Analysis of submissions considered by the PBAC - July 2011

Submissions

·      59 submissions were considered by the PBAC; submissions for three medicines were withdrawn after the publication of the PBAC agenda on 25 May 2011: dronedarone hydrochloride (Multaq), esomeprazole magnesium trihydrate with naproxen (Vimovo) and tafluprost (Saflutan).

·      57 were seeking a listing on the PBS, one on the National Immunisation program (NIP) and one on the Life Savings Drug Program (LSDP).

·      There were 47 first time submissions and 11 resubmissions.

·      18 submissions were for new medicines.

·      13 submissions were for medicines in ATC group L (9 of these were for patients with cancer).

Outcomes

·      There were 33 (61%) recommendations, 12 (22%) rejections and 4 deferrals (7%).  The outcomes for 5 (9%) submissions cannot be made public until their respective TGA outcomes are known.  This appears to be the first time this has happened.

·      The success rate for this meeting is 20% lower than the industry success rate for the past 5 years (March 2006 – March 2011; 784/947 = 83%). The rate could climb to 71% if all of the five pending submissions were recommended.

·      Only 7 of the 18 submissions for new medicines were recommended; this could increase as for 4 of the 5 pending submissions are for new medicines.

·      9 of the 14 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 5 pending submissions).

·      5 of the 12 rejected submissions are for medicines in ATC group L (4 of the 5 are for patients with cancer: ipilimumab, sunitinib, trastuzumab and lenalinomide).

·      5 of the 11 resubmissions were rejected (agomelatine, colistimethate, icatibant, lenalinomide and liraglutide).

·      Applicants that fared well were MSD (5 submissions; 4 recommendations and 1 pending) and Novartis (4 submissions; 3 recommendations and 1 deferral).  Pfizer didn’t fare so well (2 submissions; 2 rejections).

Of note

·      This was Lloyd Sansom’s last scheduled meeting as Chairman. The new Chairman Sue Hill is scheduled to take over the reins in early September after the special meeting in August http://www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr11-nr-nr133.htm?OpenDocument&yr=2011&mth=07