HCPCS
J3060
1 unit = 10 units
Phase 1
Identify what you're billing
Confirm the right ERT brand, the 10-unit billing-unit basis, and Type 1 Gaucher confirmation.
Gaucher disease treatment landscape Verified May 2026
Elelyso is one of three IV ERTs (Cerezyme, VPRIV, Elelyso) for Type 1 Gaucher disease. Two oral substrate reduction therapies (SRT) compete for the same patient population under the pharmacy benefit.
Type 1 Gaucher disease (the most common form, >90% of cases) is treated either by replacing the deficient enzyme (ERT, IV, medical benefit) or by reducing substrate accumulation (SRT, oral, pharmacy benefit). All three IV ERTs target the same enzyme deficiency at the same 60 U/kg q2w dose. Brand selection is typically driven by payer formulary, infusion-center logistics, manufacturing-supply considerations, and (rarely) immunogenicity history.
| Drug | HCPCS | Unit basis | Class | Manufacturer | FDA |
|---|---|---|---|---|---|
| Cerezyme (imiglucerase) | J1786 | 1 unit = 10 IU | IV ERT (CHO mammalian cell) | Sanofi Genzyme | 1994 |
| VPRIV (velaglucerase alfa) | J3385 | 1 unit = 100 units | IV ERT (HT-1080 human cell) | Takeda | 2010 |
| Elelyso (taliglucerase alfa) | J3060 | 1 unit = 10 units | IV ERT (plant-cell expressed) | Pfizer / Protalix | 2012 |
| Cerdelga (eliglustat) | Pharmacy benefit | — | Oral SRT | Sanofi Genzyme | 2014 |
| Zavesca (miglustat) | Pharmacy benefit | — | Oral SRT | Janssen | 2003 |
What is unique about Elelyso's plant-cell expression?
Elelyso is the first FDA-approved recombinant therapeutic protein manufactured in plant cells — specifically, a genetically engineered carrot cell suspension culture (Protalix ProCellEx platform). Imiglucerase (Cerezyme) is produced in Chinese hamster ovary (CHO) mammalian cells; velaglucerase alfa (VPRIV) is produced in a human cell line (HT-1080). Clinical efficacy and safety at the labeled 60 U/kg q2w dose are comparable across the three ERTs. The plant-cell platform is sometimes cited as a manufacturing-resilience advantage during mammalian-cell supply disruptions but does not change J-code, unit basis, modifier, or ICD-10 requirements for the biller.
Elelyso is the reference brand for J3060. No biosimilars exist for taliglucerase alfa.
Cerezyme and VPRIV are not biosimilars — they are independently developed recombinant
enzymes that compete clinically and contractually but each carry their own permanent HCPCS, NDC, and ASP.
Lifelong therapy commitment. Discontinuation generally leads to cytopenia and
organomegaly recurrence within 12–18 months. Reauthorization is annual but withdrawal of coverage
is rare in stable patients meeting biomarker targets (hemoglobin, platelets, organ volume,
chitotriosidase / lyso-Gb1).
Switching between Gaucher ERTs
Brand switches within the Gaucher ERT class are clinically straightforward (same indication, same 60 U/kg q2w dose) but require a new prior authorization under the new HCPCS and NDC. Switching FROM Cerezyme (J1786) or VPRIV (J3385) TO Elelyso (J3060) is a common scenario when a payer formulary change, supply consideration, or patient tolerability concern arises.
| Switching scenario | Payer-side action | Coding-side action |
|---|---|---|
| Cerezyme → Elelyso (formulary preference) | New PA for J3060; supply-disruption-or-preference rationale | Stop billing J1786; bill J3060 with Elelyso NDC 0069-0106-01; same E75.22 dx; no admin code change |
| VPRIV → Elelyso | New PA for J3060; same dose at clinically equivalent units/kg | Stop billing J3385; bill J3060 with Elelyso NDC; convert from 100-unit to 10-unit basis on the claim |
| Elelyso → Cerdelga (oral SRT) | New PA under pharmacy benefit; CYP2D6 genotype confirmation | Stop infusion claims entirely; transition to retail pharmacy fill |
| Elelyso → Zavesca | Rare; reserved for ERT-intolerant adults | Stop infusion claims; pharmacy benefit fill |
Do not bill J3060 for Cerezyme or VPRIV administrations. Each ERT has its own permanent
HCPCS — mismatched code/product pairs trigger immediate denial and recoupment, and may flag a
compliance review. Always match the NDC on the claim line to the J-code.
