Tepezza (teprotumumab-trbw) — J3241

About Tepezza (teprotumumab-trbw) FDA label + Amgen 2026

Fully human IgG1 monoclonal antibody that binds IGF-1R (insulin-like growth factor 1 receptor) on orbital fibroblasts, blocking the IGF-1R/TSHR signaling complex implicated in TED pathogenesis.

Tepezza (generic name: teprotumumab-trbw) is a fully human IgG1 monoclonal antibody manufactured by Amgen — acquired from Horizon Therapeutics in October 2023. It is the first and only FDA-approved treatment for Thyroid Eye Disease (TED), also called Graves' ophthalmopathy or thyroid orbitopathy. FDA approval was granted on January 21, 2020 under priority review and orphan drug designation, based on the OPTIC trial (NEJM 2020).

Mechanistically, teprotumumab binds the insulin-like growth factor 1 receptor (IGF-1R) on orbital fibroblasts and disrupts the IGF-1R / thyroid stimulating hormone receptor (TSHR) signaling complex that drives the inflammatory and adipogenic changes characteristic of TED. By blocking IGF-1R, teprotumumab reduces orbital tissue expansion (proptosis), inflammation, and diplopia — the cardinal TED symptoms. The OPTIC trial demonstrated significant reductions in proptosis (≥ 2 mm) and CAS at week 24 vs placebo, with effects observed in both active and chronic disease in subsequent analyses.

Tepezza is administered as a fixed 8-infusion course over 21 weeks (first infusion 10 mg/kg, then 20 mg/kg every 3 weeks for 7 additional infusions). It is not a chronic maintenance therapy. Boxed- warning-level safety signals include infusion reactions, exacerbation of pre-existing inflammatory bowel disease, hyperglycemia (particularly in patients with diabetes or pre-diabetes), and hearing impairment including reports of permanent sensorineural hearing loss. Pre-treatment audiogram and serial hearing monitoring are required by AAO 2024 guidance and most payer policies. Following Amgen's acquisition of Horizon in late 2023, patient support transitioned from the Horizon STAR Program to Amgen Assist 360.

Dosing & full course FDA label + OPTIC trial verified May 2026

8 IV infusions over 21 weeks. Weight-based mg/kg dosing — partial-vial waste is the norm given the single 500 mg vial SKU.

Course schedule

Worked example — 70 kg patient, full course

Worked example — 90 kg patient, single maintenance infusion

Preparation & administration

• Reconstitution: Add 10 mL Sterile Water for Injection to each 500 mg vial → 47.6 mg/mL solution. Gently swirl, do not shake. Discard if particulate or discoloration.
• Dilution: Doses ≤ 1,800 mg → dilute in 100 mL 0.9% NaCl bag; doses > 1,800 mg → 250 mL bag. Final concentration must be ≤ 5 mg/mL.
• Infusion time: First two infusions over 90 minutes; if well-tolerated, infusions 3–8 may be reduced to 60 minutes.
• Premedication: Not routinely required for the first infusion. For patients who experience an infusion reaction, premedicate with antihistamine, antipyretic, and/or corticosteroid for subsequent infusions and slow infusion rate.

NDC reference FDA NDC Directory + Amgen billing guide verified May 2026

Administration codes CPT verified May 2026

Tepezza is NOT HCPCS chemotherapy-classified. Use therapeutic IV infusion codes (96365 / 96366), not chemo admin codes (96413 / 96415).

Modifiers CMS verified May 2026

JW — the default for Tepezza

JW reports the discarded portion of a single-dose vial. Because Tepezza dosing is weight-based (10 mg/kg first infusion, 20 mg/kg subsequent) and the only vial size is 500 mg, partial-vial waste occurs on virtually every infusion unless the calculated mg dose lands on an exact 500 mg multiple (i.e., patient weight precisely 25 / 50 / 75 / 100 kg at 20 mg/kg). JW applies to most J3241 claims. Bill administered units on the primary line and wasted units on a separate line with JW. Both lines pay at ASP+6%.

