Tepezza and the teprotumumab-trbw product family
No teprotumumab-trbw biosimilar exists, and the file carries no same-class alternative with a J-code. ASP detail lives in Current Tepezza pricing.
| Brand | HCPCS | Manufacturer | Generic |
|---|---|---|---|
| Tepezza (IV) (this page) | J3241 | Amgen (formerly Horizon Therapeutics) | teprotumumab-trbw |
Tepezza is the only teprotumumab-trbw product: no biosimilar has been approved and no same-class alternative carries a J-code. There is no subcutaneous Tepezza; the sole vial is a 500 mg single-dose vial for IV infusion, reconstituted and diluted before each dose (see Tepezza dosing).
Tepezza's dose, vial sizes and administration coding are covered in full below; see Tepezza dosing.
Tepezza dosing
Tepezza treats one indication with one intravenous course: 10 mg/kg for the first infusion, then 20 mg/kg every 3 weeks for seven more, eight infusions in about 21 weeks. The label sets no dose cap.
| Indication | Starting dose | Continuing dose | Notes |
|---|---|---|---|
| Thyroid eye disease (adults) | 10 mg/kg IV for the first infusion, over at least 90 minutes | 20 mg/kg q3wk thereafter | The worked example on these pages: 20 mg/kg for 80 kg is 1,600 mg = 160 units of J3241 from four 500 mg vials with 400 mg (40 units) on a JW line, 96413 alone. The 10 mg/kg first infusion for the same patient is 800 mg = 80 units from two vials with 200 mg (20 units) on a JW line. The second infusion also runs at least 90 minutes; from the third, at least 60 minutes if the first two were well tolerated. The course is 7 infusions at 20 mg/kg after the first, eight in all, about 21 weeks; the label describes one course. |
Pretreatment workup
Tepezza may cause infusion reactions, reported in about 4% of patients in the premarketing trials; signs include transient blood-pressure increases, feeling hot, tachycardia, dyspnea, headache and muscular pain, during any infusion or within 1.5 hours after, and are usually managed with corticosteroids and antihistamines. Premedication is recommended only when the first two infusions were not well tolerated. Baseline hearing and glycemic assessment (above) are done before the first infusion.
Duration of therapy
Tepezza is course-limited, not open-ended: eight infusions spanning about 21 weeks from first to last, and the label describes a single course. Payers authorize the course as such: BCBS Florida, "Approval duration: 6 months to allow for 8 total infusions (and not to exceed 8 life-time doses)"; BCBS Kansas, "will be covered for one course of therapy per lifetime"; BCBS Louisiana, "the Company considers the use of nine or more doses of teprotumumab-trbw (Tepezza) to be investigational"; BCBS Nebraska, "38 vials/lifetime." A repeat course is a medical-policy exception, not a renewal: BCBS Michigan's reauthorization rule states, "Renewal Criteria: Not applicable as no further authorization will be provided."
Need the billing units for a patient? Convert dose to J3241 billing units →
Tepezza billing reference
HCPCS
J3241: 10 mg per billing unit. MUE 500 units per day (5,000 mg); the label sets no dose ceiling.
NDCs
One vial size, Amgen (formerly Horizon Therapeutics) labeler 75987. Pad to 11 digits with a leading zero in the 3-digit product segment for CMS-1500 Box 24A.
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
75987-130-15 | 75987-0130-15 | 500 mg single-dose vial |
N4 qualifier in CMS-1500 Box 24A shaded area with unit of measure and quantity actually drawn from the vial.
Administration
Tepezza's infusion is billed with 96413 alone in the site's catalog complex-biologic family; 96415 applies only once a drip actually runs past 90 minutes. A payer that places teprotumumab-trbw in the therapeutic-infusion family instead wants 96365, with 96366 past 90 minutes.
| CPT | Description | Use for |
|---|---|---|
96413 | Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | The Tepezza infusion, site catalog family ($133.27, Medicare PFS national non-facility, 2026) |
96415 | Chemotherapy administration, IV infusion technique; each additional hour (List separately in addition to code for primary procedure) | Only when the infusion runs past 90 minutes total ($28.39, Medicare PFS national non-facility, 2026) |
96365 | Intravenous infusion, for therapy, prophylaxis or diagnosis; initial, up to 1 hour (therapeutic-infusion family) | The alternative code at payers that place teprotumumab-trbw in the therapeutic-infusion family instead; 96366 replaces 96415 past 90 minutes there ($67.14, Medicare PFS national non-facility, 2026) |
Modifiers
JZ: required when no drug is discarded. JW: required for documented waste, on a separate line. The calculators on these pages draw the fewest 500 mg vials that cover the dose; because the only vial size is 500 mg, most weights carry a JW line — the 80 kg reference weight discards 400 mg (40 units).
