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DrugTepezza (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.


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

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