The Department of Health and Medicines Australia have been working since late 2017 to deliver on commitments to streamline medicines listing processes and revise cost recovery arrangements as set out under clause 10 of the Strategic Agreement (2017-22) (PDF 7MB) – (Word 183KB). Stage 1 PBS Process Improvements commenced 1 July 2019 and included the introduction of changes to pre-submission meetings to provide additional guidance and support for complex submissions.
In the last 3 years Commercial Eyes has worked with over 20 clients to utilise the Pre-submission service. Here we provide an overview of the process and Commercial Eyes’ insights based on our experience to date.
The Role of the Pre-Submission Meeting
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.
What is the process?
Eligibility criteria The Department have limited slots for Pre-Submission meetings and prioritise cases with novel aspects that are likely to most benefit from the meeting. If for instance the case is perceived to be for a new listing for a product with minimal differentiation to existing therapies and thus a very straightforward case, then the department may reject the request for a Pre-Submission meeting.
Timing and organising of the meeting
The meeting date must be held at least 8 weeks prior to the target PBAC submission lodgement deadline and must be requested at least 4 weeks prior to the proposed meeting date. Hence the meeting request must be requested at least 12 weeks prior to the submission lodgement deadline.
A request for a Pre-Submission meeting is made via the Health Products Portal (HPP). The Department will respond to confirm if they consider the case to be suitable and propose a date and time for the meeting.
The Briefing Paper
It is the responsibility of the Sponsor to submit a Briefing Paper to the Department, providing sufficient information to allow the Department to address the key questions posed.
The briefing paper template (available here) provides a clear structure for Sponsors to present key aspects related to the proposed submission. The structure of the document is broadly aligned with that of a PBAC submission with subheadings: Background, Population, Treatment algorithm and main comparator, Clinical Evidence, Economic evaluation, Estimated utilisation and financial estimates, and Other. The template also provides sections for Sponsors to identify question(s)/points for discussion under each subheading.
The Meeting Outcomes Statement
Should the Sponsor wish to reference the meeting minutes in the PBAC submission, they must submit the Outcomes Record (meeting minutes) within 10 business days following the meeting. The Outcomes Record is prepared by the Sponsor in the specified template and the writeup of the meeting outcomes (excluding the title and attendance pages) should aim to be concise (no more than approx. 1 page). The Department returns the ratified Outcomes Record with any required changes within 4 weeks following the meeting. Once ratified the Outcomes Record may be referenced in the PBAC submission.
Who attends the meeting?
Experienced members of the office of Health Technology Assessment and PBAC Secretariat. By default, the meeting is typically attended by 3 members of the Department.
Attendance of members of other departments should be requested prior to the meeting should the Sponsor wish to discuss topics that would involve these other departments such as:
- Managed Entry Schemes
- Funding of technologies or procedures which may be considered co-dependent with the PBAC submission
- Matters pertaining to Risk Sharing Agreements or Special Price Agreements
- Questions relating to post-PBAC listing services
Neither PBAC committee members nor members of the sub-committees attend the meeting.
What to expect from the meeting?
Given that the meeting is only one hour long, it is critical to get straight to the Department’s feedback on questions posed in the Briefing Paper. The Department members are not expected to perform research or analysis relating to the disease or drug, so it is important to provide sufficient detail in the Briefing Paper to facilitate an informed response. It may also be important to provide results of analyses, as context, to receive a suitably specific response. There is limited time to provide additional data in the discussion, so preparation is key. The feedback typically aims to predict the PBAC’s opinion on key aspects of the submission. As such Department attendees often refer to guidance documents and precedent PBAC cases as well as their experience of PBAC decision making to inform the guidance provided.
To what extent does the advice impact PBAC’s decision making?
The Department states that the advice is ‘in no way binding on the department, applicant, evaluators or committees’. However, the minutes of the meeting, if ratified by the Department as a fair reflection of the meeting outcomes, can be referenced as part of the PBAC submission.
Members of the Department who participate in the Pre-Submission meeting are likely to be assigned to the case should the submission be lodged. Our experience suggests that perceptions around aspects of the case that form from the briefing paper and meeting discussion do filter through to the PBAC assessment. For that reason, the value proposition and PBAC submission approach should be well defined prior to completing the pre-submission Briefing Paper to get the most out of the pre-submission meeting.
Would we recommend utilising this service?
Yes. Our experience has been very positive. The feedback provided has been informative and balanced with the intent to expedite and smooth the path to a successful submission. The Department have provided greater certainty over the suitability of the Population, Intervention, Comparator and Outcomes (PICO) used to define the decision problem, identified precedent cases that have given insight into PBAC decision making on key issues and highlighted publicly available information pertaining to ongoing work (e.g., other applications for funding) that may impact the case.
Almost all clients Commercial Eyes supports in developing Category 1 and 2 PBAC submissions opt for utilising this service and have expressed that they found the meeting valuable. The Pre-Submission meeting attracts a Cost Recovery fee of $14,980 (as of the 1st August 2022), but is worth the investment for eligible cases.
Author: Douglas Millar, HTA Strategist, Access, Research and Intelligence team
How can Commercial Eyes help?
The Commercial Eyes Access, Research and Intelligence team can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment.
For more information, please contact Jo Atkins, the Head of Access, Research and Intelligence at [email protected]