Public consultation for MSAC Draft Framework for the Assessment of Radiopharmaceuticals

Overview

The Medical Services Advisory Committee (MSAC) has developed a Draft Framework for the MSAC assessment of radiopharmaceuticals. 

The purpose of this Framework is to identify the supplementary information requirements to those set out in the Guidelines for preparing assessments for the Medical Services Advisory Committee (“MSAC Guidelines”) to ensure that radiopharmaceuticals to be used within the scope of a proposed MBS item descriptor in an application for a new or amended MBS item are adequately characterised and produced according to accepted standards, in order to be evaluated for clinical (diagnostic or therapeutic) noninferiority against a comparator product or products.

The question of noninferiority of radiopharmaceuticals has arisen in the context of several MSAC applications. For example, there may be a scarcity or lack of evidence to inform the safety and efficacy of a radiopharmaceutical product or products for which a new or amended MBS item descriptor(s) is being proposed, and the applicant may cite evidence for the comparator(s) as the best available evidence on which to base a claim of clinical noninferiority between the two products.

This Draft Framework and MSAC assessment applies for the purpose of MBS listing only.  Applicants must satisfy themselves in relation to the requirements of the Therapeutic Goods Act 1989 and other applicable legislation

How to participate

• The Draft Framework can be downloaded for reading by clicking on the link at the end of this webpage.
• When you are ready to provide your feedback, click on the link to the consultation survey and input your responses directly into the survey. 
• Alternatively if you prefer to provide your feedback through an attachment, there are two ways you can do this. You can send your attachment to CommentsMSAC@Health.gov.au  with the email subject heading "Consultation feedback on Draft Framework for Radiopharmaceuticals" OR proceed to the consultation survey where you can click on the option to upload an attachment after you fill in some details about yourself. If you wish you can also download a Word version of the consultation questions from the links at the bottom of the page to be used as the basis for your attachment. 
• Public consultation must be received by no later than day/date/month/year for it to be considered by the MSAC Working Group. 

   How your submission and information will be used

• Details you provide including identifying information about you or your organisation will be made available in full to a Working Group of MSAC and may be summarised and analysed for review by the Working Group. However your feedback will not be published. 
• Your feedback will be taken into account by MSAC in finalising the Draft Framework.

If you have any questions about this review and its processes please contact the MSAC Secretariat at CommentsMSAC@Health.gov.au 

Privacy notice

Your personal information is protected by law, including the Privacy Act 1988 (Privacy Act) and the Australian Privacy Principles (APPs), and is being collected by the Department, via Citizen Space, for the purposes of conducting a consultation process in relation to the Draft Framework. You can access more information about the way in which the Department will manage your personal information, including our privacy policy, at www.health.gov.au/resources/publications/privacy-policy .