HCPCS
J1743
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm enzyme, MPS subtype, weight-based dose, and premedication plan before infusion day.
MPS enzyme replacement therapy landscape FDA verified May 2026
Five distinct recombinant enzymes, one per MPS subtype. Each has its own HCPCS, NDC, dosing, and ICD-10. Confirm the subtype before billing.
Mucopolysaccharidoses are a family of lysosomal storage diseases caused by deficient glycosaminoglycan (GAG) degradation. Each subtype is caused by a different missing enzyme; therapy is enzyme-specific and not interchangeable. Elaprase treats MPS II (Hunter syndrome) only.
| Drug (generic) | HCPCS | MPS subtype | ICD-10 | Dosing | Manufacturer |
|---|---|---|---|---|---|
| Aldurazyme (laronidase) | J1931 |
MPS I (Hurler / Hurler-Scheie / Scheie) | E76.0 / E76.01 / E76.02 |
0.58 mg/kg IV weekly (~3-4 hr) | BioMarin / Sanofi Genzyme |
| Elaprase (idursulfase) | J1743 |
MPS II (Hunter) | E76.1 |
0.5 mg/kg IV weekly (~3 hr) | Takeda (Shire) |
| Vimizim (elosulfase alfa) | J1322 |
MPS IVA (Morquio A) | E76.219 |
2.0 mg/kg IV weekly (~3.5-4.5 hr) | BioMarin |
| Naglazyme (galsulfase) | J1458 |
MPS VI (Maroteaux-Lamy) | E76.29 |
1.0 mg/kg IV weekly (~4 hr) | BioMarin |
| Mepsevii (vestronidase alfa-vjbk) | J3397 |
MPS VII (Sly) | E76.29 |
4.0 mg/kg IV q2w (~4 hr) | Ultragenyx |
Subtype confirmation is mandatory before therapy. Diagnosis requires both biochemical
confirmation (low/absent enzyme activity in leukocytes or fibroblasts) AND molecular confirmation
(pathogenic variant in the IDS gene for MPS II). Payers will deny PA without both. MPS II is X-linked
recessive — the overwhelming majority of patients are male; female patients require additional
documentation (e.g., skewed X-inactivation, structural variant).
Dosing & unit math FDA label verified May 2026
From the FDA prescribing information (Takeda, BLA 125151, July 2006).
Standard regimen
- 0.5 mg/kg IV once weekly, indefinitely (lifelong therapy)
- Approved for patients ≥5 years of age with MPS II
- Total infusion time: ~3 hours with stepwise rate titration (initial slow rate then incremental increases per tolerability)
- Dilute calculated dose in 100 mL 0.9% sodium chloride injection
- Round dose to nearest mg; bill actual mg administered
- 1 mg = 1 unit of
J1743
Worked example — 70 kg adult patient
# Dose calculation
Weight: 70 kg × 0.5 mg/kg = 35 mg per dose
Vials needed: 35 / 6 = 5.83 → 6 vials (36 mg drawn)
Administered: 35 mg · Discarded: 1 mg
# Claim lines
Line 1: J1743 × 35 units, modifier JZ (administered)
Line 2: J1743 × 1 unit, modifier JW (discarded)
Admin: 96365 × 1 (initial hour) + 96366 × 2 (additional hours)
# Annual totals (52 weekly infusions)
Annual administered units: 1,820 (52 × 35)
Annual discarded units: ~52 (varies by exact mg)
Annual drug cost (Q2 2026 ASP+6%, billable): ~$1,015,962 before sequestration
Weight: 70 kg × 0.5 mg/kg = 35 mg per dose
Vials needed: 35 / 6 = 5.83 → 6 vials (36 mg drawn)
Administered: 35 mg · Discarded: 1 mg
# Claim lines
Line 1: J1743 × 35 units, modifier JZ (administered)
Line 2: J1743 × 1 unit, modifier JW (discarded)
Admin: 96365 × 1 (initial hour) + 96366 × 2 (additional hours)
# Annual totals (52 weekly infusions)
Annual administered units: 1,820 (52 × 35)
Annual discarded units: ~52 (varies by exact mg)
