Submissions
· 52 submissions were considered by the PBAC; 50 were seeking a listing on the Pharmaceutical Benefits Scheme (PBS) or the Life Saving Drugs Program (LSDP) and 2 were seeking a listing on the National Immunisation Program (NIP)
· Of the 50 PBS/LSDP submissions, 40 were first time submissions and 10 were resubmissions.
· 18 submissions were for new medicines.
· 12 submissions were for medicines in ATC group L (9 of these were for patients with cancer).
Outcomes
· There were 29 (56%) recommendations, 15 (29%) rejections and 2 deferrals (4%). The outcomes for 6 (12%) submissions cannot be made public until their respective TGA outcomes are known.
· The success rate for this meeting is 26% lower than the industry success rate for the past 5 years (March 2006 – July 2011; 817/994 = 82%). The rate could climb to 68% if all of the 6 pending submissions will result in a recommendation.
· Only 3 of the 18 submissions for new medicines were recommended; this could increase as for 4 of the 6 pending submissions are for new medicines.
· All 13 submissions that included a CEA or CUA were either rejected or deferred. (One cannot yet determine what form of economic evaluation was included in the 6 pending submissions). This is the first time in the PBAC’s public history that at least one medicine has been recommended for listing at a scheduled meeting on the basis of a CEA or CUA.
· 4 of the 15 rejected submissions are for medicines in ATC group L (4 of the 5 are for patients with cancer: vinflunine ditartrate, cabazitaxel, everolimus and plerixafor).
· 7 of the 10 resubmissions were rejected (budesonide with eformoterol fumarate dihydrate, cabazitaxel, everolimus, liraglutide, mannitol, miglustat and plerixafor). This was the PBAC’s fourth rejection of everolimus.
· Applicants that fared well were Roche (4 submissions; 3 recommendations), Novartis (4 submissions; 2 recommendations, 1 rejection and 1 pending), GSK (2 submissions; 2 recommendations) and Eli Lilly (3 submissions; 2 recommendations and 1 pending). AstraZeneca didn’t fare so well (2 submissions; 2 rejections).
Of note
· This was Sue Hill’s first meeting as Chairman.
· 2 of the 5 items (medicines) from the July meeting that awaited a TGA outcome were considered by the PBAC in November; linagliptin which was recommended and cabazitaxel which was rejected. It has since become apparent that the application to register roflumilast has been withdrawn.
