Codes & NDC
| HCPCS | Q5134 — "Inj, natalizumab-sztn (tyruko), biosimilar, 1 mg" (permanent, eff. 4/1/2024; pre-2024 used J3490/J3590) |
|---|
| NDC | 61314-543-94 (10) / 61314-0543-94 (11) — N4 qualifier |
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| Vial | 300 mg / 15 mL (20 mg/mL) single-dose |
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| Reference | Tysabri (natalizumab, J2323) — Biogen, NDC 59075-0730-15 |
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| Benefit | Medical (provider buy-and-bill); not specialty pharmacy |
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Dosing
- 300 mg IV over ~1 hour, every 4 weeks (no loading)
- 1 vial per dose; ~5 mg/min infusion rate
- 1-hr observation post-infusion (first 12 doses)
- 13 doses/year typical (q4wk × 52 weeks)
- Year-1 total: 3,900 units
TYRUKO REMS — required
Separate from Tysabri's TOUCH. Sites must enroll independently in TYRUKO REMS even if already TOUCH-certified.
- Phone: 800-489-7856 (Sandoz REMS Coordinating Center)
- Web: tyrukorems.com
- Prescriber + site + pharmacy + patient enrollment all required
- Anti-JCV antibody testing baseline + every 6 mo
- MRI baseline + 3 mo + 6 mo + every 6 mo on therapy + 6 mo post-discontinuation
Common error: using existing TOUCH cert for Tyruko. Triggers REMS audit + payer recoupment.
Administration & modifiers
| Code | When |
|---|
96365 | Therapeutic IV, 1 hr (primary) — non-chemo |
96413 | Not appropriate — natalizumab is non-chemo |
| Home admin: S9329 + 99601/99602 (REMS-certified vendor only) |
JZ/JW caveat: Per BuyAndBill, Q5134 may not be on CMS single-dose container list — JZ/JW may not apply. Verify CMS list at billing time.
ICD-10 — MS family
| Code | For |
|---|
G35.A | RRMS (primary) |
G35.C1 | Active SPMS |
G35.D | MS unspecified |
G37.9 | CIS |
G35.B0–B2 | NO — not approved for PPMS |
ICD-10 — Crohn's family
| Code | For |
|---|
K50.00 / K50.01x | Crohn's small intestine |
K50.10 / K50.11x | Crohn's large intestine |
K50.80 / K50.81x | Crohn's both |
K50.90 / K50.91x | Crohn's unspecified |
Both indications covered. Tyruko inherits Tysabri's MS + Crohn's coverage.
Payer requirements (May 2026)
| Payer | PA | Step / Preference |
|---|
| UnitedHealthcare | Yes | Combined w/ Tysabri at parity |
| Aetna | Yes | Tyruko + Tysabri preferred MS alternatives (alongside Ocrevus) |
| Carelon / Anthem | Yes | Combined natalizumab policy (PAM-077) |
| BCBS FEP | Yes | Combined natalizumab policy (5.60.013) |
No step therapy through other MS DMTs. PA criteria focus on Dx, anti-JCV testing, and TYRUKO REMS enrollment.
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $24.321 / mg (effective 4/1 – 6/30/2026) |
| 300 mg dose | $7,296.30 (300 × $24.321) |
| Annual (13 doses) | ~$94,852 |
| Tysabri J2323 ASP+6% | $24.321/mg (currently identical — pricing parity) |
Site of care
| Setting | POS | Notes |
|---|
| Physician office | 11 | 1-hr fits cleanly |
| Ambulatory infusion suite | 49 | Common |
| Hospital outpatient | 19/22 | UHC/Aetna disfavor |
| Patient home | 12 | REMS-certified vendor only |
Patient assistance — Sandoz One Source
- Phone: 1-844-726-3691 (Sandoz One Source)
- Commercial copay: up to $10,000/year
- PAP: free drug for uninsured/underinsured
- Product Replacement: spoiled/damaged
- REMS Coordinating Center: 800-489-7856
- Web: tyruko.com/tyruko-patient-support/sandoz-one-source/
BOXED WARNING — PML: Progressive multifocal leukoencephalopathy. Anti-JCV antibody testing required. MRI surveillance: baseline + 3mo + 6mo + q6mo + 6mo post-discontinuation.