Worked JW example — 70 kg patient, 20 mg/kg maintenance dose

JZ — only when no waste

JZ applies when the calculated dose equals an exact multiple of 500 mg. With the single 500 mg vial SKU, this only occurs at specific weight bands: e.g., 25 kg at 20 mg/kg = 500 mg (1 vial, JZ), 50 kg at 20 mg/kg = 1,000 mg (2 vials, JZ), 75 kg at 20 mg/kg = 1,500 mg (3 vials, JZ), 100 kg at 20 mg/kg = 2,000 mg (4 vials, JZ). One of JZ or JW must be on every J3241 claim per CMS's July 2023 single-dose container policy.

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 (e.g., mid-course ophthalmologic reassessment, new-symptom workup). Routine pre-infusion clinical assessment is bundled into the admin code.

340B modifiers (JG, TB)

For 340B-acquired Tepezza, follow your MAC's current 340B modifier policy. Hospital outpatient departments billing under OPPS are subject to specific 340B reporting requirements; office-based 340B reporting varies by MAC.

ICD-10-CM by indication FY2026 verified May 2026

TED is a manifestation of underlying thyroid dysfunction. Most payers expect at least one H05.2x or H05.81 code AND an E05.x thyrotoxicosis code in the diagnosis pointer set.

Site of care & place of service Verified May 2026

Tepezza is typically administered in hospital outpatient infusion centers, freestanding ambulatory infusion suites, and (less commonly) endocrinology/rheumatology office-based infusion suites and ophthalmology offices. Because TED patients are not typically managed primarily by oncology infusion centers, the infusion is often scheduled into rheum/endo/specialty infusion settings rather than oncology-only suites. Major commercial payers run site-of-care UM and often steer Tepezza out of HOPD into office or freestanding AIC settings to control cost.

Claim form field mapping Amgen Assist 360 billing guide 2026

From the Amgen Assist 360 Tepezza billing & coding reference (formerly Horizon By Your Side).

Payer policy snapshot Reviewed May 2026

All major payers require PA. Active TED with CAS ≥ 3, baseline audiogram, and IBD/hyperglycemia screening are the recurring gates.

Step therapy

Step therapy on Tepezza varies by payer. Some plans require prior trial of high-dose IV methylprednisolone (the EUGOGO/ATA standard prior to teprotumumab approval) for moderate-to-severe active TED, with documented inadequate response, intolerance, or contraindication, before approving teprotumumab. Other plans accept teprotumumab as first-line for moderate-to-severe active disease. Verify each payer's specific step ladder before submitting the PA packet.

Course approval

Most payers approve the full 8-infusion course up front based on the initial PA packet. Re-treatment (second course) typically requires fresh PA with documented relapse: new CAS ≥ 3, increased proptosis or diplopia from post-course baseline, and an interval of ≥ 6 months from end of the first course. Re-treatment coverage is not guaranteed and may require peer-to-peer review.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Coverage

No NCD specific to teprotumumab. Coverage falls under MAC LCDs for medically necessary biologics targeting orphan indications. All MACs cover J3241 for FDA-labeled active TED with appropriate ophthalmology evaluation, CAS documentation, and FDA-label safety monitoring. Medicare Advantage plans impose PA layered over FFS rules.

Code history

• J3241 — permanent code, "Injection, teprotumumab-trbw, 10 mg"; effective January 1, 2021 (HCPCS 2021 annual update) following the January 2020 FDA approval. Prior to permanent assignment, teprotumumab was billed under unclassified J3590 with NDC documentation.

Patient assistance — Amgen Assist 360 Amgen verified May 2026

• Amgen Assist 360 for Tepezza: 1-800-77-AMGEN (1-800-772-6436) / amgenassist360.com — centralized Amgen access program for all Amgen specialty products. Transitioned from the Horizon STAR Program following Amgen's October 2023 acquisition of Horizon Therapeutics. Provides benefits investigation, prior authorization assistance, appeal support, copay assistance enrollment, and patient case management.
• Tepezza Copay Card: commercial copay support for eligible commercially-insured patients (typically as low as $5 per infusion with annual cap); excludes Medicare, Medicaid, TRICARE, VA, and other federal program patients (federal anti-kickback statute).
• Amgen Safety Net Foundation: free product for eligible uninsured / underinsured patients meeting income thresholds; 501(c)(3) foundation administered separately from Amgen commercial.
• Foundations (Medicare patients): PAN Foundation (Thyroid Eye Disease fund when open), HealthWell Foundation, Patient Advocate Foundation Co-Pay Relief — verify open TED-specific funds quarterly (funds open and close throughout the year). TED-fund availability has been intermittent given the orphan nature of the indication.
• Web: tepezza.com · amgenassist360.com

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Tepezza?

