VPRIV (velaglucerase alfa) — HCPCS J3385

CareCost Estimate · Billing Cheat Sheet

Takeda Pharmaceuticals (originator Shire) 400-unit lyophilized single-dose vial IV infusion 60 minutes Type 1 Gaucher disease (age 4+) Reviewed: May 22, 2026 ASP: Q2 2026

⚠️

1 J3385 BILLING UNIT = 100 UNITS. A 4,200-unit dose is billed as 42 J3385 units, NOT 4,200. Submitting drug units as J3385 units overstates by 100× (~$1.6M) and triggers payer recoupment.

HCPCS

J3385

1 unit = 100 units

Typical dose

42 units

60 units/kg q2w · 70 kg pt

Modifiers

JZ + JW

Fixed 400-unit vial → waste

Admin CPT

96365

60-min therapeutic IV (non-chemo)

Medicare ASP+6%

$388.157

/billing unit · $16,302.59/dose

Codes & NDC

HCPCS	`J3385` — "Injection, velaglucerase alfa, 100 units" (permanent, since 2010)
NDC	`54092-0700-04` (11-digit) / `54092-700-04` (10-digit)
Vial	400 units lyophilized SDV; reconstitute w/ 4.3 mL SWFI → ~100 units/mL
Dilution	100 mL 0.9% NaCl, 0.2 micron filter; gentle swirl, no shake
Benefit	Medical (provider buy-and-bill or specialty pharmacy → provider; home infusion eligible after 3 mo stable)

Dosing & unit math

60 units/kg IV q2w over 60 minutes (26 doses/yr) — FDA label, ages 4+
Titrate to Hgb, platelets, organ size, biomarkers (chitotriosidase, lyso-Gb1)
J3385 unit math: billing units = drug units ÷ 100
70 kg × 60 units/kg = 4,200 drug units = 42 J3385 billing units
Vials: 4,200 ÷ 400 = 10.5 → round UP to 11 vials (4,400 units drawn)
Waste: 200 drug units = 2 J3385 units (bill on JW line)
Year-1 (admin only): 1,092 J3385 units (26 × 42)

Gaucher ERT class — brand interchangeability

Brand	HCPCS	Mfr
VPRIV (velaglucerase alfa) — FDA Feb 2010	`J3385`	Takeda
Cerezyme (imiglucerase) — reference, FDA 1994	`J1786`	Sanofi Genzyme
Elelyso (taliglucerase alfa) — FDA 2012	`J3060`	Pfizer
Oral SRT (pharmacy benefit, NOT medical): Cerdelga (eliglustat, Sanofi) · Zavesca (miglustat, Janssen)

Each ERT has its own permanent HCPCS. Mismatched code/product pairs trigger immediate denial. Switch brands → new PA + new HCPCS. VPRIV is the common switch target during Cerezyme supply disruptions or antibody-mediated efficacy loss.

Administration & modifiers

Code	When
`96365`	Therapeutic IV initial, 1 hr (primary — fits 60-min VPRIV infusion)
`96366`	Each additional hour — only if infusion actually extends past 60 min
`96413`	NOT appropriate — ERT is non-chemo

Always bill BOTH lines: J3385/JZ for administered units + J3385/JW for waste units. Single-dose vial waste IS reimbursable but must be reported.

ICD-10 — Gaucher disease

Code	For
`E75.22`	Primary — Gaucher disease (required)
`D69.6`	Thrombocytopenia (secondary)
`D64.9`	Anemia, unspecified (secondary)
`K76.89`	Other liver disease (hepatosplenomegaly)
`R16.0/.1/.2`	Hepato-/spleno-/hepatosplenomegaly
`M89.9`	Bone disorder, unsp (skeletal disease)
`M85.80`	Other bone density/structure disorder (Erlenmeyer flask)
`M87.x`	Osteonecrosis / AVN (code to anatomic site)

Confirmation required: acid β-glucosidase enzyme assay AND GBA gene mutation analysis. Geneticist, hematologist, or metabolic specialist consult typically required.

Top denials & payer requirements (May 2026)

Denial	Fix
PA without Gaucher diagnosis confirmation	Submit enzyme assay + GBA mutation results
Missing baseline disease markers	Submit Hgb, plt, organ volumes, bone status, biomarker (chitotriosidase or lyso-Gb1)
Switch from Cerezyme w/o medical necessity	Document switch rationale: supply, antibody loss-of-response, intolerance, or formulary mandate
Units inflated 100×	Resubmit with units = drug units ÷ 100
JW waste line missing	Add JW line; SDV waste is reimbursable but must be reported
Site-of-care denial (HOPD)	Move to POS 11 (office), 49 (AIC), or 12 (home) after 3-mo stability

Medicare reimbursement (Q2 2026)

Field	Value
ASP + 6%	$388.157 / billing unit (100 units)
4,200-unit dose (42 J3385 units)	$16,302.59
Waste 200 units (2 J3385 units)	$776.31 (JW line)
Annual q2w (admin only)	~$423,867
Annual q2w (admin + waste)	~$444,051

Site of care

Setting	POS	Notes
Physician office (genetics/heme/metabolic)	11	Preferred by UM
Freestanding ambulatory infusion center	49	Preferred by UM
Hospital outpatient	19/22	Disfavored after 3 mo stability
Patient home	12	Common for stable patients after 3 mo via specialty pharmacy + ERT-experienced nursing

Patient assistance — Takeda OnePath

Phone: 1-866-888-0660 (Takeda OnePath)
Services: BI/PA support, appeal assistance, copay enrollment, free-drug screening, nurse case management, infusion-site coordination
Commercial copay: available for eligible commercially-insured (excludes Medicare/Medicaid/TRICARE/VA per federal anti-kickback rules)
PAP: free drug for uninsured/underinsured meeting FPL threshold
Foundations (Medicare): National Gaucher Foundation, PAN, HealthWell, Patient Advocate Foundation — verify open LSD/Gaucher funds
Web: takedaonepath.com

NO Boxed Warning. W&P only: hypersensitivity reactions, antibody formation (lower rate than imiglucerase per published data). Manage IARs with rate reduction and pretreatment per FDA label. FDA-labeled for ages 4+; pediatric dosing same as adult weight-based.

Sources: FDA label (BLA 125249, Feb 2010), CMS ASP Q2 2026, ICGG Gaucher Registry, NORD, ASH/MGCC consensus, Takeda OnePath, UHC/Aetna LSD ERT policies. Pending SME review. carecostestimate.com/drugs/vpriv