Codes & NDC
| HCPCS | J2323 — "Inj, natalizumab, 1 mg" (permanent; reference product) |
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| NDC | 59075-730-15 (10) / 59075-0730-15 (11) — N4 qualifier |
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| Vial | 300 mg / 15 mL (20 mg/mL) single-dose, 1 vial/carton |
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| Biosimilar | Tyruko (natalizumab-sztn, Q5134) — Sandoz, NDC 61314-0543-94 |
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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; dilute in 100 mL 0.9% NaCl
- 1-hr observation post-infusion (per TOUCH)
- 13 doses/year typical (q4wk × 52 weeks)
- Year-1 total: 3,900 units J2323
TOUCH Prescribing Program — required
Separate from TYRUKO REMS. Tysabri is available only through TOUCH (Biogen). Sites administering both products must enroll in BOTH REMS independently.
- Phone: 800-456-2255 (Biogen / TOUCH)
- 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
- PML symptom screen pre-each-dose; report PML cases to Biogen
Common error: using TYRUKO REMS cert for Tysabri (or vice versa). Triggers REMS audit + payer recoupment.
Administration & modifiers
| Code | When |
|---|
96365 | Therapeutic IV, initial up to 1 hr (primary) |
96366 | Each additional hour — typically not billed (1-hr label) |
96413 | Not appropriate — natalizumab is non-chemo |
| Home admin: S9329 + 99601/99602 (TOUCH-certified vendor only) |
JZ/JW caveat: CMS single-dose container list governs JZ/JW applicability for natalizumab and has been inconsistent. Default JZ when no waste; verify MAC guidance at billing time.
ICD-10 — MS family
| Code | For |
|---|
G35.A | RRMS (primary) |
G35.C1 | Active SPMS |
G35.D | MS unspecified (acceptable) |
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 |
Crohn's PA requires documented inadequate response/intolerance to TNF inhibitors (infliximab, adalimumab, certolizumab).
Payer requirements (May 2026)
| Payer | PA | Notes |
|---|
| UnitedHealthcare | Yes | Combined natalizumab policy w/ Tyruko at parity |
| Aetna | Yes | CPB 0751; Tysabri + Tyruko both preferred MS alternatives |
| Carelon / Anthem | Yes | Combined policy PAM-077; biosimilar may be preferred at re-auth |
| BCBS FEP | Yes | Combined natalizumab policy 5.60.013 |
No step therapy through other MS DMTs. PA criteria focus on Dx (G35.x or K50.x), anti-JCV testing, and TOUCH enrollment.
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $24.321 / mg (4/1 – 6/30/2026) |
| 300 mg dose | $7,296.30 (300 × $24.321) |
| Annual (13 doses) | ~$94,852 |
| Tyruko Q5134 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 | TOUCH-certified vendor only |
Patient assistance — Biogen
- Biogen Support Services / Above MS: 1-800-456-2255
- Tysabri Co-Pay Program: commercial copay assistance (excludes Medicare/Medicaid/federal)
- Biogen Foundation PAP: free product for uninsured/underinsured
- Foundations (Medicare): HealthWell, PAN, TAF — verify open MS funds
- TOUCH: 800-456-2255 (REMS support — same number)
BOXED WARNING: Progressive multifocal leukoencephalopathy (PML); herpes encephalitis & meningitis; hepatotoxicity. Anti-JCV testing required; MRI surveillance baseline + 3mo + 6mo + q6mo + 6mo post-discontinuation. Available only through TOUCH.