Posted by Michael Wonder on 05 Aug 2015
Summary of outcomes from the March 2013 PBAC meeting
Submissions
- 54 submissions were considered by the PBAC; 51 related to the Pharmaceutical Benefits Scheme (PBS) and the remaining three related to the Life Saving Drugs Program (LSDP). One submission appears to have been withdrawn after the agenda for the meeting was published.
- 47 of the 54 submissions were for medicines, the remaining seven were for medicinal preparations (general nutrients and blood glucose indicator strips)
- Of the 54 PBS/LSDP submissions, 42 were first time submissions and 12 were resubmissions.
- 11 submissions were for new medicines.
- 14 submissions were for medicines in WHO ATC Group L (antineoplastic and immunomodulating agents) and 7 were for medicines in ATC Group A (alimentary agents)
March 2013 PBAC meeting
- The PBAC made 58 outcomes; the outcomes for another 5 submissions/medicines are unknown pending the resolution of TGA matters. The number of outcomes is greater than the number of submissions as there were a few submissions that resulted in multiple outcomes (i.e. submissions with multiple requests and/or for multiple medicines)
- The 54 submissions yielded 29 (50%) recommendations, 24 (41%) rejections and 5 deferrals (9%). The 47 submissions for medicines yielded 23 recommendations (46%), 22 rejections (44%) and 5 deferrals (10%).
- The success rate for the submissions considered by the PBAC at this meeting (50%) is greater than that for the submissions considered by the PBAC at its previous meeting in November 2012 (21 recommendations out of a total of 51 outcomes = 41%).
- Five of the 11 submissions for new medicines were recommended.
- Seven of the 13 submissions that were supported by a CEA or CUA were recommended. This result needs to be interpreted with some caution, as the type of economic evaluation that was included in 18 submissions cannot be readily determined from the PBAC short minutes. Two of the seven submissions that included a CEA or CEA were recommended on the cost minimisation basis.
- Seven of the 24 rejections are for medicines in WHO ATC Group L (antineoplastic and immunomodulating agents)
- Nine of the 12 resubmissions were recommended (either fully or in part)
- Applicants that fared well this meeting were Vitaflo (3 submissions; 3 recommendations), Bayer (3 submissions; 3 recommendations) and MS Health (1 submission; 2 recommendations). The remaining applicants did not achieve more than one recommendation. The worst performing applicant was Novartis with 4 submissions and 4 rejections.
