2 September 2022 - The agenda for the November 2022 PBAC meeting has been updated. 

A summary of changes to the agenda is provided at the end of the document.

Submissions for the following medicines or medicinal preparations have been added or revised:

• Adalimumab (Humira) and upadacitinib monohydrate (Rinvoq) – Restriction changes
• Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids, medium chain triglycerides and 2- fucosyllactose and lacto-neotetrose (Alfamino) – revised brand name
  
• Asciminib hydrochloride (Scemblix) – new resubmission
• Dupilumab (Dupixient) – revised submission purpose
• Enfortumab vedotin (Padcev) – new resubmission
• Midazolam (Zyamis) – new resubmission
• Nivolumab (Opdivo) –  new resubmission
• Olaparib (Lynparza) – new resubmission
• Ranibizumab (Susvimo) – new resubmission (initial submission was withdrawn)

Insights:

• At its March 2022 meeting, the PBAC rejected the submission for enfortumab vedotin and proposed an Early re-entry resubmission for the July 2022 meeting. The current resubmission does not meet the criteria for an Early re-entry resubmission as there is an intervening meeting cycle; but it also doesn't meet the criteria for a Standard re-entry resubmission, as it was not included in the first agenda for the November 2022 meeting. Something is amiss here.
• There is no submission for tezepelumab (Tezspire) - the short minutes from the July 2022 meeting stated that it would be considered at a future meeting.
• There is no submission for roxadustat (Evenzo) - the initial submission was withdrawn from the agenda for the March 2021 meeting. We are yet to see any sign of its registration by the TGA.
• There isn't a resubmission for sebelipase alfa (Kanuma) - will we see another submission? Perhaps the next visible step will be a listing on the LSDP.
• There isn't a resubmission for semaglutide (Wegovy) for obesity.  We are watching this space closely.

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