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PBS Changes from 1 September 2025
- Simonne Sigston
- Sep 1, 2025
- 5 min read
Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st September 2025.
This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit pbs.gov.au. Relevant information and authority application forms have been updated and can be accessed through the Services Australia website.
Uncontrolled severe asthma
Dupilumab (200 mg/1.14 ml injection, 2 x 1.14 ml syringes; 200 mg/1.14 ml injection, 2 x 1.14 ml pen devices; 300 mg/2 ml injection, 2 x 2 ml syringes; 300 mg/2 ml injection, 2 x 2 ml pen devices) (Dupixent®) is now listed on the PBS for the treatment of uncontrolled severe asthma in patients aged 6 to less than 12 years. Authority applications for initial, grandfather and continuing treatments can be made using the Online PBS Authorities system or in writing.
Chronic severe atopic dermatitis; uncontrolled severe asthma
Dupilumab (200 mg/1.14 ml injection, 2 x 1. 14 ml pen devices; 300 mg/2 ml injection, 2 x 2 ml pen devices) (Dupixent®) is now listed on the PBS for the treatment of chronic severe atopic dermatitis and uncontrolled severe asthma. Authority applications for initial and continuing treatments for chronic severe atopic dermatitis can be made either in real-time using the Online PBS Authorities system or by telephone. Authority applications for initial and continuing treatments for uncontrolled severe asthma can be made using the Online PBS Authorities system or in writing.
Cystic fibrosis
lvacaftor (13.4 mg granules, 56 sachets) (Kalydeco®) is now listed on the PBS for the treatment of cystic fibrosis in patients aged 1 month or older. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or in writing.
Fibrodysplasia ossificans progressiva (FOP)
Palovarotene (1 mg capsule; 1.5 mg capsule; 2.5 mg capsule; 5 mg capsule) (Sohonos®) is now listed on the PBS for the treatment of FOP. Authority applications for chronic treatment of FOP can be made using the Online PBS Authorities system or in writing. Prescriptions for flare-up (acute) treatment are Authority required {STREAMLINED).
Severe psoriatic arthritis; ankylosing spondylitis; severe chronic plaque psoriasis; moderate to severe hidradenitis suppurativa
Secukinumab (300 mg/2 ml injection, 2 ml pen device) (Cosentyx®) is now listed on the PBS for the treatment of severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis and moderate to severe hidradenitis suppurativa.
Polycythemia vera
Ruxolitinib (5 mg tablet; 10 mg tablet; 15 mg tablet; 20 mg tablet) (Jakavi®) is now listed on the PBS for the treatment of polycythemia vera. Authority applications for initial treatment can be made either in real-time using the Online PBS Authorities system or in writing. Applications for balance of initial treatment and continuing treatment can be made either in real-time using the Online PBS Authorities system or by telephone
Neuromyelitis optica spectrum disorder (NMOSD)
Ravulizumab (300 mg/3 ml injection, 3 ml vial; 1.1 g/11 ml injection, 11 ml vial) (Ultomiris®) has had a change in the restrictions for the treatment of NMOSD. Authority applications for initial and grandfather treatments can be made using the Online PBS Authorities system or in writing. Applications for continuing treatment can be made either in real-time using the Online PBS Authorities system or by telephone.
Severe chronic plaque psoriasis - paediatric patient
Adalimumab (20 mg/0.2 ml injection, 0.2 ml syringe; 20 mg/0.4 ml injection, 0.4 ml syringe; 40 mg/0.4 ml injection, 0.4 ml syringe; 40 mg/0.4 ml injection, 0.4 ml pen device; 40 mg/0.8 ml injection, 0.8 ml syringe; 40 mg/0.8 ml injection, 0.8 ml pen device) (multiple brands) is now listed for the treatment of severe chronic plaque psoriasis in patients under 18 years of age.
Authority applications for initial, change or recommencement of treatment can be made using the Online PBS Authorities system or in writing. Applications for continuing treatment can be made either in real-time using the Online PBS Authorities system or in writing.
