7.4 Public Summary Documents

Page last updated: October 2016

PSDs provide the public with information about PBAC decisions, and the basis and rationale for each decision. The aim is for stakeholders (including health professionals and patients) to be informed of the rationale for specific PBAC outcomes.

The availability of PSDs is the result of initiatives coming out of the AUSFTA, and is based on transparency principles supporting the provision of information regarding the basis for the subsidy of pharmaceuticals to the Australian community through the PBS. PSDs are published around four months after the relevant PBAC meeting (see Section 7.4.2).

7.4.1   Preparing the Public Summary Documents

The PBAC publishes a PSD for each submission for listing one or more medicinal/vaccine products on the PBS/NIP, except for submissions where pricing issues are the only matter considered by the PBAC.

PSDs are prepared by departmental officers reflecting the PBAC Minutes. The evidence presented in the submission, and the PBAC’s view of the evidence, is outlined in the PSD.

The purpose of the PSD is to provide consistent information for all PBAC outcomes for medicines. As the PBAC is required by legislation to take into account the effectiveness and cost of medicines proposed for subsidy compared with other therapies, the PSD includes information on the economic analysis and expected use. Some of the information presented in PSDs is subject to confidentiality considerations. The structure and confidentiality requirements of PSDs, and those submissions that do not have a PSD prepared, are subject to ongoing negotiations with pharmaceutical representative organisations such as Medicines Australia.

More information about the PSD structure is available on the PBS website.

The steps for the preparation and publication of PSDs are:

  1. Ratified minutes from the PBAC meeting form the basis of the PSD. Departmental officers redact the results of clinical trial data or other clinical studies that are not in the public domain, and the price offered for the medicinal products in the minutes:
    • Where significant portions of a data table require redaction, a descriptive paragraph must follow the table to provide sufficient context to the reader.
    • Departmental officers replace the following with a standardised agreed range
      • incremental cost-effectiveness ratio or other measure of the value proposed in the submission
      • estimated cost of supplying the medicinal/vaccine product through the PBS/NIP
      • estimated number of patients and number of packs supplied
      • budget impact of listing. Top of page
  2. The draft PSD is emailed to the sponsor’s designated contact or authorised representative. The sponsor has an opportunity to review and request any changes to the PSD it considers appropriate for understanding the information contained in the draft PSD and maintaining the sponsor’s commercial confidentiality. The sponsor is asked to provide sufficient justification to have additional content redacted. The revised draft PSD is emailed to the department within 10 working days of receipt (refer to Appendix A for contact details).
  3. Departmental officers review the revised draft PSD. The department must ensure that the PSD reflects the PBAC Minutes. It must also be in line with the transparency principles in the National Medicines Policy, which states that consumers and health practitioners should be encouraged to understand the costs, benefits and risks of medicines/vaccines.
  4. Where departmental officers form the view that the sponsor’s requested changes conflict with the requirement for consistency with the PBAC Minutes and are not in line with the transparency principles, departmental officers negotiate with the sponsor. The sponsor is asked to provide further evidence or justification for the requested changes. All negotiations for a specific PSD should be concluded two weeks before the expected publication date for the PSD.

The department is responsible for the final clearance of PSDs. The Assistant Secretary, PEB, will agree the content for publication on the PBS website. If a sponsor considers it has reached an impasse regarding the content of a PSD, the sponsor can seek further discussions with the First Assistant Secretary or Deputy Secretary responsible for PBD and the Chief Executive Officer of Medicines Australia. A copy of the finalised PSD is provided to the sponsor’s contact or authorised representative the day before publication on the PBS website.

7.4.2   Timeframe for Public Summary Document publication

Table 7.2 shows the timeframe for publishing PSDs.

Timeframe for the publication of Public Summary Documents

Type of submission

Time for publication (after the PBAC meeting)

Submissions recommended

16 weeks

Second or subsequent submissions (resubmissions) that were not recommended

16 weeks

First submissions where the PBAC did not recommend or deferred making a recommendation

18 weeks

Second or subsequent submissions (resubmissions) where the PBAC deferred a recommendation

18 weeks

 

For submissions made under the TGA–PBAC parallel process, PSDs will be prepared following standard timelines but will not be published until TGA registration has occurred.

7.4.3   Management of documentation

A specified departmental officer is assigned to prepare PSDs and negotiate with the sponsor.

All documentation is electronic and communication is via email.

PSDs conform to the Level AA accessibility requirement of the Web Content Accessibility Guidelines 2.0.

 

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