Annual drug cost (Q2 2026 ASP+6%, billable): ~$1,015,962 before sequestration
Worked example — 18 kg pediatric patient
# Dose calculation
Weight: 18 kg × 0.5 mg/kg = 9 mg per dose
Vials needed: 9 / 6 = 1.5 → 2 vials (12 mg drawn)
Administered: 9 mg · Discarded: 3 mg
Line 1: J1743 × 9 units, JZ · Line 2: J1743 × 3 units, JW
Weight: 18 kg × 0.5 mg/kg = 9 mg per dose
Vials needed: 9 / 6 = 1.5 → 2 vials (12 mg drawn)
Administered: 9 mg · Discarded: 3 mg
Line 1: J1743 × 9 units, JZ · Line 2: J1743 × 3 units, JW
Infusion administration notes
- Do not infuse with other products in the same IV line. Use a low-protein-binding 0.2 micron in-line filter
- Initial rate is slow (per label); titrate up at 15-minute intervals as tolerated — total infusion time ~3 hours
- If infusion reaction occurs: slow or interrupt the infusion, treat symptoms, and consider additional premedication for subsequent infusions
- Patients with febrile or respiratory illness should have infusions postponed until recovered
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
54092-0700-01 / 54092-0700-01 |
6 mg / 3 mL (2 mg/mL) single-dose vial — 1 vial per carton | All adult and pediatric dosing |
Use the carton/vial NDC consistently. Takeda labeler code is 54092 (formerly Shire 54092
retained post-acquisition). Submit the 11-digit NDC with N4 qualifier and ML unit of measure on the
CMS-1500 24A shaded line. Document total vials drawn and total mL prepared on infusion records to support
JZ/JW math.
Storage: Refrigerate vials at 2°C–8°C (36°F–46°F). Do not
freeze, do not shake. Diluted product should be infused immediately or stored refrigerated and used within
24 hours.
Premedication protocol Hunter Outcome Survey + label
Premedication is recommended for every infusion. The label does not mandate it but the safety experience strongly supports it.
| Patient profile | Recommended premedication | Timing |
|---|---|---|
| Standard / first infusion | Antihistamine (e.g., diphenhydramine 1 mg/kg up to 50 mg PO/IV) + antipyretic (e.g., acetaminophen 10–15 mg/kg PO) | 30–60 min pre-infusion |
| Prior infusion reaction (any severity) | Add corticosteroid (e.g., methylprednisolone 1–2 mg/kg IV or hydrocortisone 100 mg IV) | 30–60 min pre-infusion; consider H2 blocker |
| Severe phenotype + respiratory compromise | Triple premed (antihistamine + antipyretic + corticosteroid); enhanced monitoring; consider hospital setting for first several infusions | 30–60 min pre-infusion |
| Anaphylactoid history | Triple premed; epinephrine + airway support immediately available; specialist supervision required | 30–60 min pre-infusion; slowed initial infusion rate |
Anaphylaxis risk is real and ongoing. Reactions can occur after years of uneventful
therapy, including in patients without prior reactions. Every infusion site must have epinephrine,
oxygen, IV fluids, airway support, and trained personnel immediately available. Do not infuse Elaprase
in unmonitored settings.
Antibody formation is the rule, not the exception. Most patients (>50%) develop
anti-idursulfase IgG antibodies on chronic therapy. Some develop neutralizing antibodies that may reduce
clinical response. Antibody status is monitored per Hunter Outcome Survey protocols but is not required
for billing.
Phase 2
Code the claim
Therapeutic IV codes (not chemo). Long infusion = multiple additional-hour units. JW is routine.
