PBS Changes from 1 January 2023

Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1 January 2023. 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.  

Thrombopoietin-receptor agonists (TPO-RA’s for severe thrombocytopenia)

Romiplostim (Nplate®) (powder for injection 375 micrograms and powder for injection 625 micrograms) has had an amendment to the restrictions and authority required procedures for the treatment of immune-related (idiopathic) thrombocytopenia purpura. Authority applications for initial treatment can be made in writing. First continuing, subsequent continuing and change of treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.

Eltrombopag (Revolade®) (tablet 25mg and tablet 50mg ) has had an amendment to the restrictions and authority required procedures for the treatment of immune-related (idiopathic) thrombocytopenia purpura. Authority applications for initial treatment can be made in writing. First continuing, subsequent continuing and change of treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.

Diabetic macular oedema

Faricimab (Vabysmo®) (solution for intravitreal injection 28.8 mg in 0.24 mL vial) is now listed on the PBS for the treatment of diabetic macular oedema. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment is streamlined.

Neovascular (wet) age-related macular degeneration

Faricimab (Vabysmo®) (solution for intravitreal injection 28.8 mg in 0.24 mL vial) is now listed on the PBS for the treatment of neovascular (wet) age-related macular degeneration. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment is streamlined.

Systemic light-chain (AL) amyloidosis

Daratumumab (Darzalex SC®) (solution for subcutaneous injection 1,800 mg in 15 mL vial) is now listed on the PBS for the treatment of systemic light-chain (AL) amyloidosis. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. For continuing, change or recommencement treatment, applications can be made either in real time using the Online PBS Authorities system or by telephone.

Multiple myeloma

Pomalidomide (Pomalyst®, Pomolide®, Sandoz®) (3mg, 4mg, 14 tab, 21 tab) has had an amendment to the administrative advice for the treatment of multiple myeloma. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.

Rehydration in intestinal failure

Sodium chloride + Potassium Chloride + Glucose Monohydrate + citric acid (O.R.S sachets) is now listed on the PBS for the treatment of rehydration in intestinal failure. Authority applications for treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Treatment of SARS-CoV-2 infection

Molnupiravir (Lagevrio®), nirmatrelvir + ritonavir (Paxlovid®) has had an amendment to the existing listing. Authority applications for the treatment of SARS-CoV-2 infection is streamlined.

Stage IV non-small cell lung cancer

Cemiplimab (Libtayo®) has had an amendment to the existing listing. Authority applications for the treatment of Stage IV non-small cell lung cancer is streamlined.

Asthma

Beclometasone with formoterol and glycopyrronium (Trimbow®) (pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses, pressurised inhalation containing beclometasone dipropionate 200 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses) is now listed on the PBS for the treatment of asthma. Authority applications for the treatment of asthma is streamlined.

Elevated intra-ocular pressure

Dorzolamide with timolol (Vlzo-PF Dorzolatim®) (eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL) is now listed on the PBS for the treatment of elevated intra-ocular pressure as a  restricted benefit.

Severe active psoriatic arthritis

Leflunomide (tablet 10 mg, tablet 20 mg) has had an amendment to the existing listing for the treatment of severe active psoriatic arthritis as a restricted benefit.

Unrestricted benefit

Doxorubicin (as pegylated liposomal) (Caelyx®) (suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL, suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL) is now listed on the PBS under the Section 100 Efficient Funding of Chemotherapy legislative instrument as an unrestricted benefit.

1 January 2023 delisted PBS listings

Type 2 Diabetes

Ertugliflozin with metformin (Segluromet 2.5/1000, Segluromet 2.5/500, Segluromet 7.5/1000, Segluromet 2.5/500) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.

Selecting the correct restriction in the Online PBS Authorities system

Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. New questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS for multiple Authority Required (Written) programs 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.