17 March 2014 - the PBAC considered a major submission for Taliglucerase alfa (Elelyso, Pfizer) at its March 2012 meeting.  The listing requested by Pfizer for Elelyso was a Section 100 (Highly Specialised Drugs Program) or Life Saving Drugs Program listing for the long-term enzyme replacement therapy for patients with a confirmed diagnosis of Gaucher disease.  The outcome for the submission could not be made public because it was awaiting a TGA outcome.

Given the TGA outcome for Elelyso is now known, the PBAC's outcome for the submission has changed from 'Item awaiting TGA outcome' to First-time decision not to recommend.'   There is no statement on this change on the PBS website.  There is no associated PSD.  

MAESTrO Australia has been updated to reflect this change.  The submission recommendation/rejection rates for 2012 will automatically be adjusted.