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

Chronic myeloid leukaemia

There are changes to the restriction levels for dasatinib and nilotinib listed under the PBS for chronic myeloid leukaemia (CML). There have been no changes to the restriction levels of imatinib and ponatinib. Additional information regarding these changes is attached.

Dasatinib (Sprycel®) 20mg, 50mg, 70mg and 100mg tablets will continue to be PBS listed for the treatment of CML. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or by telephone. Continuing treatment is Authority Required (STREAMLINED).

Imatinib 100mg and 400mg tablets and capsules will continue to be PBS listed for the treatment of CML. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or by telephone. First continuing and subsequent continuing restrictions have been merged and continuing treatment is Authority Required (STREAMLINED).

Nilotinib (Tasigna®) 150mg and 200mg capsules will continue to be PBS listed for the treatment of CML. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or by telephone. Continuing treatment is Authority Required (STREAMLINED).

Paroxysmal nocturnal haemoglobinuria

Ravulizumab (Ultomiris®) I.V. infusion 300mg/3mL and 1100mg/11mL vial and Eculizumab (Soliris®) I.V. infusion 300mg/30mL vial are now listed on the PBS for paroxysmal nocturnal haemoglobinuria. Authority applications for initial, grandfather and continuing treatment can be made in writing.

Rheumatoid arthritis; plaque psoriasis; ankylosing spondylitis; psoriatic arthritis; juvenile idiopathic arthritis; paediatric plaque psoriasis

Etanercept (Enbrel®) injection 50mg 1mL single use dose-dispenser cartridge is now available on the PBS. Authority applications for initial and continuing treatment can be made in writing.

Acute myeloid leukaemia

Gemtuzumab ozogamicin (Mylotarg®) 5mg powder for injection is now PBS listed for the treatment of acute myeloid leukaemia. Authority applications for initial and continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Relapsed and/or refractory mantle cell lymphoma

Zanubrutinib (Brukinsa®) is now PBS listed for the treatment of relapsed and/or refractory mantle cell lymphoma. Authority applications for initial and continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Familial heterozygous hypercholesterolaemia; Non-familial hypercholesterolaemia; Familial homozygous hypercholesterolaemia

Evolocumab (Repatha®) has a design change to the automated mini-doser used in the administration of the 420mg in 3.5mL single use pre-filled cartridge. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or by telephone. Continuing treatment is Authority Required (STREAMLINED).

Steroid-refractory and steroid-intolerant chronic graft versus host disease

Methoxsalen (Uvadex®) is now PBS listed for steroid-refractory and steroid-intolerant chronic graft versus host disease in adults. Initial and continuing treatment are Authority Required (STREAMLINED).

SARS-CoV-2 infection

Molnupiravir (Lagevrio®) is now PBS listed for the treatment of SARS-CoV-2 infection. Treatment is Authority Required (STREAMLINED). For further information regarding patient eligibility, please visit the PBS website.

Infertility; Assisted Reproductive Technology

Human chorionic gonadotrophin (Brevactid®) is now PBS listed for the treatment of infertility as a Restricted Benefit. It is also now PBS listed for use in Assisted Reproductive Technology. Treatment is Authority Required (STREAMLINED).

Human chorionic gonadotrophin (Choriomon®) is now PBS listed for use in Assisted Reproductive Technology. Treatment is Authority Required (STREAMLINED).

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

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