Insights from the agenda for the November 2018 PBAC meeting

MAESTrO Database

24 August 2018 - The PBAC will consider 51 submissions at its next scheduled meeting in November.

51 is the lowest submission count since the 2017/1 meeting (40 submissions).  The average number of submissions considered by the PBAC at each scheduled meeting since 2012 is 55.

30 (59%) of the 51 submissions are major submissions.  The average number of major submissions considered by the PBAC at each scheduled meeting since 2012 is 30.

40 (78%) of the 51 submissions are initial submissions. The average number of major submissions considered by the PBAC at each scheduled meeting since 2012 is 40.

Four of the 51 submissions are for an orphan drug.

Only one of the 51 submissions is associated with a co-dependent technology.

The TGA-PBAC parallel process remains to be popular; MAESTrO Database has estimated that 14 of the 51 submissions have been lodged under the TGA-PBAC parallel process. One the 14 submissions is for sarilumab (Kevzara) for use by patients with rheumatoid arthritis. The initial submission to the TGA for sarilumab was withdrawn. Another parallel process submission is for romosozumab (Evenity) for use by patients with osteoporosis. Romozoumab is yet to be approved by the FDA and the EMA.

The minor submission from Amgen for carfilzomib (Kyprolis) is interesting insofar as it is seeking a change to the PBS restrictions  for another medicine (pomalidomide; Pomalyst).

Only one of the 51 submissions is for a new biosimilar medicine.

Six of the 51 submissions are for a programmed death receptor-1 (PD-1) antagonist. The PBAC considered six submissions for a PD-1 antagonist in July and just two in March. To date, the PBAC has considered 36 submissions for a PD-1 antagonist.


Michael Wonder

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Michael Wonder