PBS Changes 1 August

Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1 August 2024. For further information, please download the Frequently Asked Questions.

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 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 (Abrilada®) (20 mg/0.4 mL injection, 2 x 0.4 mL syringes; 40 mg/0.8 mL injection, 2 x 0.8 mL syringes; 40 mg/0.8 mL injection, 2 x 0.8 mL pen devices) is a new biosimilar now listed on the PBS 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.

Cystic fibrosis

Elexacaftor + tezacaftor + ivacaftor (&) ivacaftor (Trikafta®) (pack containing elexacaftor 100 mg + tezacaftor 50 mg + ivacaftor 75 mg granules [28] (&) ivacaftor 75 mg granules [28], 56 sachets; pack containing elexacaftor 80 mg + tezacaftor 40 mg + ivacaftor 60 mg granules [28] (&) ivacaftor 59.5 mg granules [28], 56 sachets) is now listed on the PBS for the treatment of cystic fibrosis. Authority applications for initial and continuing treatments can be made in writing.

Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion

Larotrectinib (Vitrakvi®) (25 mg capsule; 100 mg capsule; 20 mg/mL oral liquid, 2 x 50 mL) is now listed on the PBS for the treatment of solid tumours (of certain specified types) with confirmed NTRK gene fusion (locally advanced or metastatic non-small cell lung cancer (NSCLC), soft tissue sarcoma, glioma, glioneuronal tumour or glioblastoma). Authority applications for initial and grandfather treatments 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.

Neurofibromatosis type 1

Selumetinib (Koselugo®) (10 mg capsule; 25 mg capsule) is now listed on the PBS for the treatment of neurofibromatosis type 1. Authority applications for initial and grandfather treatments 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.

Hereditary transthyretin amyloidosis

Patisiran (Onpattro®) (10 mg/5 mL injection, 5 mL vial) is now listed on the PBS for the treatment of hereditary transthyretin amyloidosis. Authority applications for initial, grandfather and continuing treatments can be made either in real-time using the Online PBS Authorities system or in writing.

Vision threatening non-infectious uveitis

Adalimumab (20 mg/0.2 mL injection, 2 x 0.2 mL syringes; 40 mg/0.4 mL injection, 2 x 0.4 mL pen devices; 40 mg/0.8 mL injection, 2 x 0.8 mL pen devices; 40 mg/0.8 mL injection, 2 x 0.8 mL syringes) is now listed on the PBS for the treatment of vision threatening non-infectious uveitis. Authority applications for initial treatment can be made either in real-time using the Online PBS Authorities system or in writing. Authority applications for recommencement, grandfather, continuing (originator brand) treatments and balance of supply can be made either in real-time using the Online PBS Authorities system or by telephone. Prescriptions for continuing (biosimilar brands only) treatment are Authority required (STREAMLINED).

Pulmonary arterial hypertension (PAH)

Tadalafil (Tadalis 20®) (20 mg tablet) is now listed on the PBS for the treatment of PAH. Authority applications for initial mono, dual and triple therapy (excluding selexipag) can be made either in real-time using the Online PBS Authorities system or in writing. Applications for initial triple therapy (including selexipag) can be made either in real-time using the Online PBS Authorities system or by telephone. Authority applications transitioning to dual or triple therapy after receiving PBS-subsidised monotherapy, changing PAH agents after prior PBS-subsidised mono, dual or triple therapy and continuing treatment can be made either in real-time using the Online PBS Authorities system or by telephone.

Spinal muscular atrophy (SMA)

Onasemnogene abeparvovec (Zolgensma®) has had a change to the restriction to allow for separate switch listings for patients with pre-symptomatic SMA with 1-2 copies of the survival motor neuron 2 (SMN2) gene and for patients with pre-symptomatic SMA 3 copies of the SMN2 gene. Authority applications for treatment can be made in writing.

Generalized convulsive status epilepticus

Midazolam (Zyamis®) (5 mg/0.5 mL oral liquid, 0.5 mL syringe; 7.5 mg/0.75 mL oral liquid, 0.75 mL syringe; 10 mg/mL oral liquid, 1 mL syringe) is now listed on the PBS for the treatment of generalized convulsive status epilepticus. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Urothelial carcinoma

Nivolumab (Opdivo®) (40 mg/4 mL injection, 4 mL vial; 100 mg/10 mL injection, 10 mL vial) is now listed on the PBS for the treatment of muscle invasive urothelial carcinoma. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Relapsed or refractory Acute Myeloid Leukaemia (AML)

Gilteritinib (Xospata®) (40 mg tablet) has had a change to the clinical criteria to clarify that patients must not be undergoing or have undergone a stem cell transplant since initiating treatment. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Resectable non-small cell lung cancer (NSCLC) 

Nivolumab (Opdivo®) (40 mg/4 mL injection, 4 mL vial; 100 mg/10 mL injection, 10 mL vial) is now listed on the PBS for the neoadjuvant treatment of resectable NSCLC. Prescriptions for  treatment are Authority required (STREAMLINED).

