Codes & NDC
| HCPCS | J9380 — "Inj teclistamab cqyv 0.5 mg" (permanent, eff. 7/1/2023; pre-permanent used J3490 / J9999) |
|---|
| NDC 30 mg | 57894-0107-01 (30 mg / 3 mL, 10 mg/mL) — step-up doses |
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| NDC 153 mg | 57894-0108-01 (153 mg / 1.7 mL, 90 mg/mL) — full treatment doses |
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| Indication | R/R MM after ≥4 prior lines (PI + IMiD + anti-CD38 mAb) |
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| Benefit | Medical (provider buy-and-bill); REMS-restricted distribution |
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Step-up dosing schedule
| Day | Dose | Setting |
|---|
| Day 1 (Step-up 1) | 0.06 mg/kg SC | Inpatient + 48-hr obs |
| Day 4 (Step-up 2) | 0.3 mg/kg SC | Inpatient + 48-hr obs |
| Day 7 (Treatment 1) | 1.5 mg/kg SC | Inpatient + 48-hr obs |
| Day 14+ (Maintenance) | 1.5 mg/kg SC weekly | Outpatient (POS 11/49) |
| After ≥6 mo response | 1.5 mg/kg SC q2wk option | Outpatient (verify payer) |
Premed (dex 16 mg + Benadryl 50 mg + APAP 650-1000 mg) required 1-3 hr before each of the first three doses. Not required for ongoing maintenance after Cycle 1.
TECVAYLI REMS — required
Closed distribution. All four parties must be certified/enrolled before any dispense or administration:
- Prescriber training + REMS enrollment
- Healthcare facility certified (CRS/ICANS recognition + tocilizumab on hand)
- Pharmacy verifies prescriber + facility cert before dispensing
- Patient enrolled + counseled + carries wallet card
- Web: tecvaylirems.com
Common error: dispensing or administering without verifying all four certifications. Triggers FDA reporting + claim denial + payer recoupment.
Administration & modifiers
| Code | When |
|---|
96401 | Primary — chemo SC, non-hormonal anti-neoplastic |
96372 | Therapeutic SC — some payers accept; lower reimbursement |
JZ | Single-dose vial, no waste (rare given weight-based dosing) |
JW | Typical — report wasted units on separate line |
JZ or JW required on every J9380 claim per CMS 7/1/2023 single-dose container policy.
Unit math by patient weight
| Wt | Step-up 1 (0.06 mg/kg) | Step-up 2 (0.3 mg/kg) | Tx dose (1.5 mg/kg) |
|---|
| 60 kg | 3.6 mg = 7 u | 18 mg = 36 u | 90 mg = 180 u |
| 70 kg | 4.2 mg = 8 u | 21 mg = 42 u | 105 mg = 210 u |
| 80 kg | 4.8 mg = 10 u | 24 mg = 48 u | 120 mg = 240 u |
| 90 kg | 5.4 mg = 11 u | 27 mg = 54 u | 135 mg = 270 u |
| 100 kg | 6 mg = 12 u | 30 mg = 60 u | 150 mg = 300 u |
ICD-10 — multiple myeloma
| Code | For |
|---|
C90.02 | Most common — MM in relapse (4L+ population) |
C90.00 | MM not having achieved remission |
C90.01 | MM in remission |
Document ≥4 prior lines. PA must list each regimen + class (PI, IMiD, anti-CD38) + outcome.
Site of care
| Phase | Setting | POS |
|---|
| Step-up x3 | Inpatient hospital | 21 (DRG 825) |
| Treatment Day 7 alt | Hospital outpatient (23-hr obs) | 22 |
| Maintenance | Oncology office | 11 |
| Maintenance | Ambulatory infusion center | 49 |
Payer requirements (May 2026)
| Payer | PA | Key requirements |
|---|
| UnitedHealthcare | Yes | 4L+ docs + REMS confirmation; HOPD steerage post step-up |
| Aetna | Yes | 4L+ docs + REMS + ECOG 0-2; site-of-care steering |
| Cigna | Yes | FDA label + NCCN aligned; REMS confirmation |
| Medicare LCDs | No PA | Cover for label indication; documentation required |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $34.501 / 0.5 mg unit ($69.002/mg) (eff. 4/1 – 6/30/2026) |
| Tx dose @ 80 kg (240 u) | $8,280.24 |
| Annual weekly maint @ 80 kg | ~$430,572 (52 doses) |
| Step-up phase | Bundled in DRG (inpatient), not J9380 line-item |
Patient assistance — Janssen CarePath
- Phone: 1-877-CarePath (1-877-227-3728)
- Tecvayli Savings Program: commercial $0 first dose, ~$25K/yr cap
- J&J Patient Assistance Foundation: free drug for uninsured + Medicare hardship
- Foundations (Medicare): PAN, HealthWell, CancerCare — verify open MM funds quarterly
- Web: janssencarepath.com/patient/tecvayli
BOXED WARNING — CRS & ICANS: Cytokine release syndrome (~72%, mostly G1-2) and neurologic toxicity / ICANS (~15%) are life-threatening. Tocilizumab (Actemra J3262) on hand mandatory. 48-hr observation after each of the first three doses. Patient wallet card. Avoid driving per label after each dose.