Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1^st November 2022. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities system is also attached.

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. 

Diabetic macular oedema and retinal vein occlusion

Aflibercept (Eylea®), dexamethasone implant (Ozurdex®) and ranibizumab (Lucentis®) have had a change of authority level for the treatment of diabetic macular oedema and retinal vein occlusion. Authority applications for aflibercept, dexamethasone implant and ranibizumab for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatments is streamlined.

Subfoveal choroidal neovascularisation

Aflibercept (Eylea®), ranibizumab (Lucentis®) and brolucizumab (Beovu®) have had a change of authority level for the treatment of subfoveal choroidal neovascularisation. Authority applications for aflibercept, ranibizumab and brolucizumab for initial treatment can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatments for aflibercept and ranibizumab is now streamlined. There is no change to the continuing treatment authority level for brolucizumab.

Idiopathic pulmonary fibrosis

Nintedanib (Ofev®) and pirfenidone (Esbriet®) have had a change of authority level for the treatment of idiopathic pulmonary fibrosis. Authority applications for nintedanib and pirfenidone for initial treatment 1 (new patient) can be made either in real time using the Online PBS Authorities system or in writing.

Progressive fibrosing interstitial lung disease

Nintedanib (Ofev®) has had a change of authority level for the treatment of progressive fibrosing interstitial lung disease. Authority applications for nintedanib for initial and grandfather treatments can be made either in real time using the Online PBS Authorities system or in writing.

Myelodysplastic syndrome

Lenalidomide (Revlimid®) has had a change to the cautionary note for the treatment of myelodysplastic syndrome.

Growth hormone deficiency (paediatric)

Somatropin (all brands, forms and strengths) has had a change to the population criteria, and has a new treatment phase for the treatment of paediatric growth hormone deficiency to allow patients to switch from somatrogon for the same indication. Authority applications for somatropin for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or in writing.

X-linked hypophosphataemia

Burosumab (Crysvita®) (injection 10 mg in 1 mL, injection 20 mg in 1 mL, injection 30 mg in 1 mL) is now listed on the PBS for the treatment of X-linked hypophosphataemia. Authority applications for burosumab for initial, grandfather and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Locally advanced or metastatic breast cancer

Abemaciclib (Verzenio®) (50 mg tablet, 56, 100 mg tablet, 56, 150 mg tablet, 56) has had a change to remove the grandfather restriction.

Metastatic or locally advanced cutaneous squamous cell carcinoma

Cemiplimab (Libtayo®) (Solution for I.V. infusion 350 mg in 7 mL) is now listed on the PBS for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma. Authority applications for cemiplimab for initial, grandfather and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Metastatic non-small cell lung cancer

Cemiplimab (Libtayo®) (Solution for I.V. infusion 350 mg in 7 mL) is now listed on the PBS for the treatment of metastatic non-small cell lung cancer. Authority applications for initial and continuing treatments for cemiplimab is streamlined.

Metastatic or locally advanced non-small cell lung cancer

Tepotinib (Tepmetko®) (Tablet 225 mg (as hydrochloride monohydrate)) is now listed on the PBS for the treatment of metastatic or locally advanced non-small cell lung cancer. Authority applications for initial and continuing treatments for tepotinib is streamlined.

Central precocious puberty

Triptorelin (Diphereline®) (22.5 mg injection [1 vial] (&) inert substance diluent [2 mL ampoule], 1 pack) has had a change to remove the grandfather restriction.

Assisted reproductive technology

All IVF listings have had a change to the admin advice for the treatment of assisted reproductive technology. No requests for increased repeats will be authorised. Authority applications for initial and continuing treatments is streamlined.

Antivirals – treatment of SARS-CoV-2 infection

Molnupiravir (Lagevrio®) and nirmatrelvir + ritonavir (Paxlovid®) have had an amendment to the existing listings for Aboriginal and Torres Strait Islanders aged 30 years and older at high risk of SARS-CoV-2 infection. The number of risk factors for these patients to be considered ‘high risk’ has reduced from two (2) to one (1). Authority applications for initial and continuing treatments is streamlined.

Molnupiravir (Lagevrio®) and nirmatrelvir + ritonavir (Paxlovid®) can now be requested on a prescriber bag supply order form. Prescribers may order a maximum quantity of two (2) packs of each item once per month provided they do not already have the maximum quantity of two (2) packs on hand.

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Atezolizumab (Tecentriq®) has had a change to remove the grandfather restriction.

Resected stage II to IIIA non-small cell lung cancer

Atezolizumab (Tecentriq®) (solution concentrate for I.V. infusion 840 mg in 14 mL, solution concentrate for I.V. infusion 1200 mg in 20 mL) is now listed on the PBS for the treatment of resected stage II to IIIA non-small cell lung cancer. Authority applications for initial and continuing treatments is streamlined.

Depression

Phenelzine (Nardil®) (phenelzine sulfate tablets USP, 15 mg (Canada) 60 tablets) is now listed on the PBS for the current supply shortage under section 19a.

Myasthenia gravis

Pyridostigmine (pyridostigmine bromide 180 mg extended-release 30 tablets (Rising Pharmaceuticals)) is now listed on the PBS for the current supply shortage under section 19a.

Unrestricted benefitBevacizumab (Bevaciptin®) (solution for I.V. infusion 100 mg in 4 mL, solution for I.V. infusion 400 mg in 16 mL) is now listed on the PBS as an unrestricted benefit.

1 November 2022 delisted PBS listings

Triglycerides medium chain formula (Nutrini peptisorb®) (8 x 500 mL pouches) for dietary management of conditions requiring a source of medium chain triglycerides 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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