Tepezza (teprotumumab-trbw) is billed under HCPCS J3241 — "Injection, teprotumumab-trbw, 10 mg." The unit basis is 1 unit = 10 mg, NOT 1 mg. Convert milligrams to billing units by dividing by 10: a 70 kg patient at 10 mg/kg = 700 mg = 70 units; the same patient at 20 mg/kg = 1,400 mg = 140 units.

What CAS (Clinical Activity Score) is required for Tepezza coverage?

Most commercial payers and Medicare Advantage plans require documentation of active TED with a Clinical Activity Score (CAS) of at least 3 out of 7 on the original CAS (or out of 10 on the modified CAS used in OPTIC). CAS measures inflammatory signs — spontaneous retrobulbar pain, pain on eye movement, eyelid erythema, conjunctival injection, chemosis, caruncular edema, and lid edema. Inactive or burned-out TED (CAS < 3) is typically denied. The CAS documentation must come from an ophthalmologist or oculoplastic surgeon and be dated within the PA window (usually 30–60 days).

What is the Tepezza full course — 8 infusions, total cost?

The FDA-approved course is 8 IV infusions over 21 weeks: first infusion at 10 mg/kg, then 20 mg/kg every 3 weeks for 7 more infusions. For a 70 kg patient: first infusion 700 mg (70 units) + 7 subsequent at 1,400 mg (140 units each) = 1,050 administered units over the full course. At Q2 2026 ASP+6% of $367.908 per 10 mg unit, the administered-drug cost alone is approximately $386,303 before any vial waste. Adding typical JW waste (~30 units first dose, ~10 units per subsequent dose) brings total billed units to ~1,150 and total drug reimbursement to roughly $423,094 over the course.

What hearing-loss monitoring does Tepezza require?

Per FDA label and 2024 AAO guidance, perform a baseline audiogram (pure-tone audiometry and tympanometry) before the first Tepezza infusion. Reassess hearing function during therapy at clinician discretion — most centers re-audiogram at infusion 4 and at end-of-course (after infusion 8), with additional audiograms if the patient reports new tinnitus, autophony, ear fullness, or hearing change. Permanent sensorineural hearing loss has been reported and is a primary safety concern. Payers routinely audit for the baseline audiogram in the PA packet; missing audiogram documentation is a common denial reason.

Is Tepezza approved for pediatric use?

No. The safety and effectiveness of Tepezza have not been established in pediatric patients. There is no FDA-approved pediatric indication. Off-label pediatric use would require institutional/compendium rationale and would likely be non-covered by most payers.

Can a patient receive a second Tepezza course?

Re-treatment data are limited but emerging. A small subset of patients in OPTIC-X (the extension trial) received a second course after disease recurrence or partial response. Some payers will consider a second 8-infusion course only with documented relapse of active TED (renewed CAS ≥ 3, increased proptosis or diplopia from post-course baseline) and an interval of typically ≥ 6 months from end of the first course. Expect detailed clinical justification, fresh audiogram, and step-therapy/ utilization review. Coverage of a second course is not guaranteed and varies by payer.

What is the difference between active and inactive TED for billing?

Active TED is the inflammatory phase — typically the first 6–18 months of disease, characterized by orbital inflammation, congestion, and progressive proptosis/diplopia, with elevated CAS (≥ 3). Inactive (burned-out, fibrotic) TED is the stable phase after the inflammatory drive has resolved, with low CAS (< 3) and stable proptosis. Tepezza is FDA-approved for TED regardless of activity, but the OPTIC trial enrolled patients with active disease (CAS ≥ 4 on the 7-item scale), and most payer policies restrict coverage to active TED. Inactive/fibrotic TED Tepezza claims typically deny; surgical decompression is the standard-of-care for inactive disease.

