Tepezza Listed On The PBS

TED is a complex, progressive autoimmune disease characterised by autoantibody-mediated activation of IGF-1R and TSH receptor (TSHR) signalling complexes on retro-orbital fibroblasts.^2,3  

In Australia, an estimated 23,000 individuals live with TED at any given time,⁴ with approximately 430 new cases of moderate-to-severe TED developing annually.⁴ Among Australians already living with autoimmune thyroid disease, around one in four patients are affected by TED.⁴ Untreated or sub-optimally managed active disease can lead to progressive inflammation, tissue expansion, proptosis, diplopia, ocular pain, and potential sight-threatening complications such as dysthyroid optic neuropathy.^2,3 

Beyond physical changes, TED often exerts a heavy psychosocial toll, frequently impacting patients’ mental health, confidence, employment, and social life.^5-8 

“Existing treatment for the inflammatory phase of TED relies on systemic corticosteroids, which reduce acute inflammation. Having PBS access to teprotumumab provides a further option for a targeted therapy towards IGF-1R signalling,” said Associate Professor Jwu Jin Khong, Ophthalmologist at The Royal Victorian Eye and Ear Hospital in Melbourne.  

Clinical Data  

The PBS listing is supported by the Phase 3 OPTIC trial, which evaluated Tepezza (10 mg/kg initial dose, then 20 mg/kg every three weeks for seven additional doses) versus placebo in active moderate-to-severe TED.2  

Observations at Week 24 were:  

• Proptosis response (primary endpoint): 83% of Tepezza patients achieved a ≥2 mm reduction in proptosis versus 10% on placebo (P<0.001; NNT = 1.36).²
• Proptosis reduction: LS mean change from baseline at Week 24 was −3.32 mm with Tepezza vs. −0.53 mm with placebo (P<0.0001).^2,9
• Diplopia improvement: 68% of Tepezza patients with baseline diplopia achieved a ≥1 grade reduction versus 29% on placebo (P=0.001).² 
• Disease inactivation: 59% achieved a Clinical Activity Score (CAS) of 0 or 1 vs 21% on placebo (P<0.001).² 
• Quality of life: Mean change in GO-QOL overall score across trial visits through week 24 was 13.79 points with Tepezza vs 4.43 points with placebo (P<0.001).²

Safety Summary  

In clinical trials, the most commonly reported adverse reactions with Tepezza (occurring in ≥10% of patients) were muscle spasm (27.6%), diarrhoea (14.5%), hearing impairment (13.8%), alopecia (13.2%), hyperglycaemia (13.2%), fatigue (12.5%), nausea (10.5%), headache (10.5%), and menstrual disorders (13.0% of menstruating women).⁹ Tepezza is Pregnancy Category X and contraindicated in pregnancy.⁹ 

Dosing 

Tepezza is administered via intravenous infusion once every three weeks for a total of eight infusions over five to six months.^2,9 It was listed on the PBS from 1 November 2026 as a Section 100 / Authority Required subsidy for eligible adult patients prescribed by an appropriate specialist.¹  

References 

1. Australian Government Department of Health and Aged Care. Schedule of Pharmaceutical Benefits. From 1 November 2026. Available at: pbs.gov.au [accessed Oct 2026].
2. Douglas RS, Kahaly GJ, Smith TJ, et al. Teprotumumab for the treatment of active thyroid eye disease. N Engl J Med. 2020 Jan 23;382(4):341-352. doi: 10.1056/NEJMoa1910434.
3. Wang Y, Patel A, Douglas RS. Thyroid eye disease: how a novel therapy may change the treatment paradigm. her Clin Risk Manag. 2019 Nov 11;15:1305-1318. doi: 10.2147/TCRM.S193018.
4. Centre for Eye Research Australia. Thyroid eye disease. Available at: cera.org.au/conditions/thyroid-eye-disease. [accessed Oct 2026].
5. Park JJ, Sullivan TJ, Perry-Keene DA, et al. Assessing quality of life in Australian patients with Graves’ ophthalmopathy. Br J Ophthalmol. 2004 Jan;88(1):75-8. doi: 10.1136/bjo.88.1.75. 
6. Kahaly GJ, Petrak F, Egle UT, et al. Psychosocial morbidity of Graves’ orbitopathy. Clin Endocrinol (Oxf). 2005 Oct;63(4):395-402. doi: 10.1111/j.1365-2265.2005.02352.x.
7. Terwee CB, Gerding MN, Wiersinga WM, et al. Development of a disease specific quality of life questionnaire for patients with Graves’ ophthalmopathy: the GO-QOL. Br J Ophthalmol. 1998 Jul;82(7):773-9. doi: 10.1136/bjo.82.7.773 .
8. Cockerham KP, Padnick-Silver L, Holt RJ, et al. Quality of life in patients with chronic thyroid eye disease in the United States. Ophthalmol Ther. 2021 Dec;10(4):975-987. doi: 10.1007/s40123-021-00385-8. Epub 2021 Sep 3. Erratum in: Ophthalmol Ther. 2022 Apr;11(2):923. doi: 10.1007/s40123-022-00467-1. 
9. Amgen Australia Pty Ltd. Tepezza (teprotumumab) Australian Product Information. Available at: amgen.com.au/TEPEZZAPI [accessed October 2026].
10. Amgen Australia Pty Ltd. Tepezza (teprotumumab) Australian consumer medicine information. Available at: amgen.com.au/TEPEZZACMI [accessed Oct 2026].