6.8 Additional clinical input

Page last updated: October 2016

Additional information may be sought before or after the PBAC considers a submission.

Before the PBAC consideration, the department, the evaluators or members of the subcommittees may identify issues that would benefit from clarification or further information to improve the PBAC’s consideration of the submission.

The PBAC may also request that the department seeks further information after its consideration of the submission. This could be information for inclusion in a resubmission or to assist the department in ensuring that the recommendation to list the medicine or vaccine clearly identifies the eligible, cost-effective population, and is expressed in a way that is understandable and clinically relevant for prescribers and other health professionals.

In general, the matters for which additional input is sought include:

  • possible barriers to implementation of a restriction
  • quality use of medicines/vaccines
  • public health issues that may be associated with listing a medicine/vaccine, such as increasing antibiotic resistance for medicines
  • system issues that could affect equity and access for PBS-listed medicines
  • clarification with clinical experts about appropriate descriptions for the restriction wording.

The PBAC Secretariat will advise the sponsor if additional information is sought, and from whom. Where the responding organisations or individuals agree to release their information to the sponsor, a copy of the requested information will be provided.

6.8.1   When and from whom additional input is sought

Information is generally sought from relevant representative organisations that the department or the PBAC considers to be best placed to provide timely and accurate advice.

The PBAC and the department are aware that organisations and representative bodies need sufficient time to form an adequate and informative response, and the department seeks to work with these bodies to achieve the best response in the most efficient way. Organisations and representative bodies can request that their responses be treated as confidential, that is, the document will only be circulated as part of the PBAC agenda papers.

Information provided to the PBAC can form part of the PBAC Minutes, the PBAC Outcomes and the Public Summary Document.

 

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