PBS Changes from 1 October 2023

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

Spinal muscular atrophy

Risdiplam (Evrysdi®) (750 microgram/mL powder for oral liquid, 80 mL) has had a change to the restriction for the treatment of spinal muscular atrophy. 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.

Onasemnogene abeparvovec (Zolgensma®) (solution for injection, customised based on patient weight) is now listed on the PBS for the treatment of infants with pre-symptomatic spinal muscular atrophy and 3 copies of the SMN2 gene. Authority applications for treatment can be made in writing.

Severe growth hormone deficiency

Growth hormone (Somatropin (NutropinAq®) (10 mg/2 mL injection, 2 mL cartridge); somatropin (Genotropin GoQuick®) (12 mg injection, 1 dual chamber pen device); somatropin (Genotropin GoQuick®) (5 mg injection, 1 dual chamber pen device); somatropin (Norditropin FlexPro®) (5 mg/1.5 mL injection, 1.5 mL cartridge)) for the treatment of severe growth hormone deficiency has had a change to the restriction to remove references to Prader Willi Syndrome. Authority applications for initial treatment 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.

Severe chronic plaque psoriasis 

Bimekizumab (Bimzelx®) (160 mg/mL injection, 2 x 1mL pen device) is now listed on the PBS for the treatment of severe chronic plaque psoriasis. Authority applications for initial, grandfather and continuing treatments can be made in writing. 

Deucravacitinib (Sotyktu®) (6 mg tablet) is now listed on the PBS for the treatment of severe chronic plaque psoriasis., Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).

Risankizumab (Skyrizi®) (75mg/0.83 mL injection, 2 x 0.83 mL syringes) has had an amendment to remove the grandfather restriction.

Nausea and vomiting

Fosnetupitant + palonosetron (AkynzeoIV®) (fosnetupitant 235 mg +palonosetron 250 microgram injection, 11 vial) is now listed on the PBS for the prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.

Netupitant + palonosetron (Akynzeo®) (netupitant 300 mg + palonosetron 500 microgram capsule) has had an amendment to the clinical criteria to align restrictions with the National Comprehensive Cancer Network Guidelines for the treatment of nausea and vomiting. Prescriptions for treatment are Authority Required (STREAMLINED).

Relapsed and/or refractory multiple myeloma

Carfilzomib (Kyprolis®) (10 mg injection, 30 mg injection, 60 mg injection) is now listed on the PBS in combination with lenalidomide and dexamethasone for the treatment of relapsed and/or refractory multiple myeloma. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED). (Authority applications for lenalidomide can be made either in real time using the Online PBS Authorities system or by telephone.)

Advanced carcinoma of the cervix

Pembrolizumab (Keytruda®) (100 mg/4 mL injection, 4 mL vial) is now listed on the PBS for the treatment of advanced carcinoma of the cervix. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer 

Enfortumab vedotin (Padcev®) (20 mg injection, 30 mg injection) is now listed on the PBS for the treatment of locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer. Prescriptions for treatment are Authority Required (STREAMLINED).

Diabetes mellitus 

Insulin aspart (Fiasp Penfill®) (100 units/mL fast acting injection, 5 x 3 mL cartridges) is now listed on the PBS for the treatment of diabetes mellitus. Insulin aspart is listed as an unrestricted benefit.

Bacterial infections

Cefuroxime (Zinnat®UK) (125 mg/5 mL powder for oral liquid) is now listed on the PBS for the current supply shortage under Section 19A. Cefuroxime is listed as an unrestricted benefit.

1 October 2023 delisted PBS listings 

Vitreomacular traction syndrome

Ocriplasmin (Jetrea®RTU) (375 microgram/0.3 mL intraocular injection) has been delisted from the PBS with no “Supply Only” arrangement.

Written Authority Application Forms

Severe chronic plaque psoriasis – Updated authority applications

From 1 October 2023, the application forms used to apply for authority approval to prescribe PBS-subsidised biological agents to treat patients with severe chronic plaque psoriasis have been updated to better align with the restrictions. Prescribers will be required to include the completed Psoriasis Area and Severity Index (PASI) calculation sheets with the authority applications. The authority application forms can be found on the Psoriasis - severe chronic plaque psoriasis webpage on the Services Australia website.

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