Summary of submissions and outcomes from the July 2013 PBAC meeting

Michael Wonder, Wonder Drug Consulting

Submissions

·        53 submissions were considered by the PBAC at the scheduled meeting and another submission (resubmission) for one medicine (everolimus – Afinitor) was considered at an out of session meeting soon after.

·        The 54 submissions related to the Pharmaceutical Benefits Scheme (PBS), the other was for a medicine (ivacaftor - Kalydeco) seeking a listing on the PBS or the Life Saving Drugs Program. One submission appears to have been withdrawn after the agenda for the meeting was published (fentanyl citrate – PecFent). There was also one independent review (naproxen with esomeprazole magnesium trihydrate – Vimovo).

·        46 of the 54 submissions were for medicines; the remaining eight were for medicinal preparations (general nutrients and blood glucose indicator strips).

·        Of the 54 PBS/LSDP submissions, 39 were first time submissions and 15 were resubmissions.

·        14 submissions were for new medicines.

·        13 submissions were for medicines in WHO ATC Group L (antineoplastic and immunomodulating agents), 8 were for medicines in WHO ATC Group V (various) and 7 were for medicines in ATC Group A (alimentary agents)

Outcomes

·        The PBAC made 49 definitive outcomes; the outcomes for another 5 submissions/medicines are unknown pending the resolution of TGA matters.

·        The 49 submissions yielded 29 (59%) recommendations, 15 (31%) rejections and 5 deferrals (10%).  The 42 submissions for medicines yielded 22 recommendations (52%), 22 rejections (36%) and 5 deferrals (12%).

·        The success rate for the submissions considered by the PBAC at this meeting (59%) is slightly higher than the success rate for the submissions considered by the PBAC at its previous meeting in March 2013 (29 recommendations out of a total of 54 outcomes = 54%).

·        Six of the 14 submissions for new medicines were recommended (435).

·        Four of the nine submissions that were supported by a CEA or CUA were recommended. This result needs to be interpreted with some caution, as the type of economic evaluation that was included in many submissions cannot be readily determined from the PBAC short minutes. One submission that included a CEA and a CMA was recommended on purely on a cost minimisation basis (dimethyl fumarate –Tecfidera)

·        Seven of the 15 rejections are for medicines in WHO ATC Group L (antineoplastic and immunomodulating agents)

·        Eight of the 15 resubmissions were recommended

·        Applicants that fared well this meeting were Nutricia (5 submissions; 5 recommendations), MSD (4 submissions; 3 recommendations), AstraZeneca (4 submissions; 2 recommendations), GSK (3 submissions; 2 recommendations), Janssen-Cilag (2 submissions; 2 recommendations) & Petrus (2 submissions; 2 recommendations). The remaining applicants did not achieve more than one recommendation.  The worst performing applicant was Novartis with 6 submissions (1 recommendation, 1 deferral and 4 rejections).