Dosing & unit math FDA label verified 2025
From FDA prescribing information (BLA 022458, s033 revision).
Adult & pediatric Type 1 Gaucher (only labeled population)
- 60 units/kg IV every 2 weeks — the only FDA-labeled regimen; 26 doses per year
- Administered as a 60–120 minute IV infusion (rate adjusted per tolerance)
- Pediatric: ages ≥4 years with confirmed Type 1 Gaucher (same 60 U/kg q2w dose; no separate pediatric band)
- Not indicated for Type 2 (acute neuronopathic) or Type 3 (chronic neuronopathic) Gaucher disease
- Dose individualized over time based on hemoglobin, platelet count, hepatic and splenic volume, bone disease, and biomarker response (chitotriosidase, glucosylsphingosine / lyso-Gb1)
Unit math — the 10-unit billing unit
1 J3060 billing unit = 10 units of taliglucerase alfa. Always divide the total units administered by 10 before entering the unit count on the claim. Pediatric and low-weight adult doses will produce small billing-unit counts; high-weight adult doses produce large counts. Both are normal.
Worked example — standard adult dose (70 kg patient, 60 U/kg q2w)
# Calculate dose in taliglucerase alfa units
70 kg × 60 units/kg = 4,200 units per dose
# Convert to J3060 billing units (÷ 10)
4,200 units ÷ 10 units/billing unit = 420 billing units of J3060 administered
# Vial calculation (200-unit lyophilized vial)
4,200 units ÷ 200 units/vial = 21.0 vials → 21 vials exactly — zero waste at this round dose
Total drug drawn: 21 × 200 = 4,200 units
Discarded: 4,200 − 4,200 = 0 units waste → use JZ only (no JW line needed)
# Claim lines
Line 1: J3060 / JZ / 420 billing units (administered, no waste this line)
Admin: 96365 (initial therapeutic IV up to 1 hr) ± 96366 (each additional hour) for >1 hr infusions
ICD-10: E75.22 (+ organ codes per encounter)
# Year-1 totals (q2w schedule, 26 doses)
Total billing units billed: 10,920 (26 × 420)
Total drug cost (Q2 2026 ASP+6%): ~$443,975 before sequestration (administered drug only)
70 kg × 60 units/kg = 4,200 units per dose
# Convert to J3060 billing units (÷ 10)
4,200 units ÷ 10 units/billing unit = 420 billing units of J3060 administered
# Vial calculation (200-unit lyophilized vial)
4,200 units ÷ 200 units/vial = 21.0 vials → 21 vials exactly — zero waste at this round dose
Total drug drawn: 21 × 200 = 4,200 units
Discarded: 4,200 − 4,200 = 0 units waste → use JZ only (no JW line needed)
# Claim lines
Line 1: J3060 / JZ / 420 billing units (administered, no waste this line)
Admin: 96365 (initial therapeutic IV up to 1 hr) ± 96366 (each additional hour) for >1 hr infusions
ICD-10: E75.22 (+ organ codes per encounter)
# Year-1 totals (q2w schedule, 26 doses)
Total billing units billed: 10,920 (26 × 420)
Total drug cost (Q2 2026 ASP+6%): ~$443,975 before sequestration (administered drug only)
Worked example — non-round adult dose (75 kg patient, 60 U/kg q2w)
# Dose
75 kg × 60 units/kg = 4,500 units per dose → 450 billing units
# Vials
4,500 ÷ 200 = 22.5 → round up to 23 vials drawn (4,600 units)
Waste: 4,600 − 4,500 = 100 units = 10 billing units (JW)
# Claim lines
Line 1: J3060 / JZ / 450 billing units (administered)
Line 2: J3060 / JW / 10 billing units (discarded)
75 kg × 60 units/kg = 4,500 units per dose → 450 billing units
# Vials
4,500 ÷ 200 = 22.5 → round up to 23 vials drawn (4,600 units)
Waste: 4,600 − 4,500 = 100 units = 10 billing units (JW)
# Claim lines
Line 1: J3060 / JZ / 450 billing units (administered)
Line 2: J3060 / JW / 10 billing units (discarded)
Worked example — pediatric (25 kg child, 60 U/kg q2w)
# Dose
25 kg × 60 units/kg = 1,500 units per dose → 150 billing units
Vials: 1,500 ÷ 200 = 7.5 → 8 vials drawn (1,600 units)
Waste: 100 units = 10 billing units (JW)
Line 1: J3060 / JZ / 150 billing units
Line 2: J3060 / JW / 10 billing units
