4.4 Pre-submission meetings
The department can provide pre-submission advice on the preparation of submissions that is intended to:
- support applicants in the development of their submissions to the PBAC;
- provide applicants with experienced departmental advice based on understanding of the PBAC guidelines and relevant previous recommendations made by the PBAC; and
- identify other issues that may arise during PBAC’s consideration of the submission.
The department may also facilitate joint pre-submission meetings with the TGA, MSAC Secretariat and ATAGI Secretariat officers as appropriate.
Participation in pre-submission meetings is applicant-driven. Applicants will determine whether and when they wish to request a pre-submission meeting within the range of dates available (see the PBS calendar on the PBS website for available dates).
Applicants should note the following:
- An applicant’s participation in a pre-submission meeting does not influence the PBAC’s considerations of the submission, and does not guarantee the success of a submission.
- Advice provided by the department in the pre-submission phase is in no way binding on the department, applicant, evaluators or committees.
- Applicants must form their own judgements about how to use departmental advice.
- Members of the PBAC and its subcommittees do not attend pre-submission meetings, to ensure the PBAC decision-making remains independent. Pre-submission meetings cannot advise on or bind what the committee may think or decide.
- Departmental advice may be sought in relation to specific issues including restrictions, comparators, clinical data, economics and financials. However, the pre-submission meeting does not provide an evaluation of any aspects of the proposed submission, including evaluation of data. The department does not confirm or agree with economic approaches, claims or modelling.
- It is recommended that all applicants, including those that have received advice from the department in a pre-submission meeting, should consult the PBAC Guidelines when preparing their submission.
Pre-submission meetings will generally be available for submissions or resubmissions that meet one or more of the following criteria:
- the requested listing involves a new medicine or a new vaccine that is the first of a class in a therapeutic area, including a new medicine or new vaccine linked to a concurrent TGA Provisional or Priority designation; or
- the requested listing involves a listed medicine for an additional condition OR a listed vaccine for an additional population; or
- the requested listing involves a listed medicine or a listed vaccine that involves one or more material changes to the existing listing that requires a clinical and/or economic and/or financial evaluation;
- the requested listing is a standard re-entry pathway submission with outstanding issues that require a substantial re-assessment 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; or
- the applicant 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 (e.g. 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 pre-submission meeting request allows applicants to nominate representatives from other areas across the department, such as the DUSC Secretariat, ATAGI Secretariat, TGA and/or MSAC Secretariat if broader advice is required for their submission. Applicants cannot request specific individuals within the department. The department will determine which departmental representatives are required to attend the meeting to address the key questions raised by applicants, and departmental representatives will be confirmed with the applicant approximately two business days before the meeting.
A separate pre-submission meeting and fee will be required for each drug and/or indication where multiple PBAC submissions are proposed.
Pre-submission meetings should be fit for purpose. The department reserves the right to decline a pre-submission meeting request, following consultation with the applicant, if a meeting is unlikely to be of value. For example, a meeting may be of limited value in cases where the prospective submission is straightforward and does not satisfy the criteria outlined below. After considering the meeting application, the department may agree or not agree to hold the pre-submission meeting with the applicant.
4.4.1 Requesting a pre-submission meeting
Applicants may request a pre-submission meeting via lodgement of the Pre-submission Meeting Request via the department’s Health Products Portal (HPP). Pre-submission meeting requests should be lodged electronically by 5pm (AEDT), at least four weeks before the proposed pre-submission meeting date. The available pre-submission meeting dates are outlined in the PBS calendar available on the PBS website.
Where one or more pre-submission meetings are intended to occur, the meeting(s) must be held by week 9 of the PBAC cycle prior to the submission due day (i.e. 8 weeks prior to lodgement). Where two (2) meetings are intended, it is recommended that the first meeting is held by week 1 of the PBAC cycle prior to the submission due day (i.e. 16 weeks prior to lodgement).
Where the second meeting relies upon the advice provided in the first meeting, the applicant should ensure there is sufficient time for the applicant to prepare meeting outcomes and for acknowledgement by the department prior to the second meeting briefing paper being lodged.
Table 4.4.1 – Minimum pre-submission meeting timeline
|
Timeframe |
Requirement |
|---|---|
|
Four weeks before the intended meeting date |
Lodgement of a pre-submission meeting request |
|
Two weeks before the meeting date |
Lodgement of a pre-submission briefing paper |
|
Two days before the meeting date |
Confirmation of department attendees |
|
Two weeks after the meeting |
Meeting outcomes provided to the department |
|
Four weeks after the meeting |
Meeting outcomes confirmed by the department |
4.4.2 Arranging a pre-submission meeting
The department will respond to the pre-submission meeting request within 10 business days. The response will:
- acknowledge the request;
- provide meeting dates; and
- provide timelines for lodgement of a briefing paper.
