| HCPCS | J2356 — "Injection, tezepelumab-ekko, 1 mg" (permanent 1/1/23) |
|---|---|
| NDC (syringe) | 55513-112-01 — 210 mg/1.91 mL prefilled syringe (HCP) |
| NDC (vial) | 55513-100-01 — 210 mg/1.91 mL single-dose vial (HCP) |
| NDC (pen) | 210 mg prefilled pen / autoinjector — verify carton NDC. Self-admin OK after 1st dose. |
| Storage | 2–8°C; protect from light. RT up to 30 days max (no return to fridge). |
| Indication | Dose | Units |
|---|---|---|
| Severe asthma add-on (≥12 yr) | 210 mg SC q4wk | 210 |
| Code | When |
|---|---|
96372 | SC therapeutic, non-chemo (primary) |
JZ | Single-dose container, zero waste — default |
| NOT 96365/96366 (IV) and NOT 96413/96415 (chemo IV) and NOT 96401 (anti-neoplastic SC) | |
| Code | For |
|---|---|
J45.50 | Severe persistent asthma, uncomplicated |
J45.51 | Severe persistent w/ acute exacerbation |
J45.52 | Severe persistent w/ status asthmaticus |
| NOT J45.2x (mild interm), J45.3x (mild persist), J33.x (CRSwNP). Off-label = denial. | |
| Drug | Code | Target | Biomarker |
|---|---|---|---|
| Tezspire | J2356 | TSLP | None |
| Nucala | J2182 | IL-5 | Eos ≥150 |
| Fasenra | J0517 | IL-5Rα | Eosinophilic |
| Cinqair | J2786 | IL-5 (IV) | Eos ≥400 |
| Xolair | J2357 | IgE | IgE 30–1500 |
| Payer | PA | Requirements |
|---|---|---|
| UnitedHealthcare | Yes | Severe persistent + ICS+LABA fail + 1 prior biologic; SP transition |
| Aetna | Yes | Severe + step from biologic (some plans allow direct if eos-low + IgE-low) |
| Cigna | Yes | ICS+LABA+LTRA + step from another biologic; Accredo SP |
| Medicare LCD | Generally no PA | Severe persistent + ICS+LABA documented |
| Field | Value |
|---|---|
| ASP + 6% | $17.583 / mg (eff. 4/1 – 6/30/2026) |
| 210 mg dose | $3,692.43 |
| Annual (13 doses) | ~$48,001 (in-clinic Part B path) |
| After SP transition | Drug shifts to Part D / SP; practice claim drops to admin-only |
| Setting | POS | Notes |
|---|---|---|
| Pulm / allergist office | 11 | Preferred for first dose |
| Patient home (pen) | n/a (pharmacy) | Strongly preferred after first dose — SP fills |
| HOPD | 22 / 19 | Disfavored; UM denies for commercial plans |