25 kg × 60 units/kg = 1,500 units per dose → 150 billing units
Vials: 1,500 ÷ 200 = 7.5 → 8 vials drawn (1,600 units)
Waste: 100 units = 10 billing units (JW)
Line 1: J3060 / JZ / 150 billing units
Line 2: J3060 / JW / 10 billing units
Vial-size advantage vs Cerezyme: The 200-unit Elelyso vial produces zero waste at any
dose that is a multiple of 200 units (e.g., 70 kg × 60 = 4,200 units = 21 vials exactly). Cerezyme
(400 IU SDV) wastes 200 IU on the same weight. For non-multiple-of-200 doses, JW still applies —
never assume a "no waste" claim without checking the math.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Strength | Package Size | Units/Vial |
|---|---|---|---|
0069-0106-01 / 00069-0106-01 |
200 units taliglucerase alfa | Single-dose lyophilized vial — 1 vial per carton | 200 units (1 billing unit = 10 units → 20 billing units per vial) |
Use carton-level 11-digit NDC
00069-0106-01 on the claim form. Vial-only
NDC entry triggers payer denial. Elelyso has only a single 200-unit vial size in the US — all dose
levels are achieved by compounding multiple vials. The Pfizer labeler code is 00069.
Reconstitution: Each 200-unit vial is reconstituted with 5.1 mL of sterile
water for injection (yielding 40 units/mL), then withdrawn doses are diluted in 100–200 mL
of 0.9% sodium chloride for IV infusion. Refrigerate vials at 2°C to 8°C (36°F to 46°F)
in the original carton; protect from light; do not freeze. Use in-line filter per pharmacy protocol.
Phase 2
Code the claim
Therapeutic IV admin codes, JZ ± JW for waste, and the E75.22 anchor diagnosis.
Administration codes CPT verified May 2026
Elelyso is non-chemo enzyme replacement therapy — therapeutic IV codes only.
| Code | Description | When to use |
|---|---|---|
96365 |
Therapeutic IV infusion (non-chemo); initial, up to 1 hour | Primary code for Elelyso. Always required for the first hour of infusion. |
96366 |
Therapeutic IV infusion; each additional hour | Add when infusion runs >1 hour. Standard Elelyso infusion is 60–120 minutes; bill 1 unit of 96366 alongside 96365 for any infusion that extends past 60 minutes. |
96413 / 96415 |
Chemotherapy IV administration codes | NOT appropriate. Elelyso is enzyme replacement therapy, not chemotherapy or complex biologic. CPT chemo admin codes do not apply. |
Why therapeutic IV (not chemo IV): CPT chemo admin codes (96409–96425) apply to
complex monoclonal antibodies, cytotoxic agents, and high-complexity biologics. Taliglucerase alfa is a
recombinant enzyme — biochemically a protein replacement therapy — and is billed under
therapeutic infusion codes per AMA classification.
Modifiers CMS verified May 2026
JZ ± JW — both may apply depending on dose
Elelyso uses a single 200-unit single-dose vial; dosing is weight-based at 60 U/kg q2w. When the total dose is an exact multiple of 200 units (e.g., 70 kg × 60 = 4,200 units = 21 vials exactly), waste is zero and only JZ is needed. When the dose is not a multiple of 200, partial-vial waste must be billed on a separate JW line. Per CMS's July 2023 single-dose container policy, every J3060 claim must carry one of JZ or JW (or both on different lines).
| Modifier | When | Example (75 kg pt, 60 U/kg = 4,500 units) |
|---|---|---|
JZ | Administered units, no waste on this line | Line 1: J3060 / JZ / 450 billing units |
JW | Discarded units from single-dose vial | Line 2: J3060 / JW / 10 billing units |
Common error: Failing to bill the JW waste line when dose is not a multiple of 200
units, OR billing JW with zero units on a no-waste day. CMS audits routinely catch both. Wasted drug
from single-dose vials IS reimbursable but must be reported on a separate line with JW. No-waste days
get JZ only.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion. Routine pre-infusion clinical assessment is bundled into the infusion service.
