PBAC's latest decision on Teprotumumab: Recommended with restriction (2025). Considered for Treatment of active, moderate-to-severe thyroid eye disease (TED).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Adults aged 18 years or older with active, moderate-to-severe thyroid eye disease, defined as clinical activity score (CAS) ≥3 for the most severely affected eye and two or more of: proptosis ≥3 mm above normal, lid retraction ≥2 mm, moderate-to-severe soft-tissue involvement, or inconstant/constant diplopia.
Therapy area
Ophthalmology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Proptosis and diplopia
Key trials
OPTIC, OPTIC-X
Comparator
IV methylprednisolone (IVMP) with or without mycophenolate mofetil (MMF) in first-line setting; tocilizumab in second-line setting
Economic model
CUA
ICER note
ICER values appear to be redacted from the public summary document.