Ruconest (conestat alfa, recombinant C1-INH) — HCPCS J0596
CareCost Estimate · Billing Cheat Sheet
Pharming Healthcare
2,100 IU lyophilized SDV (150 IU/mL after recon)
IV ~5 min push
Reviewed: May 2, 2026
ASP: Q4 2026
⚠ Biller error trap — J0596 unit conversion
1 unit J0596 = 10 IU Ruconest
A 4,200 IU max dose bills as 420 units, NOT 4,200. Submitting raw IU as units inflates 10× and triggers immediate audit. #1 J0596 denial cause — always divide IU by 10.
Max dose
420 units
4,200 IU IV (capped)
Modifier
JZ / JW
JW for partial-vial waste
Admin CPT
96365
Therapeutic IV (~5 min push)
Medicare ASP+6%
$37.810
/10 IU · $15,880.20 max dose
Codes & NDC
| HCPCS | J0596 — "Inj, C1 esterase inhibitor (recombinant), Ruconest, 10 units" (permanent) |
|---|
| NDC | 42227-081-01 (10) / 42227-0081-01 (11) — N4 qualifier |
|---|
| Vial | 2,100 IU lyophilized SDV + 14 mL sterile water = 150 IU/mL |
|---|
| Origin | Recombinant — transgenic rabbit milk (NOT plasma-derived) |
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| Benefit | Medical (specialty pharmacy or buy-and-bill) |
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Dosing & unit math
- 50 IU/kg IV at first sign of HAE attack
- Max 4,200 IU (420 units) — capped, even >84 kg
- Slow IV push over ~5 min (after recon to 150 IU/mL)
- 2nd dose may be given within 24h if attack persists (max 4,200 IU)
| Weight | Dose IU | Units (÷10) | Vials / waste |
|---|
| 50 kg | 2,500 | 250 | 2 vials / 1,700 IU JW |
| 70 kg | 3,500 | 350 | 2 vials / 700 IU JW |
| 84+ kg | 4,200 (max) | 420 | 2 vials / no waste — JZ |
HAE class comparison
| Drug | HCPCS | Class | Use | ~$/IU |
|---|
| Ruconest | J0596 | Recomb IV | Acute | $3.78 |
| Berinert | J0597 | Plasma IV | Acute | $7.93 |
| Cinryze | J0598 | Plasma IV | Prophy | $6.71 |
| Haegarda | J0599 | Plasma SC | Prophy | $5.50 |
| Takhzyro | J0593 | mAb SC | Prophy | per mg |
Ruconest is materially cheaper per IU than plasma-derived alternatives — but is the only HAE product with a rabbit-allergy contraindication.
Administration & modifiers
| Code | When |
|---|
96365 | Therapeutic IV, <1 hr (primary) — non-chemo |
96374 | IV push (some MACs prefer for ~5-min push) |
96413 | NOT appropriate — Ruconest is non-chemo |
| Home admin: S9329 + 99601/99602 (post-training) |
JW is common — weight-based dosing + fixed 2,100 IU vials = partial-vial waste. Always document weight, dose, vials opened, IU discarded. One of JZ/JW required on every J0596 claim.
RECOMBINANT ORIGIN — RABBIT ALLERGY CONTRAINDICATED. Ruconest is harvested from the milk of transgenic rabbits expressing human C1-INH. Any patient with known or suspected rabbit-protein allergy
cannot receive Ruconest — absolute contraindication, anaphylaxis risk.
Pre-treatment screening required:
- Document rabbit-allergy history (pets, lab, hunting exposure)
- If any concern: refer to allergy/immunology for serum-IgE / supervised challenge
- Chart entry: "rabbit-protein allergy negative by history" before first dose
- If positive: switch to Berinert (J0597) on-demand or Takhzyro (J0593) prophy
- Have epinephrine + airway readily available during admin
On-demand only — NOT prophylaxis
Ruconest is FDA-approved for treatment of acute angioedema attacks in adolescents and adults with HAE Type I or II. PA submitted for prophylaxis will be denied.
Prophylaxis alternatives: Cinryze (J0598, IV q3-4d), Haegarda (J0599, SC twice weekly), Takhzyro (J0593, SC q2w).
ICD-10
| Code | For |
|---|
D84.1 | Defects in complement system — primary HAE Dx |
T78.3XXA | Angioneurotic edema, initial encounter |
T78.3XXD | Angioneurotic edema, subsequent |
T78.3XXS | Angioneurotic edema, sequela |
Always pair D84.1 + T78.3XXA on acute treatment claims.
Payer requirements (May 2026)
| Payer | PA | Key criteria |
|---|
| UnitedHealthcare | Yes | HAE Type I/II Dx + acute Sx + rabbit-allergy negative; specialist Rx |
| Aetna | Yes | C1-INH level/function or genetic testing; rabbit clearance |
| BCBS plans | Yes | Aligned with US HAEA / WAO-EAACI guidelines |
| Medicare (MAC) | No | FDA-labeled use under D84.1 + T78.3XXA |
Medicare reimbursement (Q4 2026)
| Field | Value |
|---|
| ASP + 6% | $37.810 / 10 IU unit (~$3.78/IU, eff. 7/1 – 9/30/2026) |
| 2,100 IU vial (210 units) | $7,940.10 |
| 4,200 IU max dose (420 units) | $15,880.20 |
| Annual (12 attacks × 3,500 IU) | ~$154,000 (70 kg patient) |
Patient assistance — Pharming RuconestKey
- Phone: 1-866-411-2848 (Pharming Patient Support / RuconestKey)
- Commercial copay program: commercially-insured (excludes Medicare/Medicaid)
- Pharming PAP: free product for uninsured / underinsured
- Foundations: PAN, HealthWell, NORD, US HAEA (Medicare patients)
- Web: ruconest.com / pharming.com