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

Myelodysplastic syndrome

Azacitidine has a change in the Authority level to existing listings for the treatment of myelodysplastic syndrome & 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.

Severe active rheumatoid arthritis

Abatacept (Orencia®) 125 mg in 1 ml pre-filled pen is a new temporary S19A PBS listing for the treatment of severe active rheumatoid arthritis. Authority applications for initial and continuing treatments can be made in writing.

Solid tumours with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion

Larotrectinib (Vitrakvi®) has multiple strengths and forms now listed on the PBS for the treatment of solid tumours with confirmed NTRK gene fusion. Authority applications for initial treatment 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.

Metastatic (Stage IV) HER2 positive breast cancer

Trastuzumab emtansine (Kadcyla®) and pertuzumab (Perjeta®) various strengths have a change in the Authority level to existing listings for the treatment of metastatic (Stage IV) HER2 positive breast cancer. Authority applications for initial and continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Acute myeloid leukaemia

Azacitidine has a change in the Authority level to existing listing for the treatment of myelodysplastic syndrome & acute myeloid leukaemia. Authority applications for initial treatment can be made either in real time using the Online PBS Authorities system or by telephone. Authority applications for continuing treatment is Authority Required (STREAMLINED).

Waldenstrom macroglobulinemia

Zanubrutinib (Brukinsa®) 80 mg capsule is now listed on the PBS for the treatment of Waldenstrom macroglobulinaemia. Authority applications for initial and continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Lambert-Eaton myasthenic syndrome

Amifampridine (Ruzurgi®) 10 mg tablet is now listed on the PBS for the treatment of Lambert-Eaton myasthenic syndrome. Authority applications for initial and continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Moderate to severe ulcerative colitis – adult

The Grandfather clause for tofacitinib (Xeljanz®) 10 mg & 5 mg capsules for the treatment of moderate to severe ulcerative colitis for adults has been removed.

Major depression & nocturnal enuresis

Imipramine 25 mg tablet is now temporarily listed on the PBS as a S19A listing under unrestricted benefit for the treatment of major depression & nocturnal enuresis.

1 July 2022 delisted PBS listings

Dantrolene (Dantrium®)

Dantrolene 50 mg capsule has been delisted from the PBS due to product discontinuation.

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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