Public Consultation - Draft 2020-21 Cost Recovery Implementation Statement (CRIS) for listing medicines on the PBS and designated vaccines on the NIP

Page last updated: 20 May 2020

As outlined in the April 2020 PBS news item – ‘Cost Recovery – Consultation Feedback’, the current COVID-19 pandemic has impacted implementation of Stage 2 PBS process improvements and supporting cost recovery arrangements. Stage 2 PBS process improvements will not be implemented from 1 July 2020 as originally planned.

Consultation is now open on the draft 2020-21 Cost Recovery Implementation Statement (CRIS). The draft 2020-21 CRIS provides information on how the Department of Health implements cost recovery for:

• Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for medicines seeking to be listed on the Pharmaceutical Benefits Schedule (PBS); or vaccines to be listed on the National Immunisation Program (NIP).
• Applicant-driven PBS listing and list management activities.

From 1 July 2020, the indicative 2020-21 fees outlined in the 2019-20 CRIS will apply.  In addition to the increase to existing fees as described in the 2019-20 CRIS, there are three key changes to the 2020  fees:

• Reduced Australian Technical Advisory Group on Immunisation (ATAGI) fees: as approved by Government, reduced ATAGI fees will apply from 1 July 2020 to reflect efficient costs.
• Further delay of deed management fees, subject to Government approval, until Stage 2 PBS process improvements are considered.
• Introduction of an Intent to Apply step for Committee secretariat submissions: from 28 July 2020, all Committee secretariat submissions will require an Intent to Apply. This will result in a slight increase to the 2020-21 evaluation fee for these submissions with the $400 Intent to Apply fee now included.

The CRIS outlines the cost recovery approach for existing fees in 2020-21, and will only recover the costs of those services that are directly requested by sponsors.

How to submit feedback

Public consultation will be open until COB Wednesday, 3 June 2020.

The Department is seeking feedback on the clarity of information provided in the draft 2020-21 CRIS to ensure the processes and fees that will apply from 1 July 2020 is clear.

Please provide your comments and feedback on the content of the draft 2020-21 CRIS via email to PBSimprovements.