Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Thyroid Eye Disease.
Treatment: Tepezza.

The insurer denied coverage for Tepezza.  The denial is upheld.

This is a patient with a history of thyroid eye disease. At her office visit, it was noted that the patient had increased pain, tearing, and swelling in both eyes. She has pressure to the left eye and diplopia has returned. She was using drops and ointment with no relief. Her doctor recommended treatment with Tepezza.

This patient, according to clinical activity score, has orbital pain, swelling of the eyelid, erythema in the eye. Chemosis, conjunctival redness consistent with thyroid eye disease. The patient has had a course of Tepezza in the past with much improvement. Years later, the provider would like to try a second course. No other elements of the ophthalmic examination including vision, pressures, or slit-lamp examinations are included in the documentation.

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient. There are no multicenter large scale comparative cohort trials with randomization assessing the long-term safety and efficacy of a second course of Tepezza in the setting of thyroid eye disease. Most of the literature support that is present is for the first course of use of Tepezza.

Medication was denied, as the plan indicated there is no coverage for unproven treatments. The plan covers proven treatments that are recognized is safe and effective for the diagnosis based on clinical evidence published in peer reviewed medical literature. Additionally, the treatment should be generally accepted as part of standard of medical care in the community and not solely for the convenience of the covered person, not the covered persons family or the provider. The request does not meet the medical necessity criteria in the policy. Secondary courses of Tepezza have not been found to be helpful for the medical condition.

Tepezza is proven for the treatment of thyroid eye disease. It is medically necessary when all of the following criteria are met: Diagnosis of Graves' disease associated with active thyroid eye disease, presence of moderately to severely active thyroid eye disease associated with at least one of the following: lid retraction of greater than or equal to 2 mm (millimeter), moderate or severe soft tissue involvement, exophthalmos of greater than or equal to 3 mm above normal for race and gender, and diplopia and one of the following: Patient must be euthyroid with thyroid function under control, or mild hypothyroidism or hyperthyroidism undergoing treatment to maintain euthyroid status, and Tepezza must be prescribed in consultation with an endocrinologist and will not be used in combination with another biologic immunomodulators, and the dosing will be in accordance with the United States Food and Drug Administration approved labeling with an authorization for a maximum of 8 doses per lifetime.

According to Hodgson, N. M. et al. (2020), "Thyroid associated orbitopathy (TAO) is a common diagnosis encountered by ophthalmologists and oculoplastic surgeons. TAO has a varying clinical presentation that can include upper eyelid retraction, restrictive strabismus, proptosis, exposure keratopathy, and optic neuropathy. In this review, we discuss the most recent literature on and the current understanding of the pathophysiology of TAO. We also review available and potential future treatment options for the management of TAO."