19 August 2016 - The outcomes from the PBAC July 2016 meeting are now in the public domain.

Submissions

• 44 submissions were considered at the July 2016 PBAC meeting. All were prepared and lodged by the pharmaceutical industry.
• 42 of the 44 submissions related to the Pharmaceutical Benefits Scheme; the other two related to the National Immunisation Programme
• 42 of the 44 submissions were for a medicine; the other two were for a vaccine
• 20 (45%) were major submissions
• 34 (76%) were initial submissions and 10 (24%) were resubmissions
• 12 (27%) submissions were for ‘new listings’
• 7 (16%) submissions included a CEA/CUA. The economic evaluation in some submissions is as yet unknown.
• 17 submissions were for medicines in WHO ATC Group L (anti-neoplastic and immunomodulating agents), 8 were for medicines in WHO ATC Group J (anti-infective agents) and 6 were for medicines in WHO ATC Group V (various agents)
• The submissions for bisoprolol fumarate with perindopril (Cosyrel) and edoxaban tosylate (Lixiana) appear to have been withdrawn. The fate of a submission for rituximab is unclear (listed in the agenda as a ‘matter arising’ (non major/minor submission).
• The PBAC considered a major submission from Pfizer for Pneumococcal polysaccharide conjugate vaccine (13 valent, adsorbed) (Prevenar 13). This submission was not included in the published agenda.

Outcomes

• The 44 submissions yielded 64 outcomes; 47 (73%) recommendations, 11 (17%) rejections, 5 (8%) deferrals and 1 (2%) no outcome. Insofar as a submission can include multiple requests; the number of outcomes exceeds the number of submissions. A submission for one medicine/combination product yielded seven outcomes.
• 5 of the 12 submissions for new listings were recommended
• The 6 submissions that included a CEA/CUA yielded 6 outcomes; 3 (50%) recommendations, 2 (33%) rejections and 1 (17%) deferral.
• 4 of the 10 rejections were for medicines in WHO ATC Group L (one of these 4 rejections is for a medicine that are not used by patients with cancer)
• The 10 resubmissions yielded 13 outcomes of which 10 (77%) were recommendations
• The applicants that fared well this meeting were MSD (2 submissions, 13 recommendations), Gilead (5 submissions, 3 recommendations, Amgen (4 submissions, 3 recommendations) & Novartis (3 submissions, 4 recommendations). The applicant that fared the poorest this meeting was Stallergenes (2 submissions, 2 rejections).