340B modifiers (JG, TB)
For 340B-acquired Elelyso, follow your MAC's current 340B modifier policy. Pfizer's billing materials do not provide 340B-specific instructions; defer to MAC LCD and your hospital's 340B compliance team.
ICD-10-CM diagnosis coding FY2026 verified May 2026
E75.22 is the primary anchor; supplementary codes document organ-system findings supporting medical necessity.
| ICD-10 | Description | Use as |
|---|---|---|
E75.22 | Gaucher disease | Primary diagnosis — required on every claim |
D69.6 | Thrombocytopenia, unspecified | Secondary — supports hematologic indication |
D64.9 | Anemia, unspecified | Secondary — supports hematologic indication |
K76.89 | Other specified diseases of liver | Secondary — documents hepatosplenomegaly findings |
R16.0 / R16.1 / R16.2 | Hepatomegaly / splenomegaly / hepatosplenomegaly | Alternate organomegaly documentation |
M89.9 | Disorder of bone, unspecified | Secondary — supports skeletal-disease indication |
M85.80 | Other specified disorders of bone density and structure | Alternate skeletal documentation (Erlenmeyer flask deformity, infarction, AVN) |
R53.83 | Other fatigue | Optional — supports symptomatic burden |
E75.22 alone is rarely sufficient for PA. Most payers require ICD-10 plus enzyme assay
+ GBA gene mutation analysis + at least one organ-system finding (cytopenia, organomegaly, or skeletal
disease). The Elelyso FDA label restricts use to patients ≥4 years with confirmed Type 1 Gaucher
— not approved for Type 2 or Type 3.
Site of care & place of service Verified May 2026
Major commercial payers run aggressive site-of-care utilization management on lysosomal storage disorder ERTs. Stable Elelyso patients are routinely steered out of HOPD into office, freestanding infusion suite, or home infusion settings.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician office (genetics / heme) | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Freestanding infusion center (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Hospital outpatient (on-campus, HOPD) | 22 | UB-04 / 837I | Disfavored after stabilization |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after stabilization |
| Patient home | 12 | CMS-1500 (with home infusion vendor) | Common for stable patients — ERT-experienced home nursing required |
Home infusion is well-established for Elelyso. After 6–12 months of incident-
free in-clinic infusions, most stable adult patients are eligible for home infusion via a contracted
specialty pharmacy + home nursing vendor. The 60–120 minute infusion duration is well-suited to
home administration. Emergency response plan and reaction medications must be on hand at first-dose
home infusions. Pfizer Gaucher Personal Support (1-855-ELELYSO) helps coordinate site-of-care
transitions for active Elelyso patients.
Claim form field mapping Pfizer Gaucher Personal Support 2025
From Pfizer Elelyso HCP coverage and reimbursement materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider (geneticist or hematologist) |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 00069-0106-01 + UN + total vials drawn (e.g., UN21 for 70 kg dose) |
| HCPCS J3060 + JZ (administered units) | 24D (drug line 1) | Bill in 10-unit billing units (e.g., 420 for 4,200 units administered) |
| HCPCS J3060 + JW (discarded units) | 24D (drug line 2) | Separate line when waste exists; report wasted units ÷ 10 (e.g., 10 for 100 units waste). Omit on zero-waste claims. |
| CPT 96365 (admin line, initial hour) | 24D | 1 unit; therapeutic IV initial |
| CPT 96366 (admin line, additional hours) | 24D | 1 unit per additional hour (60–120 min typical infusion) |
| ICD-10 primary | 21 | E75.22 — required |
| ICD-10 secondary (organ findings) | 21 | D69.6, D64.9, K76.89, M89.9 as applicable |
| PA number | 23 | Required by all major payers; lifelong therapy → reauth annually |
Phase 3
Get paid
Diagnostic confirmation (enzyme assay + GBA mutation) is the PA gatekeeper.
