Tepezza™ Approval

Tepezza™ (teprotumumab-trbw) by Horizon Therapeutics was approved by the FDA on January 21, 2020. This is the first FDA-approved drug treatment for thyroid eye disease. The FDA granted this drug priority review, fast track, breakthrough therapy, and orphan drug designation. It is an exciting development for those managing and treating thyroid eye disease patients – Ophthalmologists (particularly Neuro-ophth and Plastics), Endocrinologists, Rheumatologists, and Radiation Oncologists.

Teprotumumab is indicated for the treatment of thyroid eye disease. Clinical trials focused on patients with active, moderate-to-severe orbitopathy. The FDA approval does not differentiate between active or chronic thyroid eye disease, or severity, allowing practitioners flexibility in selecting patients they feel would benefit from the treatment.

Treatment consists of 8 infusions over a 24-week period. For full prescribing information, link here. Unless affiliated with an academic center, most ophthalmology private practices do not have access to an infusion center and will need to find a nearby center to do this because of the special skillset and equipment needed.  The manufacturer may be helpful as well.

At this point, a J code has NOT been assigned to this new drug, so your only option is to use J3590, unclassified biologic, on claims until a more specific code is available.  Use the NDC number of the drug and dosage information in box 19 on your claims, and as mentioned above, be sure to get prior authorization if possible from the payer.  For other codes involving the drug and infusion, please contact us.

www.corcoranccg.com (800) 399-6565