Summary of the agenda for the PBAC March 2017 meeting

MAESTrO Database

22 December 2016 - The PBAC will consider 40 submissions (23 major & 17 minor) at its next scheduled meeting in March.

The Committee will also consider five reports from the Drug Utilisation Subcommittee (DUSC) for medicines for:

  • Gastro-intestinal stromal tumour (1 medicine)
  • Breast cancer (1 medicine)
  • Tuberous sclerosis complex (1 medicine)
  • Osteoporosis (12 medicines)
  • Non-small-cell lung cancer (2 medicine)
  • Diabetes mellitus (>20 medicines)

11 of the 40 submissions are for a new medicine.

10 (25%) of the 40 submissions are resubmissions; most are for a new medicine (50%) or a new indication (30%).

Just under a quarter of all submissions are for oncology medicines.

Surprising, Vitaflo is the leading applicant.

Submissions of note:

  • The three submissions from the November 2016 meeting that do not have a published outcome (pembrolizumab (Keytruda), tolvaptan (Jinarc) and trifluridine with tipracil hydrochloride (Lonsurf) are all on the agenda which indicates they were either rejected or deferred.
  • Pfizer has lodged a minor submission to inform the PBAC of the outcome of the Managed Entry Scheme for crizotinib (Xalkori)
  • GSK has lodged a minor submission requesting the PBAC to declare fluticasone furoate (Arnuity Ellipta) as a 'drug' for the purposes of section 85(2) of the National Health Act
  •  MSD has lodged a major resubmission for pembrolizumab (Keytruda) for use by certain patients with non-small-cell lung cancer (NSCLC). MSD and BMS are in a race to secure a PBAC recommendation for their PD-1s for use by patients with NSCLC; MSD seems to be ahead now as it appears the PBAC will not consider submissions for nivolumab for use by patients with squamous/non-squamous cell NSCLC in March; stranger things have happened!
  • Menarini has lodged a major submission for ranolazine (Ranexa). This is an old medicine which has a poor reimbursement history outside of Australia.

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Michael Wonder

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Michael Wonder