PBS Changes from 1 November 2023

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

Paroxysmal nocturnal haemoglobinuria

Ravulizumab (Ultomiris®) (300 mg/3 mL injection, 3 mL vial; 1.1 g/11 mL injection, 11 mL vial) has had a change to the restriction for the treatment of paroxysmal nocturnal haemoglobinuria. Authority applications for initial and continuing treatments can be made in writing.

Type III Short bowel syndrome with intestinal failure

Teduglutide (Revestive®) (5 mg injection, 28 vials & inert substance diluent, 28 x 0.5 mL syringes) has had a change to the restriction for the treatment of type III Short bowel syndrome with intestinal failure. Authority applications for initial and continuing treatments can be made in writing. Balance of Supply applications can be made either in real-time using the Online PBS Authorities system or by telephone. 

Severe growth hormone deficiency

Somatropin (Saizen®) (6 mg / 1.03 mL cartridge; 12 mg / 1.5 mL cartridge) is now listed for the treatment of severe growth hormone deficiency. Authority applications for initial and grandfather treatments can be made either in real time using the Online PBS Authorities system or in writing. Authority applications for continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Acute lymphoblastic leukaemia

Blinatumomab (Blincyto®) (38.5 microgram injection) has had an amendment to the restriction criteria for the treatment of acute lymphoblastic leukaemia. Authority applications for initial 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.

Metastatic (Stage IV) HER2 positive breast cancer

Trastuzumab deruxtecan (Enhertu®) (100 mg injection) is now listed on the PBS for the treatment of metastatic (Stage IV) HER2 positive breast cancer. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.

Severe active rheumatoid arthritis

Adalimumab (Amgevita®, Hadlima®, Hyrimoz®, Idacio®, Yuflyma®), etanercept (Brenzys®) and infliximab (Inflectra®, Renflexis®) have had a change in the authority level for the treatment of severe active rheumatoid arthritis. 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 are Authority Required (STREAMLINED).

Abatacept (Orencia®), adalimumab (Humira®), baricitinib (Olumiant®), certolizumab pegol (Cimzia®),  etanercept (Enbrel®), golimumab (Simponi®), infliximab (Remicade®), tocilizumab (Actemra®) and tofacitinib (Xeljanz®) have had a change in the authority level for the treatment of severe active rheumatoid arthritis. Authority applications for initial and first continuing treatments with these originator brands can be made in writing. Prescriptions for subsequent continuing treatment are Authority Required (STREAMLINED).

Severe chronic plaque psoriasis (juvenile)

Etanercept (Enbrel®) (25 mg injection, 4 vials & inert substance diluent, 4 x 1 mL syringes; 50 mg/mL injection, 4 x 1 mL pen devices; 50 mg/mL injection, 4 x 1 mL syringes) has had a change in the authority level for the treatment of severe chronic plaque psoriasis in patients aged under 18 years. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or by telephone. Prescriptions for continuing treatment are Authority Required (STREAMLINED).

Eosinophilic oesophagitis

Budesonide (Jorveza®) (500 microgram orally disintegrating tablet; 1 mg orally disintegrating tablet) has had a change to the restriction for the treatment of eosinophilic oesophagitis to extend the required timeframe for a histological assessment to determine treatment response. Authority applications for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Chronic heart failure

Empagliflozin (Jardiance®) (10 mg tablet) is now listed on the PBS for the treatment of chronic heart failure. Prescriptions for treatment are Authority Required (STREAMLINED).

Treatment-resistant migraine

Fremanezumab (Ajovy®) (225 mg/1.5 mL injection, 1.5 mL pen device; 225 mg/1.5 mL injection, 1.5 mL syringe) has had an amendment to the existing listing for the treatment of chronic migraine. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).

Primary biliary cholangitis

Ursodeoxycholic acid (APO-Ursodeoxycholic acid®, Ursodox GH®, Ursofalk®, Ursosan®) (250 mg capsule); (Ursofalk®) (500 mg tablet) has had a change to the restriction to increase the number of repeats allowed for the treatment of primary biliary cholangitis. Prescriptions for treatment are Authority Required (STREAMLINED).

Phenylketonuria

Glycomacropeptide and essential amino acids with vitamin and minerals (Camino Pro® Bettermilk) has had a change in formulation for the treatment of phenylketonuria. Glycomacropeptide and essential amino acids with vitamin and minerals is listed as a restricted benefit.

Bacterial infection

Amoxicillin and clavulanate potassium for oral suspension (Aurobindo®) (400 mg/5 mL + clavulanic acid 57 mg/5 mL powder for oral liquid, 50 mL) is now listed on the PBS for the current supply shortage under Section 19A for the treatment of bacterial infections. Amoxicillin and clavulanate potassium for oral suspension is listed as a restricted benefit.

Prevention of thrombo-embolic disorders

Enoxaparin (Exarane™, Exarane Forte™) (20 mg/0.2 mL injection, 0.2 mL syringes; 40 mg/0.4 mL injection, 0.4 mL syringes; 60 mg/0.6 mL injection, 0.6 mL syringes; 80 mg/0.8 mL injection, 0.8 mL syringes; 100 mg/mL injection, 1 mL syringes; 120 mg/0.8 mL injection, 0.8 mL syringes; 150 mg/mL injection, 1 mL syringes) is now listed on the PBS for the prevention of thrombo-embolic disorders. Enoxaparin is listed as a restricted and an unrestricted benefit.

Deep vein thrombosis

Enoxaparin (Clexane Forte Safety-Lock®) (120 mg/0.8 mL injection, 0.8 mL syringes; 150 mg/mL injection, 1 mL syringes) is now listed on the PBS for the treatment of deep vein thrombosis. Enoxaparin is listed as an unrestricted benefit.

Steroid treatment

Methylprednisolone sodium succinate (Solu-Medrone®UK) (40 mg powder for injection) is now listed on the PBS for the current supply shortage under Section 19A. Methylprednisolone sodium succinate is listed as an unrestricted benefit.

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.