4.5 Presubmission meetings

Page last updated: October 2016

The department can provide presubmission advice on the preparation of major submissions to the PBAC to list a medicine on the PBS or vaccine on the NIP. This advice is not binding on the PBAC.

Examples of issues that benefit from a face-to-face presubmission meeting are where:

  • the medicine or vaccine is the first of a class in a therapeutic area, and in particular where a cost-effectiveness claim is being made
  • the medicine or vaccine is an extension of indication for a currently listed restriction and there will be a cost-effectiveness claim in the submission
  • the outstanding issues raised in a resubmission require a substantial rewrite of the submission evidence or revision of the economic evaluation model, and further technical advice from the department would provide useful input that cannot be obtained from another source
  • the sponsor is proposing a Managed Access Program (MAP) or complex risk-sharing arrangement (RSA) that is integral to the consideration of the PBAC. Complex RSAs include RSAs that involve collecting additional patient data (eg evidence of response) and are also referred to as Performance-based RSAs or Pay for Performance arrangements. MAPs involve prospective collection of evidence (see the framework for the managed entry scheme).

The department also meets with representatives of pharmaceutical companies to discuss regulatory and subsidy issues for newly emerging classes of medicines, while these products are being developed by the pharmaceutical company, to provide advice on trial design. Depending on the matters for discussion, attendance at these meetings can include officers from the TGA, PBD and MBD.

4.5.1   Arranging a presubmission meeting

A sponsor can email a request for a presubmission meeting to the department (refer to Appendix A for contact details). The relevant departmental officers will forward a response, including a request for information, that will help the department to allocate the correct time and ensure appropriate staff are consulted before the meeting.

The department allocates times in specific weeks for presubmission meetings. These are available on the PBS website. One or two medicines/vaccines can be discussed at each meeting. For two medicines, up to 1.5 hours will be allocated. If the sponsor wishes to discuss more than two medicines/vaccines, an additional meeting is required. Where a sponsor proposes to discuss a vaccine submission, the PBAC Secretariat will contact the relevant departmental officers in the ATAGI Secretariat in the Office of Health Protection. A representative from the ATAGI Secretariat may attend the meeting, if appropriate.

Meetings for medicines or vaccines that are considered integrated codependent submissions are held during the same allocated weeks and arranged in consultation with any other relevant area (eg the Medical Services Advisory Committee [MSAC] Secretariat). Sponsors should contact the Health Technology Assessment Access Point (HTAAP) if they have an integrated codependent submission (refer to Appendix A for contact details).

The agenda for the presubmission meeting and any relevant papers need to be provided to the department at least 14 calendar days before the meeting (refer to Appendix A for contact details). If this is not done, the department may not be able to adequately prepare for the meeting or ensure that all relevant officers are present. In the event that the agenda papers are not provided by 14 calendar days before the presubmission meeting, the department may cancel or reschedule the meeting.

Agenda papers are reviewed by the department before the meeting. If the briefing documents are unclear about the issues on which advice is sought, the department may contact the sponsor for further information. The department and sponsor representatives can discuss the need for having a meeting if issues remain unclear and the benefit of seeking advice from the department is doubtful.

The agenda papers should include a briefing document that contains an overview of the approach intended for the submission and any specific issues on which the department’s advice is sought. The documents should be concise and highlight the specific areas that the sponsor is seeking advice about (eg appropriate comparator, applicability of the studies, economic model, utilisation, developing a risk-sharing approach in the submission). Where sponsors are specific in their requests, the department can seek advice from all relevant areas and provide useful advice to the sponsor.

The department does not accept bookings to discuss submissions within 14 calendar days of the proposed date of lodgment of the submission.Top of page

4.5.2   Department of Health attendees

The officers in the Health Technology Assessment (HTA) area are responsible for reviewing the agenda papers and determining which staff from the department should attend, to make the meeting as useful to the sponsor as possible. This may include officers from HTA, drug utilisation and estimates, and pricing.

Departmental program areas that may be involved in evaluation or listing of the medicine or vaccine will also be invited to the presubmission meeting where required. For example, if a vaccine is under consideration, officers from the ATAGI Secretariat may be invited to attend.

Members of the PBAC and its subcommittees do not attend presubmission meetings.

4.5.3   Sponsor attendees

The sponsor should advise the department who will be attending the presubmission meeting and what their role at the meeting will be.

The sponsor is able to bring employees of their organisation, and members of professions such as health professionals or other health service providers. The sponsor should advise the department if attendees are contractors assisting in preparation of the submission and the name of the contracted organisation.

As the purpose of presubmission meetings is to provide technical advice, PBD holds presubmission meetings with the expectation that any external contractor will be present at the presubmission meeting in a technical role and not in any capacity as a lobbyist. The department does not support the use of presubmission meetings for the purpose of lobbying departmental officers. Lobbying activities are defined as ‘communications with a government representative in an effort to influence government decision making, including … the allocation of funding’. Additional information about the Lobbying Code of Conduct is available on the Australian Government Department of the Prime Minister and Cabinet website.

4.5.4   Conduct of the presubmission meetings

Meetings will be 1–1.5 hours long, depending on whether advice on submissions for one or two medicines or vaccines is sought.

The department treats all agenda and supporting material as in-confidence.

The department does not prepare meeting minutes, and does not review or agree to any meeting notes or outcomes written up by the sponsor about the meeting discussions.

Attendees may teleconference into the meeting. While the department is aware of the time differences between Europe, the Americas and Australia, it is generally not possible to change the meeting times to accommodate people who want to attend through teleconference.

The presubmission meetings are intended to provide sponsors with departmental advice based on its understanding of the PBAC Guidelines and relevant previous decisions made by the PBAC. They are also meant to identify any other system issues that may arise in consideration of the submission by the PBAC. Sponsors must form their own judgments about if and how to use departmental advice, and advice from the department is in no way binding.

 

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