Keytruda (pembrolizumab) — HCPCS J9271

CareCost Estimate · Billing Cheat Sheet

Merck Sharp & Dohme 100 mg / 4 mL single-dose vial IV infusion (30 min) q3w or q6w Reviewed: May 2, 2026 ASP: Q2 2026

HCPCS

J9271

1 mg = 1 unit

Dose

200 units

200 mg q3w (or 400 q6w)

Modifier

No waste at flat dose

Admin CPT

96413

Chemo IV, 1st hr (+96415)

Medicare ASP+6%

$61.251

/mg · $12,250.20/200 mg

Codes & NDC

HCPCS	`J9271` — "Injection, pembrolizumab, 1 mg" (permanent, eff. 1/1/2016)
NDC (single)	`00006-3026-02` — 1 vial / carton (100 mg)
NDC (dual)	`00006-3026-04` — 2 vials / carton (200 mg, standard adult dose)
Vial	100 mg / 4 mL (25 mg/mL) single-dose
SC sister	Keytruda Qlex (NDC 00006-3083-01 / 00006-5083-01) — no permanent J/Q code; bills via `J3490` / `J9999`
Benefit	Medical (provider buy-and-bill)

Dosing

200 mg IV every 3 weeks (most common; 17 doses/year) — 2 × 100 mg vials, no waste
400 mg IV every 6 weeks (extended; 8–9 doses/year) — 4 × 100 mg vials, no waste
Infused over 30 min; 1 mg = 1 unit
Pediatric (cHL, MSI-H/dMMR): 2 mg/kg q3w, max 200 mg/dose — partial-vial waste → JW
Year-1 (200 mg q3w): 3,400 units · (400 mg q6w): 3,400–3,600 units

Administration & modifiers

Code	When
`96413`	Chemo IV infusion, initial up to 1 hr (primary)
`96415`	Each additional hour (rare for 30-min Keytruda)
`96365/96366`	Not appropriate — PD-1 inhibitors use chemo admin codes

JZ required on virtually every claim (single-dose container, no waste at 200 mg or 400 mg flat doses). JW only on weight-based pediatric doses with documented discard.

Site of care

Setting	POS	Notes
Physician office	11	30-min fits cleanly
Ambulatory infusion	49	Common; payer-preferred
Hospital outpatient	19/22	UHC/Aetna disfavor for non-complex pts
Home infusion	12	Rare; payer-specific

ICD-10 — common indications (21+ approved)

Indication	Code
Melanoma (adv/met, adjuvant)	`C43.x`
NSCLC (PD-L1 testing for 1L mono)	`C34.x`
HNSCC (head & neck SCC)	`C00–C14`, `C32`
Classical Hodgkin Lymphoma (cHL)	`C81.x`
PMBCL	`C85.2`
Urothelial (+ Padcev combo)	`C67.x`
MSI-H / dMMR CRC	`C18–C20` + biomarker
Gastric / GEJ	`C16.x`
Esophageal	`C15.x`
Cervical (CPS ≥1)	`C53.x`
HCC (2L+)	`C22.0`
RCC (+ axitinib/lenvatinib)	`C64–C66`
Endometrial (+ Lenvima)	`C54.x`
TNBC (+ chemo)	`C50.x`
Ovarian (Feb 2026 add)	`C56.x`

Payer requirements (May 2026)

Payer	PA	Notes
UnitedHealthcare	Yes	PD-L1/biomarker docs required for select indications
Aetna	Yes	Strict for NSCLC 1L mono (TPS), HNSCC, gastric, CRC
Anthem / Carelon	Yes	Site-of-care steerage to office/AIC
Medicare (MAC LCDs)	No PA	Coverage per FDA label + NCCN

Biomarker: PD-L1 IHC 22C3 (CPT 88360/88361) for NSCLC 1L mono, HNSCC, gastric/GEJ, esophageal, cervical, TNBC, ovarian. Submit results with PA.

Medicare reimbursement (Q2 2026)

Field	Value
ASP + 6%	$61.251 / mg (4/1 – 6/30/2026)
200 mg dose (q3w)	$12,250.20
400 mg dose (q6w)	$24,500.40
Annualized (200 mg q3w × 17)	~$208,253
Sequestration ~2%	Net ~ASP + 4.3%

Patient assistance — Merck Access Program

Phone: 1-855-257-3932 (benefits, PA, appeals)
Commercial Co-pay: eligible commercially-insured pts; excludes Medicare/Medicaid/federal
Merck Patient Assistance Program (PAP): free product for uninsured/underinsured meeting income limits
Web: merckaccessprogram-keytruda.com

BOXED WARNING — Immune-Mediated Adverse Reactions: Severe and fatal pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic, and other irAEs can occur in any organ. Monitor early; treat with corticosteroids. Higher rates with allogeneic HSCT. Permanent discontinuation may be required.

Sources: Merck Access Program (Aug 2025, US-PDS-00587 03/26), FDA label, CMS ASP Q2 2026, UHC/Aetna/Carelon PD-1 policies, AAPC J9271. carecostestimate.com/drugs/keytruda