Elelyso (taliglucerase alfa) — HCPCS J3060

CareCost Estimate · Billing Cheat Sheet

Pfizer / Protalix 200-unit lyophilized single-dose vial IV infusion 60–120 min Type 1 Gaucher (ages 4+) Reviewed: May 22, 2026 ASP: Q2 2026

⚠️

1 BILLING UNIT = 10 UNITS. A 4,200-unit dose is billed as 420 billing units, NOT 4,200. Submitting units as billing units overstates by 10× and triggers payer recoupment.

HCPCS

J3060

1 unit = 10 units

Typical dose

420 units

60 U/kg q2w · 70 kg pt

Modifiers

JZ ± JW

200-U SDV → waste if not mult-of-200

Admin CPT

96365

+ 96366 if >1 hr (60–120 min)

Medicare ASP+6%

$40.657

/billing unit · $17,075.94/dose

Codes & NDC

HCPCS	`J3060` — "Injection, taliglucerase alfa, 10 units" (permanent)
NDC	`0069-0106-01` (10) / `00069-0106-01` (11)
Vial	200 units lyophilized SDV; reconstitute w/ 5.1 mL SWFI → 40 units/mL
Dilution	100–200 mL 0.9% NaCl, in-line filter per pharmacy protocol
Storage	2°C–8°C in original carton; protect from light; do not freeze
Benefit	Medical (provider buy-and-bill or specialty pharmacy → provider)

Dosing & unit math

60 units/kg IV q2w — only labeled regimen; 26 doses/yr
Ages ≥4 years (pediatric or adult); same dose
Titrate over time to Hgb, platelets, organ size, biomarkers (chitotriosidase, lyso-Gb1)
Math: billing units = total units ÷ 10
70 kg × 60 = 4,200 units = 420 billing units
Vials: 4,200 ÷ 200 = 21 vials exactly → zero waste at this weight
75 kg × 60 = 4,500 units = 450 billing units; 23 vials drawn → 100-unit waste = 10 billing units (JW)
Year-1 (admin only, 70 kg): 10,920 billing units (26 × 420)

Brand interchangeability — Gaucher ERTs

Brand	HCPCS	Unit basis	Mfr
Cerezyme (imiglucerase) — FDA 1994	`J1786`	1 u = 10 IU	Sanofi Genzyme
VPRIV (velaglucerase alfa) — FDA 2010	`J3385`	1 u = 100 u	Takeda
Elelyso (taliglucerase alfa) — plant-cell ERT, FDA 2012	`J3060`	1 u = 10 u	Pfizer/Protalix
Oral SRT (pharmacy benefit, NOT medical): Cerdelga (eliglustat, Sanofi) · Zavesca (miglustat, Janssen)

Each ERT has its own permanent HCPCS & unit basis. Mismatched code/NDC pairs trigger immediate denial. Switching brands → new PA + new HCPCS + new unit-basis conversion.

Administration & modifiers

Code	When
`96365`	Therapeutic IV initial, up to 1 hr (primary)
`96366`	Each additional hour (for >60 min infusions)
`96413`	NOT appropriate — ERT is non-chemo

Modifier logic: J3060/JZ for administered billing units. Add J3060/JW separate line ONLY when dose is not a multiple of 200 units (waste exists). Every claim must carry at least JZ.

ICD-10 — Gaucher disease (Type 1 only)

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 (Erlenmeyer flask, AVN)

Confirmation required: acid β-glucosidase enzyme assay AND GBA mutation analysis confirming Type 1. Geneticist or hematologist consult typical. Elelyso NOT labeled for Type 2 or Type 3.

Payer requirements (May 2026)

Payer	PA	Step / Preference
UnitedHealthcare	Yes	LSD ERT policy; class-level (Cerezyme/VPRIV/Elelyso); preferred brand by contract
Aetna	Yes	Gaucher disease CPB; class parity, ASH-aligned
BCBS plans	Yes	Plan-specific; some mandate Cerezyme- or VPRIV-first
Medicare (MAC LCDs)	Documentation	Covered w/ E75.22 + diagnostic confirmation

Annual reauth: submit current Hgb, platelets, hepatic/splenic volume, bone status, biomarker trend (chitotriosidase or lyso-Gb1).

Medicare reimbursement (Q2 2026)

Field	Value
ASP + 6%	$40.657 / billing unit (10 units)
4,200-unit dose (420 billing units)	$17,075.94
4,500-unit dose (450 billing units)	$18,295.65
Waste 100 units (10 billing units)	$406.57 (JW line)
Annual q2w 70 kg (admin only)	~$443,975

Site of care

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

Patient assistance — Pfizer Gaucher Personal Support

Phone: 1-855-ELELYSO (1-855-353-5976) — Gaucher Personal Support
Pfizer Bridge Program: 1-800-645-1280 — uninsured/underinsured bridge supply
Pfizer Patient Assistance Foundation (PAP): free drug for eligible uninsured / government-insured; enroll via Personal Support line
Pfizer RxPathways: 1-844-989-7284 (program finder)
Commercial copay: available for eligible commercially-insured (excludes Medicare/Medicaid)
Foundations (Medicare): National Gaucher Foundation, PAN, HealthWell — verify open LSD funds
Web: elelyso.com/personal-support

Top denials — fix list

Units inflated 10×: billed units as billing units → recall, billing units = total units ÷ 10
JW missing: non-mult-of-200 dose w/o waste line → add J3060/JW with discarded billing units
Wrong J-code: J1786 or J3385 billed for Elelyso → resubmit with J3060 + NDC 0069-0106-01
Pediatric <4 yr: Elelyso not labeled — use Cerezyme or VPRIV
Type 2/3 Gaucher: Elelyso not labeled — not approved for neuronopathic forms
Diagnostic confirmation missing: submit enzyme assay + GBA mutation analysis

NO Boxed Warning. W&P only: hypersensitivity / anaphylaxis (infrequent), infusion-associated reactions (manage with rate reduction / pretreatment / suspension), antibody formation (anti-taliglucerase IgG observed; significance variable). Premedication not routinely required by label.

Sources: FDA label (BLA 022458, s033 2025), CMS ASP Q2 2026, ICGG Gaucher Registry, ASH/MGCC consensus, Pfizer Gaucher Personal Support, UHC/Aetna LSD ERT policies. Pending SME review. carecostestimate.com/drugs/elelyso