Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st January 2024.

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. 

Complex refractory fistulising Crohn’s disease

Ustekinumab (Stelara®) (130 mg/26 mL injection, 26 mL vial; 90 mg/1 mL injection, 1 mL pre-filled syringe) is now listed on the PBS for the treatment of complex refractory fistulising Crohn’s disease. Authority applications can be made in writing.

Atypical haemolytic uraemic syndrome

Ravulizumab (Ultomiris®) (300 mg/3 mL injection, 3 mL vial; 1.1 g/11 mL injection, 11 mL vial) is now listed on the PBS for the treatment of atypical haemolytic uraemic syndrome. Authority applications can be made in writing.

Cystic fibrosis

Lumacaftor and ivacaftor (Orkambi®) (lumacaftor 150 mg + ivacaftor 188 mg granules, 56 sachets; lumacaftor 75 mg + ivacaftor 94 mg granules, 56 sachets; lumacaftor 100 mg + ivacaftor 125 mg granules, 56 sachets) is now listed on the PBS for the treatment of cystic fibrosis for patients homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene from 1 year of age to less than 2 years. It has also had a change to include an additional strength (lumacaftor 75 mg + ivacaftor 94 mg granules). Authority applications can be made in writing.

Severe Crohn’s disease; moderate to severe ulcerative colitis; Severe active juvenile idiopathic arthritis; Complex refractory fistulising Crohn’s disease; Severe active rheumatoid arthritis; Severe psoriatic arthritis; Ankylosing spondylitis; Severe chronic plaque psoriasis; Moderate to severe hidradenitis suppurativa

Adalimumab (Adalicip®) (40 mg/0.4 mL injection, pre-filled pen; 40 mg/0.4 mL injection, pre-filled syringe) has had a change to include a new biosimilar for the treatment of severe Crohn’s disease; moderate to severe ulcerative colitis; severe active juvenile idiopathic arthritis; complex refractory fistulising Crohn’s disease; severe active rheumatoid arthritis; severe psoriatic arthritis; ankylosing spondylitis; severe chronic plaque psoriasis; moderate to severe hidradenitis suppurativa.

High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Olaparib (Lynparza®) (100 mg tablet, 150 mg tablet) is now listed on the PBS for the treatment of high-grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Chronic lymphocytic leukaemia or small lymphocytic lymphoma

Acalabrutinib (Calquence®) (100 mg tablet) is now listed on the PBS for the treatment of chronic lymphocytic leukaemia or small lymphocytic lymphoma. Ibrutinib, venetoclax and zanubrutinib also have had amendments to the existing listing. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Relapsed/refractory multiple myeloma

Pomalidomide (Pomolide™) (1 mg capsule, 2 mg capsule) is now listed on the PBS for the treatment of relapsed/refractory multiple myeloma under the same circumstances as the 3 mg and 4 mg capsule listings. Authority applications for initial treatment dual therapy can be made in writing. Authority applications for initial treatment triple therapy can be made either in real-time using the Online PBS Authorities system or by telephone. Authority applications for continuing treatment can be made either in real-time using the Online PBS Authorities system or by telephone.

Stage IIIB, Stage IIIC or Stage IIID malignant melanoma

Pembrolizumab (Keytruda®) (100 mg/4 mL injection, 4 mL vial) has a change in restriction for the treatment of resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma to allow neoadjuvant treatment. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

1 January 2024 delisted PBS listings

Hypertension

Hydralazine (25 mg and 50 mg tablet) has been delisted from the PBS with a 3-month supply only arrangement.

Food absorption disorders

Medium chain triglycerides (K.Quik®) (15 x 225 mL bottle, oral liquid) has been delisted from the PBS with a 3-month supply only arrangement.

Medium chain triglycerides (MCT Pro-Cal®) (30 x 16 g sachet, powder for oral liquid) has been delisted from the PBS with a 3-month supply only arrangement.

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

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