Tepezza

Drug - Tepezza (teprotumumab-trbw) [Horizon Therapeutics USA, Inc.]

September 2020

Therapeutic Area - Thyroid Eye Disease

Approval criteria

Patient is ≥ 18 years of age AND
Must be prescribed by, or in consultation with, a specialist in ophthalmology, endocrinology, oculoplastic surgery or neuro-ophthalmology AND
Patient has not had a decrease in best corrected visual acuity (BVCA) due to optic neuropathy within the previous 6 months (e.g., decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement) AND
Patient is euthyroid (Note: mild hypo- or hyperthyroidism is permitted, which is defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels < 50% above or below the normal limits [every effort should be made to correct the mild hypo- or hyperthyroidism promptly]) AND
Patient does not have corneal decompensation that is unresponsive to medical management AND
Patient does not have poorly controlled diabetes AND
Must be used as single agent therapy AND
Patient has a clinical diagnosis of TED that is related to Graves’ Disease (e.g., Graves’ orbitopathy) AND
Patient has a baseline clinical activity score (CAS) of ≥ 4 AND
Patient has active phase TED that is non-sight threatening but has a significant impact on daily living (e.g., lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and/or inconstant or constant diplopia) AND
Patient’s onset of TED symptoms occurred within the previous 9 months AND
Patient had an inadequate response, or there is a contraindication or intolerance, to high-dose intravenous glucocorticoids
Approval is for 6 months (maximum, 8 infusions) and cannot be renewed

Quantity limits

Initial dose: 10mg/kg/dose
Additional 7 doses: 20mg/kg/dose
Patient’s weight (in kg) must be provided at time of request

Billing for Tepezza

Tepezza must be billed as a medical claim.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411