HCPCS
J0593
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the right HAE drug, route, and prophylaxis-vs-on-demand role before billing.
HAE drug class comparison — where Takhzyro fits Verified May 2026
Hereditary angioedema therapy splits into two roles: prophylaxis (prevent attacks) and on-demand (abort acute attacks). Takhzyro is prophylaxis-only; every patient still needs an on-demand rescue.
| Drug | HCPCS | Mechanism | Route | Frequency | Role |
|---|---|---|---|---|---|
| Takhzyro (lanadelumab-flyo) | J0593 |
Plasma kallikrein inhibitor mAb | SC | q2wk (q4wk after 6 mo attack-free) | Prophylaxis |
| Cinryze (C1-INH human) | J0598 |
C1 esterase inhibitor (plasma-derived) | IV | q3–4 days | Prophylaxis |
| Haegarda (C1-INH SC) | J0599 |
C1 esterase inhibitor (plasma-derived) | SC | q3–4 days | Prophylaxis |
| Berinert (C1-INH human) | J0597 |
C1 esterase inhibitor (plasma-derived) | IV | per attack | On-demand |
| Ruconest (recombinant C1-INH) | J0596 |
C1 esterase inhibitor (recombinant) | IV | per attack | On-demand |
| Firazyr / Sajazir (icatibant) | Q4084 |
Bradykinin B2 receptor antagonist | SC | per attack | On-demand |
| Kalbitor (ecallantide) | J1290 |
Plasma kallikrein inhibitor | SC | per attack | On-demand |
Why Takhzyro is differentiated: Takhzyro is the only monoclonal antibody plasma
kallikrein inhibitor for HAE prophylaxis. Compared with C1-INH replacement therapies (Cinryze IV,
Haegarda SC) which dose every 3–4 days, Takhzyro's q2wk-q4wk schedule materially reduces injection
burden — one of its primary clinical/positioning advantages.
Don't confuse mechanism class with role. Takhzyro and Kalbitor are both plasma
kallikrein inhibitors, but Takhzyro is a long-acting monoclonal antibody for prophylaxis (q2wk-q4wk) and
Kalbitor is a short-acting peptide for on-demand acute treatment (per attack). They are not
interchangeable.
Dosing & unit math FDA label verified May 2026
From the FDA-approved Takhzyro prescribing information (most recent revision) and the WAO/EAACI international HAE management guidelines.
Adult and pediatric ≥12 years
- 300 mg SC every 2 weeks (every 14 days) — starting dose for all patients
- After patient is well-controlled (e.g., attack-free for >6 months), interval may be extended to 300 mg SC every 4 weeks
- 1 mg = 1 unit — bill 300 units per dose
- q2wk schedule: ~26 doses/year (7,800 units/yr)
- q4wk schedule: ~13 doses/year (3,900 units/yr)
Pediatric 2 to less than 12 years
- 150 mg SC every 4 weeks (use 150 mg / 1 mL prefilled syringe)
- Bill 150 units per dose
- ~13 doses/year (1,950 units/yr)
Worked example — first-year billing for an adult q2wk patient
# 300 mg SC q2wk × 26 doses
Drug units billed per dose: 300 (J0593)
HCPCS: J0593 · Modifier: JZ · Presentation: 1 × 300 mg / 2 mL PFS
Admin: 96372 (SC injection — if clinic-administered)
Self-administration: pharmacy benefit, no admin CPT
# Year-1 totals
Total doses: 26
Total drug units billed: 7,800 (26 × 300)
Total drug cost (Q2 2026 ASP+6%): ~$677,399 before sequestration
After q4wk extension (year 2+): ~13 doses, ~$338,699/year
Drug units billed per dose: 300 (J0593)
HCPCS: J0593 · Modifier: JZ · Presentation: 1 × 300 mg / 2 mL PFS
Admin: 96372 (SC injection — if clinic-administered)
Self-administration: pharmacy benefit, no admin CPT
# Year-1 totals
Total doses: 26
Total drug units billed: 7,800 (26 × 300)
Total drug cost (Q2 2026 ASP+6%): ~$677,399 before sequestration
After q4wk extension (year 2+): ~13 doses, ~$338,699/year
No premedication routinely required
Takhzyro does not require pre-injection antihistamine, steroid, or other premedication. Manage rare hypersensitivity reactions per the FDA label.