Effective July 1, 2023, CMS requires JZ on every no-waste claim and JW on a separate line for documented waste; the two never appear on the same drug line and date. At the 20 mg/kg maintenance dose, an 80 kg adult's 1,600 mg draws four 500 mg vials (2,000 mg), discarding 400 mg = 40 units on a JW line.
A 70 kg patient's 1,400 mg dose draws three vials, discarding 100 mg = 10 units; a 100 kg patient's 2,000 mg dose draws four vials exactly, with nothing discarded, so the line carries JZ instead. The 10 mg/kg first infusion for the 80 kg patient is 800 mg from two vials, discarding 200 mg = 20 units on a JW line.
| Weight | Dose | Vial draw | Administered | Waste / modifier |
|---|---|---|---|---|
| 80 kg | 1,600 mg (20 mg/kg) | four 500 mg vials | 1,600 mg | 400 mg = 40 units, JW |
| 70 kg | 1,400 mg (20 mg/kg) | three 500 mg vials | 1,400 mg | 100 mg = 10 units, JW |
| 100 kg | 2,000 mg (20 mg/kg) | four 500 mg vials | 2,000 mg | None, JZ |
Claim form
CMS-1500 / 837P (physician office, AIC; POS 11/49) field map for a J3241 claim.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N4 qualifier + 11-digit NDC + UN + quantity drawn |
| HCPCS J3241 (administered; JZ only if no waste) | 24D (drug line) | Administered units, per MAC rounding |
| HCPCS J3241 + JW (when waste) | 24D (separate line) | Discarded units, per MAC rounding |
| Drug units | 24G | Administered + waste split across two lines, same DOS |
| CPT 96413 | 24D (admin line) | 1 unit for the initial hour; add 96415 only past 90 minutes |
| ICD-10 | 21 | The H05.24 exophthalmos family, H05.241–H05.249 by eye — see ICD-10 codes by indication |
| NPI | 17b / 24J / 33a | Rendering and billing provider NPI |
| PA number (when required) | 23 | Required by most commercial payers in 2026 |
Tepezza coverage
- 23 of 28 commercial payer policy sets require prior authorization; 5 do not say clearly, so confirm those on the call
- Requirements vary by payer and site of care; every payer maps to the same single indication
- Documentation is the recurring prerequisite: proptosis, a Clinical Activity Score threshold, euthyroid labs, prescription by or with an ophthalmologist or endocrinologist, and confirmation the patient is 18 or older
- Site of care review applies at 9 of 28 payers, steering the infusion toward an office, infusion center or a preferred site of service
- Another product tried first — glucocorticoids — is required at 12 of 28 payers; documentation is the more common gate at the rest
- The course is authorized once: most of the 23 quantity-limit rules cap it at eight infusions, several of them per lifetime, and both reauthorization rules in the corpus say no renewal will be granted
ICD-10 codes by indication
One FDA-indicated diagnosis, mapped to a single dxKey across the payer corpus.
| Indication | ICD-10 | Payers matching this dxKey |
|---|---|---|
| Thyroid eye disease | The H05.24 exophthalmos family (H05.241–H05.249 by eye) | 28 of 28 |
Prior authorization and prerequisites
The gate applies at 22 of 28 commercial payers in the corpus. Rule mix across the 225-rule corpus: clinical prerequisite 102, covered indication 30, prior authorization 23, quantity limit 23, dosing 19, contraindication/exclusion 11, site of care 10, not covered 3, reauthorization 2, step external 1, continuation of therapy 1.
