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

Systemic lupus erythematosus (SLE)

Anifrolumab (Saphnelo®) (300 mg 2 mL injection, 2 mL vial) is now listed on the PBS for the treatment of SLE. Authority applications for initial and grandfather treatments can be made in writing. Continuing and recommencement treatments can be made in real-time using the Online PBS Authorities system or by telephone.

Severe chronic immune (idiopathic) thrombocytopenic purpura (ITP)

Avatrombopag (Doptelet®) (20 mg tablet) has had an amendment to remove the grandfather restriction. Authority applications for initial treatment can be made either in real-time using the Online PBS Authorities system or in writing. Authority applications for first continuing or re-initiation of interrupted continuing treatments, second or subsequent continuing treatments and balance of supply or change of therapy can be made in real-time using the Online PBS Authorities system or by telephone.

Transthyretin amyloid cardiomyopathy

Tafamidis (Vyndamax®) (61 mg capsule) has had an update to the restriction for the treatment of transthyretin amyloid cardiomyopathy. 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.

Uncontrolled severe asthma & uncontrolled severe allergic asthma

Omalizumab (Xolair®) (75 mg/0.5 mL injection, 0.5 mL syringe; 150 mg/mL injection, 1 mL syringe) has had a change in authority level for continuing treatment of uncontrolled severe asthma & uncontrolled severe allergic asthma. Authority applications for initial treatment can be made in writing. Authority applications for continuing treatment can now be made either in real-time using the Online PBS Authorities system or by telephone.

Acute myeloid leukaemia (AML)

Daunorubicin + cytarabine (Vyxeos®) (daunorubicin hydrochloride 44 mg + cytarabine 100 mg injection, 1 vial) is now listed on the PBS for the treatment of AML. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Insomnia

Melatonin (Slenyto®) (1 mg modified release tablet; 5 mg modified release tablet) is now listed on the PBS for the treatment of insomnia in patients with Smith-Magenis Syndrome. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Early breast cancer

Olaparib (Lynparza®) (100 mg tablet; 150 mg tablet) is now listed on the PBS for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2) negative early breast cancer. Authority applications for initial and continuing treatments can be made in real-time using the Online PBS Authorities system or by telephone.

Cows’ milk protein enteropathy; Severe cows' milk protein enteropathy with failure to thrive; Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae; Proven combined immunoglobulin (IgE) mediated allergy to cows' milk protein and soy protein; Cows' milk anaphylaxis; Severe intestinal malabsorption including short bowel syndrome; Eosinophilic oesophagitis

Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids (Neocate® Syneo) (powder for oral liquid, 400 g) is now listed on the PBS for the treatment of cows’ milk protein enteropathy; severe cows' milk protein enteropathy with failure to thrive; combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae; proven combined immunoglobulin (IgE) mediated allergy to cows' milk protein and soy protein; cows' milk anaphylaxis; severe intestinal malabsorption including short bowel syndrome; eosinophilic oesophagitis. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Familial heterozygous hypercholesterolaemia & non-familial hypercholesterolaemia

Inclisiran (Leqvio®) (284 mL/1.5 mL injection, 1.5 mL syringe) has had a change to the restrictions for the treatment of familial heterozygous hypercholesterolaemia & non-familial hypercholesterolaemia. Authority applications for initial and grandfather treatments can be made either in real-time using the Online PBS Authorities system or by telephone. Prescriptions for continuing treatment are Authority required (STREAMLINED).

Alirocumab (Praluent®) (75 mg/mL injection, 2 x 1 mL pen devices; 150 mg/mL injection, 2 x 1 mL pen devices) has had a change to the restrictions for the treatment of familial heterozygous hypercholesterolaemia & non-familial hypercholesterolaemia. Authority applications for initial treatment can be made either in real-time using the Online PBS Authorities system or by telephone. Prescriptions for continuing treatment are Authority required (STREAMLINED).

Evolocumab (Repatha®) (140 mg/mL injection, 1 mL pen device; 420 mg/3.5 mL injection, 3.5 mL cartridge) has had a change to the restrictions and a change in authority level for the treatment of familial heterozygous hypercholesterolaemia, non-familial hypercholesterolaemia & familial homozygous hypercholesterolaemia. Prescriptions for initial and continuing treatments are now both Authority required (STREAMLINED).

Relapsed and/or refractory multiple myeloma

Selinexor (Xpovio®) (20 mg tablet) has had an amendment to remove the grandfather restriction. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone.

Opioid dependence

There has had a change to the existing listings of opioid dependence treatment medicines (buprenorphine, buprenorphine + naloxone, methadone). The maximum number of repeats has increased from 2 to 5 to provide up to six months’ treatment per prescription. Prescriptions for treatment are Authority required (STREAMLINED).

Advanced, metastatic or recurrent endometrial carcinoma

Lenvatinib (Lenvima®) (4 mg capsule; 10 mg capsule) has had an amendment to remove the grandfather restriction. Prescriptions for initial and continuing treatments are Authority required (STREAMLINED).

Pembrolizumab (Keytruda®) (100 mg/4 mL injection, 4 mL vial) has had an amendment to remove the grandfather restriction. Prescriptions for initial and continuing treatments are Authority required (STREAMLINED).

Metastatic colorectal cancer

Cetuximab (Erbitux®) (100 mg/20 mL injection, 20 mL vial; 500 mg/100 mL injection, 100 mL vial) has had a change to the restriction for the treatment of metastatic colorectal cancer. Prescriptions for initial and continuing treatments are Authority required (STREAMLINED).

Phenylketonuria

Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine (PKU Start®) (powder for oral liquid, 400 g) is now listed on the PBS for the treatment of phenylketonuria. It is listed as a restricted benefit.

Severe pain

Morphine hydrochloride trihydrate (RA-Morph®) (5 mg/mL oral liquid, 200 mL; 10 mg/mL oral liquid, 200 mL) for severe pain is now listed on the PBS for the current supply shortage under Section 19A. Morphine hydrochloride trihydrate is listed as a restricted benefit and Authority required (STREAMLINED).

Vasoactive intestinal peptide secreting tumour (VIPoma), acromegaly & functional carcinoid tumour

Octreotide (Octreotide Acetate Omega (Canada)®) (50 microgram/mL injection, 5 x 1 mL vials; 100 microgram/mL injection, 5 x 1 mL vials; 500 microgram/mL injection, 5 x 1 mL vials) for the treatment of vasoactive intestinal peptide secreting tumour (VIPoma), acromegaly & functional carcinoid tumour is now listed on the PBS for the current supply shortage under Section 19A. Octreotide is listed as Authority required (STREAMLINED).

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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