Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1^st October 2022.

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. 

Severe growth failure with primary insulin-like growth factor-1 deficiency

Mecasermin (Increlex®) (solution for injection 40 mg in 4 mL vial) is now listed on the PBS for the treatment of severe growth failure with primary insulin-like growth factor-1 deficiency. Authority applications for mecasermin for initial, grandfather and continuing treatments can be made either in real time using the Online PBS Authorities system or in writing.

Acute myeloid leukaemia, chronic myelomonocytic leukaemia and myelodysplastic syndrome

Decitabine with cedazuridine (Inqovi®) (tablet containing decitabine 35 mg + cedazuridine 100 mg) is now listed on the PBS for the treatment of acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML) and myelodysplastic syndrome (MDS). Authority applications for decitabine with cedazuridine for initial treatment of CMML can be made either in real time using the Online PBS Authorities system or in writing. Authority applications for decitabine with cedazuridine for initial treatment of AML or MDS can be made either in real time using the Online PBS Authorities system or by telephone. Continuing treatments for CMML or MDS can be made either in real time using the Online PBS Authorities system or by telephone. Continuing treatments for AML is streamlined.

Paediatric growth hormone deficiency

Somatrogon (Ngenla®) (injection 24 mg in 1.2 mL pre-filled single-use pen & injection 60 mg in 1.2 mL pre-filled single-use pen) is now listed on the PBS for the treatment of paediatric growth hormone deficiency. Authority applications for somatrogon for all treatment phases can be made either in real time using the Online PBS Authorities system or in writing.

Severe chronic plaque psoriasis

Ustekinumab (Stelara®) (injection 45 mg in 0.5 mL vial) has had a change to remove the grandfather restriction.

Ankylosing spondylitis

Upadacitinib (Rinvoq®) (tablet 15 mg) has had a change to remove the grandfather restriction.

Psoriatic arthritis

Upadacitinib (RInvoq®) (tablet 15 mg) has had a change to remove the grandfather restriction.

Subfoveal choroidal neovascularisation (CNV)

Brolucizumab (Beovu®) (120 mg/mL solution for injection in pre-filled syringe) has had a change to remove the grandfather restriction.

Castration resistant non-metastatic carcinoma of the prostate

Enzalutamide (Xtandi®) (capsule 40 mg) is now listed on the PBS for the treatment of castration resistant non-metastatic carcinoma of the prostate. Authority applications for treatment can be made in real time using the Online PBS Authorities system or by telephone.

Chelation of elevated copper levels

Trientine (Waymade®) (capsule 250 mg as dihydrochloride) is now listed on the PBS for the treatment of chelation of elevated copper levels. Authority applications for treatment can be made in real time using the Online PBS Authorities system or by telephone.

Chronic migraine

Fremanezumab (Ajovy®) (solution for injection 225 mg in 1.5 mL single dose auto-injector) is now listed on the PBS for the treatment of chronic migraines. Authority applications for initial and continuing treatments is streamlined.

Advanced or metastatic gastro-oesophageal cancers

Nivolumab (Opdivo®) (injection concentrate for I.V. infusion 40 mg in 4 mL & injection concentrate for I.V. infusion 100 mg in 10 mL) is now listed on the PBS for the treatment of advanced or metastatic gastro-oesophageal cancers. Authority applications for initial and continuing treatments is streamlined.

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx

Pembrolizumab (Keytruda®) (solution concentrate for I.V. infusion 100 mg in 4 mL) is now listed on the PBS for the treatment of recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx. Authority applications for initial and continuing treatments is streamlined.

Multiple Sclerosis

Ofatumamab has had a change to remove the grandfather treatment restriction.

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

Avelumab (Bavencio®) (solution concentrate for I.V. infusion 200 mg in 10 mL) is now listed on the PBS for the treatment of locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer. Authority applications for initial and continuing treatments is streamlined.

Acute myocardial infarction

Tenecteplase (TNKase®) (50 mg injection vial) supply shortage under section 19a.

Epilepsy

Ethosuximide (Ethosuximide Essential Generics®) (capsule 250mg) supply shortage under section 19a.

1 October 2022 delisted PBS listings

Chorionic gonadotrophin for hypogonadotrophic hypogonadism, infertility treatment has been delisted from the PBS.

Selecting the correct restriction in the Online PBS Authorities system

Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. New questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS for multiple Authority Required (Written) programs to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.

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

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