Payer policy snapshot Reviewed May 2026
All major payers gate Elelyso behind diagnostic confirmation and specialist consultation. Brand selection within the ERT class is increasingly formulary-driven.
| Payer | PA? | Diagnostic requirements | Brand preference |
|---|---|---|---|
| UnitedHealthcare Lysosomal Storage Disorder ERT policy |
Yes | E75.22 + acid β-glucosidase enzyme assay + GBA gene mutation analysis + geneticist or hematologist consult; Type 1 confirmation | Cerezyme, VPRIV, Elelyso all on policy; preferred brand may rotate by contract year |
| Aetna CPB on Gaucher disease therapies |
Yes | Same as above + at least one organ-system finding (cytopenia, organomegaly, or skeletal disease) | Aligned with NCCN/ASH guidance; class parity for IV ERTs |
| BCBS plans Vary by plan |
Yes | Generally aligned with ICGG Gaucher Registry / MGCC consensus criteria | Plan-specific; some plans mandate Cerezyme- or VPRIV-first |
Step therapy
Step therapy within the IV ERT class is uncommon but plan-specific — e.g., some BCBS plans may require Cerezyme or VPRIV failure/intolerance before approving Elelyso. Step therapy from oral SRT (Cerdelga) into IV ERT is generally not required — ERT remains the standard of care for newly diagnosed Type 1 Gaucher in patients ≥4 years.
Reauthorization
Annual reauthorization is the norm. Submit current Hgb, platelet count, hepatic and splenic volumes (typically by MRI or CT), bone disease assessment, and biomarker trend (chitotriosidase or glucosylsphingosine / lyso-Gb1). Documented stability or improvement on therapy supports continued coverage.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J3060
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions · Next update: July 1, 2026 for Q3
ASP + 6%
$40.657
per billing unit (10 units)
60 U/kg dose, 70 kg pt
$17,075.94
420 billing units (4,200 units)
Annual q2w (26 doses)
$443,975
administered drug only, before waste
Annualized cost (70 kg adult, zero-waste at this weight): 26 doses × 420 billing
units × $40.657 ≈ $443,975/year (Medicare ASP+6%). After ~2% sequestration:
~$432,000/year actual paid. At weights that produce non-round vial counts, add ~$406–$813 per
dose for the JW waste line (10–20 billing units × $40.657). ASP is updated quarterly by CMS
— next refresh July 1, 2026 for Q3.
Coverage
Elelyso is covered by all MACs under their generic Part B drug-coverage framework with appropriate E75.22 + diagnostic documentation. No NCD specific to taliglucerase alfa. Local MAC LCDs may exist for lysosomal storage disorder ERTs; verify per jurisdiction.
Code history
- J3060 — permanent code, descriptor "Injection, taliglucerase alfa, 10 units"; replaced miscellaneous J3590 / C9295 transitional codes shortly after the May 2012 FDA approval
Patient assistance — Pfizer Gaucher Personal Support & Pfizer Bridges Pfizer verified May 2026
- Pfizer Gaucher Personal Support (Elelyso-specific): 1-855-ELELYSO (1-855-353-5976) — benefits investigation, prior authorization assistance, appeal support, copay enrollment, free-drug program for eligible patients, home infusion coordination
- Pfizer Bridge Program: 1-800-645-1280 — broader Pfizer patient assistance for uninsured / underinsured patients; bridge supply for coverage gaps
- Pfizer Patient Assistance Foundation (PAP): separate 501(c)(3) charitable foundation providing free Elelyso to qualifying uninsured / government-insured patients meeting income criteria (typically up to 400% FPL, verify current threshold). Enrollment via the Personal Support line above.
- Pfizer RxPathways: 1-844-989-7284 — finder tool for Pfizer-wide patient assistance programs
- Commercial copay assistance: available for eligible commercially-insured Elelyso patients (excludes Medicare, Medicaid, federal program patients per federal anti-kickback rules)
- Foundations (Medicare patients): National Gaucher Foundation (gaucherdisease.org), PAN Foundation, HealthWell Foundation — verify open lysosomal storage disease funds quarterly; funds open and close based on donor availability
- Web: elelyso.com/personal-support · pfizerrxpathways.com
Need to model what a specific Gaucher patient will actually pay after copay assistance, deductible,
coinsurance, and OOP max for lifelong q2w therapy?
Run a CareCost Estimate — J3060 pre-loaded.
