Submissions

• 53 submissions were considered by the July 2015 PBAC meeting. 51 of the 53 submissions were prepared and lodged by the pharmaceutical industry.
• 49 of the 53 submissions related to the Pharmaceutical Benefits Scheme; the other four submissions related to the National Immunisation Program
• 47 of the 53 submissions were for medicines, two were for a medicinal preparation (nutritional supplement/blood glucose indicator strip) and the remaining four were for a vaccine
• 36 (68%) were initial submissions and 17 were resubmissions
• 9 (17%) submissions were for new medicines
• 14 submissions were for medicines in WHO ATC Group L (anti-neoplastic and immunomodulating agents), 11 were for medicines in WHO ATC Group A (alimentary system agents) and 7 were for medicines in WHO ATC Group J (anti-infective agents)

Outcomes

• The 53 submissions yielded 82 outcomes; 57 (68%) recommendations, 18 (21%) rejections, 7 (8%) deferrals and 2 (2%) ‘no outcomes’ (i.e. PBAC outcome cannot be made public until TGA outcome is known)
• 3 of the 9 submissions for new medicines were recommended (at least in part)
• 7 (70%) of the 10 submissions that were supported by a CEA or CUA were recommended. The economic evaluation in some submissions that were rejected, deferred or have no outcome is as yet unknown. This result needs to be interpreted with caution as three submissions were recommended on a different basis.
• Five of the 18 rejections were for medicines in WHO ATC Group L
• The 17 resubmissions yielded 27 outcomes of which 13 (48%) were recommendations
• The applicants that fared well this meeting were AstraZeneca (4 submissions, 4 recommendations), Roche (3 submissions, 3 recommendations) & Sanofi (3 submissions, 3 recommendations). The applicants that fared poorly this meeting were Boehringer Ingelheim (3 submissions, 2 rejections) and Mundipharma (2 submissions, 2 deferrals).