Is teprotumumab-trbw (Tepezza) 10mg medically necessary for a 47-year-old female patient with thyrotoxicosis and diffuse goiter without thyrotoxic crisis, who has previously received 7 infusions of Tepezza (teppezumab-trbw) and has a history of Graves' disease?

From the Guidelines

The requested CPT J3241 (injection of teprotumumab-trbw 10 mg) is not medically necessary for this patient with thyrotoxicosis with diffuse goiter without thyrotoxic crisis. The patient has already received 7 visits of Tepezza (teprotumumab-trbw) under a previous authorization (reference number 7932442), and according to the CPB guidelines mentioned, repeat series of Tepezza infusions are not considered eligible 1. Teprotumumab-trbw (Tepezza) is FDA-approved for the treatment of Thyroid Eye Disease (Graves' ophthalmopathy), and while this patient does have Graves' disease with evidence of proptosis on MRI, the standard treatment course is typically limited to one complete series of infusions (8 total infusions over approximately 24 weeks) 1.

Key Points to Consider

• The patient has already completed 7 visits of Tepezza, which is close to the standard treatment course of 8 infusions.
• There is no clear evidence supporting the medical necessity of additional infusions beyond the initial treatment course.
• The CPB guidelines do not consider repeat series of Tepezza infusions eligible.
• Teprotumumab-trbw has been shown to reduce proptosis and clinical activity score of disease in many patients with active TED, but it is not universally available and is associated with adverse reactions 1.

Clinical Decision

Based on the information provided and the guidelines mentioned, the request for further Tepezza administration does not meet medical necessity criteria. The patient's treatment plan should be re-evaluated to determine the best course of action, considering the potential benefits and risks of additional Tepezza infusions. The clinical documentation does not provide sufficient justification for why additional infusions beyond the standard course would be necessary, and retreatment protocols are not well-established in clinical practice 1.

From the FDA Drug Label

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. The recommended dose of TEPEZZA is an intravenous infusion of 10 mg/kg for the initial dose followed by an intravenous infusion of 20 mg/kg every three weeks for 7 additional infusions.

The patient has Thyroid Eye Disease (specifically, Thyrotoxicosis with diffuse goiter without thyrotoxic crisis) and has already received 7 infusions of Tepezza. The recommended treatment duration is 8 infusions, and the patient has already completed this course of treatment. There is no direct information in the provided drug labels that supports the medical necessity of additional Tepezza infusions beyond the initial 8-infusion course. Therefore, based on the provided information, the request for additional Tepezza infusions cannot be considered medically necessary 2.

From the Research

Patient Information

• The patient is a 47-year-old female with Graves' disease and thyroid eye disease.
• She has been treated with Tepezza (teprotumumab-trbw) and has tolerated the infusion.
• The patient's diagnosis is thyrotoxicosis with diffuse goiter without thyrotoxic crisis.

Treatment and Medication

• The patient is currently on Tepezza, with a plan to continue treatment at a dose of 10mg/kg at week 0, followed by 20mg/kg every 3 weeks.
• The requested CPT code is J3241, which corresponds to the injection of teprotumumab-trbw.
• The patient has already received 7 visits with documentation, and the provider is requesting further treatment.

Medical Necessity

• According to the study by 3, teprotumumab has been shown to be effective in reducing proptosis and improving diplopia in patients with active thyroid eye disease.
• The study by 4 highlights the importance of monitoring for hyperglycemia in patients treated with teprotumumab, as it can be a significant adverse event.
• The systematic review and meta-analysis by 5 compares the efficacy and safety of rituximab, tocilizumab, and teprotumumab in treating Graves' orbitopathy, and suggests that teprotumumab may be a viable treatment option.
• The study by 6 provides evidence on the long-term safety of teprotumumab, suggesting that it may have fewer adverse outcomes than glucocorticoids in patients with thyroid eye disease.
• The article by 7 discusses the potential role of teprotumumab as a disease-modifying treatment for Graves' orbitopathy, and highlights the need for further studies to confirm its efficacy and optimal position in the treatment pathway.

Determination and Rationale

• Based on the evidence provided, it appears that the requested CPT code J3241 is medically necessary for the patient's treatment.
• The patient's diagnosis and treatment plan are consistent with the indications for teprotumumab, and the provider has documented the patient's response to treatment.
• However, it is essential to continue monitoring the patient for potential adverse events, such as hyperglycemia, and to adjust the treatment plan as needed.