Phase 4
Fix problems
10-unit unit error, missing JW waste line, missing diagnostic confirmation, and brand-confusion are the top four.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Units appear inflated 10× | Billed taliglucerase alfa units as billing units instead of units ÷ 10 | Recall and resubmit with billing units = total units ÷ 10. A 4,200-unit dose is 420 billing units, not 4,200. |
| Wrong admin code (96413) | Chemo IV billed instead of therapeutic IV | Resubmit with 96365 (± 96366). Taliglucerase alfa is enzyme replacement, not chemotherapy. |
| JW waste line missing | Non-multiple-of-200 dose with discarded drug not reported | Add J3060 / JW line with discarded billing units. Single-dose vial waste is reimbursable but must be billed. |
| JZ missing on no-waste claim | Single-dose vial claim without JZ on administered units | Add JZ. Required since 7/1/2023 on every single-dose container claim with no waste on that line. |
| Diagnostic confirmation missing | PA submitted without enzyme assay or GBA mutation results, or with Type 2/3 diagnosis | Submit acid β-glucosidase enzyme assay + GBA mutation analysis confirming Type 1 Gaucher. Elelyso is not labeled for Type 2 or Type 3. |
| Wrong brand HCPCS | J1786 (Cerezyme) or J3385 (VPRIV) billed for Elelyso administration | Resubmit with J3060 and Elelyso NDC 0069-0106-01. Each ERT brand has its own permanent code. |
| Switch documentation missing | Patient switched from Cerezyme/VPRIV to Elelyso without rationale in PA | Submit medical-record documentation of switch rationale (formulary change, supply, tolerability) and prior-brand baseline biomarker data. |
| Pediatric age denial | Elelyso billed for patient <4 years | Confirm patient age. Elelyso is FDA-labeled for ages ≥4 years only. Younger pediatric patients require Cerezyme or VPRIV (both labeled younger). |
| Site-of-care denial (HOPD) | HOPD administration after stabilization on commercial plan with site-of-care UM | Move to office (POS 11), AIC (POS 49), or home (POS 12). Submit medical necessity letter if HOPD required for clinical reasons (history of severe reaction). |
| Annual reauth not approved | Reauth submitted without current biomarker, organ size, or hematologic data | Submit current Hgb, platelets, hepatic/splenic volume, bone assessment, and biomarker trend (chitotriosidase or lyso-Gb1) showing stability or improvement. |
Frequently asked questions
What is the HCPCS code for Elelyso?
Elelyso (taliglucerase alfa) is billed under HCPCS J3060 — "Injection, taliglucerase
alfa, 10 units." One billing unit equals 10 units, NOT 1 unit. A 4,200-unit dose
(70 kg × 60 units/kg) is billed as 420 billing units of J3060, not 4,200. J3060 has been the
permanent code for Elelyso since shortly after its 2012 FDA approval.
Elelyso vs Cerezyme vs VPRIV — how do I tell them apart on a claim?
Three brand IV ERTs treat Type 1 Gaucher disease at clinically equivalent 60 U/kg q2w doses, but each has its own permanent HCPCS, NDC, and ASP. Cerezyme (imiglucerase, Sanofi Genzyme, FDA 1994) is J1786, 1 unit = 10 IU. VPRIV (velaglucerase alfa, Takeda, FDA 2010) is J3385, 1 unit = 100 units. Elelyso (taliglucerase alfa, Pfizer/Protalix, FDA 2012) is J3060, 1 unit = 10 units. Code-to-product mismatches trigger immediate denial — always match the NDC on the claim line to the HCPCS.
What is unique about Elelyso's plant-cell expression system?
Elelyso is the first FDA-approved recombinant therapeutic protein produced in plant cells (carrot cell suspension culture, the Protalix ProCellEx platform). The clinical and billing impact is minimal — taliglucerase alfa is therapeutically equivalent to imiglucerase and velaglucerase alfa at the same 60 U/kg q2w dose. The plant-cell expression is sometimes cited as a manufacturing-supply resilience advantage independent of CHO mammalian cell capacity, but does not change J-code, dosing, modifier, or ICD-10 requirements.
Is genetic testing required to start Elelyso?
Yes. Major payers (UnitedHealthcare, Aetna, BCBS) require both an acid β-glucosidase (GBA) enzyme assay AND GBA gene mutation analysis to confirm the E75.22 Type 1 Gaucher diagnosis before approving Elelyso. The FDA label restricts Elelyso to patients ≥4 years with confirmed Type 1 Gaucher. Geneticist or hematologist consultation is typically required by payers. Elelyso is not indicated for Type 2 (acute neuronopathic) or Type 3 (chronic neuronopathic) Gaucher disease.
Is home infusion eligible for Elelyso?
