Posted by Michael Wonder on 21 Dec 2016
Summary of the agenda for the PBAC March 2017 meeting
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.
Read detailed summary
Posted by:
Michael Wonder