Administration codes CPT verified May 2026
Elaprase is a non-chemotherapy biologic. Use therapeutic IV codes, not chemo admin codes.
| Code | Description | When to use |
|---|---|---|
96365 |
Therapeutic, prophylactic, or diagnostic IV infusion; initial, up to 1 hour | Primary code, billed once per infusion. Covers the first hour. |
96366 |
Therapeutic IV infusion; each additional hour, up to 8 hours | Bill × 2 for the standard 3-hour Elaprase infusion (hours 2 and 3). |
96413 / 96415 |
Chemotherapy IV administration codes | NOT appropriate. Idursulfase is enzyme replacement, not antineoplastic. |
96374 / 96375 |
IV push codes | NOT appropriate. Elaprase must be infused over hours, not pushed. |
Document infusion start and stop times on every claim. Additional-hour units (96366) are
time-based; payers audit them frequently. The claim should reflect actual chair time, not nominal
scheduled time. A 3-hour infusion documented from 09:00 to 12:00 supports 96365 × 1 + 96366 × 2.
Observation post-infusion is bundled. Routine post-infusion monitoring is not separately
billable. If a documented adverse event requires extended observation or treatment, bill an appropriate
E/M with modifier 25 and document the clinical justification.
Modifiers CMS verified May 2026
JZ & JW — both common because of weight-based dosing
Effective July 1, 2023, CMS requires either JZ (no waste) or JW (waste) on every single-dose container claim. Because Elaprase is dosed by weight (0.5 mg/kg) but supplied in fixed 6 mg vials, partial-vial waste is the rule. JW typically applies to most adult and pediatric Elaprase claims.
- JZ line: bill the units actually administered (e.g., 35 units for a 35 mg dose)
- JW line: bill the units discarded (e.g., 1 unit if 36 mg drawn but 35 mg administered)
- Both lines must reference the same NDC; both contribute to total billable units
- Only patients whose weight produces an exact multiple of 6 mg avoid waste (rare in practice)
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.
340B modifiers (JG, TB)
For 340B-acquired Elaprase, follow your MAC's current 340B modifier policy. Many MACs require JG for most outpatient settings and TB for rural/critical-access hospitals.
Common error: Forgetting the JW line on weight-based dosing. CMS audits frequently
recoup payments for unreported waste. Document the calculated dose, total mg drawn, and total mg
administered on the infusion record so the JZ + JW lines reconcile.
ICD-10-CM FY2026 verified May 2026
E76.1 is the primary diagnosis. Add codes for documented organ involvement.
| Code | Description | Use |
|---|---|---|
E76.1 |
Mucopolysaccharidosis, type II (Hunter syndrome) | Primary diagnosis on every Elaprase claim. |
J96.x |
Respiratory failure (acute / chronic) | Common comorbidity; supports medical necessity for inpatient infusion |
I50.x |
Heart failure | Cardiac valve disease and cardiomyopathy are MPS II hallmarks |
G91.x |
Hydrocephalus | Communicating hydrocephalus from GAG accumulation |
H90.x |
Conductive / sensorineural hearing loss | Documented in majority of MPS II patients |
M24.5x |
Joint contracture | Stiff joints / claw hand deformities |
K76.89 |
Other specified diseases of liver (hepatomegaly) | Hepatosplenomegaly is a common MPS II finding |
F70–F79 |
Intellectual disabilities | For severe phenotype patients with cognitive involvement |
Diagnostic confirmation must be in the chart. Most payer LCDs require documentation of
BOTH (1) deficient or absent iduronate-2-sulfatase enzyme activity in leukocytes or fibroblasts AND
(2) a pathogenic variant in the IDS gene. Submit lab reports with the initial PA and keep them
accessible for any audit.
