Summary of PBAC meeting - November 2011

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.