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New and amended PBS listings and FAQs (March 2024)

Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 01 March 2024. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities system are 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.

Pre-symptomatic spinal muscular atrophy
Nusinersen (Spinraza®) (12 mg/ 5 mL intrathecal injection, 5 mL vial) has had a change to the restriction for the treatment of pre-symptomatic spinal muscular atrophy to include treatment of individuals with three copies of the survival motor neuron 2 gene. Authority applications for initial treatment 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.

Metastatic castration sensitive carcinoma of the prostate
Abiraterone (&) methylprednisolone (Yonsa Mpred®) (Pack containing abiraterone acetate 125 mg 120 tablets and methylprednisolone 4 mg 30 tablets) is now listed on the PBS for the treatment of metastatic castration sensitive carcinoma of the prostate. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Chronic lymphocytic leukaemia or small lymphocytic lymphoma; mantle cell lymphoma
Ibrutinib (Imbruvica®) (280 mg tablet; 420 mg tablet; 560 mg tablet) has had three new medicinal product packs added to the existing 140 mg capsule product pack for the treatment of chronic lymphocytic leukaemia or small lymphocytic lymphoma; mantle cell lymphoma. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Rheumatological conditions
Methotrexate (Methoblastin®, DBL Methotrexate®, Trexject®, Chexate®) (2.5 mg tablet; 10 mg tablet; injection 5 mg in 2 mL vial; injection 50 mg in 2 mL vial; injection 7.5 mg in 0.15 mL pre-filled syringe; injection 10 mg in 0.2 mL pre-filled syringe; injection 15 mg in 0.3 mL pre-filled syringe; injection 20 mg in 0.4 mL pre-filled syringe; injection 25 mg in 0.5 mL pre-filled syringe) has had a change to the restriction to include nurse practitioners as eligible prescribers.

Chronic heart failure
Dapagliflozin (Forxiga®) (10 mg tablet) is now listed on the PBS for the treatment of chronic heart failure where the patient has a left ventricular ejection fraction of greater than 40%. Prescriptions for treatment are Authority Required (STREAMLINED).

SARS-CoV-2 infection
Molnupiravir (Lagevrio®) (200 mg capsule) and nirmatrelvir (&) ritonavir (Paxlovid®) (nirmatrelvir 150 mg tablet (&) ritonavir 100 mg tablet) have had amendments to the existing listings for the treatment of SARS-CoV-2 infection. Prescriptions for treatment are Authority Required (STREAMLINED).

Severe pain
Hydromorphone hydrochloride (pms-HYDROmorphone®) (1 mg/mL oral liquid, 500 mL) for the treatment of severe pain is now listed on the PBS for the current supply shortage under Section 19A. Hydromorphone is listed as an Authority Required (STREAMLINED) benefit and as a restricted benefit.

Morphine hydrochloride trihydrate (Morphini HCl Streuli®) (10 mg/mL oral liquid, 20 mL) for the treatment of severe pain is now listed on the PBS for the current supply shortage under Section 19A. Morphine is listed as an Authority Required (STREAMLINED) benefit and as a restricted benefit.

More information

• 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.
• Frequently asked questions