Thyroid Eye Disease denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Tepezza infusions beyond a lifetime total of eight infusions.Thyroid eye disease (TED) is a chronic immune-mediated inflammation of the orbit. It is the most common cause of unilateral and bilateral proptosis in adults. About 25 to 50% of Grave disease (GD) cases present with thyroid eye disease (Shah, S., and Patel, B.). In early studies, long-term oral steroids were utilized to reduce active inflammation, however, multiple studies have shown a high rate of recurrence and significant adverse effects from this approach to therapy. Teprotumumab (Tepezza), a fully humanized monoclonal antibody targeted against the IGF-1 receptor, was shown to decrease inflammatory factors in TSH-dependent fibrocytes.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for a Tepezza 10 mg/kg infusion and authorization and coverage for Tepezza 20 mg/kg infusions every 3 weeks for seven (7) additional doses.Findings: Three out of three physician reviewers found that the Tepezza 10 mg/kg infusion at issue and the requested Tepezza 20 mg/kg infusions every 3 weeks for seven (7) additional doses were, and are, likely to be more beneficial than any other available standard treatments for the patient’s medical condition.Thyroid eye disease is an autoimmune disorder that is associated with hyperthyroidism and causes substantial morbidity, including orbital disfigurement, double vision, and visual loss.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Tepezza infusions beyond a lifetime total of eight infusions. The European Group on Graves’ Orbitopathy (EUGOGO) recommends intravenous steroids as first-line treatment of moderate-to-severe thyroid eye disease followed by immunomodulating drugs such as cyclosporine and biologic drugs such as Tepezza. The records provided for review suggest that systemic steroid therapy was largely ineffective for this patient, who still required orbital decompression surgery. The patient has also been treated with Tepezza. The provider has recommended additional treatment with Tepezza beyond the lifetime recommended total of eight infusions.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Tepezza 10 mg for an additional eight doses. On review of the available records, this patient presents with a history of thyroid eye disease. The patient has been treated with eight doses of Tepezza. The patient’s provider has recommended additional treatment with Tepezza. According to one study, Tepezza has been studied in two multicenter, double-masked, placebo-controlled clinical trials demonstrated both effectiveness and a promising safety profile in moderate-to-severe, active thyroid eye disease. Those studies led to the approval by the U.S. Food and Drug Administration (FDA) of Tepezza.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving thyroid eye disease, then check the rights and deadlines that apply to your plan.