Glucocorticoids first is required at 12 of 28 payers: BCBS Florida, "had an inadequate response to, had intolerable adverse effects with, or has a contraindication to at least a 6-week treatment course of high-dose IV glucocorticoids"; UHC, "History of intolerance, failure, or contraindication to oral or intravenous glucocorticoids (e.g., prednisone, methylprednisolone)"; Regence, "Treatment with an adequate course of intravenous glucocorticoids (IVGC) has been ineffective after at least 6 weeks, not tolerated, or is contraindicated."
Documentation drives most approvals: Anthem requires "Proptosis ≥ 3 mm above normal values for race and sex"; BCBS Florida requires "active TED as confirmed by a baseline Clinical Activity Score (CAS) of 3 or greater (on the 7-item scale) in the more severely affected eye"; BCBS Minnesota sets the threshold at "Clinical Activity Score (CAS) ≥ 4"; BCBS Michigan requires "Euthyroid function with free triiodothyronine (T3) and thyroxine (T4) within the normal limits for the range of the laboratory"; Aetna requires the prescriber be "an ophthalmologist or endocrinologist" and that the "Member is 18 years of age or older." BCBS South Carolina also requires an attestation that the patient is "not pregnant and been informed that appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months following the last dose of Teprotumumab-trbw," and BCBS Michigan requires a "Physician attestation a discussion has been had with the member to stop smoking if they are a current smoker."
Quantity limits (23 rules): BCBS FEP, "8 intravenous infusions (weight-based)"; BCBS Minnesota and Capital Blue, "150 billable units initially followed by 250 billable units every 3 weeks for 7 additional doses"; Anthem, "Subsequent doses: 20mg/kg every 3 weeks for seven infusions."
Contraindication and exclusion rules (11) recur around repeat courses and prior local treatment: BCBS Tennessee and HMSA, "Coverage will not be provided for repeat series of Tepezza infusions"; BCBS Louisiana, "Patient has NOT had prior surgical treatment or orbital irradiation for Thyroid Eye Disease and is NOT planning on surgical treatment or orbital irradiation for Thyroid Eye Disease during treatment with Tepezza"; Regence, "No prior surgical treatment for thyroid eye disease." BCBS South Carolina also excludes a patient with a recent decrease in best-corrected visual acuity from optic neuropathy, and Regence excludes cosmetic use without proptosis causing a significant medical complication.
Reauthorization: Capital Blue's rule reads, "Renewal: Prior authorization validity may NOT be renewed.*" BCBS Michigan's is the same in substance — neither of the corpus's two reauthorization rules permits a renewal.
Site of care / POS
Payer site-of-care UM decides the infusion setting: office (POS 11), AIC (POS 49), or hospital outpatient (POS 22 on-campus, 19 off-campus).
Nine payers place teprotumumab-trbw under site-of-care review: Aetna, "Site of Care Utilization Management Policy applies for teprotumumab-trbw (Tepezza)."; BCBS Florida, additional requirements may apply "If teprotumumab (Tepezza) is administered in a hospital-affiliated outpatient setting"; Premera, "Tepezza (teprotumumab-trbw) is subject to review for site of service administration."; Blue Shield of California requires administration "at a preferred site of service."
| Setting | POS | Claim form | Electronic | Typical use |
|---|---|---|---|---|
| Physician office / infusion suite | 11 | CMS-1500 | 837P | Most maintenance doses |
| Ambulatory infusion center (AIC) | 49 | CMS-1500 | 837P | Maintenance post site-of-care steering |
| On-campus hospital outpatient | 22 | UB-04 / CMS-1450 | 837I | First dose, reaction history |
| Off-campus hospital outpatient | 19 | UB-04 / CMS-1450 | 837I | First dose at off-campus HOPD |
| Patient home | 12 | CMS-1500 | 837P | Home infusion permitted by some payers (verify) |
Check the patient's actual policy: See Tepezza coverage by payer →
Current Tepezza pricing
Medicare ASP+6%: $381.627 / 10 mg · $61,060.32 / 1,600 mg. Sequestration reduces Medicare's 80% share by 2% (effective ASP+4.3% overall). Commercial plans pay a contracted rate that differs by payer and state.