NDC & presentation reference FDA NDC Directory verified May 2026
| Presentation | Use | Bill |
|---|---|---|
| 300 mg / 2 mL single-dose prefilled syringe | Adults and pediatric ≥12 yr (q2wk or q4wk after attack-free extension) | 300 units J0593 + JZ |
| 150 mg / 1 mL single-dose prefilled syringe | Pediatric 2 to <12 yr (q4wk) | 150 units J0593 + JZ |
Verify the carton-level NDC at billing time. Takeda has updated NDC formats for
Takhzyro since launch; the current 11-digit NDC printed on the dispensed carton is what the payer
expects on the claim form. Use the NDC from the actual dispensed package, not a stored reference.
Single-dose only. Both Takhzyro presentations are single-dose prefilled syringes
— no multi-dose vial exists. JZ applies on every claim where the full labeled dose is
administered.
Phase 2
Code the claim
SC route — admin CPT 96372, never IV codes. Self-admin shifts billing to pharmacy benefit.
Administration codes CPT verified May 2026
Takhzyro is a subcutaneous injection. IV administration codes are wrong.
| Code | Description | When to use |
|---|---|---|
96372 |
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular | Primary code for clinic-administered Takhzyro. Non-chemo SC injection. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Takhzyro is SC, not IV. |
96413 / 96415 |
Chemotherapy IV infusion | NOT appropriate. Takhzyro is not chemo and is not IV. |
96401 |
Chemotherapy administration, SC/IM; non-hormonal anti-neoplastic | NOT appropriate. Takhzyro is not anti-neoplastic. |
| None (pharmacy benefit) | Patient self-administers at home with drug from specialty pharmacy | Most common scenario after first-dose training. No admin CPT billed. |
Why 96372 (not 96365): The CPT distinction is route, not duration. Takhzyro is a
subcutaneous injection delivered via prefilled syringe; the 96365–96366 family applies only to
intravenous infusions. Use 96372 for any clinic-administered SC injection of Takhzyro.
Common error: Billing 96365 or 96413 because Takhzyro is a high-dollar specialty
biologic. Route, not cost or biologic status, drives the CPT family. SC injection = 96372.
Self-administration vs clinic administration Reviewed May 2026
Takhzyro's billing pathway changes once the patient is trained.
| Scenario | Benefit | Drug claim | Admin claim |
|---|---|---|---|
| First dose / training in clinic | Medical (buy-and-bill or specialty pharmacy ship-to-office) | J0593 × 300 + JZ + ICD-10 (D84.1 etc.) | 96372 by the prescriber/practice |
| Subsequent in-clinic dose (rare) | Medical (buy-and-bill) | J0593 × 300 + JZ | 96372 |
| Patient self-administers at home (most common) | Pharmacy / specialty pharmacy benefit | NDC-based pharmacy claim; no J-code billed by prescriber | None — patient injects |
Specialty pharmacy is the dominant pathway. Most commercial and Medicare Part D plans
route Takhzyro through specialty pharmacy after the first dose. The specialty pharmacy ships the
prefilled syringes to the patient's home; the patient self-injects per training. The prescriber's
practice does not bill J0593 or 96372 for self-administered doses.
First-dose site-of-care — verify with the payer. Some payers require the first
dose to be administered in clinic with same-day patient training documented; others permit
specialty-pharmacy-only dispensing from day one. This is plan-specific.
Modifiers CMS verified May 2026
JZ — required on virtually every claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Takhzyro 300 mg / 2 mL and 150 mg / 1 mL are single-dose prefilled syringes; the labeled dose is administered in full with no waste. JZ applies to virtually every J0593 claim.
JW — rarely applicable
Because Takhzyro is supplied as single-dose prefilled syringes at the labeled adult and pediatric doses, there is no partial-syringe scenario. JW (discarded amount) does not typically apply. One of JZ or JW must be on every J0593 claim per CMS's July 2023 single-dose container policy — practically, JZ.
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 injection (e.g., HAE specialist consult plus first-dose training). Routine pre-injection clinical assessment is bundled into 96372.
340B modifiers (JG, TB)
For 340B-acquired Takhzyro, follow your MAC's current 340B modifier policy.
