PBS Changes from 1 December 2023
Information relating to the new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st December 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.
Update to Safety Net Early Supply Rule for 60-day prescriptions of PBS medicines
Following the Pharmaceutical Benefits Advisory Committee’s recommendation, from
1 December 2023, the PBS Safety Net early supply rule will be updated to a 50 day interval (currently 20 days) to discourage stockpiling and reduce the quantity of unused medicines in the community.
The early supply interval for the following 3 items will be updated on 1 January 2024:
- 13550E / nicorandil 10 mg tablet, 60
- 13551F / nicorandil 20 mg tablet, 60
- 13552G / moxonidine 400 microgram tablet, 30
Severe Crohn’s disease
Upadacitinib (Rinvoq®) (15 mg tablet, 30 mg tablet, 45 mg tablet) is now listed on the PBS for the treatment of severe Crohn’s disease. Authority applications for initial, grandfather and continuing treatments can be made in writing. Authority applications for balance of supply can be made either in real time using the Online PBS Authorities system or by telephone.
Severe active juvenile idiopathic arthritis
Tofacitinib (Xeljanz®) (5 mg tablet; 1 mg/mL oral liquid, 240 mL) is now listed on the PBS for the treatment of severe active juvenile idiopathic arthritis. 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).
Ankylosing spondylitis
Adalimumab (Amgevita®, Hadlima®, Hyrimoz®, Idacio®, Yuflyma®), etanercept (Brenzys®), and infliximab (Inflectra®, Renflexis®) have had a change in the authority level for the treatment of ankylosing spondylitis. Authority applications for initial treatment with these biosimilar brands can be made either in real time using the Online PBS Authorities system or by telephone. Prescriptions for continuing treatment with these biosimilar brands are Authority Required (STREAMLINED).
Metastatic castration sensitive carcinoma of the prostate
Darolutamide (Nubeqa®) (300 mg tablet) is now listed on the PBS for the treatment of metastatic castration sensitive carcinoma of the prostate. 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.
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids (EleCare®LCP) (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. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.
Extensive-stage small cell lung cancer
Durvalumab (Imfinzi®) (120 mg/2.4 mL injection, 2.4 mL vial; 500 mg/10 mL injection, 10 mL vial) is now listed on the PBS for the treatment of extensive-stage small cell lung cancer. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).
Locally advanced, metastatic or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer)
Durvalumab (Imfinzi®) (120 mg/2.4 mL injection, 2.4 mL vial; 500 mg/10 mL injection, 10 mL vial) is now listed on the PBS for the treatment of locally advanced, metastatic or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer). Prescriptions for this treatment are Authority Required (STREAMLINED).
Adjuvant management of breast cancer
Zoledronic acid (APO-Zoledronic Acid®) (4 mg/5 mL injection, 5 mL vial) has had an amendment to the listing to include the adjuvant management of breast cancer in post-menopausal women. Prescriptions for this treatment are Authority Required (STREAMLINED).
Advanced or metastatic gastro-oesophageal cancers
Nivolumab (Opdivo®) (40 mg/4 mL injection, 4 mL vial; 100 mg/10 mL injection, 10 mL vial) has had an amendment to the existing listing for the treatment of advanced or metastatic gastro-oesophageal cancers. Prescriptions for this treatment are Authority Required (STREAMLINED).
Stage II or Stage III triple negative breast cancer
Pembrolizumab (Keytruda®) (100 mg/4 mL injection, 4 mL vial) is now listed on the PBS for the treatment of Stage II or Stage III triple negative breast cancer. Prescriptions for this treatment are Authority Required (STREAMLINED).
Gyrate atrophy of the choroid and retina; Urea cycle disorders
Essential amino acids formula with vitamins and minerals (EAA Supplement®) (powder for oral liquid, 30 x 12.5 g sachets) has had a change in formulation for the treatment of gyrate atrophy of the choroid and retina; urea cycle disorders. Essential amino acids formula with vitamins and minerals is listed as a restricted benefit.
Chronic hepatitis B infection
Adefovir (Adefovir dipivoxil 10 mg tablet) for the treatment of chronic hepatitis B infection is now listed on the PBS for the current supply shortage under Section 19A. Prescriptions for this treatment are Authority Required (STREAMLINED).
Severe Pain
Morphine sulphate (Hikma) (2 mg/mL oral solution, 100 mL and 500 mL) for the treatment of severe pain is now listed on the PBS for the current supply shortage under Section 19A. Morphine sulphate is listed as a Streamlined authority and as a restricted benefit.
Morphine sulphate (Martindale Pharma) (10 mg/5 mL oral solution, 100 mL and 300 mL) for the treatment of severe pain is now listed on the PBS for the current supply shortage under Section 19A. Morphine sulphate is listed as a Streamlined authority and as a restricted benefit.
1 December 2023 delisted PBS listings
Gastro-oesophageal reflux disease; duodenal and gastric ulcers
Ranitidine (Zantac Syrup®) (150 mg/10 mL oral liquid, 300 mL) has been delisted from the PBS with no supply only arrangement.
Chemotherapy-induced neutropenia; mobilisation of peripheral blood progenitor cells; assisting bone marrow transplantation; assisting autologous peripheral blood progenitor cell transplantation; severe congenital neutropenia; severe chronic neutropenia; chronic cyclical neutropenia
Filgrastim (Neupogen®) (300 microgram/mL injection, 10 x 1 mL vials; 480 microgram/1.6 mL injection, 10 x 1.6 mL vials) has been delisted from the PBS with a 3 month supply only arrangement.
Constipation
Rhamnus frangula + sterculia (Normacol Plus®) (80 mg/g + 620 mg/g granules, 500 g) has been delisted from the PBS with a 4 month supply only arrangement.
Macrogol-3350 + sodium chloride + bicarbonate + potassium chloride (Movicol Liquid®) (13.125 g/25 mL + 350.7 mg/25 ml + 178.5 mg/25 mL + 46.6 mg/25 mL oral liquid, 500 mL) has been delisted from the PBS with a 6 month supply only arrangement.
HIV infection
Raltegravir (Isentress®) (25 mg and 100 mg chewable tablets) has been delisted from the PBS with a 6 month supply only arrangement.
Cystic fibrosis
Pancrelipase (Panzytrat 25 000®) (25 000 units capsule) has been delisted from the PBS with a 6 month supply only arrangement.
Diabetes
Insulin neutral human + insulin isophane human (Mixtard 50/50 Penfill 3 mL®) (50 units/mL + 50 units/mL injection, 5 x 3 mL cartridges) has been delisted from the PBS with a 6-month supply only arrangement.
Hormone replacement therapy
Estradiol + dydrogesterone (Femoston-Conti®) (1 mg + 5 mg tablet) has been delisted from the PBS with a 3-month supply only arrangement.
Changes to prescriber’s declaration section on application forms
From 1 December 2023, if you are submitting a PBS authority application form via the Health Professional Online Service (HPOS) form upload function for severe Crohn’s disease (PB087, PB088 and PB235), and ankylosing spondylitis (PB074, PB251), you now only need to tick the declaration box and provide the date. If returning the form by post, your signature and the date is still required.
From 14 December 2023, the remaining severe Crohn’s disease as well as all moderate to severe ulcerative colitis application forms will also be able to be submitted via HPOS form upload function by ticking the declaration box and date.
Changes to Online PBS Authorities system
For more information visit the Online PBS Authorities system website.
Services Australia has a broad range of educational resources on the Health Professional Education Resources website. This includes simulations, podcasts, and an infographic on the Online PBS Authorities system.
Visit 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. By using HPOS you’ll get a faster processing response and will avoid any postage delays.