PBS Changes from 1 August 2023

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

Ankylosing spondylitis

Tofacitinib (Xeljanz®) (5 mg tablet) is now listed on the PBS for the treatment of ankylosing spondylitis. Authority applications for initial, grandfather and continuing treatments can be made in writing.

Non-radiographic axial spondyloarthritis

Upadacitinib (Rinvoq®) (15 mg tablet) is now listed on the PBS for the treatment of non-radiographic axial spondyloarthritis. Authority applications for initial and grandfather treatments can be made in writing. Applications for continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Metastatic castration sensitive carcinoma of the prostate

Enzalutamide (Xtandi®) (40 mg capsule) 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.

Locally advanced or metastatic breast cancer

Palbociclib (Ibrance®) (75 mg tablet, 100 mg tablet, 125 mg tablet) has had an amendment to remove the grandfather restriction. Authority applications for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

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 a few changes to the listing:

• There has been a reduction in authority level. Prescriptions for treatment are now Authority Required (STREAMLINED).
• Prescribers no longer need to be registered with the MS 2 Step Prescribing Program.
• Nurse practitioners have been included as an eligible prescriber type. All prescribers must comply with the provisions of State/Territory law when prescribing this drug. 
   

Acromegaly, functional carcinoid tumour, non-functional gastroenteropancreatic neuroendocrine tumour

Lanreotide (Mytolac®) (60 mg/0.5 mL injection, 0.5 mL syringe; 90 mg/0.5 mL injection, 0.5 mL syringe; 120 mg/0.5 mL injection, 0.5 mL syringe) is now listed on the PBS for the treatment of acromegaly, functional carcinoid tumour and non-functional gastroenteropancreatic neuroendocrine tumour. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).

Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma

Trabectedin (Yondelis®) (Powder for I.V. infusion 1 mg) is now listed on the PBS for the treatment of advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma. Prescriptions for initial, grandfather and continuing treatments are Authority Required (STREAMLINED).

Chronic migraine

Eptinezumab (Vyepti®) (100 mg/mL injection, 1 mL vial) is now listed on the PBS for the treatment of chronic migraine. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).

Multiple sclerosis

Diroximel fumarate (Vumerity®) (231 mg enteric capsule) has had an amendment to remove the grandfather restriction. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).

Nicotine dependence

Varenicline (APO-Varenicline (Canada)®) (500 microgram tablet) for the commencement of a short-term (12 weeks or 24 weeks) course of treatment for nicotine dependence is now listed on the PBS for the current supply shortage under Section 19A. Prescriptions for treatment are Authority Required (STREAMLINED).

Ketogenic diet

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate (KetoVie® 3:1; KetoVie® 4:1; KetoVie Peptide® 4:1) (Oral liquid 250 mL, 30) is now listed on the PBS for patients requiring treatment with a ketogenic diet. It is listed as a restricted benefit.

Hypercholesterolaemia

Colestyramine (JAMP-Cholestyramine ®) (4g powder for oral liquid, 30 sachets) for the treatment of primary hypercholesterolaemia is now listed on the PBS for the current supply shortage under Section 19A. Colestyramine is listed as a restricted benefit.

1 August 2023 delisted PBS listings 

Diabetes mellitus type 2

Ertugliflozin (Steglatro®) (5 mg tablet, 15 mg tablet) has been delisted from the PBS with a “Supply Only” arrangement for six months.

Ertugliflozin + sitagliptin (Steglujan®) (5 mg/100 mg tablet, 15 mg/100 mg tablet) has been delisted from the PBS with a “Supply Only” arrangement for six months.

Fungal or yeast infection

Ketoconazole (Nizoral®) (2% shampoo, 60 mL) has been delisted from the PBS with a “Supply Only” arrangement for two months.

HIV infection

Efavirenz (Stocrin®) (200 mg tablet; 600 mg tablet) has been delisted from the PBS with a “Supply Only” arrangement for six months.

Tyrosinaemia

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine (XPhen®, Tyr Maxamum®) (powder for oral liquid, 500 g) has been delisted from the PBS with no “Supply Only” arrangement.

Hypertension

Eprosartan (Teveten®) (400 mg tablet) has been delisted from the PBS with a “Supply Only” arrangement for six months.

Perioperative use in ophthalmic surgery, Invasive ocular infection and Suspected Pseudomonal eye infection 

Gentamicin (Genoptic®) (0.3% eye drops, 5 mL) has been delisted from the PBS with a “Supply Only” arrangement for three months.

Severe Pain

Morphine (Anamorph®) (30 mg tablet) has been delisted from the PBS with no “Supply Only” arrangement.

Chemotherapy

Epirubicin (Epirube®) (50 mg/25 mL injection, 25 mL vial) has been delisted from the PBS with no “Supply Only” arrangement.

Phenylketonuria

Amino acid formula with vitamins and minerals without phenylalanine (PKU gel®) (powder for oral liquid, 24 g sachets) has been delisted from the PBS with a “Supply Only” arrangement for six months.

Written Authority Application Forms

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