PBAC Public Summary Documents - July 2016 meeting

PBAC

28 October 2016 - The public summary documents (positive recommendations and subsequent decisions not to recommend) from the July 2016 PBAC meeting are now available.

Some interesting findings:

  • The PBAC rejected MSD's request for “a limited “a”-flagging system for Brenzys (etanercept) where substitution is permitted at a pharmacy level for naïve to molecule patients only”. The PBAC considered that such an ‘a’ flag would not work in practice as it relies on the dispenser knowing whether the patient is etanercept treatment naïve and this information is not always available to the dispenser.
  • The requested basis for the listing of Taltz (ixekizumab) was cost minimisation versus ustekinumab. This was despite the claim of superiority in comparative effectiveness versus ustekinumab.  The PBAC noted that in the sponsor’s pre-PBAC response, the nominated main comparator was changed to secukinumab. The PBAC considered that any of the currently PBS listed bDMARDs could be an appropriate comparator, and that in the absence of demonstrated superior comparative effectiveness or safety over the alternative bDMARDs, ixekizumab should be cost-minimised to the least costly bDMARD.
  • The minor submission for Utrogestan (progesterone) nominated a mixed comparator comprising all PBS listed vaginal formulations and TGA approved doses. Previously, the sponsor nominated Crinone 8% (90 mg) progesterone gel as the comparator. The PBAC considered that any form of progesterone currently listed on the PBS for ART could be an appropriate comparator. At the time of PBAC consideration, progesterone pessary and progesterone 8% vaginal gel were listed on the PBS. The PBAC noted that progesterone pessary was the lowest priced of these comparators. The PBAC advised that in the absence of demonstrated superior comparative effectiveness or comparative safety over the least costly comparator, progesterone 200 mg capsule should be cost-minimised to the least costly comparator, progesterone pessary.

Read PBAC Public Summary Documents

Michael Wonder

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Michael Wonder