In response to an application by CSL Seqirus to the Pharmaceutical Benefits Advisory Committee (PBAC), the Pharmaceutical Benefits Scheme (PBS) listing of Tavneos^® (avacopan) that was recommended by the PBAC in March 2024 has come into effect on 1 October 2024. This listing was supported by a submission from ASCIA.

The Authority PBS listing of Tavneos^® (avacopan) is for anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis.

Treatment Phase: Induction treatment Clinical criteria:

• The condition must be severe granulomatosis with polyangiitis; OR

• The condition must be severe microscopic polyangiitis, AND

• The condition must be active at the time of the first prescription for this drug per treatment cycle, AND

• Patient must have ANCA associated vasculitis that is either: (i) organ-threatening, (ii) life-threatening disease, AND

• Patient must be undergoing concomitant therapy with at least another drug therapy as part of a regimen specified in this drug's approved Product Information, AND

• Patient must not receive more than 12 months of PBS-subsidised treatment with this drug per induction.

A prescriber may apply for more than one induction treatment for their patient avacopan 10 mg capsule,

More information is available on the PBS website https://www.pbs.gov.au/medicine/item/14605Q

This news item was issued on 3 October 2024 by Jill Smith, CEO of ASCIA, the peak professional body for clinical immunology and allergy in Australia and New Zealand.