Management of Thyroid Eye Disease: A Consensus Statement by the American Thyroid Association and the European Thyroid Association

Abstract

Thyroid eye disease (TED) remains challenging for clinicians to evaluate and manage. Novel therapies have recently emerged, and their specific roles are still being determined. Most patients with TED develop eye manifestations while being treated for hyperthyroidism and under the care of endocrinologists. Endocrinologists, therefore, have a key role in diagnosis, initial management, and selection of patients who require referral to specialist care. Given that the need for guidance to endocrinologists charged with meeting the needs of patients with TED transcends national borders, and to maximize an international exchange of knowledge and practices, the American Thyroid Association and European Thyroid Association joined forces to produce this consensus statement.

Teprotumumab in thyroid eye disease: wonder drug or great divider?

“…TEP was first line preference by 37% of American endocrinologists compared to only 2% by European endocrinologists (40). This confirmed the impression shared by the leadership of both professional organisations that there was a need for joint guidance to their members, which ultimately led to publication of the Joint American Thyroid Association and European Thyroid Association Consensus Statement on TED at the end of 2022 (9).…”

“…The price of TEP for a course of treatment is approximately $360,000 for a 75 kg patient, more than 5,000 times the cost of a course of intravenous glucocorticoids (9). If the 37% of patients who relapse (https://www.fda.gov/media/133429/download, accessed 29.3.23) are re-treated with TEP the cost per patient would double, and in some patients (yet unclear what percentage) additional treatments including rehabilitative surgery may be required resulting in further costs (which are expected to be less compared to glucocorticoid-treated patients, as fewer surgical decompressions are expected after TEP treatment).…”

“…The cost of TEP treatment is unprecedented in the field of TED considering that the drug cost of the standard treatment (a 12-week course of intravenous methylprednisolone) is €70 in Europe ($172.08 in the USA) and the cost of a course of treatment with rituximab (another biologic used in TED) (37) is between €338 ($990) and €4,308 ($19,636), depending on whether it is prescribed in Europe or USA and the dose regimen (9). Financial assistance is available for patients in the USA without insurance, but it is unclear what proportion of the US population who are eligible for TEP on clinical grounds, have access to this treatment.…”

“…The recently published Joint American and European Thyroid Association Consensus Statement on TED recognises the importance of the above and states: "there is a case for all stakeholders, including professional organizations, insurers, health care providers, patients and their advocates, and drug manufacturers, to Version_29. 3.23 engage in discussions on how costly treatments for TED can be made more accessible" (9).…”

“…TED can result in altered appearance and other significant symptoms, impacts negatively on patients' quality of life (QOL) (3,4), is associated with poor socioeconomic outcomes (3,5,6), and excess mortality (7,8). The traditional standard of care for active, moderate to severe TED is systemic glucocorticoids, which however has limited efficacy with overall response rates of 23-53% (9), little impact on proptosis, and relapse rate of about 20%, although disease inactivation is reported in up to 80% of cases (10),…”