Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st October 2023.

This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit pbs.gov.au. 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.

To learn more about these updates, please contact Services Australia directly.

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