Framework for the introduction of parallel TGA and PBAC processes
Clauses 24 and 25 of the Memorandum of Understanding state that:
From 1 January 2011, the Commonwealth will no longer require the respective registration and reimbursement evaluation and assessment processes for major submissions to be undertaken sequentially, noting the following:
(a) A PBS listing cannot occur prior to the product being listed on the Australian Register of Therapeutic Goods;
(b) A PBAC recommendation will not be made public before a decision by the Therapeutic Goods Administration (TGA) that a product is registrable for the relevant indications;
(c) Publication of PBAC outcomes will not occur until TGA outcomes are known;
(d) Current arrangements for publication that an application has been made to the PBAC will continue.
Any additional costs in processing PBAC applications resulting from any consequent misalignment of applications through the two processes will be borne by applicants under cost recovery arrangements.
Submissions received after 1 January 2011 may be submitted according to the new process. For practical purposes, this process will start with major submissions lodged by the March 2011 cut-off for consideration by the PBAC in July 2011.
The current PBAC process requires the presentation of the TGA delegate’s overview at the time a major submission is lodged. Subsequently, the resolution of the Australian Committee on Prescription Medicines (ACPM) also becomes available and is provided to the PBAC prior to the PBAC’s consideration of the major submission. The PBAC Secretariat monitors the final TGA indication for differences from PBAC recommended restriction, which may require, on a case-by-case basis, the PBAC to review its recommendation.
Under the TGA-PBAC parallel processes, a submission to the PBAC may be lodged at any time from the date of lodgement of a TGA registration dossier. Sponsors will be permitted to submit the TGA delegate’s overview up to one week prior to the PBAC meeting (at the same time the pre-PBAC responses are provided to the PBAC Secretariat).
The PBAC timelines are quicker than those of the TGA: four months from lodgement to PBAC consideration, compared to a minimum of seven months from lodgement to an initial overview by the TGA delegate, a further month for consideration by the Advisory Committee on Prescription Medicines (ACPM) and a further month for the final registration decision (giving a total of nine months). See Attachment A for a diagrammatic representation of timelines.
This will be the fastest timeline under the revised TGA arrangements which will come fully into effect in November 2011. This means that if applications are lodged simultaneously to TGA and PBAC as is an option proposed under the MOU, PBAC consideration would precede any consideration by TGA.
The degree of risk of discrepancy between PBAC and TGA outcomes reduces as follows:
- Greatest risk: PBAC consideration precedes initial TGA delegate’s overview
- PBAC consideration comes between initial TGA delegate’s overview and ACPM consideration
- PBAC consideration comes between ACPM consideration and final TGA registration decision
- Least risk: PBAC consideration follows final TGA registration decision
The risks in submitting to the PBAC too far in advance of receipt of the TGA delegate’s overview have been recognised by the
industry. A prudent approach would be for sponsors to submit at the time of response to the consolidated set of questions
from the TGA during the 5th month of the registration process, as sponsors will be made aware of the TGA issues of concern
and how the application is progressing at this point. Additionally, the delegate’s overview will be received in time for consideration
by the PBAC when it considers the submission. However, it is up to sponsors to decide when to lodge a submission.
Under parallel processes, a major PBAC submission may be lodged without the TGA delegate’s overview. The submission will be evaluated and considered by the Economics Sub-Committee (and Drug Utilisation Sub-Committee, if required) in the usual manner. Sponsors may, however, submit a TGA delegate’s overview at any point of time following lodgement of the submission up until one week prior to the PBAC meeting.
The PBAC will consider the submission based on the information it has before it and, as per current practice, may recommend, reject or defer the submission. Also, as per current practice, minutes of PBAC considerations will be prepared and provided to the sponsor following the meeting.
As per current practice, a sponsor may commence pricing negotiations immediately following a positive recommendation from the PBAC.
Industry acknowledges that the PBAC has indicated that it will generally not be able to make a positive recommendation in the absence of a TGA delegate’s overview because of reduced confidence in a submission which does not contain information and interpretation that the PBAC typically places considerable weight on. Medicines Australia acknowledges that this is the PBAC’s prerogative and is outside the policy and process improvements agreed to within the MoU.
As such it is important that industry members are fully aware of the increased probability of a deferral or rejection should they decide to have a submission considered by the PBAC without the inclusion of the TGA delegate’s overview. Sponsors will need to incorporate such a risk when considering the timing of any lodgement of a submission.
The MoU states that “a PBS listing cannot occur prior to the product being listed on the Australian Register of Therapeutic Goods”.Indeed, as products may now receive a positive recommendation from the PBAC prior to the ACPM resolution and final conditions of listing on the ARTG being known, a process will be formalised to check that any proposed PBS listing is fully consistent with the final TGA registration.
It is proposed that the Department develop a process and pro-forma that would enable a rapid assessment of the consistency of the final TGA listing conditions with the PBAC recommendation. The initial assessment would be undertaken by the PBAC Secretariat in conjunction with the Pharmaceutical Evaluation Section.
Name of drug
ACPM meeting date and resolution
TGA registration date
TGA approved product information
As it is the case currently for out-of-session listings, all PBAC members would be notified of the preliminary assessment undertaken by the Department and would be asked to consider whether a review of the PBAC recommendation is needed. If a review is needed, the matter will be re-considered at the next available PBAC meeting
Whilst it is acknowledged that differences between the TGA delegate’s proposed course of action and ACPM resolution which would materially affect the conditions of a PBS listing or the basis of a PBAC decision are historically infrequent, they do occur. The frequency of such occurrences, however, may be reduced further as a consequence of recent reforms in TGA Business Processes. Under these reforms, the delegate’s engagement with the ACPM is being reviewed. A possible option is that the delegate identifies specific questions requiring advice from ACPM. In other words, the ACPM may be required to consider more specific questions raised by the delegate rather than the full application. Importantly, these questions will generally be known at the point of the delegate’s overview. These will thus be known by the PBAC should the overview be made available to the PBAC Secretariat in time for consideration of the PBS submission.
Public disclosure of information for submissions considered by the PBAC ahead of the TGA’s delegate overview
- The receipt of a submission will be made public in the usual way 6 weeks before a PBAC meeting.
- The sponsor of a submission rejected by the PBAC will be informed of the outcome, and will be provided with the reasons for the rejection in the usual way through the PBAC minutes. A Public Summary Document will be developed as per current practice for first time rejections.
- The sponsor of a submission deferred by the PBAC will be informed of the outcome and details of the PBAC consideration as above. However, no Public Summary Document will be issued until the TGA’s delegate overview becomes available.
Process to be followed if the number of submissions exceeds the Department’s evaluation capacity
Should the number of submissions lodged exceed the Department’s evaluation capacity, the Department will discuss possible solutions with Medicines Australia, which may include a process and criteria to prioritise submissions.
Impact on submissions for vaccines
Pre-submission advice from the Australian Technical Advisory Group on Immunisation (ATAGI) remains essential to sponsors in the development of a PBAC submission and to the PBAC. Currently ATAGI’s process of preparing pre-submission advice commences at the time an application for the vaccine is lodged with the TGA. In the future, ATAGI night need to be alerted by the sponsor earlier than this so ATAGI has sufficient time to prepare its pre-submission advice and the sponsor can finalise its submission accordingly.
Review of Parallel Process arrangements
It is proposed that the AMWG conduct a review of the parallel processing after 12 months with a view to ensuring that the new arrangements are consistent with the intent of that which was agreed between the Commonwealth government and Medicines Australia under the MoU. The views of both the PBAC and the TGA will be sought as part of this review.
Published 18 February 2011