PBS Changes from 1 May 2023
Information relating to the new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st May 2023 can be found below. For further information, please download the Frequently Asked Questions.
This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit the PBS website. Relevant information and authority application forms have been updated and can be accessed through the Services Australia website.
Moderate to severe ulcerative colitis
Ustekinumab (Stelara®) (Injection 90 mg in 1 mL pre-filled syringe, solution concentrate for I.V. infusion 130 mg in 26 mL) is now listed on the PBS for the treatment of moderate to severe ulcerative colitis. Authority applications for initial and grandfather treatments can be made in writing. Continuing and Balance of Supply authority applications can be made either in real time using the Online PBS Authorities system or by telephone.
Moderate to severe ulcerative colitis
Ozanimod (Zeposia®) (920 micrograms 28 capsules, initiation pack containing 230 micrograms 4 capsules and 460 micrograms 3 capsules) is now listed on the PBS for the treatment of moderate to severe ulcerative colitis. Authority applications for initial and grandfather treatments can be made in writing. Continuing and Balance of Supply authority applications can be made either in real time using the Online PBS Authorities system or by telephone. Authority application for dose escalation occurring at initial treatment, or re-initiation of treatment is streamlined.
Moderate to severe ulcerative colitis
Upadacitinib (Rinvoq®) (Tablet 15 mg, tablet 30 mg, tablet 45 mg) is now listed on the PBS for the treatment of moderate to severe ulcerative colitis. Authority applications for initial and grandfather treatments can be made in writing. Continuing and Balance of Supply authority applications can be made either in real time using the Online PBS Authorities system or by telephone.
Systemic light chain amyloidosis
Daratumumab (Darzalex SC®) (Solution for subcutaneous injection 1.8 g in 15 mL vial) has had an amendment to remove the date of the histology report from the restriction requirement. Authority applications for initial and grandfather treatments can be made either in real time using the Online PBS Authorities system or in writing. Continuing authority applications can be made either in real time using the Online PBS Authorities system or by telephone.
Cystic fibrosis
Elexacaftor + tezacaftor + ivacaftor (&) ivacaftor (Trikafta®) (Pack containing 56 tablets elexacaftor 100 mg + tezacaftor 50 mg + ivacaftor 75 mg (&) 28 tablets ivacaftor 150 mg, pack containing 56 tablets elexacaftor 50 mg + tezacaftor 25 mg + ivacaftor 37.5 mg (&) 28 tablets ivacaftor 75 mg) has had an amendment to the existing listing to expand the patient demographic to allow patients from 6 years of age who have at least one F508del mutation on the cystic fibrosis transmembrane conductance regulator (CFTR) gene to receive treatment for cystic fibrosis. Authority applications for initial and continuing treatments can be made in writing.
Chronic myeloid leukaemia
Asciminib (Scemblix®) (Tablet 20 mg, tablet 40 mg) is now listed on the PBS for the treatment of chronic myeloid leukaemia (CML) for two treatment groups: (i) patients with CML previously treated with two or more tyrosine kinase inhibitors (TKIs); and (ii) patients with CML previously treated with one or more TKI and harbouring the T315I mutation. Authority applications for initial and grandfather treatments for group (i) can be made either in real time using the Online PBS Authorities system or by telephone. Group (i) continuing treatment is streamlined. Authority applications for initial, grandfather and continuing treatments for group (ii) can be made either in real time using the Online PBS Authorities system or in writing.
Castration resistant metastatic carcinoma of the prostate
Abiraterone and methylprednisolone (Yonsa® Mpred™) (Pack containing 120 tablets abiraterone (as acetate) 125 mg and 60 tablets methylprednisolone 4 mg) is now listed on the PBS for the treatment of castration resistant metastatic carcinoma of the prostate. Authority applications for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.
Olaparib (Lynparza®) (Tablet 100 mg, 150 mg) has had an amendment to remove the grandfather restriction.
Attention deficit hyperactivity disorder
Methylphenidate (Ritalin® LA) (Capsule containing methylphenidate hydrochloride 10 mg, 20 mg, 30 mg, 40 mg, 60mg (modified release)) has had an amendment to expand the patient demographic to allow access for adults with a retrospective diagnosis of attention deficit hyperactivity disorder. Authority applications for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.
Achondroplasia
Vosoritide (Voxzogo®) (Powder for injection 400 microgram with diluent, powder for injection 560 microgram with diluent, powder for injection 1.2 mg with diluent) is now listed on the PBS for the treatment of achondroplasia in patients whose epiphyses are not closed. Authority applications for initial, grandfather and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.
Alzheimer’s disease
Galantamine (Capsule modified release 8 mg, 16 mg, 24 mg), memantine (Tablet 10 mg, 20 mg), donepezil (Tablet 5 mg, 10 mg), rivastigmine (Capsule 1.5 mg, 3 mg, 4.5 mg, 6 mg. Patch 4.6 mg, 9.5 mg, 13.3 mg) have had a change to the prescribing instructions for the initial authority approval for Alzheimer's disease. Authority applications for up to 6 months’ initial treatment can be made in real time using the Online PBS Authorities system or by telephone and prescribers will no longer be required to submit a written application to complete the balance of an initial script. Authority applications for continuing treatment remain as streamlined.
Alcohol dependence
Naltrexone (Naltrexone GH®) (Tablet 50 mg) has had a reduction in authority level for the treatment of alcohol dependence. Authority applications are now streamlined.
Stage IV clear cell variant renal cell carcinoma
Pembrolizumab (Keytruda®) (Solution concentrate for I.V. infusion 100 mg in 4 mL) in combination with lenvatinib (Lenvima®) is now listed on the PBS for the treatment of stage IV clear cell variant renal cell carcinoma. Authority applications for initial, grandfather and continuing treatments are streamlined.
Phenylketonuria
Glycomacropeptide formula with docosahexaenoic acid and low phenylalanine (PKU Sphere Liquid®) (Oral liquid 237 mL, 15) is now listed on the PBS for the treatment of phenylketonuria as a restricted benefit.
Progressive fibrosing interstitial lung disease
Nintedanib (Ofev®) (Capsule 100 mg, capsule 150 mg) has had an amendment to remove the grandfather restriction.
Eosinophilic oesophagitis
Budesonide (Jorveza®) (Orally disintegrating tablet 500 microgram, 1 mg) has had an amendment to remove the grandfather restriction.
Stage IV (metastatic) non-small cell lung cancer
Nivolumab (Injection 40mg/4mL, 100mg/10mL) (Opdivo®) and Ipilimumab (Injection 50mg/10mL) (Yervoy®) have had amendments to remove the grandfather restrictions.
Unresectable locally advanced or metastatic triple-negative breast cancer
Sacituzumab govitecan (Trodelvy®) (Injection 180 mg) has had an amendment to remove the grandfather restriction.
Balance of Supply in the Online PBS Authorities system
Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. Questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.