Summary of submissions and outcomes from the March 2014 PBAC meeting

Michael Wonder, Wonder Drug Consulting Pty Ltd

www.maestrodatabase.com

Submissions

·        54 submissions were considered by the March 2014 PBAC meeting

·        51 submissions related to the Pharmaceutical Benefits Scheme (PBS), two to the PBS (Section 100) or the Life Saving Drugs Program (LSDP) and one to the National Immunisation Program (NIP)

·        51 of the 54 submissions were for medicines, two were for a medicinal preparation (nutritional supplement/blood glucose indicator strip) and one was for a vaccine

·        38 were initial submissions and 16 were resubmissions

·        13 submissions were for new medicines

·        17 submissions were for medicines in WHO ATC Group L (anti-neoplastic and immunomodulating agents), 8 were for medicines in WHO ATC Group G (genito-urinary system) and 7 were for medicines in WHO ATC Group R (respiratory system)

Outcomes

·        The 54 submissions yielded 54 definitive outcomes; 35 (65%) recommendations, 14 (26%) rejections and 5 deferrals (9%)

·        The success rate for the submissions considered by the PBAC at this meeting (65%) is lower than the success rate for the submissions considered by the PBAC at its previous meeting in November 2013 (38 recommendations out of a total of 47 submissions/outcomes = 81%)

·        Six of the 13 submissions for new medicines were recommended (46%)

·        Ten (48%) of the 21 submissions that were supported by a CEA or CUA were recommended.  This result needs to be interpreted with caution as two submissions were recommended on a different basis and others with recommended with ‘conditions’ that the sponsors concerned have already stated are unacceptable in their present form.

·        Four of the 14 rejections are for medicines in WHO ATC Group L

·        Seven (43%) of the 16 resubmissions were recommended

·        The applicants that fared well this meeting were Novartis (6 submissions; 4 recommendations), MSD (4 submissions; 4 recommendations), Bayer (4 submissions; 3 recommendations) & Pfizer (3 submissions; 2 recommendations).  The applicants that fared poorly this meeting were Roche with 4 submissions (2 deferrals and 2 rejections) and GSK with 4 submissions (1 recommendation and 3 rejections).

For more details, go to www.maestrodatabase.com