Yes, for stable patients after several months of incident-free in-clinic infusions. Home infusion (POS 12) is increasingly preferred by commercial payer utilization management for stable Gaucher ERT patients. Coordinate through a specialty pharmacy with ERT-experienced home nursing; emergency response plan and reaction medications must be on hand for first home-administration. The 60–120 minute infusion duration is well-suited to home administration once tolerability is established. Pfizer Gaucher Personal Support (1-855-ELELYSO) helps coordinate site-of-care transitions.
What is the pediatric dose for Elelyso?
The FDA label dose is 60 units/kg IV every 2 weeks for both pediatric (≥4 years) and adult patients, administered as a 60–120 minute IV infusion. There is no separate pediatric dosing band. Vial math is the same as adults: total units ÷ 10 = billing units; vials drawn = ceiling(total units ÷ 200) at the 200-unit SDV size. For a 25 kg child, that's 1,500 units = 150 billing units, drawn from 8 vials with 100 units (10 billing units) waste on a JW line.
What is the Medicare reimbursement for J3060?
For Q2 2026, the Medicare Part B payment limit for J3060 is $40.657 per billing unit (10 units) under ASP + 6%. A 60 U/kg dose for a 70 kg patient (4,200 units = 420 billing units) reimburses at approximately $17,075.94 per infusion, or roughly $443,975/year on a q2w schedule (26 doses). Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Can a patient switch from Cerezyme or VPRIV to Elelyso?
Yes. Brand switches within the Gaucher ERT class are clinically straightforward (same indication, same
60 U/kg q2w dose) but require a new prior authorization under the new HCPCS and NDC. Stop billing the
previous J-code (J1786 Cerezyme or J3385 VPRIV) and bill J3060 with the Elelyso NDC
0069-0106-01 going forward. Same E75.22 diagnosis, same 96365/96366 administration codes.
Document the switch rationale (formulary change, supply, tolerability) in the medical record to support
PA approval.
Does Elelyso have a Boxed Warning?
Yes. The current Elelyso FDA label (revised December 29, 2025) carries a BOXED WARNING for HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS. Life-threatening reactions have occurred during both early and extended treatment phases. Elelyso must be administered in a healthcare setting with appropriate monitoring and access to resuscitation equipment; discontinue immediately and treat with epinephrine for severe reactions. Additional W&P: infusion-associated reactions (manage with rate reduction, pretreatment, or temporary suspension) and anti-taliglucerase alfa IgG antibody formation. Premedication is not routinely required by FDA label but may be used for patients with prior infusion reactions.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- FDA Drugs@FDA — ELELYSO (taliglucerase alfa) Prescribing Information (s033, 2025)
- DailyMed — ELELYSO (taliglucerase alfa) full label
- Pfizer Gaucher Personal Support — access & reimbursement resources
- Pfizer RxPathways / Pfizer Patient Assistance Foundation
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J3060 reference
- FDA NDC Directory — NDC 0069-0106-01 (Elelyso 200-unit SDV)
- UnitedHealthcare — Lysosomal Storage Disorder ERT medical drug policy
- Aetna CPB — Enzyme Replacement Therapy for Gaucher Disease
- National Gaucher Foundation — clinician resources & ICGG Gaucher Registry context
- ASH / MGCC consensus guidance — Gaucher disease management
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer LSD ERT policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label | Event-driven | Tied to Pfizer document version + FDA label revision date. |
| Brand class comparison (Cerezyme, VPRIV, Cerdelga, Zavesca) | Event-driven | Updated when any brand has an FDA label change, recall, or new indication. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
Pfizer, payer documents — all linked above). Editorial review in progress. Until that review is
complete, treat this as a draft reference and verify each cited source for high-stakes claims.
Change log
- — SME audit pass. Boxed Warning corrected: current FDA label (revised Dec 29, 2025) carries a BOXED WARNING for hypersensitivity reactions including anaphylaxis — prior page text describing "no Boxed Warning" was inconsistent with the current label and has been corrected. HCPCS J3060 verified at 10 units per billing unit (Q2 2026 payment limit $40.657/unit).
- — Initial publication. ASP data: Q2 2026 ($40.657/billing unit). Manufacturer source: Pfizer Gaucher Personal Support 2025. FDA label: current 2025 revision (BLA 022458, s033). Includes Gaucher class comparison (Cerezyme/VPRIV/Elelyso + oral SRT), plant-cell expression notes, and brand interchangeability guidance.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Diagnostic and dosing criteria reference the FDA label, ICGG Gaucher Registry data, and ASH/MGCC consensus guidance. We do not paraphrase from billing-software vendor blogs.