ICD-10-CM for hereditary angioedema FY2026 verified May 2026
HAE Type I and Type II are coded under the complement-deficiency family. The exact code your payer expects can vary — D84.1 is the most commonly used.
| Code | Description | Use for Takhzyro |
|---|---|---|
D84.1 |
Defects in the complement system | Most commonly accepted ICD-10 for HAE Type I/II. Use as primary diagnosis. |
D89.49 |
Other complement deficiency | Alternate; some payer policies reference this. |
T78.3XXA / T78.3XXD / T78.3XXS |
Angioneurotic edema (initial / subsequent / sequela) | Sometimes used to document attack history; not the preferred primary for HAE prophylaxis claims. |
D84.81 — D84.89 |
Other specified immunodeficiencies | Rarely used; verify per payer. |
HAE diagnosis confirmation is standard for PA. Most payers (UHC, Aetna, BCBS plans)
require lab-confirmed HAE Type I (low C1-INH antigen + low functional C1-INH) or Type II (normal/high
C1-INH antigen + low functional C1-INH); some accept genetic confirmation. Document the confirmatory
lab results in the PA submission alongside the ICD-10.
Site of care & place of service Verified May 2026
Takhzyro's most common pathway is patient home self-administration after first-dose clinic training. Major payers (UHC, Aetna) route Takhzyro through specialty pharmacy as the default. HOPD and infusion suite settings are uncommon for an SC prefilled-syringe drug.
| Setting | POS | Claim form | Notes |
|---|---|---|---|
| Patient home (self-admin) | 12 | Pharmacy benefit (NCPDP) | Most common. Specialty pharmacy ship-to-patient. |
| Allergy/immunology office (first dose, training) | 11 | CMS-1500 / 837P | Common for first dose; 96372 admin. |
| Hospital outpatient | 22 | UB-04 / 837I | Uncommon; not typically required for SC PFS. |
| Off-campus PBD | 19 | UB-04 / 837I | Uncommon. |
Allergy/immunology referral typical. HAE is rare; most major payers want the diagnosis
and treatment plan documented by an allergy/immunology specialist. Primary-care prescription of
Takhzyro often triggers a PA reject for specialist consultation.
Claim form field mapping Takeda OnePath 2026
From Takeda OnePath HCP coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider (allergy/immunology typical) |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + carton NDC + ML + 2 mL (300 mg) or 1 mL (150 mg) |
| HCPCS J0593 + JZ | 24D (drug line) | JZ on virtually every claim |
| Drug units | 24G | 300 (adult/q2wk or q4wk) or 150 (pediatric <12 yr) |
| CPT 96372 (admin line) | 24D (admin line) | For clinic-administered doses only; not for self-admin |
| ICD-10 | 21 | D84.1 primary; T78.3xxx as secondary if documenting attack history |
| PA number | 23 | Required by all major payers |
Phase 3
Get paid
HAE diagnosis confirmation + specialist consult are the gating PA criteria.
Payer policy snapshot Reviewed May 2026
All major payers require PA, lab-confirmed HAE Type I/II, and (typically) specialist consultation. Site-of-care is straightforward for an SC prefilled-syringe drug.
| Payer | PA? | Diagnostic confirmation | Specialist consult | Site-of-care |
|---|---|---|---|---|
| UnitedHealthcare HAE LCD / Med Drug policy |
Yes | Required: low C1-INH antigen or low functional C1-INH (Type I/II); attack history documented (≥1 attack/month or ≥1 ER visit) | Allergy/immunology typical | Specialty pharmacy benefit after first dose |
| Aetna CPB + Medical Drug policies |
Yes | Lab-confirmed HAE Type I/II or genetic confirmation; documented attack history | Allergy/immunology typical | Specialty pharmacy after first dose |
| BCBS plans Vary by plan |
Yes | Generally aligned with WAO/EAACI HAE management guidelines | Plan-specific | Plan-specific; specialty pharmacy common |
| Medicare Part B | Coverage by MAC LCD | FDA-labeled indication required | Implied via specialty consult notes | Buy-and-bill (clinic admin) or DME-equivalent home pathway |
Step therapy
Some payers require failure of (or contraindication to) C1-INH replacement prophylaxis (Cinryze IV or Haegarda SC) before approving Takhzyro. Many do not, given Takhzyro's q2wk-q4wk dosing convenience. Verify per-payer at the time of PA.