Chronic heart failure

Empagliflozin (Jardiance®) (10 mg tablet) is listed on the PBS for the treatment of chronic heart failure and a change to the listings to allow prescribing by nurse practitioners in a Shared Care Model. Prescriptions for treatment are Authority required (STREAMLINED).

Locally advanced or metastatic non-small cell lung cancer (NSCLC); Stage IV (metastatic) NSCLC; extensive-stage small cell lung cancer; advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma; resected early stage (Stage II to IIIA) NSCLC

Atezolizumab (Tecentriq SC®)  (1.875 g/15 mL injection, 15 mL vial is now listed on the PBS for the treatment of locally advanced or metastatic NSCLC; Stage IV (metastatic) NSCLC; extensive-stage small cell lung cancer; advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma; resected early stage (Stage II to IIIA) NSCLC. Prescriptions for initial and continuing treatments are Authority required (STREAMLINED).

Locally advanced or metastatic differentiated thyroid cancer

Cabozantinib (Cabometyx®) (20 mg tablet; 40 mg tablet; 60 mg tablet) is now listed on the PBS for the treatment of locally advanced or metastatic differentiated thyroid cancer. Prescriptions for initial, grandfather and continuing treatments are Authority required (STREAMLINED).

Asthma

Beclometasone + formoterol (Fostair®) (beclometasone dipropionate 100 microgram/actuation + formoterol fumarate dihydrate 6 microgram/actuation inhalation, 120 actuations) is now listed on the PBS for the treatment of asthma. Prescriptions for treatment are Authority required (STREAMLINED).

Phenylketonuria

Amino acid formula with vitamins and minerals without phenylalanine (PKU Lophlex Select LQ®) (oral liquid, 30 x 125 mL pouches) is now listed on the PBS for the treatment of phenylketonuria. It is listed as a restricted benefit.

Scabies

Permethrin (Permethrin Cream 5% w/w (Encube Ethicals, USA®)) is now listed on the PBS for the current supply shortage under Section 19A. It is listed as an unrestricted benefit.

Elevated intraocular pressure

Timolol (Timoptol XE 0.50% (South Africa)®) (0.5% eye drops, 2.5 mL) is now listed on the PBS for the current supply shortage under Section 19A. It is listed as an unrestricted benefit.

Delisted PBS Listings 1 August 2024

Familial heterozygous hypercholesterolaemia; non-familial hypercholesterolaemia

Alirocumab (Praluent®) (75 mg/mL injection 2 x 1 mL pen devices; 150 mg/mL injection 2 x 1 mL pen devices) has been delisted from the PBS with a 6 month supply only arrangement.

Various indications relating to combined allergy to cow's milk protein and soy protein, protracted diarrhoea, cystic fibrosis, enterokinase deficiency, biliary atresia, maldigestion and malabsorptive disorders

Protein hydrolysate formula with medium chain triglycerides (Alfare®) (powder for oral liquid, 400g) has been delisted from the PBS with a 12 month supply only arrangement.

Bacterial infections

Ceftriaxone (Ceftriaxone Viatris®) (1g injection, 5 vials) has been delisted from the PBS with no supply only arrangement.

Eye inflammation

Fluorometholone (FML Liquifilm®) (0.1% eye drops, 5 mL) has been delisted from the PBS with a 6 month supply only arrangement.

Megaloblastic anaemias; folinic acid rescue

Folinic Acid (Leucovorin Calcium (Pfizer Australia Pty Ltd)®) (100 mg/10 mL injection, 10 x 10 mL ampoules) has been delisted from the PBS with no supply only arrangement.

Elevated intraocular pressure

Tafluprost (Saflutan®) (0.0015% eye drops, 30 x 0.3 mL ampoules) has been delisted from the PBS with no supply only arrangement.

Diabetes mellitus

Insulin neutral human + insulin isophane human (Mixtard 30/70 InnoLet®) (insulin neutral human 30 units/mL + insulin isophane human 70 units/mL injection, 5 x 3 mL pen devices) has been delisted from the PBS with a 3 month supply only arrangement.

Update on Melatonin - 1 July 2024 PBS Listing

We have received several enquiries from prescribers in regards to the intent of the continuing treatment with PBS-subsidised melatonin for insomnia.

As the clinical criteria for continuing treatment states that “Patient must have previously received PBS-subsidised treatment with this drug for this condition”, patients requiring continuing treatment would be expected to have Smith-Magenis Syndrome confirmed by genetic testing, as per the initial treatment clinical criteria for the treatment of insomnia with melatonin.

More Information

For more information about the Online PBS Authorities system visit the Services Australia website.

Services Australia has a broad range of educational resources on the Health Professional Education Resources website. This includes simulations, podcasts, and an infographic on the Online PBS Authorities system. 

Visit the Services Australia website to find the most up-to-date authority application form for each drug, program or condition.