Talvey (talquetamab-tgvs) — HCPCS J3055
CareCost Estimate · Billing Cheat Sheet
Janssen Biotech (J&J)
3 mg/1.5 mL & 40 mg/1 mL single-dose vials
Subcutaneous injection
Reviewed: May 2, 2026
ASP: Q4 2026
HCPCS
J3055
1 unit = 0.25 mg (NOT 1 mg)
Route
SubQ
Inj 1–2 min · CPT 96401
Modifier
JZ
JW for waste (>1 vial)
REMS
Required
Site + Rx + Pt enroll
ASP+6% Q4 2026
$77.473
/0.25 mg unit · $309.89/mg
BOXED WARNING — Cytokine Release Syndrome (CRS, ~76%) & Neurologic Toxicity incl. ICANS (~10%):
Life-threatening. Step-up doses + first treatment dose require 48-hour inpatient/observation
setting equipped for CRS/ICANS management. Tocilizumab (Actemra J3262) on hand.
BILLER ERROR TRAP — J3055 unit basis is 0.25 mg, not 1 mg. A 32 mg dose
(0.4 mg/kg × 80 kg) bills as 128 units, NOT 32 units. Underbilling by 4× drops
~$9,584 to ~$2,396 per dose. Verify mg × 4 = units on every claim.
Codes & NDC
| HCPCS | J3055 — "Inj talquetamab-tgvs 0.25 mg" (eff. 4/1/2024; pre-2024 used J3490/J3590/C9399) |
|---|
| NDC (3 mg) | 57894-501-01 (10) / 57894-0501-01 (11) — N4 qualifier |
|---|
| NDC (40 mg) | 57894-502-01 (10) / 57894-0502-01 (11) |
|---|
| Vials | 3 mg / 1.5 mL (2 mg/mL); 40 mg / 1 mL (40 mg/mL) single-dose |
|---|
| Class | GPRC5D × CD3 bispecific T-cell engager (first-in-class) |
|---|
| Benefit | Medical (provider buy-and-bill, REMS-certified site) |
|---|
Two dose schedules — major billing impact
| Day | Weekly schedule | Biweekly (q2wk) |
|---|
| 1 | 0.01 mg/kg (step-up) | 0.01 mg/kg (step-up) |
| 4 | 0.06 mg/kg (step-up) | 0.06 mg/kg (step-up) |
| 7 | 0.4 mg/kg (1st full dose) | 0.4 mg/kg (step-up) |
| 10 | — | 0.8 mg/kg (1st full dose) |
| Maint. | 0.4 mg/kg SC weekly | 0.8 mg/kg SC q2wk |
Schedule choice belongs to prescriber. Biweekly cuts visit count ~50% but doubles per-dose drug volume + chair time. Verify which schedule on each PA submission.
TALVEY REMS — required
Sites + prescribers + pharmacies + patients all enroll. Patient receives wallet card.
- Phone: 1-855-825-5249 (TALVEY REMS)
- Web: talveyrems.com
- Document REMS enrollment in chart + claim notes
- Prescriber retraining if AE pattern triggers REMS audit
Common error: Administering at non-enrolled site — REMS violation, payer recoupment, JCAHO citation risk.
Administration & modifiers
| Code | When |
|---|
96401 | Chemo SC, non-hormonal anti-neoplastic (preferred) |
96372 | SC therapeutic (some payers; lower pay) |
JZ | Single-dose vial, no waste (most adult doses) |
JW | Discarded portion (heavy patients spanning 40 mg vial) |
Premedication: dexamethasone + diphenhydramine + acetaminophen 1–3 hr before each step-up dose + first full treatment dose. Bill premeds separately.
ICD-10 — Multiple Myeloma
| Code | For |
|---|
C90.00 | MM, not in remission |
C90.01 | MM, in remission |
C90.02 | MM in relapse (most common for Talvey 4L+) |
Indication: R/R MM in adults with ≥4 prior lines including PI, IMiD, and anti-CD38 mAb. Document all 4 prior lines in PA.
TALVEY-specific toxicity (NOT Tecvayli/Elrexfio)
- Oral toxicity (~80%): dysgeusia, dry mouth, dysphagia — impacts nutrition
- Skin toxicity (~62%): rash, palmar-plantar erythrodysesthesia
- Nail disorders (signature)
- Weight loss — nutrition consult
GPRC5D target = oral/skin/nail effects. BCMA bispecifics (Tecvayli, Elrexfio) do NOT have this profile. Manage with dental hygiene, lubricating mouthwashes, dose modifications.
Payer requirements (May 2026)
| Payer | PA | Step / Preference |
|---|
| UnitedHealthcare | Yes | ≥4L docs + REMS enrollment + GPRC5D rationale |
| Aetna | Yes | CPB 0975 (bispecifics) — similar ≥4L criteria |
| Cigna | Yes | Site-of-care UM common for step-up |
| Medicare LCDs | Cover | On-label use; site-of-care steerage post-step-up |
Medicare reimbursement (Q4 2026)
| Field | Value |
|---|
| ASP + 6% / unit | $77.473 / 0.25 mg (= $299.504/mg) |
| Step-up Day 1 (0.8 mg, 80 kg) | ~$247.91 (3.2 units) |
| Step-up Day 4 (4.8 mg, 80 kg) | ~$1,487.48 (19.2 units) |
| 0.4 mg/kg dose (32 mg, 80 kg) | ~$9,916.54 (128 units) |
| 0.8 mg/kg dose (64 mg, 80 kg) | ~$19,833.09 (256 units) |
| Annual weekly (~50 doses) | ~$479,206 |
| Annual biweekly (~26 doses) | ~$498,374 |
Site of care
| Setting | POS | When |
|---|
| Hospital inpatient | 21 | Step-up + 1st full dose (48-hr obs) |
| 23-hr observation | 22 | Step-up alternative (some sites) |
| Hospital outpatient | 22/19 | Maintenance after first cycle |
| Physician office | 11 | Stable maintenance (REMS-cert only) |
| Cancer center / ASC | 24/49 | Maintenance, REMS-cert site |
Patient assistance — Janssen CarePath
- Phone: 1-877-CarePath (1-877-227-3728)
- Talvey Savings Program: commercial copay support (excludes Medicare/Medicaid/federal)
- Janssen Patient Assistance Foundation (J&J PAF): free product, uninsured / underinsured
- Foundations: PAN, HealthWell, LLS, CancerCare for Medicare patients
- Web: talvey.com/janssen-carepath
- Companion: tocilizumab (Actemra J3262) stocking for CRS rescue