Quantity limits
Typical limit: 2 prefilled syringes per 28 days (matches q2wk dosing). After attack-free extension to q4wk, the limit drops to 1 PFS per 28 days. Pediatric (2–<12 yr) limit: 1 × 150 mg PFS per 28 days.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J0593
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$86.846
per mg / per unit
300 mg dose (q2wk or q4wk)
$26,053.80
300 units × ASP+6%
150 mg dose (pediatric q4wk)
$13,026.90
150 units × ASP+6%
Annualized cost (Medicare ASP+6%): 300 mg q2wk × 26 doses = ~$677,400/year.
300 mg q4wk × 13 doses (after attack-free extension) = ~$338,700/year.
Pediatric 150 mg q4wk × 13 doses = ~$169,350/year. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Coverage
No nationally-published NCD specific to lanadelumab. Coverage falls under MAC LCDs for HAE biologics and the generic Part B drug-coverage framework. Most MACs cover J0593 for FDA-approved on-label HAE prophylaxis indications with appropriate ICD-10 (D84.1) and confirmatory lab documentation.
Code history
- J0593 — permanent code, "Injection, lanadelumab-flyo, 1 mg" (1 mg = 1 unit). FDA approval August 2018; pediatric ≥2 yr expansion February 2023.
Patient assistance — Takeda OnePath / Takhzyro Co-pay Program Takeda verified May 2026
- Takhzyro Patient Support / OnePath: 1-866-861-1750 (Takeda OnePath) — benefits investigation, prior authorization assistance, appeal support, nurse training for self-administration
- Takhzyro-specific support line: 1-833-927-3658
- Takhzyro Co-pay Program: commercially-insured eligible patients may pay as little as $0 for first dose and reduced copay thereafter (excludes Medicare, Medicaid, VA/DoD, Tricare, federal program patients)
- Takeda Patient Assistance Foundation: free product for uninsured / underinsured patients meeting income requirements
- Foundations: for Medicare patients, refer to HealthWell Foundation HAE fund or US HAEA Scholarship/Patient Support — verify open HAE funds quarterly
- Web: takhzyro.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 — J0593 pre-loaded.
Phase 4
Fix problems
Wrong admin code (96365 IV), missing diagnosis confirmation, and self-admin/medical-benefit confusion are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (96365 / 96413) | IV admin code billed for SC injection | Resubmit with 96372. Takhzyro is SC, not IV. |
| HAE diagnosis not confirmed | PA submitted without C1-INH antigen / functional level | Submit confirmatory lab results (low C1-INH antigen or low functional C1-INH); attach genetic test if Type II ambiguous. |
| No specialist consult on file | PCP-prescribed; no allergy/immunology consult documented | Submit allergy/immunology consult note. Many payers require specialist involvement for HAE biologics. |
| Wrong benefit (medical vs pharmacy) | Self-administered dose billed as J0593 medical claim | Self-admin doses run through specialty pharmacy. Only first dose / clinic-administered doses bill J0593 + 96372 medical. |
| JZ missing | Single-dose PFS claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Quantity limit exceeded | 3 PFS billed in 28 days | q2wk = 2 PFS / 28 days; q4wk = 1 PFS / 28 days. Verify schedule; submit attack-free extension justification if transitioning. |
| Step therapy failure | No prior C1-INH prophylaxis trial documented | Submit clinical justification for first-line Takhzyro (dosing convenience, contraindication to plasma-derived C1-INH, etc.) or document prior C1-INH trial. |
| Used for acute attack | Takhzyro billed for ER attack visit | Takhzyro is prophylaxis only. Acute attacks need on-demand therapy: Berinert (J0597), Ruconest (J0596), Firazyr/Sajazir (Q4084), or Kalbitor (J1290). |
Frequently asked questions
What is the HCPCS code for Takhzyro?
Takhzyro (lanadelumab-flyo) is billed under HCPCS J0593 — "Injection, lanadelumab-flyo,
1 mg." Each milligram equals one billable unit, so the standard 300 mg SC q2wk dose is billed as 300
units. J0593 is a permanent code.