7 infusions of 20 mg/kg per course, after the 10 mg/kg first infusion (20 mg/kg IV every 3 weeks for an 80 kg adult, seven times after the 10 mg/kg first infusion; a course is eight infusions and the label describes one course) at $76,458.67 per infusion — drug (including the 40-unit JW line) plus 96413 administration — total $535,210.69 before the sequester. That total covers the seven 20 mg/kg infusions only. The 10 mg/kg first infusion adds a further $38,162.70 in drug (two 500 mg vials, 80 units administered plus 20 units JW) before its own administration charge, completing the eight-infusion course over about 21 weeks.
Other weights at the 20 mg/kg maintenance dose, drug line only: a 70 kg patient's 1,400 mg dose (three 500 mg vials, 100 mg = 10 units JW) prices at $53,427.78 administered plus $3,816.27 JW; a 100 kg patient's 2,000 mg dose draws four 500 mg vials exactly, with nothing discarded, pricing at $76,325.40 with no JW line (JZ instead).
| Basis | Rate / unit (10 mg) | 1,600 mg total |
|---|---|---|
| Medicare ASP+6% (Q4 2026) | $381.627 | $61,060.32 |
| Aetna commercial median (37 of 37 payer files carry a rate) | $383.89 | $61,422.40 |
Look up commercial reimbursement →
Patient cost
The patient's actual responsibility depends on: payer allowed rate · benefits · − assistance · = patient responsibility.
Calculate a Tepezza patient estimate →
Copay & financial assistance
Commercial: the Amgen Commercial Co-Pay Program (via Amgen By Your Side) for Tepezza Program (Amgen By Your Side) is unusual among manufacturer cards: eligible commercially insured patients pay $0 for both the drug and the infusion administration, with the annual maximum available by calling Amgen By Your Side at 833-469-8331; office-visit fees are not covered. Uninsured: Amgen runs no free-drug program for Tepezza; it refers uninsured patients to independent foundations (checked September 27, 2026). The Assistance Fund's Thyroid Eye Disease fund has no stated maximum; Good Days' Thyroid Eye Disease fund keeps no waitlist when it is not enrolling, and TotalAssist's Thyroid Eye Disease fund is also on file; check each fund's current status on the funds list.
Common Tepezza denials & fixes
| Denial reason | Common cause | Fix |
|---|---|---|
| Admin code family mismatch | 96365 billed at a payer expecting the site's 96413 complex-biologic family, or the reverse | Confirm which family that payer's policy places teprotumumab-trbw in before billing; add 96415 (or 96366) only past 90 minutes. |
| JW line missing, or JW billed on a JZ draw | Discarded drug not reported separately, or a no-waste draw mistakenly carries JW | Report discarded mg on a separate JW line only when the draw exceeds the dose; use JZ otherwise. |
| Units exceed the 500-unit MUE | Dose computed at 20 mg/kg for a patient over 250 kg (5,000 mg), triggering the J3241 daily MUE | Confirm the ordered dose against the 500-unit MUE before the draw; the label itself sets no ceiling. |
| Glucocorticoids not documented | PA submitted without evidence of an inadequate response, intolerance or contraindication to oral or IV glucocorticoids, required at 12 of 28 payers | Submit the glucocorticoid trial-and-failure record the payer's policy names, or the contraindication/intolerance documentation. |
| Repeat course requested | A second series submitted after a completed 8-infusion course | Confirm lifetime-course status before submitting; BCBS Tennessee and HMSA state coverage "will not be provided for repeat series of Tepezza infusions," and neither of the corpus's two reauthorization rules permits a renewal. |
| CAS or proptosis measurement missing | PA submitted without a baseline Clinical Activity Score or proptosis measurement documented | Submit the CAS (3 or 4 or higher, by payer) or proptosis measurement (3 mm or more above normal) the payer's policy requires. |
| Specialist prescriber not confirmed | PA submitted without confirmation the prescriber is, or is consulting, an ophthalmologist or endocrinologist | Submit the specialist attestation the payer's policy requires. |
| Site of care mismatch | Infusion billed at a setting the payer's site-of-care policy does not allow | Confirm the authorized site before scheduling. |
Frequently asked questions
What is the J code for Tepezza?
