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

Moderate to severe chronic pouchitis

Vedolizumab (Entyvio®) (300 mg injection) is now listed on the PBS for the treatment of moderate to severe chronic pouchitis. Authority applications for initial, recommencement and grandfather treatments 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.

Severe Crohn's disease

Upadacitinib (Rinvoq®) (15 mg tablet; 30 mg tablet; 45 mg tablet) for the treatment of severe Crohn's disease has had an amendment to remove the grandfather restriction. Authority applications for initial and continuing treatments can be made in writing.

Acute myeloid leukaemia (AML)

Daunorubicin + cytarabine (Vyxeos®) (daunorubicin hydrochloride 44 mg + cytarabine 100 mg injection) is now listed under the Efficient Funding of Chemotherapy (EFC) Program on the PBS, instead of the Highly Specialised Drugs (HSD) Program, for the treatment of AML. Authority applications for induction therapy and consolidation therapy can be made either in real-time using the Online PBS Authorities system or by telephone.

Androgen deficiency; micropenis; pubertal induction; constitutional delay of growth or puberty

Testosterone

(AndroForte® 5) (testosterone 5% (50 mg/mL) cream, 50 mL) has had a change to the restrictions to allow for non-scrotal application. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Attention deficit hyperactivity disorder

Lisdexamfetamine (Vyvanse®) and methylphenidate (Concerta®; METHYLPHENIDATE-TEVA XR®; Methylphenidate XR ARXO®; Ritalin LA®; Rubifen LA®) have had updates to the restrictions. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Von Hippel-Lindau (VHL) disease

Belzutifan (Welireg®) (40 mg tablet) is now listed on the PBS for the treatment of Von Hippel-Lindau (VHL) disease. Authority applications for initial, recommencing, grandfather and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Unresectable Stage III or Stage IV malignant melanoma

Nivolumab + relatlimab (Opdualag®) (nivolumab 240 mg/20 mL + relatlimab 80 mg/20 mL injection, 20mL vial) is now listed under the Efficient Funding of Chemotherapy (EFC) Program on the PBS, instead of the Highly Specialised Drugs (HSD) Program, for the treatment of unresectable Stage III or Stage IV malignant melanoma. Prescriptions for treatment are Authority required (STREAMLINED).

Endometriosis

Dienogest (Visanne®) (2 mg tablet) is now listed on the PBS for the treatment of endometriosis. Prescriptions for treatment are Authority required (STREAMLINED).

Epilepsy; Palliative care

Clonazepam (Clonazepam USP (Advagen PharMa, USA)®) (2 mg tablet) for the treatment of epilepsy and for palliative care is now listed on the PBS for the current supply shortage under Section 19A. Authority applications for the treatment of epilepsy can be made either in real-time using the Online PBS Authorities system or by telephone. Clonazepam is listed as a restricted benefit for use in patients receiving palliative care.

Hypercholesterolaemia

Ezetimibe (Ezetimibe USP (Camber, USA)®) (10 mg tablet) for the treatment of hypercholesterolaemia is now listed on the PBS for the current supply shortage under Section 19A. Ezetimibe is listed as an unrestricted and restricted benefit.

Chemotherapy and inflammatory conditions

Methotrexate (Methoblastin®) (10 mg tablet) 10 tablet pack size is now listed on the PBS for the treatment of chemotherapy and inflammatory conditions. It is listed as an unrestricted benefit.

Hypercholesterolaemia 

Ezetimibe and ezetimibe+statin fixed dose combination listings (various brands) have had amendments to the restriction level from Authority required (STREAMLINED) to unrestricted benefit, and 60 Day Prescription items have been amended to restricted benefit.

1 December 2024 delisted PBS listings

Relapsed and/or refractory multiple

myeloma

Elotuzumab (EmpIiciti®) (300 mg injection; 400 mg injection) has had its initial item code delisted from the PBS with no supply only arrangement. Continuing treatment with elotuzumab is only available through the PBS for existing eligible patients from 1 December 2024.

Severe dry eye syndrome

Carmellose sodium (Refresh Liquigel®) (1% eye drops, 15 mL) has been delisted from the PBS with a 2 month supply only arrangement.

Carmellose sodium (Refresh Tears Plus®) (0.5% eye drops, 15 mL) has been delisted from the PBS with a 2 month supply only arrangement.

Carmellose sodium + glycerol (Optive®) (carmellose sodium 0.5% + glycerol 0.9% eye drops, 15 mL) has been delisted from the PBS with a 2 month supply only arrangement.

Febrile neutropenia

Cefepime (Cefepime Kabi® (1 g & 2 g injection) has been delisted from the PBS with no supply only arrangement.

Familial homozygous hypercholesterolaemia; familial heterozygous hypercholesterolaemia; non-familial

hypercholesterolaemia

Evolocumab (Repatha@) (420 mg/3.5 mL injection, 3.5 mL cartridge) has been delisted from the PBS with a 6 month supply only arrangement.

For more information about the Online PBS Authorities system visit www.servicesaustralia.gov.au/hppbsauthorities.

Services Australia has a broad range of educational resources on the Health Professional Education Resources website. This includes simulations, podcast and an infographic on the Online PBS Authorities system. Visit https://hpe.servicesaustralia.gov.au/pharmaceutical-benefits-scheme.html.

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.

For more information go to servicesaustralia.gov.au/hpos. To learn more about these updates, please contact Services Australia directly.

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