How many units do I bill for a 300 mg Takhzyro dose?
Bill 300 units of J0593 per 300 mg adult dose. The 300 mg / 2 mL prefilled
syringe is single-dose, so JZ modifier applies (no waste). For pediatric patients aged 2–12 years
receiving 150 mg q4wk, bill 150 units.
What administration CPT do I use for Takhzyro?
CPT 96372 — "Therapeutic, prophylactic, or diagnostic injection (specify substance
or drug); subcutaneous or intramuscular." Takhzyro is a SUBCUTANEOUS injection (NOT intravenous), so
do NOT bill 96365 (therapeutic IV) or 96413 (chemo IV). After patient
training, most patients self-administer at home — in that case the drug is dispensed via
specialty pharmacy benefit and no admin CPT is billed by the prescriber.
Do I bill JZ or JW for Takhzyro?
Bill JZ on virtually every Takhzyro claim. The 300 mg / 2 mL prefilled syringe is
single-dose with zero waste at the labeled 300 mg dose. JW does not typically apply
because Takhzyro is delivered as a single-dose prefilled syringe — there is no partial-vial
dosing. One of JZ or JW must be on every J0593 claim per CMS's July 2023 single-dose container policy.
What is the Medicare reimbursement for J0593?
For Q2 2026, the Medicare Part B payment limit for J0593 is $86.846 per mg (ASP + 6%). The standard 300 mg SC q2wk dose reimburses at approximately $26,053.80 per dose. Annualized cost (Medicare ASP+6%): approximately $677,000 for q2wk dosing or $339,000 for q4wk dosing (after attack-free extension). Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What is the dosing for Takhzyro?
Adult and pediatric ≥12 years: 300 mg SC every 2 weeks. After the patient is well-controlled (e.g., attack-free) for >6 months, the dosing interval may be extended to 300 mg SC every 4 weeks. Pediatric patients aged 2 to <12 years: 150 mg SC every 4 weeks. Do not use Takhzyro for acute HAE attacks — it is for prophylaxis only.
How does Takhzyro compare to other HAE drugs?
Takhzyro (J0593) is a monoclonal antibody plasma kallikrein inhibitor for SC prophylaxis, dosed q2wk-q4wk. C1-INH replacement for prophylaxis: Cinryze (J0598, IV q3-4d), Haegarda (J0599, SC q3-4d). On-demand acute treatment: Berinert (J0597, C1-INH IV), Ruconest (J0596, recombinant C1-INH IV), Firazyr/Sajazir (Q4084, icatibant SC), Kalbitor (J1290, ecallantide SC). Takhzyro's main differentiator is the convenient q2wk-q4wk dosing schedule and that it is a monoclonal antibody rather than C1-INH replacement.
Is Takhzyro for acute HAE attacks?
No. Takhzyro is approved only for routine prophylaxis to prevent HAE attacks. It is NOT indicated for treatment of acute attacks. For acute attacks, on-demand therapies such as Berinert, Ruconest, Firazyr/Sajazir, or Kalbitor are used. Patients on Takhzyro prophylaxis still need an on-demand rescue therapy available.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Takhzyro — manufacturer site (Takeda)
- DailyMed — TAKHZYRO (lanadelumab-flyo) Prescribing Information
- FDA Drugs@FDA — Takhzyro (lanadelumab) approval package, BLA 761090
- CMS — Medicare Part B Drug ASP Pricing File
- Takeda OnePath — HCP coding & coverage support
- US Hereditary Angioedema Association (US HAEA) — patient + clinician resources
- WAO/EAACI international HAE management guidelines
- UnitedHealthcare — HAE / Medical Drug Coverage Policy
- Aetna — Medical Drug & CPB policies for HAE biologics
- FDA National Drug Code Directory
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 | Event-driven | Tied to manufacturer document version + FDA label revision date. |
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 ($86.846/mg ASP+6%). Manufacturer source: Takeda OnePath HCP materials. FDA label: most recent revision (BLA 761090). Includes HAE class comparison (Takhzyro vs Cinryze, Haegarda, Berinert, Ruconest, Firazyr/Sajazir, Kalbitor).
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. Indication and dosing claims are verified against the current FDA label revision and WAO/EAACI international HAE management guidelines. We do not paraphrase from billing-software vendor blogs.