6 January 2016 - The PBAC noted that the intent of the submission was to initiate a dialogue rather than to request PBS listing. The PBAC did not consider the timing of the submission to be appropriate and stated that it was not an optimal use of time and scarce resources. The PBAC therefore advised the Department to consider amending the guidelines for the TGA-PBAC parallel process to prevent the consideration of such premature submissions in the future.

For more details, go to: http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2015-03/Files/evolocumab-psd-march-2015.pdf