What admin CPT do I use for Tepezza infusion?

Tepezza is NOT HCPCS chemotherapy-classified. Use CPT 96365 (therapeutic, prophylactic, or diagnostic IV infusion; initial, up to 1 hour) for the first hour and add 96366 (each additional hour) for time beyond 60 minutes. The first Tepezza infusion is administered over approximately 90 minutes; subsequent infusions can be reduced to 60 minutes if the first two are well-tolerated. Bill 96365 × 1 + 96366 × 1 for a 90-minute infusion (or 96365 alone if subsequent infusions land within 60 minutes). Do NOT bill 96413 — chemo admin codes are wrong for teprotumumab.

What ICD-10 codes support Tepezza claims?

Primary indication codes: H05.20–H05.23 (exophthalmos — unspecified, displacement, edema, hemorrhage), H05.81 (extraocular muscle myopathy of orbit / Graves' orbitopathy), and the underlying thyroid disorder (typically E05.00–E05.91 Graves' / thyrotoxicosis family). Most payers expect pairing of an H05.2x or H05.81 code with an E05.x code in the diagnosis pointer set to document TED as the secondary manifestation of thyroid dysfunction. Laterality matters: use the correct H05.811 (right) / H05.812 (left) / H05.813 (bilateral) subcategory when documented.

Source documents

1. FDA — TEPEZZA prescribing information (BLA 761143)
   FDA-approved label; full prescribing information including dosing, warnings, monitoring (hearing, IBD, hyperglycemia, IRR)
2. DailyMed — TEPEZZA (teprotumumab-trbw) lyophilized powder
   Current FDA label, NDC, package insert
3. Tepezza HCP — Amgen prescriber resources (billing & coding, reimbursement)
   Manufacturer billing reference, claim form mapping, NDC and reimbursement information
4. Amgen Assist 360 — patient access program
   Benefits investigation, PA assistance, copay support, appeal support (formerly Horizon STAR Program pre-acquisition)
5. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
6. SEER CanMED — HCPCS J3241 reference
7. OPTIC trial (NEJM 2020) — Douglas et al., Teprotumumab for the Treatment of Active Thyroid Eye Disease
   Pivotal phase 3 trial supporting FDA approval (January 2020); 24-week 8-infusion course at 10 mg/kg then 20 mg/kg q3w
8. OPTIC-X extension trial — teprotumumab re-treatment / long-term follow-up
   Extension data on re-treatment of OPTIC non-responders and durability of response
9. American Academy of Ophthalmology — Thyroid Eye Disease Preferred Practice Pattern
   AAO clinical practice guidance for TED diagnosis, activity scoring, and treatment
10. American Thyroid Association (ATA) — Guidelines for hyperthyroidism and Graves' disease
    ATA guideline framework for Graves' disease management including orbitopathy
11. EUGOGO — European Group on Graves' Orbitopathy guidelines
    European consensus guidelines on TED management, including CAS scoring and treatment algorithms (IV steroids, teprotumumab, surgical decompression)
12. UnitedHealthcare — Teprotumumab (Tepezza) medical drug policy
13. Aetna — Clinical Policy Bulletin 0904 (Teprotumumab)
14. Cigna — Teprotumumab (Tepezza) coverage policy
15. CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)

Refresh cadence

Reviewer

Change log

• May 22, 2026 — SME audit: confirmed BLA 761143 with latest label revision Nov 10, 2025 (DailyMed). Clarified that Tepezza carries no formal Boxed Warning — severe safety profile is captured in label Warnings & Precautions only; updated hero, factcard, and SAFETY ALERTS callout accordingly. Added embryo-fetal toxicity W&P (contraception during therapy + 6 months post). Verified FDA label indication is "Thyroid Eye Disease" with no active/chronic distinction (payer policies may still gate on CAS ≥ 3 — called out separately). ASP data: Q2 2026 ($367.908 / 10 mg unit). Manufacturer source: Amgen Assist 360 (formerly Horizon STAR) 2026.

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, dosing, and safety profile are verified against the current FDA label revision and OPTIC trial publication. We do not paraphrase from billing-software vendor blogs.

Found an error? Email hello@carecostestimate.com.