Site of care & place of service Verified May 2026
Elaprase requires a setting with full anaphylaxis support and trained personnel. The 3-hour infusion plus observation makes office and ambulatory infusion suite the most common settings. Home infusion is possible for stable patients with good tolerability history but is uncommon.
| Setting | POS | Claim form | Suitability |
|---|---|---|---|
| Specialty / metabolic clinic | 11 | CMS-1500 / 837P | Preferred for first 6–12 months |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Common for stable patients |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Preferred for patients with severe phenotype or prior reactions |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Acceptable; payer site-of-care UM may apply |
| Inpatient (initial dose escalation) | 21 | UB-04 / 837I | Sometimes used for first infusion in high-risk patients |
| Patient home | 12 | CMS-1500 (with home infusion S-codes) | Possible for stable, reaction-free patients via specialty home infusion vendor |
Home infusion requires conservative criteria. Most home infusion vendors require: at
least 6–12 months of in-clinic infusions without significant reactions, stable premedication
regimen, caregiver training, and a written emergency plan. Some payers prohibit home infusion of
idursulfase entirely.
Claim form field mapping Takeda OnePath 2026
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 54092-0700-01 + ML + total mL drawn (e.g., 18 mL for 6 vials) |
| HCPCS J1743 + JZ (administered units) | 24D (drug line 1) | Bill mg actually administered |
| HCPCS J1743 + JW (discarded units) | 24D (drug line 2) | Bill mg discarded; same NDC |
| Drug units | 24G | mg administered (line 1) / mg discarded (line 2) |
| CPT 96365 + 96366 (admin lines) | 24D | 96365 × 1 (initial hour) + 96366 × 2 (additional hours, ~3-hr total) |
| ICD-10 | 21 | E76.1 primary; add organ involvement codes as documented |
| PA number | 23 | Required by all major payers |
| Patient weight (in clinical record) | n/a (chart) | Must justify weight-based dose; payers may request copy on appeal |
Phase 3
Get paid
PA + diagnostic confirmation + specialist documentation. Lifelong therapy — renewals on schedule.
Payer policy snapshot Reviewed May 2026
All major payers cover idursulfase for confirmed MPS II. PA is universal; criteria are stable across plans.
| Payer | PA? | Key requirements | Renewal |
|---|---|---|---|
| UnitedHealthcare Lysosomal Storage Disease ERT policy |
Yes | Confirmed MPS II diagnosis (enzyme assay + IDS gene); prescriber is geneticist, metabolic specialist, or in consultation; patient ≥5 yr | Annually with documented clinical response or stability |
| Aetna CPB MPS / Lysosomal Storage Diseases |
Yes | Same diagnostic confirmation; patient ≥5 yr; specialist prescriber | Annually |
| BCBS plans Vary by plan; most use medical-policy ERT criteria |
Yes | Aligned with FDA label + AAP / metabolic specialty guidelines | Plan-specific (most annual) |
| Medicare (MAC LCDs) | n/a | Coverage for FDA-approved on-label use under generic biologic LCDs | n/a |
Step therapy
Not applicable. Idursulfase is the only FDA-approved enzyme replacement therapy for MPS II. There is no equivalent or alternative product, and payers do not require trials of other therapies before approving Elaprase.
Specialist requirement
Most payers require that the prescriber be (or be in formal consultation with) a clinical geneticist, metabolic specialist, or pediatric specialist with experience treating lysosomal storage diseases. Document the consulting specialist on the PA submission.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J1743
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$558.221
per mg / per unit
35 mg dose (~70 kg adult)
$19,537.74
35 units × ASP+6%
Single 6 mg vial
$3,349.33
6 units × ASP+6%
Annualized cost: 0.5 mg/kg × 52 weekly infusions. For a 70 kg adult (35 mg/dose),
approximately $1,015,962/year in drug cost (Medicare ASP+6%, billable units only). For
a 30 kg child (15 mg/dose), approximately $435,412/year. Sequestration (~2%) reduces
actual paid to roughly ASP + 4.3%. Elaprase is among the highest annualized-cost drugs Medicare Part B
covers per beneficiary.
