PBS Changes from 1 September 2023

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

60-day prescriptions of PBS medicines – Stage 1

From 1 September 2023, many patients living with an ongoing health condition who are stable on their current treatment will be able to receive twice the medication for the cost of a single prescription. This will apply to more than 300 common medicines listed on the pharmaceutical benefits scheme (PBS) and will be implemented in 3 stages over 12 months.

Stage one, from 1 September 2023, includes 92 medicines (256 PBS items) and represents roughly one third of all the medicines eligible for 60-day prescriptions. The 256 PBS items include the different forms (strength and presentation) of the stage one medicines. For more information go to health.gov.au

Acute myeloid leukaemia

Azacitidine (Onureg®) (200 mg tablet, 300 mg tablet) is now listed on the PBS for the treatment of acute myeloid leukaemia. Authority applications for initial and continuing treatments (following intensive induction chemotherapy) can be made either in real-time using the Online PBS Authorities system or by telephone. Authority applications for continuing treatment (dose escalation therapy) can be made either in real-time using the Online PBS Authorities system or in writing.

Chronic lymphocytic leukaemia or small lymphocytic lymphoma - treatment naïve

Zanubrutinib (Brukinsa®) (80 mg capsule) is now listed on the PBS for the treatment of chronic lymphocytic leukaemia or small lymphocytic lymphoma – treatment naïve. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Chronic lymphocytic leukaemia or small lymphocytic lymphoma – relapsed/refractory disease

Zanubrutinib (Brukinsa®) (80 mg capsule) is now listed on the PBS for the treatment of chronic lymphocytic leukaemia or small lymphocytic lymphoma – relapsed/refractory disease. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Cows' milk protein enteropathy. Severe cows' milk protein enteropathy with failure to thrive. Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae. Cows' milk anaphylaxis. Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein. Severe intestinal malabsorption including short bowel syndrome. Eosinophilic oesophagitis.

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides with 2-fucosyllactose and lacto-N-neotetraose (Alfamino®) (powder for oral liquid, 400 g) has had a change in formulation for the treatment of cows' milk protein enteropathy; severe cows' milk protein enteropathy with failure to thrive; combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae; cows' milk anaphylaxis; proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein; severe intestinal malabsorption including short bowel syndrome; eosinophilic oesophagitis. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Chronic hyperkalaemia

Patiromer (Veltassa®) (8.4 g powder for oral liquid, 30 sachets; 16.8 g powder for oral liquid, 30 sachets) is now listed on the PBS for the treatment of chronic hyperkalaemia. 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).

Recurrent, unresectable or metastatic triple negative breast cancer

Pembrolizumab (Keytruda®) (100 mg/4 mL injection, 4 mL vial) is now listed on the PBS for the treatment of recurrent, unresectable or metastatic triple negative breast cancer. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).

Termination of an intra-uterine pregnancy

Mifepristone and misoprostol (MS-2 Step®) (Pack containing 1 tablet mifepristone 200 mg and 4 tablets misoprostol 200 micrograms) has had an amendment to the existing listing for the treatment of termination of an intra-uterine pregnancy. Authorised midwives have been included as an eligible prescriber type. Prescriptions for treatment are Authority Required (STREAMLINED).

Severe hypoglycaemia

Glucagon hydrochloride (GlucaGen® Hypokit (Germany)) (1 mg powder and solvent for solution for injection) for the treatment of severe hypoglycaemia is now listed on the PBS for the current supply shortage under Section 19A. Glucagon hydrochloride is listed as an unrestricted benefit.

Opioid overdose

Naloxone nasal spray (Nyxoid® (UK)) (1.8 mg/actuation nasal spray) for emergency treatment of a known or suspected opioid overdose is now listed on the PBS for the current supply shortage under Section 19A. Naloxone nasal spray is listed as an unrestricted benefit.

Written Authority Application Forms

Severe asthma – Updated authority applications

From 1 September 2023, the application forms used to apply for authority approval to prescribe PBS-subsidised biological agents to treat patients with severe asthma have been updated to better align with the restrictions. The authority applications can be found on the Severe asthma webpage on the Services Australia website.

Services Australia understand having access to PBS-subsidised medicines can be critical to patient care. That’s why it’s important to ensure you use the most recently published written authority application form. To align with PBS listing changes, forms are updated on the first of the month. Using the most recent form will help avoid delays in obtaining authority approval.

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. 

Use the Health Professional Online Services upload function to submit your completed written authority application forms and any supporting documents or evidence. You’ll get a faster processing response using HPOS and will avoid any postage delays.

For more information go to servicesaustralia.gov.au/hpos