Summary of submissions and outcomes from the November 2016 PBAC meeting

MAESTrO Database

19 December 2016 - 70 submissions were considered at the July 2016 PBAC meeting (this includes submissions relating to “Other Matters”).

Submissions

  • All 70 submissions related to the Pharmaceutical Benefits Scheme
  • 63 of the 70 submissions were for a medicine; the other seven were for a medicinal preparation
  • Whilst it is clear that some submissions were not prepared/lodged by the medicine’s/medicinal preparations sponsor, one cannot determine precisely how many were.
  • 30 (43%) were major submissions
  • 47 (67%) were initial submissions and 23 (33%) were resubmissions
  • 14 (20%) submissions were for ‘new medicines’
  • 23 (33%) submissions included a CEA/CUA. The economic evaluation in some submissions is as yet unknown.
  • 32 submissions were for medicines in WHO ATC Group L (anti-neoplastic and immunomodulating agents), 6 were for medicines in WHO ATC Group R (respiratory system) and 6 were for medicines in WHO ATC Group V (various agents)
  • Five submissions appear to have been withdrawn.
  • The PBAC considered at least four minor submissions that were not included in the published agenda.

Outcomes

  • The 70 submissions yielded 109 outcomes; 75 (69%) recommendations, 22 (20%) rejections, 9 (8%) deferrals and 3 (3%) no outcome. Insofar as a submission can include multiple requests; the number of outcomes exceeds the number of submissions. A submission for one medicine yielded twelve outcomes.
  • 5 of the 14 new medicines were recommended
Michael Wonder

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Michael Wonder