Libtayo (cemiplimab-rwlc) — HCPCS J9119

CareCost Estimate · Billing Cheat Sheet

Regeneron Pharmaceuticals 350 mg / 7 mL single-dose vial (50 mg/mL) IV infusion every 3 weeks (fixed) Reviewed: May 2, 2026 ASP: Q2 2026

HCPCS

J9119

1 mg = 1 unit

Fixed Dose

350 units

350 mg q3w · 1 vial

Modifier

Standard (1 vial = full dose)

Admin CPT

96413

Chemo IV (30 min)

Medicare ASP+6%

$29.762

/mg · $10,416.70/dose

SIGNATURE INDICATION: First drug ever FDA-approved (Sep 2018) for locally advanced or metastatic cutaneous SCC not curable by surgery or radiation. Primary anti-PD-1 in dermatologic oncology.

Codes & NDC

HCPCS	`J9119` — "Inj, cemiplimab-rwlc, 1 mg" (permanent)
NDC	`61755-008-01` (10) / `61755-0008-01` (11) — N4 qualifier
Vial	350 mg / 7 mL (50 mg/mL) single-dose vial
BLA	761097 · FDA approval Sep 28, 2018 (cSCC)
Benefit	Medical (provider buy-and-bill); not specialty pharmacy

Dosing — multi-indication matrix

Indication	Dose	Combo
Adv. cSCC	350 mg q3w	Mono
Adv. BCC (post-HPI)	350 mg q3w	Mono
NSCLC 1L mono	350 mg q3w	Mono (PD-L1 ≥50%)
NSCLC 1L + chemo	350 mg q3w	+ Platinum
Cervical (post-platinum)	350 mg q3w	Mono

Single fixed dose across ALL indications (NOT weight-based)
1 vial per dose — matches dose 1:1 (no waste)
~17 doses/year (q3w × 52 weeks)
Year-1 total: 5,950 units

cSCC / BCC niche

Libtayo's distinct identity: first checkpoint inhibitor approved for advanced cSCC (2018) and labeled for advanced BCC (2021, post-HPI). High-volume in dermatologic oncology, head & neck surgery, and Mohs-affiliated practices.

cSCC: for patients not curable by surgery or radiation. Document tumor size, location, prior failed local therapy, comorbidities.
BCC: requires prior HPI failure (vismodegib or sonidegib) or HPI intolerance.
Many patients elderly, transplant-recipients, or significant comorbidity load.

Administration & modifiers

Code	When
`96413`	Chemo IV, 1 hr (primary) — despite immunotherapy
`96415`	Each additional hour (combo NSCLC + chemo)
`96365`	NOT appropriate — cemiplimab is chemo admin
JZ	Standard on virtually every claim (no waste)
JW	Rare — only with dose reduction / partial-vial waste

Checkpoint class comparison

Drug	HCPCS	Dose
Libtayo	`J9119`	350 mg q3w
Keytruda	`J9271`	200 mg q3w / 400 mg q6w
Opdivo	`J9299`	240 q2w / 480 q4w
Tecentriq	`J9022`	1200 mg q3w
Imfinzi	`J9173`	10 mg/kg q2w / 1500 mg q4w
Jemperli	`J9272`	500 mg q3w → 1000 mg q6w

ICD-10 — cSCC by site

Code	Site
`C44.4x`	SCC of skin of face (most common)
`C44.42x`	SCC scalp/neck
`C44.5x`	SCC of skin of trunk
`C44.6x`	SCC of skin of upper limb
`C44.7x`	SCC of skin of lower limb
`C77.x / C78.x / C79.x`	Metastatic cSCC documentation

ICD-10 — BCC by site & other

Code	For
`C44.41`	BCC of skin of face
`C44.51`	BCC of skin of trunk
`C44.61 / C44.71`	BCC upper / lower limb
`C34.x`	NSCLC (mono & combo)
`C53.x`	Cervical cancer (post-platinum)

Payer requirements (May 2026)

Payer	PA	Key requirement
UnitedHealthcare	Yes	PD-L1 (NSCLC mono); HPI failure (BCC); surg/RT contraind. (cSCC)
Aetna	Yes	CPB 0892; biomarker for NSCLC mono; site-of-care UM
BCBS plans	Yes	NCCN-aligned; varies by plan

PD-L1 only matters for NSCLC monotherapy. NOT required for cSCC, BCC, cervical, or NSCLC + chemo.

Medicare reimbursement (Q2 2026)

Field	Value
ASP + 6%	$29.762 / mg (effective 4/1 – 6/30/2026)
350 mg dose	$10,416.70 (350 × $29.762)
Annual (~17 doses)	~$177,084
Code history	Permanent J9119; pre-perm J9999/J3490

Site of care

Setting	POS	Notes
Physician office (onc/derm)	11	Preferred
Ambulatory infusion suite	49	Preferred
Hospital outpatient	19/22	UHC/Aetna disfavor after 3 mo
Patient home	12	Rare for IV oncology IO

Patient assistance — Libtayo Surround

Phone: 1-877-542-2826 (Libtayo Surround Support)
Co-Pay Program: $0 first dose for commercial (excl. Medicare/Medicaid)
Regeneron Patient Foundation: free drug for uninsured/underinsured (501(c)(3))
Foundations (Medicare): PAN, HealthWell, CancerCare — verify open funds
Web: libtayohcp.com

SEVERE / FATAL irAEs (treat as Boxed analog): immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies (hypothyroidism most common; T1DM, adrenal insufficiency, hypophysitis), nephritis, severe dermatologic reactions (SJS/TEN/DRESS), infusion reactions. Hold for grade 2; steroid + permanent discontinue grade 3+. Same management as Keytruda/Opdivo/Tecentriq/Imfinzi.

Sources: FDA label (rev. 2025, BLA 761097), CMS ASP Q2 2026, Regeneron Libtayo Surround, NCCN (cSCC/BCC/NSCLC/Cervical), UHC/Aetna ICI policies, AMA CPT. carecostestimate.com/drugs/libtayo