PBS Changes from 1 April 2023

Information relating to the new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st April 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.  

Chronic rhinosinusitis with nasal polyps
Mepolizumab (Nucala®) (Injection 100 mg in 1 mL single dose pre-filled pen) is now listed on the PBS for the treatment of chronic rhinosinusitis with nasal polyps. Authority applications for initial and grandfather treatment can be made in writing. Authority applications for continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Sapropterin (Kuvan®) (tablet (soluble) containing sapropterin dihydrochloride 100 mg, powder for oral solution 500 mg (as dihydrochloride)) has had an amendment to extend the current listing to allow adults to be eligible for sapropterin responsiveness testing and to also allow access to continuing treatment for those who are sapropterin responsive. Authority applications for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Stage II or III oesophageal cancer or gastro-oesophageal junction cancer
Nivolumab (Opdivo®) (Injection concentrate for I.V. infusion 40 mg in 4 mL, injection concentrate for I.V. infusion 100 mg in 10 mL) is now listed on the PBS for the adjuvant treatment of patients with stage II or III oesophageal cancer or gastro-oesophageal junction cancer who have previously received platinum-based chemoradiotherapy and surgery. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.

Human immunodeficiency virus (HIV) infection
Abacavir (Ziagen®) (20 mg/mL oral liquid 240 mL) has been amended to an Authority Required restriction for patients aged less than 13 years of age and for patients that are unable to take tablets. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.

Hypercalcaemia and symptomatic Paget disease of bone
Calcitonin salmon (salcatonin) (Miacalcic 100®) (100 units/mL, 1 mL ampoules) has been amended to an Authority Required restriction for patients who cannot tolerate bisphosphonates due to kidney disease. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.

Hypertension
Methyldopa (Aldomet®) (250 mg, 100 tablets) has been amended to an Authority Required restriction for the treatment of hypertension during pregnancy. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.

Asthma
Fluticasone propionate (Flixotide Junior®, Axotide Junior®) (50 mcg/actuation, 120 actuations) has been amended to an Authority Required restriction for patients aged less than six years of age with initiation required by a respiratory physician or paediatrician. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.

Moderate to severe chronic graft versus host disease
Ruxolitinib (Jakavi®) (Tablet 5 mg, Tablet 10 mg) is now listed on the PBS for the treatment of moderate to severe chronic graft versus host disease. Authority applications for initial, grandfather and continuing treatments are streamlined.

Grade II to IV acute graft versus host disease 
Ruxolitinib (Jakavi®) (Tablet 5 mg, Tablet 10 mg) is now listed on the PBS for the treatment of grade II to IV acute graft versus host disease. Authority applications for initial, grandfather and continuing treatments are streamlined.

SARS-CoV-2 infection
Nirmatrelvir + ritonavir (Paxlovid®) has had an amendment to include patients aged 60-69 years old who are at high risk of requiring hospitalisation for COVID-19 infection. Authority applications are streamlined.

Phenylketonuria 
Amino acid formula with vitamins and minerals without phenylalanine (PKU Squeezie®) (Oral gel 85 g, 30) is now listed on the PBS as a restricted benefit.

1 April 2023 delisted PBS listings 

Diabetes
Insulin aspart 100 units/mL fast acting injection (Fiasp®, Fiasp FlexTouch®) (10 mL vial and 3 mL pen)  has been delisted from the PBS with “Supply Only” arrangements for six months.

Intra-ocular pressure
Apraclonidine (Iopidine 0.5%®) has been delisted from the PBS with no “Supply Only” arrangements.

Severe disabling pain
Hydromorphone (Jurnista®) (4 mg, 8 mg, 16 mg, 32 mg, 64 mg modified release tablets) has been delisted from the PBS with “Supply Only” arrangements for one month.

Multiple sclerosis
Interferon beta-1a (Avonex®) has been delisted from the PBS with no “Supply Only” arrangements.

Androgen deficiency
Testosterone 5 mg/24 hours patch (Androderm®) has been delisted from the PBS with no “Supply Only” arrangements.

Selecting the correct restriction 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.