Coverage
No NCD specific to idursulfase. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J1743 for FDA-approved on-label use in confirmed MPS II with appropriate ICD-10 (E76.1) and diagnostic documentation.
Code history
- J1743 — permanent code, "Idursulfase injection" (1 mg = 1 unit). Established shortly after the July 2006 FDA approval.
Patient assistance — Takeda OnePath Takeda verified May 2026
- Takeda OnePath / Elaprase Patient Support: 1-866-861-1750 — benefits investigation, prior authorization assistance, appeals support, infusion site coordination, dedicated case manager
- Commercial copay assistance: available to eligible commercially-insured patients (excludes Medicare, Medicaid, TRICARE, and other federally-funded program patients)
- Patient Assistance Program (PAP): free product for uninsured / underinsured patients meeting income criteria
- Independent foundations (federally-insured patients): NORD MPS II Fund; HealthWell Foundation (when open); Patient Access Network (PAN) — verify open MPS funds quarterly
- National MPS Society: mpssociety.org — family resources, educational materials, advocacy, and limited financial assistance
- Web: elaprase.com · takedaonepath.com
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J1743 pre-loaded.
Phase 4
Fix problems
Diagnostic documentation gaps, missing JW, and wrong admin code are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Diagnosis not confirmed | PA submitted without enzyme assay AND IDS gene results | Submit both lab reports with retroactive PA. Keep originals on file for audit. |
| Wrong admin code (96413) | Chemo IV billed instead of therapeutic IV | Resubmit with 96365 + 96366 × 2. Idursulfase is enzyme replacement, not antineoplastic. |
| JW units missing | Wasted drug not reported on weight-based dose | Add JW line for discarded units. JZ on administered units; JW on wasted units. Same NDC on both lines. |
| Missing additional-hour units | Only 96365 billed for 3-hour infusion | Add 96366 × 2 with documented start/stop times. Without this, 2 hours of chair time go unreimbursed. |
| Specialist requirement | Prescriber not a geneticist or metabolic specialist | Document consulting specialist on PA. Most payers accept formal consultation; document the consulting physician's NPI and consultation note. |
| Patient age <5 yr | Off-label use in younger pediatric patient | Patient must be ≥5 yr per FDA label. Off-label use in younger patients requires LMN with specific clinical rationale. |
| Patient weight not documented | Weight-based dose without supporting weight in chart | Add patient weight to encounter note; some payers will ask for it on appeal. |
| Site of care (HOPD) | HOPD setting after stable on therapy on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49) for stable patients. Submit medical necessity letter if HOPD required for safety. |
Frequently asked questions
What is the HCPCS code for Elaprase?
Elaprase (idursulfase IV) is billed under HCPCS J1743 — "Idursulfase injection."
Each milligram equals one billable unit. The 6 mg single-dose vial bills as 6 units when used in full.
J1743 has been a permanent code since shortly after the July 2006 FDA approval. Always pair with ICD-10
E76.1 (mucopolysaccharidosis type II / Hunter syndrome).
How is Elaprase dosed?
0.5 mg/kg IV once weekly, lifelong, for patients ≥5 years with mucopolysaccharidosis II (MPS II / Hunter syndrome). Infusion time is approximately 3 hours with stepwise rate titration; observation post-infusion is recommended. Round dose calculations to the nearest mg and bill the actual mg administered. A 70 kg adult receives 35 mg per dose (35 units of J1743).
What administration CPT do I use for Elaprase?
CPT 96365 ("Therapeutic IV infusion, up to 1 hour") as the initial unit, plus CPT
96366 ("each additional hour, up to 8 hours") × 2 for the typical 3-hour Elaprase
infusion. Do NOT use 96413 — Elaprase is a recombinant enzyme (non-chemotherapy biologic).
Document infusion start and stop times on every claim.
Do I need JZ or JW on Elaprase claims?
