugs in oncology. Sequestration ~2% reduces actual paid to ~ASP+4.3%.
Site of care
| Setting | POS | Notes |
|---|
| OP cancer center (extended obs) | 22 / 11 | Increasingly common; 24-hr OP obs manageable |
| Hospital outpatient | 22 | Common for C1 step-up |
| Inpatient observation | 21 | If site lacks extended OP obs |
| Physician office | 11 | Acceptable for C3+ maintenance |
| Ambulatory infusion suite | 49 | Acceptable for C3+ maintenance |
Less stringent than MM bispecifics (24-hr obs vs 48-hr) — OP-manageable.
Patient assistance — Genentech Access Solutions
- Phone: 1-866-422-2377
- Commercial copay: up to $25,000/year ($0 copay eligible)
- Genentech Patient Foundation: free product for uninsured/underinsured
- Foundations: PAN, HealthWell, CancerCare, LLS Co-Pay Assistance (Medicare)
- Web: genentech-access.com/hcp/brands/lunsumio.html