Codes & NDC
| HCPCS | J0202 — "Inj, alemtuzumab, 1 mg" (permanent, eff. 1/1/2015) |
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| NDC | 58468-0200-01 (10) / 58468-0200-01 (11) — N4 qualifier |
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| Vial | 12 mg / 1.2 mL (10 mg/mL) single-dose; refrigerate 2–8°C; dilute before infusion |
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| Benefit | Medical (provider buy-and-bill) via REMS-certified specialty pharmacy |
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| Approved | Nov 14, 2014 (BLA 103948); 2018 stroke/dissection BW added |
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Dosing — two-course induction
- Course 1 (Mo. 0): 12 mg/day IV × 5 consecutive days (60 mg total)
- Course 2 (Mo. 12): 12 mg/day IV × 3 consecutive days (36 mg total)
- Optional Course 3 (≥ Mo. 24) and Course 4 (≥ Mo. 36): 12 mg × 3 days each, if disease activity returns
- ~4-hour infusion + mandatory 2-hr post-infusion observation
- Bill 12 units J0202 per day; Course 1 = 60 units, Course 2 = 36 units
Lemtrada REMS — required
Mandatory enrollment for prescribers, sites, pharmacies, and patients. 48-month post-last-dose monitoring required.
- Web: lemtradarems.com
- Verify enrollment current before each infusion day
- Monthly CBC w/ diff + serum creatinine + UA w/ microscopy
- Quarterly TSH; annual skin/HPV exam
- Available only via REMS-certified specialty pharmacy
Third-line restriction: per FDA label, reserve for patients with inadequate response to ≥2 prior MS DMTs.
Administration & premedication
| Code | When |
|---|
96365 | Therapeutic IV, initial up to 1 hr (alemtuzumab — non-chemo) |
96366 × 3 | Each additional hour (4-hr total infusion) |
96367 / 96375 | Sequential premed infusion / IV push |
| Premed days 1–3 of each course: methylprednisolone 1,000 mg IV; antihistamine + antipyretic each day; herpes antiviral prophylaxis (acyclovir 200 mg PO BID) starting Day 1 × 2 mo |
Some payers/MACs accept chemo admin codes (96413 + 96415 × 3) given complex prep, anaphylaxis monitoring, and 4-hr infusion. Verify per-MAC.
ICD-10 — relapsing MS only
| Code | For |
|---|
G35.A | RRMS (preferred primary) |
G35.C1 | Active SPMS (covered) |
G35.D | MS unspecified (specific code preferred) |
G35.B0/B1/B2 | NO — PPMS not approved; auto-deny |
G37.9 | CIS — not approved; generally rejected |
Payer requirements (May 2026)
| Payer | PA | Step therapy |
|---|
| UnitedHealthcare | Yes | Yes — ≥2 prior DMT failures + AIC site preferred |
| Aetna | Yes | Yes — ≥2 prior DMT failures + REMS attestation |
| Anthem / Carelon | Yes | Yes — ≥2 prior DMT failures |
| BCBS FEP | Yes | Yes — documented failure of preferred DMTs |
Universal step therapy. Document ≥2 prior MS DMTs (drug, dose, dates, reason for failure/intolerance) + REMS enrollment + 48-mo monitoring acknowledgment.
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $2,440.415 / mg (4/1 – 6/30/2026) |
| 12 mg daily dose | $29,285.00 (12 × $2,440.415) |
| Course 1 drug (60 mg) | ~$146,425 (5 days × $29,285) |
| Course 2 drug (36 mg) | ~$87,855 (3 days × $29,285) |
| Two-course total | ~$234,280 (drug only; ex premed/admin) |
Site of care
| Setting | POS | Notes |
|---|
| Ambulatory infusion ctr | 49 | Preferred — anaphylaxis-ready |
| Physician office | 11 | Must support 8-hr chair time + emergency mgmt |
| Hospital outpatient | 19/22 | UHC/Aetna site-of-care UM disfavors |
| Patient home | — | Not appropriate — anaphylaxis risk |
Patient assistance — Sanofi / MS One to One
- Sanofi Patient Connection (PAP): 1-888-847-4877 — free drug for uninsured/underinsured
- MS One to One Co-Pay Program: 1-855-676-6326 — commercial copay (excludes Medicare/Medicaid/federal)
- MS One to One Patient Support / MS LifeLines: nurse, REMS navigation, infusion coordination — 1-855-676-6326
- Foundations (federal): HealthWell, PAN, TAF — check MS funds before each course
- Web: lemtrada.com · lemtradahcp.com · sanofipatientconnection.com
FOUR BOXED WARNINGS: (1) Autoimmunity — ITP, anti-GBM/glomerular nephropathies, autoimmune hepatitis, thyroid; (2) Infusion reactions — serious/anaphylactic, monitor 2 hr post; (3) Stroke & cervicocephalic arterial dissection; (4) Malignancies — thyroid cancer, melanoma, lymphoproliferative. REMS required.