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).
