PBS Changes from 1 May 2025

Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st May 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.

Diabetic macular oedema (DMO)

Faricimab (6 mg/0.05 ml intraocular injection, 0.05 ml syringe) (Vabysmo®) is now listed on the PBS for the treatment of DMO. Authority applications for initial treatment can be made either in real-time using the Online PBS Authorities system or in writing. Prescriptions for continuing treatment are Authority required (STREAMLINED).

Subfoveal choroidal neovascularisation (CNV)

Faricimab (6 mg/0.05 ml intraocular injection, 0.05 ml syringe) (Vabysmo®) is now listed on the PBS for the treatment of CNV. Authority applications for initial treatment can be made either in real-time using the Online PBS Authorities system or in writing. Prescriptions for continuing treatment are Authority required (STREAMLINED).

Pulmonary arterial hypertension (PAH)

Macitentan+ tadalafil (macitentan l O mg+ tadalafil 40 mg tablet) (Opsynvi®) is now listed on the PBS for the continuing treatment of combination therapy for PAH. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Hereditary transthyretin amyloidosis

Vutrisiran (25 mg/0.5 ml injection, 0.5 ml syringe) (Amvuttra®) is now listed on the PBS for the treatment of hereditary transthyretin amyloidosis. Authority applications for initial, grandfather and continuing treatments can be made either in real-time using the Online PBS Authorities system or in writing.

Treatment resistant major depression

Esketamine (28 mg/2 actuations nasal spray, 2 actuations; 28 mg/2 actuations nasal spray, 2 x 2 actuations; 28 mg/2 actuations nasal spray, 3 x 2 actuations) (Spravato®) is now listed on the PBS for the treatment of treatment resistant major depression. Authority applications for initial (induction), grandfather and continuing (non-induction) treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Epcoritamab (4 mg/0.8 ml injection, 0.8 ml vial; 48 mg/0.8 ml injection, 0.8 ml vial) (Epkinly®) is now listed on the PBS for the treatment of relapsed or refractory DlBCL. Authority applications for initial and grandfather treatments can be made either in real-time using the Online PBS Authorities system or by telephone. Prescriptions for continuing treatment are Authority required (STREAMLINED).

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae; severe intestinal malabsorption including short bowel syndrome; eosinophilic oesophagitis; cows' milk protein enteropathy; severe cows' milk protein enteropathy with failure to thrive; proven combined immunoglobulin E (lgE) mediated allergy to cows' milk protein and soy protein; cows' milk anaphylaxis Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides (powder for oral liquid, 400 g (Essential Care Jr®)) has had a change in formulation. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Stage 111B / IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSClC) Amivantamab (350 mg/7 ml injection, 7 ml vial) (Rybrevant®) is now listed on the PBS for the treatment of Stage IIIB / IIIC (locally advanced) or Stage IV (metastatic) NSCLC. Authority applications for initial, grandfather and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Amyotrophic lateral sclerosis

Edaravone (30 mg/20 ml injection, 10 x 20 ml ampoules) (Radicava®) is now listed on the PBS for the treatment of amyotrophic lateral sclerosis. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Severe myoclonic epilepsy in infancy (Dravet Syndrome)

Fenfluramine (fenfluramine hydrochloride 2.2 mg/ml oral liquid, 360 ml) (Fintepla®) is now listed on the PBS for the treatment of severe myoclonic epilepsy in infancy (Dravet Syndrome). Authority applications for treatment can be made either in real-time using the Online PBS Authorities system or by telephone.

Schizophrenia

Aripiprazole (720 mg/2.4 ml modified release injection, 2.4 ml syringe; 960 mg/3.2 ml modified release injection, 3.2 ml syringe) (Ability Asimtufii®) is now listed on the PBS for the treatment of schizophrenia. Prescriptions for treatment are Authority required (STREAMLINED).

Endometriosis

Relugolix + estradiol + norethisterone acetate (relugolix 40 mg + estradiol 1 mg + norethisterone acetate 500 microgram tablet, 28 (Ryeqo®) is now listed on the PBS for the treatment of endometriosis.

Prescriptions for initial and continuing treatments are Authority required (STREAMLINED).

Acute coronary syndrome (myocardial infarction or unstable angina)

Prasugrel (5 mg tablet; 10 mg tablet) (Prasugrel Lupin®) is now listed on the PBS for the treatment of acute coronary syndrome (myocardial infarction or unstable angina). Prescriptions for treatment are Authority required (STREAMLINED).

Contraception

Drospirenone (drospirenone 4 mg tablet [24] (&) inert substance tablet [4]. 4 x 28) (Slinda®) is now listed on the PBS for contraception. It is listed as an unrestricted benefit.

Phenylketonuria

Glycomacropeptide and essential amino acids with vitamins and minerals (containing 10 g of protein equivalent powder for oral liquid, 30 x 15 g sachets) (PKU Build 10®) is now available in a new pack size for the dietary management of phenylketonuria. It is listed as a restricted benefit.

Corticosteroid-responsive dermatoses

Clobetasol (clobetasol propionate 0.05% cream 30 g; clobetasol propionate 0.05% ointment 30 g) (Xobet®) is now listed on the PBS for the treatment of corticosteroid-responsive dermatoses. It is listed as a restricted benefit.

Hypertension

Prazosin (1 mg capsule) (Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA)) is now listed on the PBS for the current supply shortage under Section 19A. It is listed as an unrestricted benefit, and as a restricted benefit for 60-day supply.

1 May 2025 delisted PBS listings

Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent; septicaemia, suspected; septicaemia, proven

Cefotaxime (1 g injection) (DBL Cefotaxime®) has been delisted.

Schistosomiasis

Praziquantel (600 mg tablet, 8) (Biltricide®) has been delisted.

Perioperative use in ophthalmic surgery; invasive ocular infection; suspected Pseudomonal eye infection

Tobramycin (0.3% eye drops, 5 ml; 0.3% eye ointment, 3.5 g) (Tobrex®) has been delisted.

Anti-inflammatory/ immunosuppressive agent

Methylprednisolone (40 mg injection [l chamber](&) inert substance diluent [l ml chamber], 1 dual chamber vial) (Solu-Medrol®) has been delisted.

Bacterial Infection

Gentamicin (80 mg/2 ml injection, 10 x 2 ml ampoules) (Pfizer Australia Pty Ltd) has been delisted.

Multiple sclerosis

Siponimod (250 microgram tablet, 120) (Mayzent®) has been delisted.

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, 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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