Applicants can contact the department via email at: PBACpresubmissionmeetings@health.gov.au for any further information or questions regarding the meeting.
A standard agenda for the meeting (aligned with the PBAC Guidelines) is included in the Pre-submission Briefing Paper (briefing paper). The indicative times should align with the key questions provided in the briefing paper, which will be used to guide the discussion at the meeting.
Meetings for medicines that are considered integrated codependent submissions are arranged in consultation with the MSAC Secretariat. Applicants should also contact the Health Technology Assessment Access Point (HTAAP) if they have an integrated codependent submission (refer to Appendix A for contact details).
* Note: All templates are available on the PBS website for applicants to access at any time to assist with their planning.
4.4.3 Pre-submission briefing material
Applicants are required to submit the completed briefing paper at least 10 business days before the scheduled meeting. The purpose of the template is to prompt applicants to identify and articulate key issues, concerns and areas of uncertainty in their submission preparations. This will assist the department to prepare and deliver a more focused discussion and to ensure the meeting is as useful as possible for the applicant. As applicants’ interests and concerns will differ, the template serves as a guide only, and applicants are not required to provide responses to all items.
Briefing papers should provide a balance of sufficient detail to gain the required advice, yet should avoid inclusion of detailed data, full study and trial reports or complex model structures. The paper should not include promotional material for the company or medicine/vaccine.
Key questions/points for discussion should include the concerns of the applicant in relation to each topic to help guide preparation for the meeting. In the interests of ensuring the pre-submission discussion is valuable for the applicant, the department may contact the applicant prior to the meeting to seek clarification on information provided in the briefing paper.
If the briefing paper is not provided at least 10 business days before the meeting, the department will decline the meeting date or reschedule the meeting.
4.4.4 Pre-submission meeting attendance
Applicants representatives should be based on the expertise needed to discuss the key questions provided in the briefing paper. Applicants are able to bring employees of their organisations and members of professions such as health professionals or other health service providers. The applicant should advise the department who will be attending the pre-submission meeting and what their role at the meeting will be.
If contracted advisors and any other third-party agents accompanying the applicant
to a pre-submission meeting, the applicants are responsible for ensuring these nominated
representatives understand and agree to the department’s confidentiality requirements.
The department welcomes the participation of consumer organisations or clinician input
in
pre-submission meetings. Conflict of interest declarations will be required as well
as confirmation that all aspects of the briefing paper has been fully shared by the
applicant with all participants, including consumers.
External contractors attending on behalf of applicants are to participate in a technical role and not in any capacity as a lobbyist. Pre-submission meetings are not for 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 via the Attorney-General’s Department website.
Applicants are able to specify in the meeting request form the areas of the department from which they wish to seek advice. These requests will be assessed against the content of the briefing paper.
Applicants and the department are responsible for ensuring only people contributing to the meeting are in attendance to ensure meeting numbers are kept to a useful number and an effective meeting is able to occur. Applicants and representatives from the department may attend meetings in person, or via teleconference.
4.4.5 Pre-submission meeting agenda
The department treats all agenda and supporting material as in-confidence.
The applicant is requested to provide indicative times for each agenda item included
in the
briefing paper. The discussion is informed by the briefing paper and key questions.
Pre-submission meetings will be scheduled for one hour.
When closing the meeting, the department may summarise the advice provided. In addition, the department and applicants can provide feedback on their experience of the pre-submission meeting and general satisfaction with the pre-submission meeting process, for evaluation purposes. An evaluation statement from the applicant and the department will be captured in the meeting outcomes record.
4.4.6 Documenting pre-submission meeting outcomes
The meeting outcomes record is the responsibility and at the discretion of the applicant. The meeting outcome record should capture the department’s advice provided in response to the key questions discussed during the meeting and must be completed using the template provided by the department.
Applicants are required to return the meeting outcomes record to the department within 10 business days following the meeting. The department will review the meeting outcomes record, and confirm the main discussion points or provide information about discrepancies within 10 business days of receipt. The meeting outcomes record will then be considered final.
If a second pre-submission meeting appears to be likely, the applicant may want to aim to provide the first meeting outcomes record within five business days after the meeting to assist with meeting outcomes record being finalised prior to the second meeting. In these circumstances, the department will aim to reply within five business days of receipt.
Applicants should note that the department’s response to the meeting outcomes record remains non-binding, and that the meeting outcomes record is not an opportunity to seek additional advice. Should further advice be required, applicants may request a second pre-submission meeting.
Applicants may choose to attach their pre-submission meeting outcomes record to their submission. However, it should be noted the meeting outcomes record remain non-binding and are guidance to support submission development only. The PBAC will continue to consider submissions according to the relevant information requested in the PBAC Guidelines.