Yes. Per CMS's July 2023 single-dose container policy, every J1743 claim must carry JZ (no waste) or JW (waste). Because Elaprase is weight-based dosing from a fixed 6 mg vial, partial-vial waste is the rule, not the exception — JW typically applies. Bill the administered units on the JZ-style line and the discarded units on a separate JW line. Only patients whose dose is an exact multiple of 6 mg avoid waste.
What is the Medicare reimbursement for J1743?
For Q2 2026, the Medicare Part B payment limit for J1743 is $558.221 per mg (ASP + 6%). A typical 35 mg adult dose reimburses at approximately $19,537.74 per infusion before sequestration. Annualized at 52 weekly infusions for a 70 kg patient, total drug cost is approximately $1,015,962 per year. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Is premedication required for Elaprase?
Premedication is recommended (not strictly required by label) for all patients: an antihistamine and an antipyretic 30–60 minutes before each infusion. In patients with prior infusion reactions or pre-existing respiratory compromise, add a corticosteroid. Anaphylaxis has been observed in approximately 16% of patients in the global Hunter Outcome Survey, so emergency medications and trained personnel must be on-site for every infusion.
What ICD-10 code is required for Elaprase?
E76.1 — "Mucopolysaccharidosis, type II" (Hunter syndrome) is the primary diagnosis.
Payers also expect documentation of confirmatory testing: low or absent iduronate-2-sulfatase (IDS)
enzyme activity in leukocytes/fibroblasts AND a pathogenic IDS gene variant. Add supplementary codes
for organ involvement.
What patient assistance is available for Elaprase?
Takeda OnePath / Elaprase Patient Support — 1-866-861-1750 — provides benefits investigation, prior authorization assistance, copay support for commercially-insured patients, and the Patient Assistance Program for uninsured / underinsured patients meeting income criteria. Federally-insured patients (Medicare, Medicaid, TRICARE) are excluded from the commercial copay program but may qualify for assistance through NORD MPS II fund or HealthWell when open.
How does Elaprase differ from other MPS enzyme replacement therapies?
Each MPS subtype has its own enzyme deficiency and its own dedicated ERT — they are not
interchangeable. Aldurazyme (laronidase, J1931) is for
MPS I (Hurler). Elaprase (J1743) is for MPS II (Hunter). Vimizim
(elosulfase alfa, J1322) is for MPS IVA (Morquio A). Naglazyme
(galsulfase, J1458) is for MPS VI (Maroteaux-Lamy). Mepsevii (vestronidase,
J3397) is for MPS VII (Sly). All are weight-based weekly or biweekly IV infusions with
similar long infusion times and hypersensitivity profiles.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — ELAPRASE (idursulfase) Prescribing Information
- FDA Drugs@FDA — Elaprase label PDF
- Takeda OnePath — Elaprase Patient Support
- Elaprase HCP / patient site
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J1743 reference
- UnitedHealthcare — Lysosomal Storage Disease ERT Coverage Policy
- Aetna — CPB Mucopolysaccharidoses / Lysosomal Storage Diseases
- FDA National Drug Code Directory (NDC 54092-0700-01)
- Hunter Outcome Survey (HOS) — international Elaprase registry. Published safety data including infusion reaction frequency (~16%) and antibody formation rates.
- AAP / ACMG clinical guidelines — mucopolysaccharidosis II diagnosis and management.
- National MPS Society — mpssociety.org
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 policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, premedication | Event-driven | Tied to manufacturer document version + FDA label revision date. Elaprase label is stable post-2006 approval. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, 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
- — Initial publication. ASP data: Q2 2026 (J1743 = $558.221/mg). Manufacturer source: Takeda OnePath 2026. FDA label: current Elaprase PI (BLA 125151, original approval July 2006). MPS class comparison includes Aldurazyme (J1931), Vimizim (J1322), Naglazyme (J1458), and Mepsevii (J3397).
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. Premedication recommendations reflect FDA label guidance and Hunter Outcome Survey safety data. We do not paraphrase from billing-software vendor blogs.