TEPROTUMUMAB-TRBW INJ,LYPHL
Clinical Criteria Summary
Indications & Disease Severity
- Diagnosis of Graves’ disease
- Active thyroid eye disease with Clinical Activity Score (CAS) of 4 or greater
- Moderate-severe thyroid eye disease with at least one of the following: lid retraction ≥ 2mm, moderate or severe soft-tissue involvement, proptosis ≥3 mm above normal for race and sex, periodic or constant diplopia
Exclusion Criteria
- Urgent surgical ophthalmological intervention needed (e.g., compressive optic neuropathy, severe exposure keratopathy)
- Pregnant or planning to become pregnant during treatment or for 6 months following treatment
Contraception & Pregnancy Management
- Patients who can become pregnant: Implement effective contraception prior to initiation and continue for at least 6 months after stopping treatment; discontinue if pregnancy occurs during therapy
- Patients with partners who can become pregnant: Use a barrier contraceptive during treatment and for 6 months after treatment (unless surgically sterile)
Monitoring & Clinical Management
- Monitor patients with diabetes or pre-diabetes for hyperglycemia during the course of treatment
- Correct hypo- or hyperthyroidism in patients who are not euthyroid
- Address smoking cessation due to increased risk of disease progression and severity
- Insufficient data to support retreatment after a full 8-infusion course; subsequent courses require local case-by-case adjudication
Provider Requirements
- Restricted to VA/VA Community Care provider who is a neuro-ophthalmologist or ophthalmologist with oculoplastic training (generally co-managed with an endocrinologist)