Tepezza (teprotumumab-trbw) bills under HCPCS J3241, where 1 billing unit equals 10 mg. At the label's 20 mg/kg maintenance dose, an 80 kg adult receives 1,600 mg, reported as 160 units of J3241 on the administered line plus 40 units on a JW line.
Is Tepezza billed with 96413 or 96365?
96413, in the site's catalog complex-biologic infusion family — the label's minimum is 90 minutes for the first two infusions and 60 minutes after that if they were well tolerated, so 96415 (each additional hour) applies only once a drip actually runs past 90 minutes. A payer that places teprotumumab-trbw in the therapeutic-infusion family instead wants 96365, with 96366 past 90 minutes.
How many units of Tepezza does an 80 kg patient need?
At the 20 mg/kg maintenance dose, an 80 kg adult receives 1,600 mg, billed as 160 units of J3241 (1 unit = 10 mg). The draw pulls four 500 mg vials (2,000 mg), so 400 mg is discarded and reported as 40 units on a separate JW line. The 10 mg/kg first infusion for the same patient is 800 mg = 80 units, drawn from two vials with 200 mg = 20 units JW.
What is the dosing for teprotumumab-trbw by indication?
Tepezza is one course: 10 mg/kg for the first infusion, then 20 mg/kg every 3 weeks for seven more, eight infusions in all; the label sets no dose cap and describes no second course:
- Thyroid eye disease = 20 mg/kg every 3 weeks (the course is 7 infusions at 20 mg/kg after the first, eight in all, about 21 weeks; the label describes one course)
How often is Tepezza given?
Every 3 weeks after the first infusion, eight infusions in all over about 21 weeks. The label describes a single course, and the corpus's two reauthorization rules do not permit a renewal — a second course is a medical-policy exception, not a routine reauthorization.
How is Tepezza waste billed?
Discarded drug from the single 500 mg vial goes on a separate J3241 line with modifier JW; a dose with nothing discarded takes JZ instead. The 20 mg/kg maintenance dose for an 80 kg adult draws four vials and discards 400 mg = 40 units (JW); a 100 kg patient's 2,000 mg dose draws four vials exactly, with nothing discarded (JZ).
Does Tepezza require prior authorization?
Yes, at 22 of 28 payers in the teprotumumab-trbw corpus. The recurring gate is documentation — proptosis, a Clinical Activity Score of 3 or 4 or higher, euthyroid labs, prescription by or with an ophthalmologist or endocrinologist, and confirmation the patient is 18 or older — and glucocorticoids tried first, required at 12 of 28 payers.
Can a second course of Tepezza be billed?
The label describes one course of eight infusions, and the corpus treats it as a lifetime maximum. BCBS Tennessee and HMSA state that coverage "will not be provided for repeat series of Tepezza infusions"; BCBS Louisiana considers "more than one series of teprotumumab-trbw (Tepezza) per lifetime to be investigational"; neither of the corpus's two reauthorization rules permits a renewal. A repeat course would need a new prior authorization reviewed as an exception, not a standard renewal.
Does the Tepezza co-pay program pay the infusion fee?
Yes, and unusually completely. The Amgen Commercial Co-Pay Program (via Amgen By Your Side) for Tepezza Program (Amgen By Your Side) lets eligible commercially insured patients pay $0 for both the drug and the infusion administration; office-visit fees are not covered, and the annual maximum is available by calling Amgen By Your Side at 833-469-8331. The program excludes Medicare, Medicaid, TRICARE, VA and other government coverage; Amgen runs no free-drug program for Tepezza; it refers uninsured patients to independent foundations (checked September 27, 2026).
Sources
- FDA label (DailyMed), TEPEZZA (teprotumumab-trbw), revised 07/2026
- CMS, Medicare Part B Drug ASP Pricing File, Q4 2026
- CMS, Physician Fee Schedule Look-Up Tool
- Amgen By Your Side patient support and Amgen Commercial Co-Pay Program (via Amgen By Your Side) for Tepezza Program
- 28 commercial payer policies, current as of Aug 2026
Dataset dates: pricing Q4 2026 · payer policies Oct 2026 · assistance Sep 2026.