Severe Crohn's disease - paediatric patients
Adalimumab (20 mg/0.2 ml injection, 0.2 ml syringe; 20 mg/0.4 ml injection, 0.4 ml syringe; 40 mg/0.4 ml injection, 0.4 ml syringe; 40 mg/0.4 ml injection, 0.4 ml pen device; 40 mg/0.8 ml injection, 0.8 ml syringe; 40 mg/0.8 ml injection, 0.8 ml pen device; 80 mg/0.8 ml injection, 0.8 ml syringe; 80 mg/0.8 ml injection, 0.8 ml pen device) (multiple brands) has had a change in the restrictions for the treatment of severe Crohn's disease in patients aged 6 to 17 years inclusive.
Authority applications for initial, change or recommencement of treatment, and continuing treatment can be made either in real-time using the Online PBS Authorities system or in writing.
Moderate to severe ulcerative colitis - paediatric patient
Adalimumab (20 mg/0.2 ml injection, 0.2 ml syringe; 20 mg/0.4 ml injection, 0.4 ml syringe; 40 mg/0.4 ml injection, 0.4 ml syringe; 40 mg/0.4 ml injection, 0.4 ml pen device; 40 mg/0.8 ml injection, 0.8 ml syringe; 40 mg/0.8 ml injection, 0.8 ml pen device; 80 mg/0.8 ml injection, 0.8 ml syringe; 80 mg/0.8 ml injection, 0.8 ml pen device) (multiple brands) has had a change in the restrictions for the treatment of moderate to severe ulcerative colitis in patients aged 6 years of age or older. Authority applications for initial, change or recommencement of treatment can be made using the Online PBS Authorities system or in writing. Applications for continuing
treatment can be made either in real-time using the Online PBS Authorities system or by telephone.
Giant cell tumour of bone; bone metastases
Denosumab (120 mg/ml injection, 1 ml syringe) (Xgeva®) is now listed on the PBS for the treatment of giant cell tumour of bone and bone metastases. Prescriptions for treatment are Authority required (STREAMLINED).
Attention deficit hyperactivity disorder
Methylphenidate hydrochloride (10 mg, 20 mg, 30 mg, 60 mg modified release capsules) (Methylphenidate Orifarm 10 mg (Sweden)®; Methylphenidate Orifarm 20 mg (Sweden)®; Methylphenidate Orifarm 30 mg (Sweden)®; Methylphenidate Orifarm 60 mg (Denmark)®) for the treatment of attention deficit hyperactivity disorder is now listed on the PBS for the current supply shortage under Section 19A. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.
Chronic hepatitis B and chronic hepatitis C
Peginterferon alfa-2a (135 microgram/0.5 ml injection, 4 x 0.5 ml syringes; 180 microgram/0.5 ml injection, 4 x 0.5 ml syringes) (Pegasys (Ireland)®) for the treatment of chronic hepatitis B and chronic hepatitis C is now listed on the PBS for the current supply shortage under Section 19A. Peginterferon alfa-2a is listed as an unrestricted benefit.
Hypertension
Prazosin (2 mg capsule) (Prazosin Hydrochloride Capsules, USP 2 mg (Novitium Pharma, USA)®) for the treatment of hypertension is now listed on the PBS for the current supply shortage under Section 19A. Prazosin is listed as a restricted benefit.
1 September 2025 delisted PBS listings
Hereditary transthyretin amyloidosis
Patisiran (10 mg/5 ml injection, 5 ml vial) (Onpattro®) no longer has a listing for Grandfather arrangements.
Stage IV renal cell carcinoma
Cabozantinib (20 mg tablet; 40 mg tablet; 60 mg tablet) (Cabometyx®) no longer has a listing for Grandfather arrangements.
For more information about the Online PBS Authorities system, visit www.servicesaustralia.gov.au/hppbsauthorities.
Services Australia has a broad range of educational resources on the Health Professional Education Resources website. This includes simulations, a podcast and an infographic on the Online PBS Authorities system. Visit https://hpe.servicesaustralia.gov.au/pharmaceutical-benefits-scheme.html.
Visit servicesaustralia.gov.au/hpwrittenauthoritydrugs on the Services Australia website to find the most up-to-date authority application form for each drug, program or condition.
For more information, go to servicesaustralia.gov.au/hpos. To learn more about these updates, please contact Services Australia directly.
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