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PBS Changes from 1 August 2025
- Anja Locke
- Aug 1
- 4 min read
Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st August 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.
High-risk neuroblastoma
Eflornithine (192 mg tablet) (lfinwil®) is now listed on the PBS for the treatment of high-risk neuroblastoma. Authority applications for initial treatment can be made either in real-time using the Online PBS Authorities system or in writing. Applications for grandfather and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.
Fabry disease
Migalastat (123 mg capsule) (Galafold®) has had a change to the number of repeats from 5 to 6. Authority applications for initial and grandfather treatments can be made in writing. Applications for continuing treatment can be made either in real-time using the Online PBS Authorities system or by telephone.
Uncontrolled severe asthma; uncontrolled severe allergic asthma; severe chronic spontaneous urticaria
Omalizumab (75 mg/0.5 ml injection, 0.5 ml syringe; 150 mg/ml injection, 1 ml syringe)
(Omlyclo®) is a biosimilar now listed on the PBS for the treatment of uncontrolled severe asthma, uncontrolled severe allergic asthma and severe chronic spontaneous urticaria.
Omalizumab (75 mg/0.5 ml injection, 0.5 ml pen device; 150 mg/ml injection, 1 ml pen device; 300 mg/2 ml injection, 2 ml pen device) (Xolair®) is now listed on the PBS for treatment of uncontrolled severe asthma, uncontrolled severe allergic asthma and severe chronic spontaneous urticaria.
Omalizumab (150 mg/ml injection, 1 ml syringe) (Xolair®) has been delisted.
Severe chronic plaque psoriasis; severe psoriatic arthritis; severe Crohn's disease; complex refractory fistulising Crohn's disease; moderate to severe ulcerative colitis
Ustekinumab (45 mg/0.5 ml injection, 0.5 ml syringe; 90 mg/ml injection, 1 ml syringe; 130 mg/26 ml injection, 26 ml vial) (Steqeyma®) is a biosimilar now listed on the PBS for the treatment of severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn's disease, complex refractory fistulising Crohn's disease and moderate to severe ulcerative colitis.
Stage 111B, IIIC, 111D or Stage IV malignant melanoma (nivolumab); Stage Ill or Stage IV malignant melanoma (ipilimumab)
Nivolumab (40 mg/4 ml injection, 4 ml vial; 100 mg/10 ml injection, 10 ml vial) (Opdivo®) and ipilimumab (50 mg/10 ml injection, 10 ml vial; 200 mg/40 ml injection, 40 ml vial) (Yervoy®) have had a change to their restrictions. Authority applications for initial and continuing treatment with nivolumab can be made either in real-time using the Online PBS Authorities system or by telephone. Prescriptions for ipilimumab induction treatment are Authority required
(STREAMLINED
Osteoporosis; giant cell tumour of bone; bone metastases
Denosumab (60 mg/ml injection, 1 ml syringe) (Jubbonti®); (120 mg/1.7 ml injection, 1.7 ml vial) (Wyost®) are biosimilars now listed on the PBS for the treatment of osteoporosis, giant cell tumour of bone and bone metastases. Prescriptions for initial and continuing treatment are Authority required (STREAMLINED).
Advanced, metastatic or recurrent endometrial carcinoma
Durvalumab (120 mg/2.4 ml injection, 2.4 ml vial; 500 mg/10 ml injection, 10 ml vial) (lmfinzi®) is listed on the PBS for the treatment of advanced, metastatic or recurrent endometrial carcinoma. Prescriptions for initial and continuing treatment are Authority required (STREAMLINED).
Advanced Parkinson's disease
Foslevodopa + foscarbidopa (foslevodopa 2.4 g/10 ml+ foscarbidopa 120 mg/10 ml injection, 7 x 10 ml vials) (Vyalev®) is now listed on the PBS for the treatment of advanced Parkinson's disease. Prescriptions for treatment are Authority required (STREAMLINED).
Contraception
Drospirenone (drospirenone 4 mg tablet [24] (&) inert substance tablet [4], 3x28) (Slinda®) is now listed on the PBS for contraception. It is listed as an unrestricted benefit.
1 August 2025 delisted PBS listings
Glaucoma and ocular hypertension
Betaxolol (0.5% eye drops, 5 ml) (Betoptic®) has been delisted.
Acute myocardial infarction
Tenecteplase (50 mg injection, 10 ml syringe) (Metalyse®) has been delisted.
Locally advanced or metastatic differentiated thyroid cancer
Cabozantinib (20 mg tablet; 40 mg tablet; 60 mg tablet) (Cabometyx®) no longer has a listing for Grandfather arrangements.
Vision threatening non-infectious uveitis
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 pen device; 40 mg/0.4 ml injection, 0.4 ml syringe; 40 mg/0.8 ml injection, 0.8 ml pen device; 40 mg/0.8 ml injection, 0.8 ml syringe) 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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