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Guidelines for Initiation of Stakeholder Meetings

Preliminary matters

From time to time, the Pharmaceutical Benefits Advisory Committee ("PBAC") finds itself in the position of being unable to recommend a drug for listing on the basis of cost-effectiveness, due either to an insufficient degree of clinical effectiveness and/or a high price.

The purpose of these Guidelines is to provide for meetings between PBAC and stakeholders where there is an application for a drug which treats a serious, disabling or life-threatening condition, where there are no other realistic treatment options for that condition, but where insufficient cost-effectiveness prevents PBAC from recommending listing.

Stakeholders may include the drug's sponsor or manufacturer, patient groups, medical specialists and general practitioners with a particular recognised interest in the drug, and the Department of Health and Aged Care.

The aim of these meetings is to inform stakeholders of the situation, to seek their views, and if possible to define a listing restriction acceptable to the parties which will give the best possible cost-effectiveness, even if at a level which would normally be unacceptable (the "Rule of Rescue"). The meetings are not intended as an appeals mechanism, but as a "without prejudice", non-adversarial process in order to facilitate a re-submission to PBAC by the sponsor or manufacturer.

It is recognised that where an application for listing is rejected, sponsors and manufacturers who consider PBAC's decision to contain an error of law may wish to apply to the Federal Court for review of the decision. PBAC considers it inadvisable to conduct a stakeholder meeting while litigation of this nature is pending. However, to allow sponsors and manufacturers to protect their position while pursuing the option of a stakeholder meeting, PBAC and the Commonwealth will not oppose an application to the Federal Court for an extension of time in which to file for review of a decision, where the delay in filing results from following the procedures set down in these Guidelines in the circumstances described.

All information discussed at these meetings will be subject to the secrecy provision contained at section 135A of the National Health Act 1953. Each person attending the meeting will be required to sign an undertaking to maintain the confidentiality of the matters discussed at the meeting.

Guidelines:

  1. Stakeholder meetings may be initiated by the PBAC or the sponsor on occasions when the PBAC Chair, in consultation with other PBAC members as appropriate, is satisfied each of the following have been met:
  • the drug is indicated for a serious or disabling or life-threatening condition for which there is no other realistic management option. This could include drugs which are indicated where other management options have failed for such conditions (last resort); and
  • the PBAC is unable to recommend a listing because clinical and/or cost effectiveness are such as to make approval by the usual process unlikely; and
  • all reasonable normal options, which may include a re-submission, have been exhausted; and
  • the PBAC considers there are grounds to define a listing restriction which would be accepted by the stakeholders and would give the best possible (if still normally unacceptable) cost effectiveness under the 'rule of rescue'; and
  • the PBAC and the sponsor agree there is a reasonable likelihood that progress will be able to be made which will assist the PBAC in reaching a recommendation.
  1. Stakeholder meetings will only be held in limited circumstances and it is expected that they would not exceed around four each year;
  2. Those taking part will be subject to the confidentiality provisions of the National Health Act, have access to the main elements of the PBS submission and will be advised in detail of the outcome of any further PBAC consideration resulting from the stakeholder meeting. Each party will be required to sign a confidentiality undertaking and declare any potential conflict of interest before participating in the meeting;
  3. No legal representatives are to be included;
  4. Any outcome from a stakeholder meeting will be fully and properly considered by the PBAC at its next meeting but will not be binding on the PBAC. It is anticipated that the outcome of the meeting will assist the sponsor in preparation of a re-submission to the PBAC within the usual timeframes;
  5. The meeting will normally comprise: the PBAC chair or delegate, who will chair the meeting, and one or more other PBAC members, as appropriate; company representatives; nominees of patient support groups (when appropriate); clinicians (nominated by the relevant professional body); Departmental personnel and the APMA (if requested by the sponsor).

What are the procedures for convening a stakeholder meeting?

  1. Request for a stakeholder meeting

A request to convene a stakeholder meeting may be made by:

  1. the PBAC
  2. the sponsor.

The procedure will depend on which party has requested the meeting as follows:

  1. The PBAC

The PBAC secretariat will notify the sponsor and any key stakeholders at least 10 working days in advance that a stakeholder meeting will be convened, unless otherwise agreed. The PBAC secretariat will state specifically in writing the terms to be considered by the stakeholder meeting. The PBAC will not utilise the stakeholder meetings for any other purpose than to resolve matters raised by the PBAC in its review of the application that has prevented a positive recommendation of the product from occurring. The PBAC will not convene a stakeholder meeting unless it has a reasonable belief that it will resolve issues that prevented a positive recommendation to list the product.

  1. The Sponsor

The Sponsor will send a request to convene a stakeholder meeting to the PBAC Chair and the PBAC secretariat outlining the reasons for such a request, which must demonstrate that the criteria for convening a stakeholder meeting have been met.

The PBAC secretariat will seek to notify the sponsor within 10 working days as to whether the request has been accepted or declined, but if this is not possible (such as when the appropriate PBAC members are overseas), the sponsor will be advised of the reason for this. If the request is declined the PBAC must be able to demonstrate that the criteria for a stakeholder meeting have not been met. If the request is accepted the PBAC secretariat will notify the Sponsor and any key stakeholders at least 10 working days in advance that a stakeholder meeting will be convened.

  1. Meeting Preparation

If a stakeholder meeting is to be convened, the PBAC secretariat will contact the sponsor to seek input and agreement on:

  • items for the Agenda
  • attendees
  • date

The agenda and list of attendees will be agreed to by the PBAC and sponsor and will be made available to all parties at least 5 working days prior to the meeting. The agenda will contain the full reasons for the PBAC not recommending the PBS listing of the product under discussion.

The PBAC Secretariat will ensure that all parties sign confidentiality agreement and conflict of interest forms, prior to the commencement of the meeting.

  1. Documentation

The PBAC secretariat will prepare draft minutes of the meeting as soon as is practicable.

The draft minutes will be circulated to all persons who attended the meeting The parties will have 5 working days to respond. The final minutes will be circulated to all attendees and the full PBAC Committee within a further 5 days after the response deadline. The final minutes will note any areas where one or more of the parties are not able to agree on the detail of what transpired or was agreed at the meeting.